Analysis of indian patent regime in the present biotechnology boom

... making, using, offering for sale, selling or importing for these purposes the patented product This is in conformity with Article 28(1)(a) of the TRIPS Agreement In the case of the grant of a patent. .. from being destroyed by fungal infections The Indian government filed a complaint in the USPTO accusing W.R Grace of copying an Indian invention A complaint was also made to European Patent Office73... the drug controller, and in case the medicine is to be administered orally, the food department 16 The “exclusive privileges” included the rights of making, selling, licensing and using the invention

1 TABLE OF CONTENTS TABLE OF CONTENTS.......................................................................................................................... 1 SUMMARY ................................................................................................................................................ 3 TABLE OF CASES ................................................................................................................................... 4 CHAPTER I: AN OVERVIEW OF TRADITIONAL KNOWLEDGE AND INTELLECTUAL PROPERTY RIGHTS .............................................................................................................................. 6 1.1 INTRODUCTION ................................................................................................................................. 6 1.3 BIOPIRACY...................................................................................................................................... 24 1.3.1 Case Study: Turmeric ............................................................................................................. 27 1.3.2 Case Study: Neem................................................................................................................... 28 1.3.3 Case Study: Basmati............................................................................................................... 31 1.4 APPLICATION OF CONVENTIONAL IPRS ON TRADITIONAL KNOWLEDGE .................................... 36 1.4.1 Patents, TRIPS and traditional knowledge ............................................................................ 37 1.4.2 Other forms of IPRs and traditional knowledge.................................................................... 46 1.5 SOCIAL IMPACT OF PATENTING TRADITIONAL KNOWLEDGE........................................................ 49 1.6 PROTECTION .................................................................................................................................. 52 1.6.1 Methods of Protection ............................................................................................................ 57 CHAPTER II: DEFENSIVE PROTECTION OF TRADITIONAL KNOWLEDGE .................... 60 2.1 INTRODUCTION ............................................................................................................................... 60 2.2 PRIOR ART ..................................................................................................................................... 61 2.2.1 The legal position ................................................................................................................... 62 2.2.2 Recommendations and Conclusion ........................................................................................ 68 2.3 DATABASES ................................................................................................................................... 73 2.3.1 Legal Protection of Databases............................................................................................... 76 2.3.2 Endeavours in India................................................................................................................ 89 2.3.3 Advantages of traditional knowledge databases ................................................................... 93 2.3.4 Criticism of the traditional knowledge databases ................................................................. 93 2.3.5 Recommendations................................................................................................................... 97 2.3.6 Conclusion ............................................................................................................................ 100 2.4 COMPULSORY DISCLOSURE OF ORIGIN ..................................................................................... 103 2.4.1 Challenges in Disclosure of Origin...................................................................................... 113 2.4.2 Conclusion ............................................................................................................................ 116 2.5 PRIOR INFORMED CONSENT ....................................................................................................... 117 2.5.1 Challenges in obtaining PIC ................................................................................................ 124 2.5.2 Case Study: The Jeevani experience .................................................................................... 125 2.5.3 Recommendations and conclusion ....................................................................................... 127 2.6 CONCLUSION ................................................................................................................................ 129 CHAPTER III: POSITIVE PROTECTION OF TRADITIONAL KNOWLEDGE .................... 131 3.1 INTRODUCTION ............................................................................................................................. 131 3.2 SUI GENERIS RIGHTS ................................................................................................................... 131 3.2.1 Sui Generis protection systems-legal sanctions................................................................... 137 3.2.2 Geographical Indications (GI)............................................................................................. 144 3.2.3 Other sui generis Indian Acts............................................................................................... 149 3.2.4 Recommendations and Conclusion ...................................................................................... 160 3.3 ACCESS AND BENEFIT SHARING (ABS) .................................................................................... 163 3.3.1 The Bonn Guidelines ............................................................................................................ 164 3.3.2 Relevant provisions in other Indian Legislation.................................................................. 167 3.3.3 Indian benefit sharing instance ............................................................................................ 169 3.3.4 Suggestions and conclusion.................................................................................................. 170 2 3.4 GLOBAL BIOCOLLECTING SOCIETY (GBS) ............................................................................... 172 3.4.1 GBS in India ......................................................................................................................... 177 3.4.2 Conclusion ............................................................................................................................ 180 3.5 CONCLUSION ................................................................................................................................ 181 CHAPTER IV: PATENTABILITY OF MODERN BIOTECHNOLOGY INVENTIONS IN INDIA...................................................................................................................................................... 183 4.1 INTRODUCTION ............................................................................................................................. 183 4.1.1 Classification of modern biotechnology .............................................................................. 185 4.2 DIAMOND V. CHAKRABARTY ....................................................................................................... 188 4.3 RELAXIN ....................................................................................................................................... 193 4.4 ONCOMOUSE ................................................................................................................................ 196 4.5 ETHICAL ISSUES OF BIOTECHNOLOGY PATENTING IN INDIA ...................................................... 202 4.5.1 India and Article 27(3)(b) .................................................................................................... 203 4.6 INDIA’S PATENT POLICY PRIOR TO TRIPS AND SUBSEQUENT DRIVERS FOR CHANGE .............. 210 4.7 PATENT (AMENDMENT) ACT 2005 ............................................................................................. 218 CHAPTER V: CONCLUDING OBSERVATIONS.......................................................................... 224 BIBLIOGRAPHY.................................................................................................................................. 232 3 Summary The Truman declaration divided the world into the “developed” and “underdeveloped”. Save those living in USA, Europe, Japan and few other countries, most human beings became citizens of the Underdeveloped World as the wholesale march towards development, Western style, became the mantra for progress that was almost entirely indifferent to nature. The ensuing large-scale environmental disorders have brought this Baconian model of growth and development to the brink. It has also provided a fresh opportunity for traditional knowledge, culture and wisdom to come to the forefront of decision-making by consumer sectors. India, with its rich repertoire of such a traditional knowledge base, has a definite edge while preparing its own roadmap for sustainable development and poverty alleviation. Wizening from biopiracy episodes and for promoting investment in biotechnology, the Indian government has spruced up the patent legislation. The instant thesis highlights the efficacy of the methods of protecting traditional knowledge and analyses the new provisions introduced in Indian statute laws for preservation and promotion of traditional technology and encouragement for investment in modern biotechnology. It is seen that while there has been movement in enactment of legislation, there are latches and ambiguities which need to be clarified. The problems of unclear definitions, overlapping and sometimes contradictory provisions in the new laws, when rectified, would lead to stronger protection for traditional knowledge and genetic resources, and a generally more robust patent regime in India. 4 TABLE OF CASES CASE PAGE Basmati patent case 30 Bellsouth Advertising & Publishing Corp v. Donnelly Information Publishing Inc and another 999 F2d 1436 (11th Cir. 1993) 1445 77 Blacklock v. Pearson [1915] 2 Ch. 376 37 British Horseracing Board Ltd v William Hill Organisation Ltd Case C203/02 Burlington Home Shopping v. Rajnish Chibber 1995 PTC (15) 278 82 Catnic Components Ltd and Another v. Hill & Smith Ltd. [1982] RPC 183 70 CCH Canadian Ltd. v. Law Society of Upper Canada [2004] S.C.C. 13 85 Commissioner of Patents v. President and Fellows of Harvard College and Ors. 2002 SCC 76 187,196 Diamond v. Chakrabarty 447 U.S. 303 (1980) 84 43,187,188 Dimminaco AG v. Controller of Patents and Designs. & Others,(Aid No.1 of 2002) 191,205 Eastern Book Company v. Navin J. Desai A.I.R. 2001 Delhi 185. 85,102 Feist Publications v. Rural Telephone Service 499 US 340, 113 L Ed 2d 358, 11 S Ct 1282 (1991) 77,80,102 Fomento Industrial S.A. Biro Swan Ltd. v. Mentmore Mfg. Co. Ltd. (1956) RPC 87 65,66 Foster v. Mountford (1976) 29 FLR 233 47,69 Himalaya Drug Company v. Sumit Suit No.S-1719 of 2000 88,102 Howard Florey /Relaxin [1995] EPOR 541 187,193 Improver Corporation v. Remington Consumer Products Ltd [1990] FSR 181 70 Institute National Des Appellations v. Brown-Forman Corp., 47 USPQ2d 1875, (TTAB 1998) 145 Kelly v. Morris (1866) L.R. 1 Eq. 697 37 5 Lallubhai Chakubhai v. Chimanlal & Co. (1935) A.I.R. 1936 Bombay 99 65 Matthew Binder & Co. v. West Publishing Co. (158 F.3d 674, 48 U.S.P.Q. 2d (BNA) 1560 (2d Cir. 1998); 158 F. 3d 693, 48 U.S.P.Q. 2d (BNA) 1545 (Cir.1998) 77 Merck & Co Inc v. Pharmaforte Singapore Pte Ltd, [2000] 3 SLR 717 70 Merrell Dow Pharmaceuticals Inc.v. H N Norton & Co. [1996] R.P.C. 76, HL 12 Monsanto Canada Inc. v. Schmeiser, [2004] 1 S.C.R. 902, 2004 SCC 34 (CanLII) 52,199 Moore v. Regents of the University of California 793 P.2d 479 204 Mother's Restaurant v. Mother's Other Kitchen, Inc., 218 U.S.P.Q. 1046 (TTAB 1983) 33 Neem patent case 98,62,71 Plant Genetic Systems/Glutamine Synthetase Inhibitors (T356/93) [1995] E.P.O.R. 357 203 P.L.G. Research Ltd. v. Ardon International Ltd. [1993] F.S.R. 197 64 Scotch Whiskey Association v. Pravara Sakhar Shakar Karkhana Ltd A.I.R. 1992 Bombay 294 147 Societe Technique De Pulverisation Step v. Emson Europe (1993) RPC 513 (CA) 70 Telstra Corporation Limited v. Desktop Marketing Systems Pty Ltd [2001] 51 I.P.R. 257 80 Turmeric patent case 26 University of London Press v. University Tutorial Press [1916] 2 Ch. 601 81 Warren Publishing Inc. v. Microdos Data Corp and others (522 US 963 (1997)) 77 V.Govindan v. E.M.Gopalakrishna and Anr AIR 1955 Madras 391 84 6 CHAPTER I: KNOWLEDGE RIGHTS AN OVERVIEW OF TRADITIONAL AND INTELLECTUAL PROPERTY 1.1 INTRODUCTION The Egyptian rulers, during their imperial expeditions were known to bring back exotic foliage from different nations with them. One of the earliest recorded plant hunting expeditions took place 5000 years ago when Pharaoh Sankhkara sent ships to Gulf of Aden to collect cinnamon and cassia used for embalming the dead.1 The recent years witnessed a different form of trade in foliage and genetic material. Farnsworth, the distinguished pharmacognosist, indicated that in 1980 a quarter of the prescriptions dispensed from community pharmacies in the United States2 contained active principles from the higher plants.3 Rapid growth of new technologies in genetic engineering and biotechnology has led to an increased commercial interest in the wealth of biological resources and the traditional knowledge of developing nations. India has been one of the world’s biologically and culturally diverse countries.4 India is also one of the most advanced developing countries in terms of scientific capabilities, including the life sciences.5 She is the only developing country to appear 1 JUMA CALESTOUS, THE GENE HUNTERS: BIOTECHNOLOGY AND THE SCRAMBLE FOR SEED, (1989) 38. 2 Hereinafter referred to as US. 3 N.R. FARNSWORTH, Pharmaceutical Technology, (August 1995) 14. 4 India is one of the 12-mega diverse countries of the world. With only 2.5% of the land area, India already accounts for 7.8% of the global recorded species. India is also rich in traditional and indigenous knowledge, both coded and informal. See, National Biodiversity Authority website at < http://www.nbaindia.org> (last accessed on 5 July 2005). 5 According to Lall, India had 869,000 tertiary-level students of natural sciences in 1990. S LALL, Technological Change and Industrialization in the Asian Newly Industrializing Economies: Achievements and Challenges, in TECHNOLOGY, LEARNING AND INNOVATION: EXPERIENCES OF NEWLY INDUSTRIALIZING ECONOMIES: ACHIEVEMENTS AND CHALLENGES (L. Kim & R. Nelson eds., 1990) 13-68 at 44. 7 in a survey of top ten countries for industrial literature citations.6 Although India has developed research capabilities in a broad range of biotechnologies and biotechnology applications,7 awareness about intellectual property rights has historically been poor in India. The developed countries have complained that intellectual property rights8 protection is weak in India, thereby deterring them from investing in research there.9 However, the last decade has been the era of activity in the field of intellectual property rights in the country. After the ratification of the Agreement on Trade Related Aspects of Intellectual Property Rights,10 there have been three amendments to the Indian Patent Act of 1970. In a bid to protect the vast traditional knowledge and related genetic resources, provisions have been introduced in the Indian Patent Act, and further Acts 6 P K B MENON, Development of New Generic Technologies in India, in NEW GENERIC TECHNOLOGIES IN DEVELOPING COUNTRIES (M R Bhagavan ed., 1997) 99. 7 In fact Ranbaxy, an Indian pharmaceutical company, has sued Novartis on its own turf, in United States. For further discussion see Section 4.1 Chapter IV of the thesis. 8 Hereinafter also referred to as IPR / IPRs. 9 The Indian press had highlighted the findings of the recent World Bank Development Report, which claims that "at least 25 per cent of global chemical and pharmaceutical companies are unwilling to invest in India as the protection offered to intellectual property rights (IPR) by New Delhi is too inadequate to allow them to transfer the latest and effective technologies." Source: The Hindu Business Line, Mumbai, October 5, 1998, 9. 10 Agreement on Trade Related Aspects of Intellectual Property Rights (hereinafter referred to as TRIPS ): The final round of the multilateral trade negotiations which had commenced at Uruguay culminated at the Marrakesh Ministerial held at Marrakesh, Morocco in December 1993 with the establishment of the World Trade Organization (WTO). To standardize the IPR regimes, the members of the WTO signed the multilateral agreement Trade-Related Aspects of Intellectual Property Rights (TRIPS) in the same ministerial. The TRIPS aimed to achieve a global intellectual property rights regime through the following methods: -the broadening of existing rights; -the creation of new (sui generis) rights;-the progressive standardization of the basic features of IPR. TRIPS efforts toward harmonizing the IP regimes in the member states are evident through its various articles. By Article 3, the members accepted the principle of ‘National Treatment’ whereby each member state is required to provide similar IP protection to the right holders irrespective of their nationality. Article 4 lays down the ‘Most Favoured Nation’ principle whereby any favour or concession granted by a state to any other state should be extended to all the other member states of the WTO. It is presently the most relevant treaty on global IPR regimes. A detailed discussion is available inter alias at Chapter IV. 8 have been legislated. The present thesis is a study of the current patent scenario in India. The major concern India has shared with some of the biodiverse developing nations is the protection of traditional knowledge. Not only are these issues of concerns within hard intellectual property law, but also raise important development and social issues as Convention on Biological Diversity demonstrates. In Chapter I of the thesis, definitions and classifications of traditional knowledge have been stated. Subsequently instances of disputes regarding unauthorized exploitation of genetic resources and associated traditional knowledge have been discussed. This is followed by a comprehensive study of the impact of patenting traditional knowledge; the suitability of standard intellectual property11 laws to protect traditional knowledge and positive and defensive methods of protecting traditional knowledge. Chapter II begins with an analysis of the problems of having a non uniform definition of “prior art” for assessing the novelty of an invention. This is followed by discussions on traditional knowledge databases and India’s efforts to establish such databases; and; compulsory disclosure of origin and prior informed consent as two defensive methods for protecting traditional knowledge and India’s initiatives in these regards. Chapter III discusses positive protections to traditional knowledge: developing sui generis rights for traditional knowledge, access and benefit sharing provisions between the traditional knowledge holders and the bio prospectors with an Indian 11 Hereinafter also referred to as IP. 9 example of benefit sharing with Kani tribe and finally the efficacy of establishment of Global Bio-collecting Society, suggested by Peter Drahos, in the Indian context. Aside from protecting traditional knowledge and taking into account interests of indigenious people, India aspires to participate in modern day biotechnology of food and medicines. Chapter IV deals with some issues relating to the modern biotechnological inventions and India’s probable position in case of patenting of third generation biotechnology inventions. It concludes with a brief overview of the relevant changes in the Patent (Amendment) Act 2005. Evolution of Patent Act in India According to W.R.Cornish, “Patents are rights granted in respect of inventions, i.e. technological improvements, great and small, which contain at least some scintilla of inventiveness over what is known”.12 It has a prohibitive tenor as well.13 Patent precludes anybody but the inventor or his authorized person to use the patented invention without the inventor’s permission or without paying royalty to the inventor.14 Like other proprietary rights, a patent allows the patent-holder to exercise 12 WILLIAM CORNISH & DAVID LLEWELEYN, INTELLECTUAL PROPERTY: PATENTS, COPYRIGHTS, TRADEMARKS AND ALLIED RIGHTS, (5th ed. 2003) ¶ 1-05. 13 A literal translation of the Latin litterae patents, letters patent referred to open letters or official documents by which certain privileges, rights, ranks or titles were conferred by sovereign rulers. Letters patent were first issued in the sixth century in Europe for discovery and conquest of foreign lands on their behalf. This has prompted them to be called instruments of “colonization” by Vandana Shiva, a noted scholar and environmentalist in India. See, Nic Paget-Clarke, An Interview with Dr. Shiva, at < http://www.inmotionmagazine.com/shiva.html > (last accessed 3 August 2004). 14 Patent is “The right which they accord is to prevent all others—not just imitators, but even independent devisers of the same idea—from using the invention for the duration of the patent”. See, supra note 12. 10 monopoly over his property, the invention, for a stipulated period subject to the restrictions imposed by the other laws of the land.15 The first legislative enactment on patents in India granting “exclusive privileges”16 to inventors for a period of 14 years was Act VI of 1856. The Indian Patents and Designs Act of 1911 repealed all the previous pieces of legislation regarding patents in India. During 1911 and 1970, in bids to improvise patent legislation, various amendments were introduced. In 1957, Government of India set up the Ayyangar Committee under Justice Rajagopala Ayyangar for suggestions regarding revision of patent law. Justice Ayyangar submitted his report in 1959, which, overcoming various impediments developed into the Patents Act, 1970, the present statute on patents in India. The Act, along with Patent Rules came into force on 20th April 1972. India joined World Trade Organization17 in 1994 and TRIPS Agreement was promulgated in 1995. In July 1996, US initiated WTO dispute settlement procedures over India's failure to implement its TRIPS obligations, namely setting up of mailbox facilities and granting Exclusive Marketing Rights.18 The European Union19 made a 15 For instance, the owner of a patent of a new medicine can not market the medicine without appropriate permissions from other authorities, namely, the drug controller, and in case the medicine is to be administered orally, the food department. 16 The “exclusive privileges” included the rights of making, selling, licensing and using the invention in India for a period of 14 years. The Act of 1856 was modified and re-enacted as Act XV of 1859. This Act was followed by the Patterns and Designs Protection Act, 1872 and Protection of Inventions Act in 1883. These two Acts were further modified by the Inventions and Designs Act of 1888. 17 World Trade Organization (also and hereinafter referred to as WTO): The World Trade Organization is an international body overseeing trade agreements among its 148 member states. Established in 1995, after a series of trade negotiations, the WTO functions as a forum for discussing existing and new trade rules and as a dispute settlement body among the member states. More about WTO can be found in the official home page at < http://www.wto.int > (last accessed 3 October 2005). 18 TRIPS Article 70.8 (mailbox provision) requires a country such as India, which did not provide product patent protection to pharmaceutical products on January 1, 1995, to establish, starting on that date, a system that will permit innovators to file patent applications for such products. In addition, once the conditions of Article 70.9 are met, the product that is the subject of the patent application that was registered in the mailbox will be granted "exclusive marketing rights" if it was not yet patentable. Exclusive marketing rights are also, and hereinafter in the thesis referred to as EMRs. 11 similar complaint on 1st April 1997. The final panel report on this case was issued in August 1997 wherein it was held that India had failed to meet her obligations under the TRIPS. In 1998, India joined the Patent Co-operation Treaty20, and a chapter was added to Patent Rules 1972 providing for filing of international patent applications in India under the PCT. To comply with the WTO ruling, The Patent (Amendment) Act 1999 was passed in March 1999, including Exclusive Marketing Rights21 and establishing a mailbox to receive foreign patent applications.22 Subsequently the Patent Act was amended in 200223 and 2004.24 The Patents Amendment Act 2005, Article 70.8, TRIPS: Where a Member does not make available as of the date of entry into force of the WTO Agreement patent protection for pharmaceutical and agricultural chemical products commensurate with its obligations under Article 27, that Member shall: (a) notwithstanding the provisions of Part VI, provide as from the date of entry into force of the WTO Agreement a means by which applications for patents for such inventions can be filed; (b) apply to these applications, as of the date of application of this Agreement, the criteria for patentability as laid down in this Agreement as if those criteria were being applied on the date of filing in that Member or, where priority is available and claimed, the priority date of the application; and (c) provide patent protection in accordance with this Agreement as from the grant of the patent and for the remainder of the patent term, counted from the filing date in accordance with Article 33 of this Agreement, for those of these applications that meet the criteria for protection referred to in sub paragraph (b). 19 Hereinafter also referred to as EU. 20 Patent Cooperation Treaty (hereinafter referred to as PCT): The Patent Cooperation Treaty is a multilateral agreement that provides for filing of an international application when protection is sought for an invention in several countries. The Treaty was concluded in 1970, amended in 1979, and modified in 1984 and 2001. The membership to the Treaty is open to the Paris Convention member countries. As per Article 3, patent aspirants of contracting states of PCT can simultaneously obtain priority for their inventions without having to file separate application in their countries of interest. In addition the system provides much longer time for filing patent application in member countries. The time available under Paris Convention for securing priority in other countries is 12 months from the date of initial filing. Under the PCT, the time available could be as per Article 22(1), maximum 30 months. Further, an inventor is also benefited by the search report prepared under the PCT system to be sure that the claimed invention is novel. As per Article 31, the inventor can also opt for preliminary examination before filing in other countries to be doubly sure about the patentability of the invention. The text of the Treaty is at < http://www.wipo.int/pct/en/texts/pdf/pct.pdf > (last accessed 1 September 2005). 21 Also known as EMRs. 22 The Patent (Amendment) Ordinance was passed in January 1999, which became an Act in March 1999. Chapter IVA Sections 24A-D of the Patents Amendment Act 1999 provided for EMRs. 23 As per Section 48(a) of the Indian Patents Act, 1970 as amended in 2002 a patent confers on the owner the exclusive right by himself, his agents, assignees or licensees to prevent any third party, without explicit authorization, from making, using, offering for sale, selling or importing for these purposes the patented product. This is in conformity with Article 28(1)(a) of the TRIPS Agreement. In the case of the grant of a patent for a method or process of manufacture, this right extends to the ‘product obtained directly by the patented process. See, Section 48(b), the Patents act, 1970 as amended in 2002. This is in conformity with Article 28(1)(b) of TRIPS. 24 Sources: P.NARAYANAN, INTELLECTUAL PROPERTY LAW, (3rd ed., 1998), 9-15; RAJIV JAIN & RAKHEE BISWAS, LAW OF PATENTS, (2d ed. 1999), 1.1 - 1.10. 12 amending the Patent Act of 1970, has been passed by the Upper House of the Indian Parliament and is now the Act in force for patents in India.25 1.2 Traditional knowledge About 80 percent of the world’s population relies on traditional medicines in some way. 26 Reliance may be due to the costs or cultural choice. Traditional biotechnological knowledge has developed among the indigenous community and has been disseminated by the traditional medical practitioners to the incumbents. Its present importance is twofold. First, it is estimated that over one-third of the world’s population lacks regular access to affordable essential drugs. Traditional medicine is widely available, accessible and affordable to most people. It is still a widely practiced way of medical treatment in various parts of the world. Second, the high possibility of future drugs being based on traditional plant remedies is in large part rooted in the fact that precedents exist in the discovery of aspirin, antibiotics and quinine.26 There have been various attempts subsequently to 25 Patent Amendment Ordinance 2004 was passed by the Indian Parliament on 26 December 2004. The Ordinance was ratified into an Act by the Parliament on 24 March 2005. See, Patent Legislation Passed, March 2005, at < http://www.cptech.org/ip/health/c/india/patents-act-amendments.html > (last accessed on 19 September 2005). 26 Lord Hoffman summarises the procedure behind the discovery from drugs from natural ingredients. In the judgement in the case of Merrell Dow v. Norton, his Lordship wrote, “The Amazonian Indians have known for centuries that cinchona bark can be used to treat malaria and other fevers. They used it in a form of powdered bark. In 1820, French scientists discovered that the active ingredient, an alkaloid called quinine, could be extracted and could be used more effectively in the form of sulphate of quinine. In 1944, the structure of alkaloid molecule (C20H24N2O2) was discovered. This meant that the substance could be synthesized. Imagine a scientist telling an Amazonian Indian about the discoveries of 1820 and 1944. He says: “We have found the reason why the bark is good for fevers is that it contains an alkaloid with a rather complicated chemical structure which reacts with the red corpuscles in the bloodstream. It is called quinine.” The Indian replies: “That is very interesting. In my tribe, we 13 manufacture drugs from natural ingredients on the basis of information based on traditional knowledge. The following two tables illustrate some relevant figures.27 Global Sales for Products Derived from Genetic Resources, 1997 (USD in billion)28 Product USDbn Botanical medicines 20+ Ornamental horticultural produce 16-19 Agriculture produce 300-450+ Commercial agricultural seed 30 The following table shows the total global gross sales in these industries and the component of product sales that are of natural origin. Estimated Global sales in the Pharmaceutical, Personal Care and Cosmetics, And Crop Protection Industries, and Component of Products derived from Genetic Resources, 1997 (USD bn) Product USD bn Pharmaceuticals 300 Personal care and cosmetics 55 Crop protection 30 Sales of natural origin (USD bn) 75(using a conservative 25%) 2.8+ 0.6-3 The highest seller in the aforesaid tables, traditional pharmaceutical products, falls under the genus of traditional knowledge which includes other forms of knowledge call it the magic spirit of the bark.” ” He held that if a particular usage of a substance was known, nonidentification of the active ingredient causing the particular usage would not prevent it from forming part of prior art. Merrell Dow v. H N Norton & Co. [1996] R.P.C. 76, HL. 27 The tables have been cited from: KERRY TEN KATE & SARAH A LAIRD, THE COMMERCIAL USE OF BIODIVERSITY: ACCESS TO GENETIC RESOURCES AND BENEFIT SHARING, (Repr. ed., 2000) 315. 28 The aforesaid figures relate to certain products which are solely derived from genetic resources. There are some products which could have been produced using various components not involving genetic resources. Only a proportion of these products are derived from genetic resources. 14 like folklore and trade secrets. For protecting traditional knowledge, it is necessary to devise a definition of the knowledge that would be protected under this category. Some endeavours regarding defining traditional knowledge are being enumerated in the following discussion.29 Blakeney30 has said that the intellectual creations of the traditional communities were initially classified as “folklore”. Subsequently World Intellectual Property Organization,31 and United Nations Educational, Scientific and Cultural Organization,32 convened a ‘Group of Experts on the Protection of Expressions of Folklore by Intellectual Property’ who discussed the appropriate terminologies in this context. In the meeting held in Paris in December, 1984, objection to the use of the 29 Singapore, for instance, noted that the fact that there was no clear consensus as to the specific scope of traditional knowledge hindered discussions regarding commitments is this area. Singapore position on TRIPs: Non-Paper by Singapore, Council for Trade-Related Aspects of Intellectual Property Rights, JOB(00)/7853, 11 December 2000. Also see The CIPR (Commission of Intellectual Property Rights) Report of September, 2002. The CIPR has held that there is no widely accepted definition of traditional knowledge. It is a combination of a wide range of concerns and objectives. CIPR, Integrating Intellectual Property Rights and Development Policy, Report of the Commission of Intellectual Property Rights, September 2002, 75, 78. 30 Michael Blakeney; The Protection of Traditional Knowledge under Intellectual Property Law, [2000] E.I.P.R., 251. 31 World Intellectual Property Organization (commonly known as and hereinafter referred to as WIPO in the instant thesis) is one of the 16 specialized agencies of the United Nations system of organizations dealing with the promotion and protection of intellectual property. Based in Geneva it was established under a treaty, “ The Convention Establishing the World Intellectual Property Organization of July 14, 1967” It operates under United Nations Education, Scientific and Cultural Organization (UNESCO) and entered into force in 1970. The treaty was subsequently amended in 1979 and 2000. At present it has 183 signatories. See, G.GREGORY LETTERMAN, BASICS OF INTERNATIONAL INTELLECTUAL PROPERTY LAW, (2001) 26-27. Also see, About WIPO, at http://www.wipo.int/about-wipo/en/overview.html ( last accessed on 22 July 2005) and Member States, at http://www.wipo.int/members/en/ ( last accessed on 25 April 2006). 32 United Nations Educational, Scientific and Cultural Organization (commonly known as and hereinafter referred to as UNESCO in the instant thesis) is an agency under the United Nations. It was estbalished in 1946 and is headquartered in Paris, France, with over 50 field offices and several institutes and centres throughout the world. The Organization’s main objective is to contribute to peace and security by promoting collaboration among the nations through education, science and culture in order to further universal respect for justice, for the rule of law and for the human rights and fundamental freedoms (Article 1 of UNESCO’s Constitution). 191 nations belong to UNESCO. UNESCO pursues its action through five major programmes: education, natural sciences, social & human sciences, culture and communication & information. Projects sponsored by UNESCO include literacy, technical, and teacher-training programmes; international science programmes; regional and cultural history projects, the promotion of cultural diversity; international cooperation agreements to secure the world’s cultural and natural heritage and to preserve human rights. More about the organization can be found at the UNESCO website at www.unesco.org (last accessed on 3 July 2005). 15 term “folklore” was raised on the ground that the term implied “a negative connotation of being associated with the creations of lower or superseded civilizations”.33 However, the objections being superseded, the 1985 meeting provided an inclusive definition for “Expressions of Folklore” which read as follows: “(…) “expressions of folklore” mean productions consisting of characteristic elements of the traditional artistic heritage developed and maintained by a community, or by individuals reflecting the traditional artistic heritage developed and maintained by a community, in particular: (i) verbal expressions, such as folk tales, folk poetry and riddles; (ii) musical expressions, such as folk songs and instrumental music; (iii) expressions by action, such as folk dances, plays and artistic forms or rituals, whether or not reduced to a material form; and (iv) tangible expressions, such as (a) production of folk art, in particular, drawings, paintings, carvings, sculptures, pottery, terracotta, mosaic, woodwork, metalware, jewellery, basket weaving, needlework, textiles, carpets, costumes; (b) musical instruments; (c) architectural forms.”34 This terminological approach was the subject of an in-depth discussion at the World Forum on the Protection of Folklore, convened by WIPO and UNESCO in Phuket, Thailand in April 1997.35 The aforesaid definitions had remained functional till 33 “Report”, Copyright: Monthly Review of the World Intellectual Property Organization, 1985, 41, ¶ 22. 34 Id. at 47-48. 35 The Forum was convened in response to the recommendations in February 1996 of the WIPO Committee of Experts that arrangements be made for the organization of an international forum to 16 objections to the use of the term “folklore” for referring to all indigenous knowledge were raised at the above conference. It was pointed out that the definition failed to include all aspects of life of the indigenous people, including their scientific knowledge.36 The term “traditional knowledge” was coined to address the lapses of the term “folklore”. A major distinction was that, folklore, chiefly dealing with artistic expressions, is discussed in terms of copyright protection, while traditional knowledge, involving scientific knowledge including inventions, is considered in terms of other form of intellectual property protection, particularly patents.37 Attempts to define traditional knowledge have been made by various international conventions. The various conventions have used the terms ‘traditional knowledge’ and ‘indigenous knowledge’ in different contexts. Significant work has been done on this subject by WIPO in response to the need for greater clarity in respect of terminology and the subject matter covered under it.38 The WIPO Secretariat made explore “issues concerning the preservation and protection of expressions of folklore, intellectual property aspects of folklore and the harmonization of different regional interests”. 36 Unesco-WIPO World Forum on the Protection of Folklore, UNESCO/WIPO/FOLK/PKT/97/1,March 17, 1997 at < http://www.ompi.int/meetings/en/details.jsp?meeting_id=3074 > (last accessed on 3 June 2004). 37 Blakeney, supra note 30 at 252. 38 Discussions regarding selecting suitable terminologies were held by the Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional knowledge and Folklore in their preliminary meetings. WIPO established the Intergovernmental Committee (IGC) on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore in October 2000 to discuss and debate issues relating to traditional knowledge, genetic resources and folklore. Along with the WIPO members, independent bodies and non-governmental organizations can also participate in the IGC proceedings as observers. The functions of the IGC include policy debate, reports on national experiences, empirical surveys, exchange of experience of indigenous and local communities, analysis of legal and policy options for enhanced protection of traditional knowledge, crafting specific practical tools, development of recommendations for revision of the international patent system to take account of traditional knowledge, and capacity building and awareness initiatives. The IGC has met 8 times since inception, the last meeting being in Geneva in June 2005. More about the IGC can be found at the WIPO website, at < http://www.wipo.int/tk/en/igc > (last accessed on 24 June 2005). Also see, < WIPO/GRTKF/IC/3/9, at http://wipo.int/traditionalknowledge/report > last accessed on 24 June 2005). 17 use of the following working concept of ‘traditional knowledge’ for the purposes of the fact-finding missions in 1998-1999:39 “Traditional Knowledge’ … refer[s] to tradition-based literary, artistic or scientific works; performances; inventions; scientific discoveries; designs; marks, names and symbols; undisclosed information; and all other tradition-based innovations and creations resulting from intellectual activity in the industrial, scientific, literary or artistic fields”. This definition further explains that “tradition-based” refers to “knowledge systems, creations, innovations and cultural expressions which have generally been transmitted from generation to generation; are generally regarded as pertaining to a particular people or its territory; and, are constantly evolving in response to a changing environment.” The Convention on Biological Diversity40 has provided an alternative description of traditional knowledge in its provisions. Article 8(j) of the CBD provides for each 39 Inter-Governmental Committee on Intellectual Property and Genetic Resources, Traditional knowledge and Folklore, at < http://www.wipo.int/documents/en/meetings/2002/igc/doc/grtraditionalknowledgefic3_9.doc> (last accessed on 13 December 2004). 40 The Convention on Biological Diversity (commonly known as and hereinafter referred to as CBD in the instant thesis) entered into force on 29 December 1993. It is the outcome of the Earth Summit in Rio de Janeiro, Brazil in 1992. It contains three national level obligations: to conserve, to sustainably use, and to share the benefits of biological diversity. Other aspects of biodiversity such as in situ and ex situ conservation of wild and domesticated species; access to genetic resources and technology, including biotechnology; new and additional financial resources, and safety of release or experimentation on genetically-modified organisms, also known as bio-safety were included in the convention. Parties to the Biodiversity Treaty “affirm sovereign rights over the biological resources found within their countries, while accepting responsibility for conserving biological diversity and using biological resources in a sustainable manner,” according to an International Union for the Conservation of Nature (IUCN) assessment of the treaty. The treaty, in its article on objectives, commits Parties to “fair and equitable sharing of the benefits arising out of the utilization of genetic resources.” Other Articles of the Convention discuss Access to Genetic Resources, Access to and Transfer of Technology, and Handling of Biotechnology and Distribution of its Benefits. India has been a member of the treaty since 1994. For full text see CBD website, at (last accessed on 4 September 2005). 18 contracting party to incorporate in its domestic legislation, the following definition of traditional knowledge: “(…) knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles (…)”.41 CBD explains that traditional knowledge has “[d]eveloped form experience and gained over the centuries and adapted to the local culture and environment, traditional knowledge is transmitted orally form generation to generation.”42 Characterizing traditional knowledge, CBD states, “it [traditional knowledge] tends to be collectively owned and takes the form of stories, songs, folklore, proverbs, cultural values, beliefs, rituals, community laws, local language, and agricultural practices, including the development of plant species and animal breeds.” CBD, in a separate document, has qualified “traditional knowledge” to be a “term used to describe a body of knowledge built by a group of people through generations living in close contact with nature. It includes a system of classification, a set of empirical observations about the local environment, and a system of self-management that governs resource use (…). In the context of knowledge, innovation is a feature of indigenous and local communities whereby tradition acts as a filter through which innovation occurs. In this context, it is traditional methods of research and application and not always particular pieces of knowledge that persist. Practices should therefore be seen as the manifestations of knowledge and innovation”.43 41 Convention of Biological Diversity, Article 8(j): Traditional Knowledge, Innovations and Practices: Introduction, at < http://www.biodiv.org/programmes/socio-eco/traditional/default.asp > (last accessed on 4 September, 2005). 42 id. 43 Convention of Biological Diversity, Traditional Knowledge And Biological Diversity: Note by the Executive Secretary, UNEP/CBD/TKBD/1/2, Hague, 18 October 1997, ¶¶ 84, 86. 19 It should be kept in mind that WIPO and CBD have different accents. While the former strives to promote “simpler, cheaper and more secure” intellectual property protection throughout the world,44 the later aims to achieve conservation and sustainable development of world biodiversity.45 The definition of WIPO has a comparatively wider scope as it explicitly recognizes that traditional knowledge is “constantly evolving”46. The UNESCO and the WTO have offered other significant definitions of traditional knowledge. These are: • “The traditional knowledge and expressions of indigenous cultures are defined as the ways in which indigenous cultures are expressed and which are manifestations of worldviews of the indigenous peoples of the Pacific. Traditional knowledge and cultural expressions are any knowledge or any expressions created, acquired and inspired (applied, inherent or abstract) for the physical and spiritual well-being of the indigenous peoples of the Pacific. The nature and use of such knowledge and expressions are transmitted from one generation to the next to enhance, safeguard and perpetuate the identity, well-being and rights of the indigenous peoples of the Pacific”.47 44 World Intellectual Property Organization, WIPO’s Vision, at < http://www.wipo.int/aboutwipo/en/dgo/pub487.htm > (last accessed on 3 September 2004). 45 Convention of Biological Diversity, Sustaining Life on Earth: How the Convention on Biological Diversity promotes nature and human well-being , at < http://www.biodiv.org/doc/publications/guide.asp > (last accessed on 3 September 2004). 46 World Intellectual Property Organisation, Inter-Governmental Committee on Intellectual Property and Genetic Resources, Traditional knowledge and Folklore, at < http://www.wipo.int/documents/en/meetings/2002/igc/doc/grtraditional knowledgefic3_9.doc > (last accessed on 15 August 2004). 47 UNESCO Symposium on the Protection of Traditional knowledge and Expressions of Indigenous Cultures in the Pacific Islands, Noumea, 15-17 February 1999: Final Declaration, at (last accessed on 3 September 2004). 20 • “Traditional knowledge consists largely of innovations, creations and cultural expressions generated or preserved by its present possessors, who may be defined and identified as individuals or whole communities, natural or legal persons, who are holders of rights. The economic, commercial and cultural value of this traditional knowledge for its possessors warrants and justifies a legitimate interest that this knowledge be recognized as a subject matter of intellectual property”.48 “Indigenous knowledge” is either used to describe knowledge held and used by communities, peoples and nations that are indigenous, or to denote knowledge which is itself indigenous, in the sense of specifically originating in a certain region or country, that is, “indigenous means belonging to, or specific to, a particular place”.49 Whichever sense of ‘indigenous knowledge’ is used, the general usage seems to suggest that all indigenous knowledge is traditional knowledge, although it is likely that some traditional knowledge may not have the specific characteristic of being “indigenous”.50 There are again several definitions for the term “indigenous people”, but essentially the term refers to people who characteristically exist under “conditions of severe disadvantage relative to others within the states constructed around them.”51 A distinction between traditional knowledge and indigenous knowledge may be drawn from the example of the codified forms of one of the traditional knowledge 48 World Trade Organization, Proposal on Protection of the Intellectual Property Rights Relating to the Traditional knowledge of Local and Indigenous Communities: Communication from Bolivia, Colombia, Ecuador, Nicaragua, and Peru, WT/GC/W/362, WTO, Geneva, 12 October 1999. 49 Graham Dutfield , Comment on the Draft WIPO Report on Fact-finding Missions on Intellectual Property and Traditional Knowledge: Intellectual Property Needs and Expectations of Traditional Knowledge Holders (1998-1999) dated December 12, 2000 at < http://www.wipo.int/tk/en/tk/ffm/ffmreport-comments/msg00016.html > (last accessed on 3 September 2004). 50 J. Mugabe, “Intellectual Property Protection and Traditional Knowledge,” Intellectual Property and Human Rights (WIPO, 1999), 97 at 98-99. 51 See, S. JAMES ANAYA, INDIGENOUS PEOPLES IN INTERNATIONAL LAW, (1996) 3. 21 systems in India, the Ayurveda52. The word is a combination of the two Sanskrit words “Ayu” and “Veda”. The word “Ayu” would mean “life”, (in the sense of living span) while “Veda” refers to the knowledge. Crudely translated, the word would mean “the knowledge for long life”. This is a classical codified medical system and is not folk or developed by indigenous people. Thus traditional medical knowledge system would not be synonymous to an indigenous knowledge or folk knowledge. Hence while all indigenous knowledge is traditional, not all traditional knowledge is indigenous. Dutfield, in his comments on the Draft Report says that “‘Indigenous’ means belonging to, or specific to, a particular place.”53 It is in this sense that the term ‘indigenous knowledge” is used in the instant thesis. Some have objected to the use of the word ‘traditional’ and have preferred the word ‘customary’ while referring to such knowledge. It has been apprehended that usage of the word ‘traditional’ would preclude the modern innovations made in the areas. Further, for establishing antiquity of a particular knowledge, documentary proof might be sought. The term ‘customary knowledge’ would not involve such issues.54 In the instant thesis the term “traditional knowledge” is used to comprehend customary knowledge. The definitions are only a generic description of forms of traditional knowledge and do not achieve the distinct classification of traditional knowledge. WIPO has held that the term ‘traditional knowledge’ is a working term only and it “acknowledges the right of indigenous groups, local communities and other TK 52 R.A. Mashelkar, Protecting intellectual property,at < http://www.indiaseminar.com/2005/547/547%20r.a.%20mashelkar.htm > (last accessed on 22 June 2005). 53 Dutfield , supra note 49. 54 World Intellectual Property Organization, Traditional Knowledge – Operational Terms and Definitions, WIPO/GRTKF/IC/3/9,May 20, 2002, ¶ 19, at < http://www.wipo.int/documents/en/meetings/2002/igc/pdf/grtkfic3_9.pdf > (last accessed on 3 July 2005). 22 holders to decide what constitutes their own knowledge, innovations, cultures and practices, and the ways in which they should be defined.”55 To conclude on the subject of overlapping and inadequate definitions of traditional knowledge, WIPO has observed that different terms may therefore be used for overlapping subject matter and the same term may be used in contrasting ways, so it may only be possible or desirable to settle on a particular definition in the context of a specific legal instrument and with a defined policy goal.56 A more pragmatic approach to treating traditional knowledge is explaining what kinds of knowledge should be protected. If any protection system is to be established, it is essential that the subject matter of the protection is clearly identified, as all such knowledge will need to be documented in some way. Categories of traditional knowledge could include: agricultural knowledge; scientific knowledge; technical knowledge; ecological knowledge; medicinal knowledge, including related medicines and remedies; biodiversity-related knowledge; “expressions of folklore” in the form of music, dance, song, handicrafts, designs, stories and artwork; elements of languages, such as names, geographical indications and symbols; and movable cultural properties.57 Excluded from this description of traditional knowledge would 55 World Intellectual Property Organization, WIPO Report on Fact-finding Missions on Intellectual Property and Traditional Knowledge: Intellectual Property Needs and Expectations of Traditional Knowledge Holders (1998-1999), 25. ‘TK’ and ‘tk’ are frequently used acronyms of traditional knowledge. 56 WIPO/GRTKF/IC/3/9, supra note 54 ¶ 15. See also, CIPR, supra note 29. 57 UNESCO, in its thesaurus, puts forward the following classifications of traditional knowledge: 1. Ethno-botany: this field includes cultural environmental resources and indigenous people’s ancestral remains, human genetic materials. 2. Traditional architecture: this field includes all sites of cultural significance and immovable cultural property and their associated knowledge. 3. Traditional technology: this field includes traditional resource management techniques including traditional conservation measures and scientific, agricultural, technical and ecological knowledge, and the skills required to implement this knowledge (including that pertaining to resource use practices and systems of classification). 4. Traditional medicine: this field includes all forms of traditional medicine that is based on knowledge of diseases and curative methods and therapeutic substances. 5. Traditional agriculture: this field includes methods and implements used in traditional forms of agriculture and growing crops. 6. Traditional folklore: this field includes cultural dances, ceremonies and ritual 23 be items not resulting from intellectual activity in the industrial, scientific, literary or artistic fields, such as human remains, languages in general and other similar elements of “heritage in the broad sense”.58 Further, given the diversity of traditional knowledge, it is not possible to regard the whole genre for the same IP protection.59 For instance, while traditional fables may be considered for copyright protection, traditional medicines would be discussed under patent protection. Hence a classification is often useful. But the boundaries of the above classifications are flexible and in many cases overlap and require evaluation for more than one intellectual property protection. For instance most indigenous medicine would be involving genetic resources and perhaps accompanying rituals. One instance of traditional medical knowledge using genetic resources is the Indian medical treatise of Ayurveda. This codified medical system, in the form of written literary work, will be a subject matter to be discussed for copyright protection which protects original literary works. However the medicines prepared will involve herbal resources and the protection of such medicine will be a patent law issue. The consensus among the scholars around the world has been to identify ‘medicine, food performances and practices, games and sports, music, language, names, stories, traditions, songs in oral narratives. UNESCO Thesaurus, available at (last accessed on 24 July 2004). 58 World Intellectual Property Organization, Traditional Knowledge: Glossary of Terms, at (last accessed on 24 July 2004). 59 According to CIPR, there is also confusion about what is meant by “protection” and its purpose since protection should not be used in the IP sense. See supra note 29. While in the IP sense, protection, would crudely refer to maintenance of the monopoly rights of the IP holder, for traditional knowledge it would encompass a wide range of concerns from the prevention of loss and erosion of traditional knowledge to acknowledgment of the knowledge holders and preservation and proper dissemination with sharing of benefits with the knowledge holders. 24 and agriculture’60 as the thrust areas and introduce specific protections to this priority zone.61 For the purpose of this thesis, “traditional knowledge” would refer to knowledge with the following attributes: i. Knowledge which has evolved over time and has been transmitted through generations. ii. Knowledge which is traceable to particular groups of people either having common residence area, or common religion, language or culture. iii. The knowledge which has developed for the physical and/or spiritual upliftment of the people. iv. The knowledge involves nature, by way of genetic resources. v. The knowledge may be held or created by the community or by an individual in the community. vi. The knowledge has economic or cultural value. 1.3 BIOPIRACY In many cases relating to exploitation of traditional knowledge, the southern bloc of less developed nations have often alleged underhand dealings of ‘biopiracy’ in the hands of the north bloc, more developed nations. Biopiracy is not defined in any of the conventions relating to traditional knowledge. It relates to “the appropriation of the knowledge and genetic resources of farming and indigenous communities by 60 See generally, World Intellectual Property Organization, Inventory of Existing Online Databases Containing Traditional knowledge Documentation Data, WIPO/GRTKF/IC/3/, available at (last accessed on 12 September 2004) and see, also, the website of the Indigenous Knowledge and Development Monitor, at ( last accessed on 12 September 2004). 61 In the instant thesis, unless expressly mentioned, traditional knowledge would refer to medicinal, food and agricultural knowledge only. 25 individuals or institutions seeking exclusive monopoly control (usually patents or plant breeders' rights) over these resources and knowledge”.62 The alleged appropriation of resources and knowledge include patenting of preexisting forms of knowledge or practices that are absent from the popular public databases, and the commercial monopolisation of such practices, or knowledge, in manners which deleteriously affect the interests of the knowledge holder communities. Researching genetic material on the basis of the available prior knowledge and developing new drugs, with longer shelf life, which are administered effortlessly, per se is not contrary to the interests of indigenous peoples or threat to biodiversity. The indigenous communities allege that the pharmaceutical industry has, in many instances not taken their consent, as facilitators, before going ahead with the commercial exploitation of the traditional knowledge. While bio-prospecting helps in identifying traditional knowledge with commercial potential, biopiracy appropriates these resources and knowledge by way of privatizing them for commercial gain without obtaining prior informed consent from or awarding compensation to the knowledge holder group. The prevalent types of biopiracy are as follows: a) The granting of invalid patents These are patents granted for inventions which are either not novel or are not inventive having regard to the traditional knowledge already in the public domain. Such patents may be granted either due to oversight of the patent examiner or because the examiner did not have access to the knowledge. It might also be granted due to disparity of definition followed by the different IP regimes since the national patent 62 Admitting the dearth of definition of biopiracy, CIPR has incorporated the quoted definition propounded by The Action Group on Erosion, Technology and Concentration (ETC Group). See, supra note 29 at 74. 26 regime (for example, as in US) may not recognize some forms of public disclosure of traditional knowledge as prior art. b) The granting of valid but bad patents Patents may correctly be granted under national law on inventions derived from a community’s traditional knowledge or genetic resources. It could be argued this might still constitute biopiracy for the reasons mentioned below: • Patenting standards are too low. Patents are allowed, for instance, for inventions which amount to little more than discoveries, or involve minor tinkering of the naturally occurring organisms. • Even if the patent represents a genuine invention, however defined, no arrangement had been made to obtain prior informed consent from the communities holding the knowledge or resource which was the origin to the invention, and for sharing the benefits of commercialization of the invention with the knowledge holder community.63 A number of cases involving patenting of traditional knowledge have attracted international attention. As a result, the issue of traditional knowledge has been brought to the fore of the general debate surrounding intellectual property. The examples of turmeric, neem and basmati illustrate the issues that can arise when patent protection is granted to inventions relating to traditional knowledge already in the public domain. 63 Article 15(4), (5), Convention on Biological Diversity, available at (last accessed on 19 October 2005). 27 1.3.1 Case Study: Turmeric Background Turmeric64 has been used in India from ancient times for a variety of purposes. It is used in Indian cuisine as a seasoning; the cloth industry uses turmeric as a natural dye while its skin lightening and antiseptic qualities makes it a frequently use home remedy as well as an important component of traditional Indian medicines. Patent In March 1995, two expatriate Indians at the University of Mississippi Medical Centre, Jackson were granted a US patent65 for turmeric to be used to heal wounds. Challenge The Indian Council for Scientific and Industrial Research (CSIR) filed a case with the US Patent Office challenging the patent on the grounds of “prior art”, i.e. existing public knowledge. CSIR explained that turmeric has been used for thousands of years for healing wounds and rashes and therefore its use as a medicine was not a new invention. CSIR’s claim had to be backed by written documentation claiming traditional wisdom. CSIR went so far as to present an ancient Sanskrit text and a paper published in 1953 in the Journal of the Indian Medical Association. The US Patent Office upheld the objection and cancelled the patent on 14 August 1997 for lack of novelty. Implication Had the US patent not been revoked, it would have prevented Indian companies from marketing turmeric for wound healing in the US. If the US government was 64 65 Scientific name: Curcuma longa L., Zingiberaceae. US Patent Number 5,401,504. 28 successful in pushing the instant patent in other countries including India, commercialization of turmeric for would healing in India would have become illegal.66 Observation Turmeric is perhaps the first case which was successfully challenged for the appropriation of traditional medical knowledge. Furthermore, the patent description contained the following information: “Turmeric, a yellow powder developed from the plant Curcurma longa, is commonly used as a food colorant in many Indian dishes and imparts a bitter taste ... Although it is primarily a dietary agent, turmeric has long been used in India as a traditional medicine for the treatment of various sprains and inflammatory conditions…turmeric is a natural product that is readily available in the food store”. 67 Even after such admission in the patent application, the patent was granted by the United States Patent and Trademarks Office.68 Dutfield has observed: “This case seems to indicate unwillingness on the part of patent examiners in the United States to accept the evidence of traditional knowledge as prior art unless it has been validated by scientists and published in learned - preferably North American or European journals”.69 1.3.2 Case Study: Neem Background 66 Another example of alleged biopiracy is the Enola bean patent case described in note 321 here after. The text of the patent no. 5,401,504 is available at < http://patent.womplex.ibm.com> (last accessed on 12 June 2004). 68 United States Patent and Trademarks Office is hereinafter referred to as USPTO. 69 Graham Dutfield, Is novelty still required for patents in the United States? the case of turmeric, at (last accessed on 12 June 2004). 67 29 Neem70 is a tropical tree with wide adaptability and is especially suited to semi-arid conditions. Though it is now grown in many Asian countries and in the tropical regions of the western hemisphere, neem is considered to be part of India's genetic bio-diversity because of its wide use. Patent Two patents for inventions based on neem were granted to W.R. Grace in 1990 and 1994. The earlier patent is “for improving the storage stability of neem seed extracts containing azadirachtin,” a chemical that is an active agent in neem.71 The second patent is “for storage of stable insecticidal composition comprising neem seed extract" which permitted "increasing the shelf-life stability of azadirachtin solution”. 72 The fungicidal effect of hydrophobic extracts of neem seeds was known and used for centuries on a broad scale in India, both in Ayurvedic medicine to cure dermatological diseases, and in traditional Indian agricultural practices to protect crops from being destroyed by fungal infections. The Indian government filed a complaint in the USPTO accusing W.R. Grace of copying an Indian invention. A complaint was also made to European Patent Office73 to revoke the European patent. The patent has been struck down by the EPO after it was proved that neem had been used as insecticide through similar methods for a very long time by the Indian farmers.74 While Europe follows a world-wide novelty system, US recognizes only written foreign knowledge as prior art. Since the neem formulations were traditionally used 70 Scientific name: Azadirachta Indica Patent No. 4,946,681. 72 Patent No. 5,124,349. 73 Hereinafter referred to as EPO. 74 On 8 March 2005, European Patent Office dismissed the appeal made against their 2000 order to revoke the neem patent. See, India wins Landmark Patent Battle, at (last accessed on 10 March 2005). 71 30 by farmers in Indian, no written literature could be produced to support this age-old agricultural practice, and hence neem is still a valid patent in United States. Implications Traditionally, the Indian farmers would make a water-soluble extract from the neem seeds and administer to the crops. In 1992, W.R. Grace secured its rights to the formula that used the emulsion from the Neem tree's seeds to make a powerful pesticide. They asserted that this process was a discovery because they said that this entailed manipulation yielding greater and better results. The divergent view is that the product marketed by the patentee is a mere manipulation of the solution used in India and is thus obvious. Since the use of neem as a pesticide is renowned, the patent lacked novelty. Moreover due to the prior art base and the available technology, the patented product was obvious.75 A consequence of the patent is that W R Grace started importing neem seeds from India for its production. The diversion of neem seeds from being almost a free resource to the current exorbitantly high price has resulted in making the neem seeds unaffordable for the poor local farmers.76 As the processing and exporting of the seeds and neem oil is no longer available to them, the farmers are at the receiving end.77 75 VANDANA SHIVA, PROTECT OR PLUNDER? UNDERSTANDING INTELLECTUAL PROPERTY RIGHTS, (2001) 61. 76 Indian Rupee is hereinafter referred to as INR. United States Dollar is hereinafter referred to as USD. As a result of the export, the price of neem sky-rocketed from a mere INR 300 (USD 7 approx.) to the current levels of INR 3000 (USD 68.9 approx.)-6000 (USD 137.7 approx.) a ton. See, All India Level Price, at (last accessed on 23 August 2004). 77 Since the patents under attack were concerned with purer forms and more stable forms of the active ingredient, it may be argued that these purer and more stable forms are not found in prior art. While it has been discussed in Chapter II section 2.2.2 herein that prior art should be construed broadly, it can be disputed whether the prior art was actually novelty defeating. Following such a view, the claims may be considered new. However, there still would remain the question of inventiveness, i.e., whether purification and stabilization would have been obvious in regard to the prior art. It could also be argued that whether mere purification would not lead to a very low standard of inventiveness. To avoid such controversies regarding evaluation of prior art, the Indian Patent Amendment Act 2005, under Section 3(p) excludes inventions based on traditional knowledge from patentability. See note 316 hereinafter. 31 1.3.3 Case Study: Basmati Background Basmati is the long grained aromatic rice grown in the Himalaya foothills in the northwestern parts of India and in Pakistan and is a major export crop for both countries.78 Patent In 1997, Rice Tec, a Texas company, acquired a patent in a novel method of breeding a long grain of aromatic rice, in a novel method of preparing and cooking the rice, and in the grains themselves.79 Rice Tec's claims are for a a specific rice plant (Claims 1-11, 78 The word “basmati” in, Hindi, the official language of India, means fragrant. The Basmati rice is so named because of its distinctive aroma. 79 Patent number 5663484. The full 20 claims of the patent are as follows: (1). A rice plant, which plant when cultivated in North, Central or South America, or Caribbean Islands a) has a mature height of about 80 cm to about 140 cm; b) is substantially photoperiod insensitive; and c) produces rice grains having i) an average starch index of about 27 to about 35, ii) an average 2acetyl-1-pyrroline content of about 150 ppb to about 2,000 ppb, iii) an average length of about 6.2 mm to about 8.0 mm, an average width of about 1.6 mm to about 1.9 mm, and an average length to width ratio of about 3.5 to about 4.5, iv) an average of about 41% to about 67% whole grains, and v) an average lengthwise increase of about 75% to about 150% when cooked. (2). The rice plant of claim 1, wherein said starch index of i) consists of the sum of percent amylose of about 24 to about 29 and of alkali spreading value of about 2.9 to about 7. (3). The rice plant of claim 2, wherein said rice grains additionally have an average burst index of about 4 to about 1. (4). The rice plant of claim 2, wherein said rice grains consist of less than about 20% chalky, white belly or white center grains. (5). The rice plant of claim 1, wherein said plant produces about 3,000 lbs to about 10,000 lbs of seed per acre. (6). The rice plant of claim 1, which plant a) has a mature height of about 119 cm; and b) produces rice grains having i) an average starch index of about 29, an average percent amylose of about 24.5, and an average alkali spreading value of about 4.5, ii) an average 2acetyl-1-pyrroline content of about 400 ppb, iii) an average length of about 6.75 mm, an average width of about 1.85 mm, and an average length to width ratio of about 3.65, iv) an average of about 50% whole grains, and v) an average lengthwise increase of about 90% when cooked. (7). The rice plant of claim 1, which plant a) has a mature height of about 115 cm; and b) produces rice grains having i) an average starch index of about 29, an average percent amylose of about 26.2, and an average alkali spreading value of about 2.9, ii) an average 2-acetyl-1-pyrroline content of about 150 ppb, iii) an average length of about 7.26 mm, an average width of about 1.85 mm, and an average length to width ratio of about 3.92, iv) an average of about 45% whole grains, and v) an average lengthwise increase of about 75% when cooked. (8). A rice plant produced from Bas 867 seed having the accession number ATCC 75941. (9). A rice plant produced from RT1117 seed having the accession number ATCC 75939. (10). The rice plant of claim 1, which plant a) has a mature height of about 115 cm; and b) produces rice grains having i) an average starch index of about 28.9, and average percent amylose of about 25.8, and an average alkali spreading value of about 3.1, ii) an average 2-acetyl-1-pyrroline content of about 400 to about 450 ppb, iii) an average length of about 6.49 mm, an average width of about 1.77 mm, and an average length to width ratio of about 3.87, iv) an average of about 41% whole grains, and v) an average lengthwise increase of about 90% when cooked. (11). A rice plant produced from RT1121 seed having the accession number ATCC 75940. (12). A seed produced by the rice plant of any of claims 1 to 11. (13). A rice grain derived from the seed of claim 12. (14). A progeny plant of the rice plant of any of claims 1 to 11. (15). A rice grain, which has i) a starch index of about 27 to 32 14), for seeds that germinate the patented rice plant(Claim 12), for the grain that is produced by the rice plant (Claims 13, 15-17), and for the method of selecting plants for breeding and propagating particular grains of rice (Claims 18-20). The patent led to a series of protests by the farmers and the citizens of India and Pakistan since Basmati has been a chief export item from these countries. The government of Indian applied for re-examination of the patent at the USPTO. The attorneys for the Indian government stated: "Rice Tec has got a patent for three things: growing rice plants with certain characteristics identical to Basmati, the grain produced by such plants, and the method of selecting rice based on a starch index (SI) test devised by Rice Tec, Inc.”.80 The challenge was based on the fact that the plant about 35, ii) a 2-acetyl-1-pyrroline content of about 150 ppb to about 2,000 ppb, iii) a length of about 6.2 mm to about 8.0 mm, a width of about 1.6 mm to about 1.9 mm, and a length to width ratio of about 3.5 to about 4.5, iv) a whole grain index of about 41 to about 63, v) a lengthwise increase of about 75% to about 150% when cooked, and v) a chalk index of less than about 20. (16). The rice grain of claim 15, which has a 2-acetyl-1-pyrroline content of about 350 ppb to about 600 ppb. (17). The rice grain of claim 15, which has a burst index of about 4 to about 1. (18). A method of selecting a rice plant for breeding or propagation, comprising the steps of: a) preparing rice grains from rice seeds; b) determining i) the percent amylose (PA), and ii) the alkali spreading value (ASV) of samples of said grains; c) summing said PA and said ASV to obtain the starch index (SI) of said grains; d) identifying a rice plant which produces grains having an average PA of about 22 to about 29, an average ASV of about 2.9 to about 7, and an average SI of about 27 to about 35; e) selecting a seed from said plant; and f) growing said seed into a plant. (19). A method of selecting a rice plant for breeding or propagation, comprising the steps of: a) preparing rice grains from rice seeds; b) determining i) the percent amylose (PA), and ii) the alkali spreading value (ASV) of samples of said grains; c) summing said PA and said ASV to obtain the starch index (SI) of said grains; d) cooking a sample of said grains and determining the percent elongation of cooked grains; e) identifying a rice plant which produces grains having an average PA of about 22 to about 29, an average ASV of about 2.9 to about 7, an average SI of about 27 to about 35, and an average cooked grain elongation of about 75% to about 150%; f) selecting a seed from said plant; and g) growing said seed into a plant. (20). A method of selecting a rice plant for breeding or propagation, comprising the steps of: a) preparing rice grains from rice seeds; b) determining i) the percent amylose (PA), and ii) the alkali spreading value (ASV) of samples of said grains; c) summing said PA and said ASV to obtain the starch index (SI) of said grains; d) determining the burst index of a sample of said grains; e) identifying a rice plant which produces grains having an average PA of about 22 to about 29, an average ASV of about 2.9 to about 7, an average SI of about 27 to about 35, and an average burst index of about 4 to about 1; f) selecting a seed from said plant; and g) growing said seed into a plant. 80 Basmati Case Study available at (last accessed on 3 July 2005). 33 varieties and grains already exist as a staple in India.81 The patent was not novel and was an obvious invention, being based on rice that is already being imported in theUS. India's attorneys also seeked to challenge the use of the term "basmati" in conjunction with the patent and in marketing of the rice.82 Such use of the term created confusion as to geographic origin83 and usurped the goodwill and recognition established with basmati rice grown and sold from India.84 As a result of the re-examination application filed by the Indian government through an NGO named APEDA85, Rice Tec agreed to withdraw the claims. On 29 January, 2002, the USPTO issued a Reexamination Certificate and cancelled claims 1-7, 10, 81 See Vandana Shiva, Basmati Biopiracy: Rice Tec Must Withdraw All Patent Claims For Basmati Seeds And Plants, The Hindustan Times (November 20, 2000), available at ( last accessed on 3 July 2004). 82 Id. 83 Basmati might not be protected as a geographical indication since the word ‘Basmati’ does not indicate the geographical origin of that particular rice but describes an attribute. Moreover, neither India nor Pakistan had a relevant enactment protecting geographical indictaions at the time of the issuance of the patent in 1997. Under Article 24.9, TRIPS does not require a member to protect geographical indications unless they are protected in their country of origin. India legislated The Geographical Indications of Goods (Registration and Protection) Act in 1999 is discussed in Chapter II sections 3.2.2 of the thesis. 84 Trademark law could have also been a basis for challenging the use of Basmati. Rice Tec could be prevented from marketing Basmati rice in a way that creates confusion with the Indian product. But, in order to be successful for such a claim, the Indian government would have to show likelihood of confusion among consumers since 15 USC (Chapter 22 dealing with trademarks) § 1114(a)-(b) specifies likelihood of confusion as an element of trademark infringement claim. Rice Tec did not trademark the term "Basmati" and it has been careful in marketing its product so as not to use the term Basmati as an indication of source. In UK, Rice Tec markets the product as Texmati rice, since British law protects the use of the term Basmati to refer to rice coming from India and Pakistan. Rice Tec also uses Texmati in its US sales, but uses the term Basmati on its packaging. The Indian government could argue that this use of the term Basmati is what creates confusion among consumers. The term Basmati need not be federally registered as a trademark for India to raise the claim since under 15 USC § 1125(a) confusing or deceptive marks are recognized even if the marks are not registered. However, Rice Tec would have a strong argument that India cannot bring an infringement action because "Basmati" could not be protected as a trademark. Rice Tec's strongest argument is that Basmati is really a descriptive mark; the word means fragrant and hence describes a major attribute of the product. Under 15 USC § 1052(f), descriptive marks are protected only if they have secondary meaning, that is, the term makes the ordinary consumer recognize the source of the product as opposed to the product itself. In this vein, Rice Tec could also argue that under 15 USC § 1064(3), which permits cancellation of trademarks that are generic, the term Basmati has become a generic term for a particular category of rice and hence cannot be protected. Finally, even if the Indian government could win on the point of the strength of the mark, Rice Tec still has a good argument that its use of the term Basmati does not cause confusion among consumers, who can see that rice comes from Texas, not India. This is because in the case of Mother's Restaurant v. Mother's Other Kitchen, Inc., 218 U.S.P.Q. 1046 (TTAB 1983), the Court rejected opposition claim by Canadian company alleging likelihood of confusion between Canadian company's registered Mother's mark and US company's Mother's mark because “prior use and advertising of a mark in connection with goods or services marketed in a foreign country...creates no priority rights in said marks in the United States”. 85 Agricultural and Processed Food Products Export Development Authority. 34 and 14-20 (the broad claims covering the rice plant) and entered amendments to claims 12-13 on the definition of chalkiness of the rice grains. Claims 8, 9, and 11 covering the specific samples of the plant from the genetically modified seed itself still stand. Implications Rice Tec has lost its claims that provide a specific written description of the plants that the company claims ownership in. Rice Tec must rely on the seeds deposited at the ATCC86 since under claims 8, 9 and 11 it still has valid claims in the plants that are germinated from the seed. The title of the patent now reads: “Bas 867, TR1117 and RT 1121” based on the rice lines developed by Rice Tec.87 Other cases like the Hoodia Cactus patent88 and the Hessian Jute patent89 have also fueled the biopiracy outcries from the third world countries.90 86 American Type Culture Collection. The abstract reads: “the invention relates to novel rice lines and to plants and grains of these lines. The invention also relates to a novel means for determining the cooking and starch properties of rice grains and its use in identifying desirable rice lines. Specifically, one aspect of the invention relates to novel rice lines whose plants are semi-dwarf in stature, substantially photoperiod insensitive and high yielding, and produce rice grains having characteristics similar or superior to those of good quality Basmati rice. Another aspect of the invention relates to novel rice lines produced from novel rice lines. The invention provides a method for breeding these novel lines. A third aspect...relates to the finding that the starch index (SI) of a rice grain can predict the grain's cooking and starch properties, to a method based thereon for identifying grains that can be cooked to the firmness of traditional Basmati rice preparations, and to the use of this method in selecting desirable segregants in rice breeding programs”. See supra note 79. 87 88 Hoodia Cactus: The San, who live around the Kalahari Desert in southern Africa, have traditionally eaten the Hoodia cactus to stave off hunger and thirst on long hunting trips. In 1995 South African Council for Scientific and Industrial Research (CSIR) patented Hoodia’s appetite-suppressing element. In 1997 they licensed the patent to the UK biotech company, Phytopharm. In 1998, the pharmaceutical company Pfizer acquired the rights to develop and market P57, a potential slimming drug and cure for obesity (a market worth more than £6 billion), from Phytopharm for up to $32 million in royalty and milestone payments. On hearing of possible exploitation of their traditional knowledge, the San People threatened legal action against the CSIR on grounds of “biopiracy”. They claimed that their traditional knowledge had been stolen, and CSIR had failed to comply with the rules of the Convention on Biodiversity, which requires the prior informed consent of all stakeholders, including the original discoverers and users. An understanding now has been reached between the CSIR and the San whereby the San, recognised as the custodians of traditional knowledge associated with the Hoodia plant, will 35 The aforesaid cases are illustrative of the fact that industries are looking towards the vast bio-resources and the traditional knowledge of their use in field of medicine. When patent protection is granted to products based on traditional knowledge already in the public domain, they can be challenged on the grounds of novelty and inventive step, as seen above. While some jurisdictions, for instance the EPO, subject the patent applications through strict scrutiny before the patents are granted, other patent systems follow the rules of ‘first to file’ and ‘issue first – revoke later’. What this receive a share of any future royalties. See, The SAN and the CSIR to formulate benefit-sharing model for anti-obesity patent , 22 March, 2002 available at (last accessed on 5 July 2004). Joint media release by the South African San Council and the CSIR, Scientists and South African San join forces in research project on San use of indigenous plants: Bioprospecting agreement between the CSIR and the South African San Council signed in Upington, 28 October 2004, available at (last accessed on 12 December 2004). 89 Jute ‘Hessian’ Patent: Jute is a principal agricultural produce of India. It is a natural fiber and has qualities of being cheap, its fabrics being used for various purposes including garments and covers. Geo-Hess, a UK based company, in view of present day global concerns on non-biodegradability of plastics and anticipating the huge market demands of bio-degradable covers, sometime in 1994 filed an application for European Patent claiming the use of Hessian (a jute variety) sheet as a bio-degradable cover for waste. The European Patent (no 728048) was given to Geo-Hess, for the use of ‘Hessian’ cloth on landfill sites, to cover rubbish. Geo-Hess then claimed that anyone covering rubbish with ‘Hessian’ cloth would have to pay a royalty of 65 per cent of the cost of ‘Hessian’ in the UK, where the company was registered. The company also sent claim notices to a number of firms that were using Hessian for covering land-fills, prior to the patent grant. The patent application was contested by the Jute Manufacturers Development Council (JMDC), in India, on the grounds that the invention lacked both novelty and inventive merit. The argument made by the JMDC was that when canvas, a jute variety, was well known as waste cover there can be no invention in suggesting use of Hessian, another jute variety, for same purpose. EPO opposition division based its decisions on the documentation and arguments of the JMDC and revoked the GEOHESS patent citing non-inventiveness. It is submitted that the EPO decision does not give merit to the argument against novelty in use of Hessian, as covering cloth. This is because the traditional use of jute in India was not documented adequately. See, JMDC website at http://www.jute.com (accessed on 12 October 2004). 90 While this is not a biopiratical invention, an example of controversies relating to multi national corporations and developing countries is the issue of cultivation of Monsanto’s genetically modified Bt.Cotton in India. Though some claim that Bt.cotton, with its enhanced capacity to ward off bollworm pests, is a success; others condemn the Government of India decision to allow the cultivation of the transgenic cotton, and, refer to instances of failure of the genetically modified seeds to deliver results, or of instances where farmers have been defrauded with fake seeds. For a supporting view, see, Bt Cotton Creates Three Times the Earnings for Indian Farmer at Council of Biotechnology Information website at http://www.whybiotech.com/index.asp?id=4515 (accessed on 4 October 2005) ; R.B. Barwale, V.R. Gadwal, Usha Zehr, & Brent Zehr, Prospects for Bt Cotton Technology in India, at (last accessed on 4 October 2005). For a dissenting view see, amongst others, Rhea Gala, India’s Bt cotton Fraud, at (last accessed on 4 October 2005).; Dr. Suman Sahai’s views in Sheela Bhatt, Expert demands inquiry into Bt cotton cultivation, at (last accessed on 4 October 2005). 36 implies is that the person who files the patent application first, and has the earliest priority date, is awarded the patent, whether or not he is the inventor or the owner. Also in the patent systems in most countries, biotechnology patents are granted without much initial challenge or search, with the good faith belief that in case of an illegality, the actual inventor will initiate revocation proceedings. This system of fairness does not work where the true owners, are far distanced from the modern world of patents and industry like in many cases of traditional knowledge. In the cases discussed above, invalid patents were issued because the patent examiners were not aware of the relevant traditional knowledge. Traditional knowledge collections do not form part of the prior art databases available to many patent examiners. To be fair to the present system, a patent examiner can only examine an application against all ‘known’ inventions. In the case of traditional knowledge, the policy of secrecy by traditional knowledge holders makes it difficult for a thorough search to be fruitful. 1.4 APPLICATION OF CONVENTIONAL IPRS ON TRADITIONAL KNOWLEDGE According to WIPO, intellectual property refers to creations of the mind: inventions, literary and artistic works, and symbols, names, images, and designs used in commerce.91 Cornish has stated that “Intellectual property protects applications of ideas and information that are of commercial value.”92 The whole range of intellectual property includes patents protecting technological inventions; copyright protecting literary, artistic or musical creations; trade mark laws protecting trademarks against 91 See, World Intellectual Property Organization, About Intellectual (last accessed on 5 November 2004). 92 See supra note 12, at 4. Property, at 37 imitation. The list is not exhaustive since new kinds of intellectual creations are emerging. These inventions deserve protection but are often not very easily protected through standard IP protection laws.93 1.4.1 Patents, TRIPS and traditional knowledge The different categories of traditional knowledge may fall within different intellectual property rights protection94 such as: patents, copyrights95, trademarks,96 geographical indications.97 Protection for biological resources through intellectual property rights legislation, such as patents, have traditionally been excluded on grounds of public morality because of the need to encourage everyone from the smallest farmer to multinational companies to foster innovations and to prevent commercialisation of critical sectors like food and healthcare. However pharmaceutical companies have 93 An example is computer programs. Due to word limit limitations and limited relevance to the central theme of the thesis, the issue of copyright protection of software is not being discussed. It is only mentioned that Under Section 7A of Singapore Copyright Act, Chapter 63, enforce from 1 January 2005, literary work includes computer programs. While this is consistent with the position taken by the international for a, since TRIPS, under Article 10, provides for protection of computer programs as literary works, whether patents are more suitable rights for protecting computer programs is still a much debated issue. 94 The interface of some of these rights and traditional knowledge is discussed in Chapter III, section 3.2 of the thesis. 95 Copyright: Copyright is a right given for a limited period against the copying of defined types of cultural, informational; and entertainment productions. These works include literary, dramatic, musical and artistic works, cinematography film and sound recordings. Copyright mostly relates to the right to copy or reproduce the work in which copyright subsists. The right is to reward “that distinctness which results from the creator’s myriad choices made in the course of constructing the work in the chosen medium.” According to Cornish, the basis of copyright lies in the personal character in the subject matter of the copyright work. It is the expression of the work which is protected rather than the idea behind it. Hence copyrights are not concerned with the originality of ideas but that of the thought or expression. While the parameters for evaluation of originality of ideas or aesthetic value are subjective, copyright aims to protect the more tangible skill, judgment, labour and economic investments made in the work. Hence lists like timetable index in Blacklock v. Pearson [1915] 2 Ch. 376; or street directories in Kelly v. Morris (1866) L.R. 1 Eq. 697 have been recognized as copyrightable subject matters. See, supra note 12 at ¶ 1-06. 96 Trademark: A trademark is a formally registered symbol identifying the manufacturer or distributor of a product. A person selling his goods under a trademark acquires a limited exclusive right for use of the mark in relation to the goods. Such right is recognized as a property in the trade mark and is protected under the common law till such mark is used. See, supra note 12 at ¶ 15-04 to 15-07. 97 See, Chapter III section 3.2.2. 38 attempted to protect traditional antidotes to modern diseases98 by patents though requirements of patentability often do not match the attributes of folk medicines. Some conflicts stem from the fact that folk medicines include knowledge of traditional cures involving herbs, leaves, and other treatments often unknown to the rest of the world.99 These cures are tailor-made to suit the genetic makeup of people who are immune from certain diseases thus far considered incurable in other parts of the world but vulnerable to some other diseases unique to their genetic make. World Health Organization100 defines traditional medicine as “the sum total of all the knowledge and practices, whether explicable or not, used in diagnosis, prevention and elimination of physical, mental or social imbalance and relying exclusively on practical experience and observations handed down from generation to generation, whether verbally or in writing”.101 Indigenous knowledge, being part of the public domain and being trans-generational and communally shared, is therefore not protectable. Evaluation of the suitability of patents for protection of traditional knowledge and related genetic resources reveals that the subject has not been effectively dealt with in 98 For example, the rosy periwinkle, unique to the Madagascar region, contains properties that can cure certain forms of cancer. See, http://www.herbs2000.com/herbs/herbs_periwinkle.htm (accessed on 5 June 2005). The anti-cancer drugs ‘vincristine’ and ‘vinblastine’, developed from this plant, resulted in annual sales of around USD 100 million for Bristol-Myers Squibb. See, NAOMI ROHT-ARRIAZA, Of Seeds and Shamans: The Appropriation of the Scientific and Technical Knowledge of Indigenous and Local Communities, in, BORROWED POWER: ESSAYS ON CULTURAL APPROPRIATION (Bruce Ziff & Pratima V. Rao, eds., 1997) 255 at 256. 99 Traditional medicines, catering to local ailments and comprising of locally available resources including foliage, are difficult to replicate in other geographical locations. 100 World Health Organisation, also referred to as WHO is a United Nation’s organisation established to supervise health care around the world. It was established in 1948 and is headquartered in Geneva. Presently it has 192 member states, including all UN Member States except Liechtenstein. More about WHO can be found at http://www.who.int/ (last accessed on 5 October 2005). 101 See, World Health Organisation, Traditional Medicine Programme., at (last accessed on 4 September 2004). 39 international IPR laws. The most significant IPR treaties in the context of biodiversity and international trade regime are CBD and TRIPS. While CBD incorporates measures for protection of traditional knowledge, the more far-reaching TRIPS, is silent about the subject. Patents are covered under Article 27 of the TRIPS. ‘Patentable Subject Matter’, enumerated in Article 27, reads: “Subject to the provisions of paragraphs 2 and 3, patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application. Subject to paragraph 4 of Article 65, paragraph 8 of Article 70 and paragraph 3 of this Article, patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced”. Article 27(2)102 goes on to list grounds for exclusion from patentability. It allows Member States to bar the patenting of inventions when the commercial exploitation conflicts with ordre public or morality. This includes protection of human, animal or plant life or health or to avoid serious prejudice to the environment.103 Article 27(3)(a) further permits member states to exclude diagnostic, therapeutic and surgical methods for the treatment of humans and animals. Article 27(3)(b)104 extends the list of 102 Article 27(2) TRIPS Agreement: Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law. 103 However as per Article 27(3)(b), members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof. The provisions of this subparagraph shall be reviewed four years after the date of entry into force of the WTO Agreement. 104 Article 27(3)(b), TRIPS Agreement: Members may also exclude from patentability: …(b)plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any 40 permissible exclusions to include plants, animals, other than microorganisms, and essentially biological processes for the production of plants and animals other than non-biological and micro-biological processes. Whilst Articles 27(2) and (3) do set out important permissible exclusions, it must be stressed that Article 27(3)(b) requires members to protect plant varieties either by patents or by an effective sui generis system. Further, Article 27(3)(b) does not allow exclusion for microorganisms and non-biological and micro-biological processes. Given the importance of Article 27(3)(b), its provisions are made expressedly subject to review four years after date of entry into force of the WTO Agreement. This option intensifies the debate concerning IPRs for biological and genetic resources between the technology-rich North and the gene-rich South. Article 27(3)(b) has been used by some member nations to ban patenting of life forms especially those falling under biotechnology domain. There has been continuous pressure from countries like the US to review the ban on patenting of life forms. These countries have argued that biotechnology inventions involve extraction or isolation of genes found in plants and animals, and since the results of the biotechnological processes are essentially microbiological, the resultant products should be granted patent protection just like other organic chemicals. The divergent view is that, since Article 27(3) (b) sanctions excluding ‘essentially biological processes’,105 combination thereof. The provisions of this subparagraph shall be reviewed four years after the date of entry into force of the WTO Agreement. 105 Dutfield quotes the EPO guidelines for examiners whereby it has been stated, “The question whether a process is essentially biological is one of degree depending on the extent to which there is technical intervention by man in the process; if such intervention plays a significant part in determining or controlling the result it is desired to achieve, the process would not be excluded.” See, GRAHAM DUTFIELD, INTELLECTUAL PROPERTY, BIOGENETIC RESOURCES AND TRADITIONAL KNOWLEDGE, (2004) 29. 41 all biological and naturally existent materials like plants and animals should be excluded from patentability.106 Article 27(2) of TRIPS has two approaches. If it is considered that patent systems take on a broad role of “managing technological change” instead of “promoting technological change”, the presence of ordre public or the morality bars in the patent system can be justified.107 However, if the role of patents is considered to be encouraging innovation, it is to be noted that ordre public or morality concerns have little to do with novelty, or inventive step of an invention. Hence such issues may be dealt with outside the patent system.108 Two reviews have been taking place in the TRIPS Council, as required by the TRIPS Agreement: a review of Article 27(3)(b) which deals with patentability or nonpatentability of plant and animal inventions, and the protection of plant varieties, and a review of the entire TRIPS Agreement required by Article 71.1.109 The Doha Declaration110 has also provided a mandate to WTO for looking into conflicts between the CBD and the TRIPS as well as how to deal with traditional knowledge and genetic material, and the rights of the communities where these originate. 106 There is uncertainty regarding the definition of the term ‘essentially biological processes’ in TRIPS. The EU Biotechnology Directive sheds some light when it restricts ‘essentially biological processes’ to crossing and selection. It can be interpreted that while modern genetic engineering processes are likely to avoid the bar, traditional techniques used by farmers and breeders to create new varieties may well be unpatentable by the bar that attacks ‘essentially biological processes’. 107 PETER DRAHOS, Foreword, PERSPECTIVES ON INTELLECTUAL PROPERTY, IP IN BIODIVERSITY AND AGRICULTURE (Peter Drahos & Michael Blakeney eds., 2001) v-vi. 108 See, Chapter IV section 4.4 of the thesis. 109 World Trade Organization, Trips: Reviews, Article 27.3(B) And Related Issues, WTO, at (last accessed 13 October 2005). 110 World Trade Organization, Doha Ministerial Declaration, 14 November, 2001, ¶ 19, available at (last accessed on 13 October 2005). 42 Review of Article 27(3)(b) Article 27(3)(b) was the only provision in the TRIPS Agreement subject to an early review in 1999. The review of Article 27(3)(b) has spotlit a wide range of contentious issues. These range from the patentability exclusion of microorganisms and all processes for developing plants and animals, to the requirement of making disclosure of information about source of a genetic resource or a traditional knowledge used, prior informed consent and compliance with national access/benefit laws as preconditions to the grant of the patent. According to Correa, there was no agreement in the Council for TRIPS on the meaning of "review"111. Developed countries had held that it is a "review of implementation" which was called for, while for developing countries a “review” should open the possibility of revising the provision itself. The views of developed countries can be summarized by the Swiss Submission112 which states that Article 27(3)(b) is a well balanced provision taking into account interests of all WTO Members. Regarding protection of traditional knowledge, the Swiss suggest enacting national legislatures incorporating disclosure and prior informed consent provisions. The alternative approach supported by the Swiss is the creation of a new IP right for traditional knowledge under the sui generis option in Article 27(3)(b). EU,113 as a party to the CBD has submitted to the WTO that TRIPs allowed members sufficient flexibility to modulate patent protection as a function of 111 Carlos Correa, Review of the TRIPS agreement Fostering the transfer of technology to developing countries, at (last accessed on 3 September 2005). 112 World Trade Organization. Review of Article 27.3(b) - The Relationship between the TRIPs Agreement and the Convention on Biological Diversity, and the Protection of Traditional Knowledge: Communication from Switzerland, Council for Trade-Related Aspects of Intellectual Property Rights, IP/C/W/400/Rev. 1, WTO, Geneva, 18 June 2003. 113 The European Commission represents the European member states at WTO meetings. See, The European Communities and the WTO, at (last accessed on 15 July 2004). 43 their needs, interests or ethical standards. Hence they felt no necessity to amend Article 27(3)(b).114 US proposed the elimination of the exception for plants and animals, and that plant varieties should be protected in accordance with the International Union for the Protection of New Varieties of Plants115 as revised in 1991116. This may be interpreted as a reflection of the philosophy of USPTO that “anything under the sun” is patentable.117 The African Group has submitted that they propose the revision of Art 27(3) (b) so as to mandate the prohibition of patents on plants, animals, micro-organisms, essentially biological processes for the production of plants or animals, and non-biological and microbiological processes for the production of plants or animals. They have further held that any plant variety protection legislature should protect farmers’ rights and 114 World Trade Organization , Review of Article 27.3(b) of the TRIPS Agreement, and the Relationship between the TRIPS Agreement and the CBD and the Protection of Traditional Knowledge and Folklore — “A Concept Paper”: Communication from the European Communities and their Member States, Council for Trade-Related Aspects of Intellectual Property Rights , IP/C/W/383, WTO, Geneva, 17 October 2002. 115 UPOV: UPOV is an abbreviation of Union Pour la Protection des Obtentions Vegetable (Union for Protection for new Varieties of Plants).The UPOV Convention signed in Paris in 1961 has been amended in 1972, 1978 and 1991. The 1991 Act is in force since April 1999. The purposes of the UPOV Convention are to oblige member states of the Union to recognise and secure to breeders of new plant varieties an industrial property right, by way of plant breeder's right (PBRs), to harmonise such rights and to encourage cooperation between member states in their administration of such rights by granting them an exclusive property right on the basis of a set of uniform and clearly defined principles. To be eligible for protection, varieties have to meet certain conditions such as being distinct from existing, commonly known varieties and sufficiently homogeneous and stable. Specifically, as per Articles 6 to 9, a plant variety aiming for protection should be novel, distinct, stable and uniform. Protection is given to plant breeders as an incentive to the development of agriculture, horticulture and forestry. UPOV further provides a common basis for the examination of plant varieties in different member states of UPOV for determining whether a plant variety merits protection under UPOV. See, UPOV website at (last accessed on 13 September 2005). 116 United States held that “The TRIPS Council will initiate work on this item in 1999, to consider whether it is desirable to modify the TRIPS Agreement by eliminating the exclusion from patentability of plants and animals and incorporating key provisions of the UPOV agreement regarding plant variety protection”. See, World Trade Organization, Preparations for the 1999 Ministerial Conference General Council Discussion on Mandated Negotiations and the Built-In Agenda: Communication from the United States, WT/GC/W/115, WTO, Geneva, 19 November 1998. 117 Diamond v. Chakrabarty, 447 U.S. 303 (1980). The case has been discussed in Chapter IV section 4.2. 44 traditional knowledge, and ensure the preservation of biological diversity.118 The views expressed by the African Group are a reiteration of the suggestions made by Kenya at the beginning of the review in 1999, on behalf of the Group. The suggestions read that all patenting of living matter should be banned worldwide under TRIPS, and that any regime for plant varieties should protect the rights of farmers and local communities.119 The Brazilian submission120 held that biopiracy was a key issue that had to be resolved under CBD and, also, TRIPS. They held that TRIPS should be amended so as to compulsorily require applicants applying for a patent relating to biological resources or traditional knowledge to provide for disclosure of origin of the resource and the traditional knowledge; evidence of prior informed consent and proof of benefit sharing arrangement under national laws. This was in contrast to the US stand that compulsory disclosure of origin for inventions involving biological resources amounted to discrimination among technologies. It was held in the Brazilian submission that “Procedures adopted for granting patents often have to be different depending on the ‘field of technology’”.121 Further it was argued that introduction of such an obligation would not burden the patent offices since the onus of providing the information and documentary evidences would be on the applicant. 118 World Trade Organization, Taking forward the Review of Article 27.3(b) of the TRIPs Agreement: Joint Communication from the African Group, IP/C/W/404, WTO, Geneva, 26 June 2003. 119 World Trade Organization, Preparations for the 1999 Ministerial Conference - The TRIPS Agreement: The Communication by Kenya on behalf of the African Group, WT/GC/W/302, WTO, Geneva, 6 August 1999. Kenya’s views on the review of Article 27(3)(b) evoked emotive responses among the NGOs who circulated a joint statement in support of the proposals by the African Group. For the statement and the list of organisations supporting the views see, Call for Support For African Group Proposal on Trips Article 27.3b on Patenting of Life, at (last accessed on 23 August 2004). 120 The WTO document which aired the views of Brazil, Bolivia, Cuba, Dominican Republic, Ecuador, India, Thailand, Peru and Venezuela is for the sake of convenience called the Brazilian submission. World Trade Organization, The Relationship between the TRIPS Agreement and the CBD and the Protection of Traditional knowledge, IP/C/W/403, WTO, Geneva, 24 June 2003. 121 See, id. ¶ 11. 45 Singapore’s position on Article 27(3)(b) had been clarified in the Singapore position paper to the TRIPs Council.122 Singapore held that while it was relatively more common to research on unicellular organisms, and hence the compulsory patentability of microorganisms and microbiological processes, future research in higher order animals could not be ruled out. Singapore proposed inclusion of plants and animals under patentable subject matter.123 The polar views held by US and African Group on the subject of the review led to a stalemate. The Seattle Ministerial of the WTO in 1999, and the Cancun Trade talks in 2003, notwithstanding the expectations raised, failed to deliver results. The review is still on at the WTO. Till date, no amendment of TRIPS has been effected to incorporate traditional knowledge related issues.124 The current structure of patent regime or the existing IPR infrastructure as a whole does not provide adequate protection to ‘inventions’ based on traditional knowledge. A summation of issues regarding the interface between traditional knowledge and patent protection reveals the following inconsistencies: • IPRs protect individual property rights whereas traditional knowledge is by and large collective;125 122 Non-Paper by Singapore, supra note 29. Section 13 of Singapore Patent Act, dealing with patentable inventions, enumerates novelty, inventive step and industrial applicability as the substantive requirements of patentability. Section 13(2) states that an invention which “which would be generally expected to encourage offensive, immoral or anti-social behaviour” would not be a patentable invention. The act does not provide further exclusions. Hence Singapore’s pro-patent stance has been inherent in the Patent Act. 124 Some countries have suggested that Articles 29 and 62 of TRIPS Agreement can accommodate provisions like disclosure of origin of resources used. See discussion in Chapter II, section 2.4. 125 World Trade Organization, Review of Article 27.3(b) - Communication from Brazil , Council for Trade-Related Aspects of Intellectual Property Rights, IP/C/W/228, 24 November 2000. World Trade Organization, Protection of Biodiversity and Traditional Knowledge - The Indian experience Submission by India, Committee on Trade and Environment Council for Trade-Related Aspects of Intellectual Property Rights, IP/C/W/198, 14 July 2000. For views of representative of Venezuela,see, World Trade Organization, Minutes of Meeting, 20-21 October 1999, Council for Trade-Related Aspects of Intellectual Property Rights, IP/C/M/25, ¶ 86. 123 46 • Traditional knowledge is developed over a period of time and is intergenerational and therefore, may not meet the criteria of novelty and/or inventive step or originality required by IPRs;126 • Communities often hold this knowledge in parallel which makes it difficult to determine title holders;127 • Communities lack adequate education, awareness and resources to take advantage of IPRs;128 • Communities do not use scientific methods but trial and error over time.129 In short, traditional knowledge paradigm, being created communally and developed over long period of time, does not fit the patent law requirements of inventorship, novelty, inventive step and industrial application. 1.4.2 Other forms of IPRs and traditional knowledge In recent surveys of the existing protection of traditional knowledge and folklore, a number of countries have provided further examples of how IP tools have been utilized to promote and protect traditional knowledge and folklore.130 Aboriginal and Torres Strait Islander artists in Australia have obtained a national certification trademark.131 This certification mark or Label of Authenticity is intended to help promote the marketing of their art and cultural products and deter the sale of products falsely claiming to be of Aboriginal origin. The ability to extend the life of 126 See id. Brazil, IP/C/W/228; India, IP/C/W/198. See supra note 125 Brazil, IP/C/W/228; India, IP/C/W/198. 128 See supra note 125, India, IP/C/W/198. 129 See supra note 125, IP/C/M/25, ¶ 86. 130 World Intellectual Property Organization, Reviews of Existing Intellectual Property Protection of TK, WIPO/GRTKF/IC/3/7 and WIPO/GRTKF/IC/3/10, WIPO, Geneva, 25 March 2002. 131 See, NIAAA and the Label of Authenticity, at (last accessed on 11 September 2004). 127 47 trademarks132 indefinitely and the possibility of collective ownership of such rights suggest that they may be especially suitable for protecting traditional knowledge. Geographical indications133 may also be used to protect traditional products or crafts if specific characteristics of such products can be attributed to a particular geographical origin. However, trademarks and geographical indications can only prevent the use of the protected marks or indications; they do not protect the knowledge, or the technologies embracing that knowledge, as such. Laws of Confidence134 can be utilized to protect traditional knowledge.135 Trade secrets have been an effective way of protecting IP.136 Trade secrets work by allowing individuals or companies to prevent commercially valuable information lawfully within their control from being disclosed to, acquired by, or used by others without their consent in a manner contrary to honest commercial practices. Restricting access to territories of the knowledge holders and exchanging information with outsiders through agreements that secure confidentiality or economic benefits would be appropriate means to this end. Some non-public forms of traditional knowledge may be in the manner of a trade secret by the attachment of sacred or ceremonial significance to such knowledge. Possible examples include herbal potions, plants, fruits, geological deposits, and the like. 132 133 134 See supra note 96. Geographical indications have been morefully discussed in Chapter III, Section 3.2.2. Laws of Confidence are based on the philosophy that “A person ought to keep a secret if he has said that he will do so.” Laws of Confidence have been allowed a wide jurisdiction and a wide range of information can be protected under them. See, supra note 12, at 263. 135 Sale of a book was challenged since it contained sacred knowledge divulged to the author, an anthropologist, 35 years ago by the members of the Pitjantjatjara clan in Australia. The court found that the information was of deep cultural and religious significance to the tribe and even if divulged to the anthropologist, was protected by laws of confidence. Its publication had amounted to a breach of confidence. It was ruled that damages after the publication was not an appropriate remedy and injunction was granted to prevent the sale of the book. Foster v. Mountford (1976) 29 FLR 233. 136 For example, the formula for Coca-Cola was never patented but guarded as trade secret and thus may never be made known to the public. 48 The disadvantages of trade secrets protection are that trade secrets protect knowledge which is undisclosed and not in public domain. A major amount of traditional knowledge is widely available in the public domains of communities, states and even beyond the borders of the states, in the neighbouring countries and other countries where such usages are practiced by migrants from that nation. This is thus not at all a very effective form of protection of traditional knowledge and usages practiced by millions in a community. The protection would fail to have any effect for the safeguard of turmeric or neem, and the related knowledge since such information is commonly known and used widely by millions in India and her neighboring countries. Secondly, if an inventor chooses to commercialize his innovation as a trade secret, the growth of ideas may be hindered. Enforcing legal rights would also require the holder of the knowledge to prove that steps had been taken to ensure that the knowledge was protected as a secret. This could prove to be a problem in the case of traditional knowledge since while agreements may be used to prevent disclosure of knowledge, the traditional societies would not have resorted to such measures even within the particular community. Thirdly, propagation and application are fundamental features of traditional knowledge and have been upheld by the international document CBD which has advocated the notion of apposite propagation and diffusion of traditional knowledge in Article 8(j) by incorporating the idea of dissemination of traditional knowledge and “promote their wider application”. Trade secrets, or any other application of Laws of Confidence, would absolutely prohibit the promulgation of the particular information being protected. 49 Further, by granting exclusive rights in an invention, for example, the IP system encourages further innovation, rewards creative effort, and protects the investment necessary to make and commercialize the invention. The patent system also encourages people to disclose inventions, rather than retain them as trade secrets, thus enriching the store of publicly-available knowledge and promoting further innovation by other inventors. Public dissemination is an important IP objective. It may be said that, by definition, Laws of Confidence contrast with the public disclosure principle that generally underlies the patent system and may not be a fit-all system for protecting traditional knowledge. 1.5 SOCIAL IMPACT OF PATENTING TRADITIONAL KNOWLEDGE Patent monopolies, held by corporations, institutes or by individuals, on plant and animal varieties, on genes, and on new medicines, threaten to harm developing countries in four ways. First, by raising prices such that less affluent citizens have little access to these new developments; second, by blocking local production when the patent owner so chooses; third, for agricultural varieties, by forbidding farmers to continue breeding varieties as has been done for thousands of years and also by promoting certain varieties of particular crops, which have more economic viability, while, the other varieties head toward extinction due to non-use. Biodiversity, especially in plants and marine organisms, benefits society as a source of new products and continued economic productivity. Many of today’s most important pharmaceutical drugs are based on compounds originally found in diverse species of plants and other organisms. Similarly, the productivity of modern agriculture is entirely dependent on the inclusion of genes for disease resistance and 50 other characteristics taken from traditional crops and similar wild varieties in widely used crop varieties. An example of loss of biodiversity is the Green Revolution.137 After witnessing the drawbacks of using genetically modified seeds and artificial fertilizers, people have realized the importance of the old farming systems,138 since with high yielding variety seeds replacing the native cropping systems, diversity is lost.139 Also important is informal knowledge about biodiversity, held in knowledge systems of indigenous people especially in the developing world. This knowledge is a valuable source for new products in these sectors, as well as for sustainable use and conservation of local ecosystems. Genetic engineering, which has broken the barriers 137 The Green Revolution was a technological process of improvement of agricultural techniques which began in Mexico in 1944 but soon spread to other parts of the world. The research was funded by the Rockfeller Foundation and the Ford Foundation. The aim was to eliminate hunger by improving crop performance through the use of high yielding variety seeds, irrigation, fertilizers, pesticides and mechanization. It was extensively adopted in the developing countries of Asia and Latin America. Almost 75 percent of Asian rice areas were sown with these new varieties. Such techniques were used for almost half of the wheat grown in Africa and more than half of that in Latin America and Asia, and about 70 percent of the world's corn production. Overall, it was estimated that 40 percent of all farmers in the Third World were using Green Revolution seeds, with the greatest use found in Asia, followed by Latin America. The success in increasing yields was undisputable. The per capita production increased every year following 1950. During the Green Revolution, the rotation of diverse crops like wheat maize, millets, pulses and oil seeds were replaced by monocultures of wheat and rice. The introduced crop varieties came from a very narrow genetic base compared to the high genetic variability in the varieties of traditional rice and wheat plants. As the marginal lands and croplands were homogenized, diversity disappeared. Further in the transformation of mixed and rotational cropping of wheat jowar, bajra, barley, pulses and oilseeds into monocultures and multicropping of wheat and rice, and the conversion of wheat and rice from diverse native varieties suited to different soil, water and climatic conditions to monocultures of single varieties derived from the exotic varieties of seeds in the banks of CIMMYT (Centro International de Mejoramiento de Maiz Y Trigo or the International Maize and Wheat Improvement Centre, Mexico) and IRRI ( International Rice Research Institute, Philippines), little concern was shown to protect traditional farming practices in the least developed countries. For centuries, farmers in the developing agrarian countries had maintained the land's fertility by carefully managing the soil, water, and nutrients as well as by preserving the genetic diversity of the crops and livestock on which their farming depended. Much of the technology of the Green Revolution ignored these practices based on the traditional knowledge of the farming communities. See, generally, VANDANA SHIVA, THE VIOLENCE OF THE GREEN REVOLUTION, (1991). 138 Green Revolution—An Assessment, at (last accessed on 13 September 2004). 139 See, generally, Roht-Arriaza, supra note 98. 51 of cell and molecular biology, has also stood to gain from the wealth of traditional knowledge. In the recently concluded ‘Human Genome Project’, the knowledge of the genetic codes of peoples in certain communities has helped the scientists in conducting a far more focused research.140 Through biotechnology tools, the desirable characteristics of a plant’s genetic resources are synthesized through rDNA transplantation technology, and a new plant variety is created. The importation of genetic characteristics in plants and animals is assisted by the prior knowledge of the strengths and weaknesses of various species. In many cases, genetic engineering has helped in creating new varieties of seeds that remove the traditional vulnerabilities found in crops, thus allowing agriculture dependent countries to achieve stability.141 Despite such exchanges between traditional knowledge and modern biotechnology research, the relationship between the knowledge holders and the pharmaceutical industry has been pragmatically worded in the following quote: “While many modern medicines are plant-derived, the origins of these pharmaceuticals and their relationship to the knowledge of the indigenous people in the tropical forests are usually not credited”.142 Since their knowledge and genetic resources are used in commercial ventures, for the sake of fairness, the knowledge holders must be compensated. Moreover the information embodied in the genetic constitution of the particular variety, becoming 140 For more information on the Human Genome Project, see, “A Vita Legacy”, at (last accessed on 15 July 2004). 141 See, supra note 90. Donald E. Bierer, Thomas J. Carlson, & Steven R. King, Shaman Pharmaceuticals: Integrating Indigenous Knowledge, Tropical Medicinal Plants, Medicine, Modern Science and Reciprocity into a Novel Drug Discovery Approach, at , (last accessed on 14 July 2004). 142 52 the subject matter of patent, does not remain freely available for further use. This impedes further research and sometimes, regular activities. The areas profoundly affected by biotechnology, particularly through DNA technology are medicine and agriculture, both of which are very vital zones for developing countries.143 Nevertheless, the importance of patenting products from such biodiverse resources cannot be undermined, since if the refined or improved product is not patented, it would be a deterrent to the researchers to continue research. It would also hamper the dissemination of valuable knowledge since a person can enjoy the benefits of a natural resource located in some other part of the world through such refined products.144 What is necessary is striking a balance between the drawbacks and the advantages of protecting products originating from traditional resources, so that the available resources could be used gainfully for the people at large. 1.6 PROTECTION Traditional knowledge systems appear to be an alternative paradigm to conventional intellectual rights systems properties in regard to the development and management of knowledge. ‘Protection’ means very different acts in IP law and in ordinary usage. In reference to IPR, ‘protection’ means that the owner of a patent, a copyright, a trademark or some other intellectual property has the right to exclude others from using or reproducing it. This is the way by which a specific intellectual property is protected. 143 An instance of such monopoly is the Canadian case of Monsanto v. Schmeiser. See note 543 here after. 144 For instance, Ginseng of China is now useable by the rest of the world only because it is available in an edible capsule form. 53 In ordinary usage, ‘protection’ has a much broader sense. It is in this sense that the term is used in regard to traditional knowledge. In the context of traditional knowledge, ‘protection’ is meant in the sense of continued existence and development of traditional knowledge. This implies protecting the whole social, economic, cultural and spiritual contexts of knowledge, something which is beyond the scope of IPRs.145 It is evident, from all the ‘bad patents’ on traditional knowledge granted throughout the world, that the procedures for examining patent applications are unsuitable for considering traditional knowledge while scouring for prior art for a particular invention. It is imperative that procedures for granting patents are reviewed so as to take into account all available information contained in the databases, publications and other sources. In its report on a series of fact-finding missions, WIPO146 sought to summarise the concerns of traditional knowledge holders as follows: • concern about the loss of traditional life styles and of traditional knowledge, and the reluctance of the younger members of the communities to carry forward traditional practices • concern about the lack of respect for traditional knowledge and holders of traditional knowledge • concern about the misappropriation of traditional knowledge including use of traditional knowledge without any benefit sharing, or use in a derogatory manner • lack of recognition of the need to preserve and promote the further use of traditional knowledge. 145 146 For CIPR’s views, see supra note 59. World Intellectual Property Organization, “Intellectual Property Needs and Expectations of Traditional Knowledge Holders”, WIPO Report on Fact-Finding Missions, 1998-1999, WIPO, Geneva (Publication Number 768E). 54 CBD has been the most vocal international instrument regarding the recognition, maintenance and protection of traditional knowledge. Article 10(c) of the CBD provides that “Each Contracting Party shall…Protect and encourage customary use of biological resources in accordance with traditional cultural practices that are compatible with conservation or sustainable use requirements…”. The idea of protection of traditional knowledge has also been included in Article 8(j) of the CBD. It says: “Each Contracting Party shall, as far as possible and as appropriate: …respect, preserve and maintain knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use of biological diversity and promote their wider application with the approval and involvement of the holders of such knowledge, innovations and practices and encourage the equitable sharing of the benefits arising from the utilization of such knowledge, innovations and practices…” From the contents of the aforesaid article, it seems that the CBD suggests the following measures for protection of traditional knowledge: • clarification of standards concerning the availability, scope and use of rights (which could include intellectual property rights) in knowledge, innovations and practices of indigenous and local communities, as well as the establishment of measures concerning the enforcement of those rights; • promotion of wide application of such knowledge, innovations and practices with the approval and involvement of the holders of such knowledge; 55 • encouragement of the equitable sharing of the benefits arising from the utilization of such knowledge, innovations and practices. Implementation of CBD in the area of conserving, maintaining and promoting wider application of traditional knowledge mostly concerns creation and development of registers and databases of traditional knowledge.147 Databases would enable the patent examiners to conduct a more accurate and comprehensive search for prior art in the field of traditional knowledge thus reducing the possibility of infringement of the same. Though there are many alternatives schemes for protection of traditional knowledge, these schemes can only be adopted at a national level.148 Attempts to safeguard traditional knowledge have been made under the auspices of the international organizations WIPO and the UNEP.149 147 United Nations University--Institute of Advanced Studies, The Role of Registers and Databases in the Protection of Traditional Knowledge: A Comparative Analysis, January 2004, available at, (last accessed on 15 July 2004). 148 Portugal has adopted a unique position by issuing a decree that establishes the legal regime of registration, conservation, safeguarding and transfer of autochthonous vegetable material with actual or potential interest for the agrarian, agriculture-forest activities and landscape, including local varieties and spontaneous material, as well as the associated knowledge. This involves: (a) Identification, description and registration of resources in the Registry of Plant Genetic Resources (RPGR); (b) Provision for third parties to access or use the traditional knowledge and to obtain results that are identical to those obtained by the knowledge holder. (c) The traditional knowledge owner can maintain the secrecy of the traditional knowledge, by merely notifying its brief particulars in a public gazette. (d) Where the traditional knowledge is not already in the public domain or being used in any industrial purposes, registration will entitle the owner of the traditional knowledge, • To prevent unauthorized third parties from reproducing, imitating and or using, directly or indirectly, for commercial purposes; • To assign, transfer or license the rights in traditional knowledge, including transfer by succession; • Traditional knowledge that is the subject matter of specific industrial property registrations is excluded from protection. (e) The registration of traditional knowledge shall provide effects for a period of 50 years from the date of the application, renewable for an identical period. See, Portugal, Decree-law no. 118/2002, April 20 2002, available at (last accessed on 13 August 2004). 149 United National Environment Program - CBD 56 The International Undertaking of 1983 was the first comprehensive international agreement dealing with plant genetic resources for food and agriculture. It was adopted by the Food and Agriculture Organization of the United Nations150 Conference in 1983, as an instrument to promote international harmony in matters regarding access to plant genetic resources for food and agriculture. The Undertaking had established that “plant genetic resources are a heritage of mankind to be preserved, and to be freely available for use, for the benefit of present and future generations”.151 Article 15 of the CBD deviates considerably from the aforesaid “plant genetic resources are a heritage of mankind” philosophy and affirms a state's sovereign rights over its genetic resources and its ability to regulate access to genetic resources. Parties to the CBD, however, must also facilitate access to genetic resources for environmentally sound purposes, subject to mutually agreed terms, and prior informed consent.152 The parties also must fairly and equitably share the results of research and development and the benefits arising from commercial and other use of genetic resources with the party providing such resources.153 By creating these rules relating to access to genetic resources, the CBD seeks to conserve biological diversity, sustainable use of its components, and share fairly and equitably the benefits arising from the use of genetic resources.154 Commensurate pieces of access legislation have 150 Food and Agriculture Organization (FAO), at (last accessed on 17 July 2005). International Undertaking of Plant Genetic Resources is available at (last accessed on 17 July 2005). 152 CBD, Article 15(2)-(5). See supra note 41. 153 CBD, Article 15(6). See supra note 41. 154 CBD, Article 1. See supra note 41. 151 57 been enacted in various countries. The Peruvian Regulations155 were the first to introduce plant breeders’ rights156 where a patent application must disclose along with proof the origin of the genetic resource of the plant variety and of the knowledge used in the invention.157 A similar requirement has been incorporated in Decision 391 of the Andean community on a Common Regime on Access to Genetic Resources. Bangladesh, Brazil, Denmark, Costa Rico and Organization of African Unity158 are some other jurisdictions with analogous provisions. Pakistan has a draft law on access and community rights. India has a number of relevant laws, the significant ones being the Biological Diversity Act (2002) and India’s Plant Variety Protection and Farmer’s Rights Act (2003).159 1.6.1 Methods of Protection The WIPO recognizes two classifications of protection of traditional knowledge: the defensive methods and the positive methods.160 The defensive methods are measures to prevent the unauthorized use of traditional knowledge or genetic resources, specially by obtaining IPRs on the traditional knowledge and the related genetic resources. The positive methods refer to the means to promote maintenance, 155 Peruvian Law Introducing a Protection Regime for the Collective Knowledge of Indigenous Peoples Derived from Biological Resources, available at (last accessed on 3 July 2005). 156 See note 417 here after. 157 Article 6 supra note 155. 158 Also referred to as OAU hereafter. 159 These Acts are discussed in Chapter III section 3.2.3. 160 “Defensive protection of traditional knowledge are measures that ensure that other parties do not obtain IP rights over pre-existing traditional knowledge. One example of such defensive protection is the development of traditional knowledge databases that may be used as evidence of prior art to defeat a claim to a patent on such traditional knowledge; and positive protection of traditional knowledge, or the use of existing legal mechanisms to protect and promote traditional knowledge. In some countries, legislation has been developed specifically to address the positive protection of traditional knowledge. Providers and users may also enter into contractual agreements and/or use existing IP systems of protection.” See, Traditional Knowledge, at (last accessed on 14 September 2005). 58 development and sustainable use of traditional knowledge for the benefit of the knowledge holding communities. 6.1(a) Defensive protection The need for defensive protection arises from the history of biopiracy faced by communities around the world. The enormous expenses involved in challenging a bad patent and the uncertainty of the outcome of such exercise has prompted the intellectual property regimes to follow the ‘prevention is better than cure’ philosophy and work out certain checks which would deter bio-prospectors from improperly procuring genetic resources or usurping traditional knowledge. It refers to provisions adopted in law or by regulatory authorities to prevent intellectual property right claims to a knowledge granted to unauthorized persons or organizations. Defensive protection of traditional knowledge can be provided in a number ways. In the Chapter II, the following forms of protection would be discussed: • The problem arising out of lack of consensus on the of definition of “Prior Art” • Compilation of traditional knowledge databases • Compulsory disclosure of origin of genetic resources used and the related traditional knowledge • Prior informed consent 6.1(b) Positive protection Positive measures to protect traditional knowledge imply that the right holders acquire some form of intellectual property right such as patent or any alternative right provided in a sui generis system. Mere assertion of a proprietary right over knowledge 59 may be insufficient to prevent abuse since a large amount of traditional knowledge has fallen into public domain and can not be controlled by the users. A more effective way may be to allow the use of such knowledge but to require that such use be subject to the consent of the knowledge holders and that they also be compensated. National legislation and enactments are the chief modes of achieving this form of protection. The following forms of positive protection of traditional knowledge are discussed in Chapter III of the thesis: • Development of a Sui generis system of traditional knowledge protection • Legislation governing access to the genetic resource and the related traditional knowledge • Establishment of Global Bio-collecting Society (GBS) Though a distinction has been made in the forms of protection, defensive protection refers to provisions adopted in law or by regulatory authorities to prevent claims of intellectual property rights to traditional indigenous knowledge to be granted to unauthorized persons, positive protection may also serve to provide defensive protection. The distinction between the two is thus often not well defined. 60 CHAPTER II: DEFENSIVE PROTECTION OF TRADITIONAL KNOWLEDGE 2.1 INTRODUCTION A no patent situation, probably, would have best served the purposes of traditional knowledge161 since it has not been developed for accrual of economic benefits but has been a way of life for millions across the world162. The fashion of resorting to ethnic ways of life leading to an evergrowing interest in products made from natural resources, and vindication of enormous financial returns for biotechnology corporations dealing with such products have prompted the commercialisation and commodification of traditional lifestyles, viz., the knowledge and practices and the genetic resources used by people in their daily lives. The biopiracy instances described in the previous chapter and the deluge of protests by the affected nations and people across the world has shown that traditional resources need to be brought under legal protection. Though the genetic resources can be protected through criminal legislation,163 the practice or the knowledge associated with that resource, being intangible, can not be protected with physical property protection laws alone. 161 Discussion on the definition of traditional knowledge in Chapter I, section 1.2. India’s late Prime Minister Indira Gandhi succinctly summed up the national sentiment regarding patents in biotechnology at the World Health Assembly in 1982: "The idea of a better-ordered world is one in which medical discoveries will be free of patents and there will be no profiteering from life and death." Quoted in Jean Lanjow, “The Introduction of Pharmaceutical Product Patents in India: ‘Heartless Exploitation of the Poor and Suffering’?”, Economic Growth Center, Yale University, August 26, 1997, 1. 163 Criminal legislation can be invoked in case of physical theft of genetic resources. Section 378 of the Indian Penal Code, (1860) holds that “whoever, intending to take dishonestly any moveable property out of possession of any person without that person’s consent, moves that property in order to such taking, is said to commit theft.” In Explanation 1 to the section it is stated that a thing attached to earth becomes capable of being subject of theft once severed from earth. The offence, under Section 379 is punishable with imprisonment upto three years and/or a fine. In the case of Dunyapat (1919) 42 All 53, it was held that removal of another man’s tree blown down by storm amounted to theft. RATANLAL RANCHHODDAS AND DHIRAJLAL KESHAVLAL THAKORE, RATANLAL & DHIRAJLAL'S THE INDIAN PENAL CODE (ACT XLV OF 1860), (29th ed., 2002) 1837. 162 61 Intellectual property laws have been found to be the closest option for protection of traditional knowledge and resources.164 WIPO has suggested that traditional knowledge may be protected through a combination of the standard intellectual property laws and sui generis legislation.165 India has, in the recent years, amended the patent act and enacted a number of sui generis legislation so as to protect traditional knowledge and modern biotechnological and pharmaceutical inventions. While the defensive protection and the positive protection methods stated in Chapter I now find place in the Indian laws, their efficacy would be limited unless such measures are included in international intellectual property rights agreements. This Chapter begins with a discussion on one of the obstacles in the evolution of an international intellectual property rights system, the concept of prior art. Next, the efficacy of traditional knowledge databases is considered. Finally two other defensive protection modes of preventing illegal acquisition of property rights on traditional knowledge and resources: the system of compulsory disclosure of origin and, submission of proof of prior informed consent with patent applications and their introduction to Indian laws are discussed. 2.2 PRIOR ART Though TRIPS emerged as a new force for harmonization of intellectual property regimes, there still remain significant areas of variance both in law and in procedure particularly in case of patents. Article 27(1) of TRIPS has determined the substantive requirements of a patentable invention namely, novelty, inventive step and industrial The Biodiversity Act of 2002 in India has also introduced access laws. See Chapter III section 3.3.1 of the thesis. 164 The limitations of standard IP laws in protecting traditional knowledge have been discussed in Chapter I section 1.4 of the thesis. 165 Traditional Knowledge, at (last accessed on 5 July 2005). 62 application. TRIPS or the other international agreements have not clarified the scope of information to be considered while evaluating novelty. The member countries have the latitude to form their own requirements of delimiting prior art. In regard to patents, prior art would deem such information ‘which would invalidate a patent or limit its scope’.166 A patent application is pitched against the available corpus of relevant knowledge, or the prior art, to ensure that the issued patent is being granted for an invention which is new. This is also to check that a patent, being a monopoly right, does not remove information already in the public domain to private ownership. A dispute regarding the same patented invention in different jurisdictions can result in diametric outcomes due to dissimilar interpretations of terminology.167 A case in point is prior art. Having different evaluation systems in various patent laws, ‘prior art’ has been a cause of contention among nations. 2.2.1 The legal position While TRIPS does not define novelty, the Regulations under the PCT168 provide that the description in a patent application should include “the background art which, as far as known to the applicant, can be regarded as useful for the understanding, searching and examination of the invention, and, preferably, cite the documents reflecting such art”.169 Accordingly, there may be requirements to disclose known prior art or to provide information about corresponding patent proceedings in other 166 University of Auckland Library, Patent Glossary, at (last accessed on 5 August 2004). 167 The neem patent by W.R. Grace, was revoked in the European Commission, but was held valid by United States Patents and Trademark Office. The case has been discussed in Chapter I section 1.3.2 of the thesis. 168 Supra note 20. 169 PCT, Rule 5.1 9(a)(ii). 63 jurisdictions. Disclosure of known prior art may be within the invention description itself, or by reference to relevant documents. There is reference in TRIPS to the option of requiring “information concerning the applicant’s corresponding foreign applications and grants”170 to be submitted with the patent application. The US described this obligation in the following terms: “…Each individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the USPTO, which includes a duty to disclose to the Office all information known to that individual to be material to patentability….”171 While the disclosure of the relevant prior art in the patent application is encouraged, most jurisdictions place the responsibility of evaluating the novelty of the invention on the patent granting authorities. A number of countries follow a world wide definition of prior art that does not discriminate between written and oral information. Others, whilst recognizing domestic oral art, do not recognize foreign undocumented usages, practices and information. In these countries patents may be granted because the invention has not been used domestically though it may have been used elsewhere. Some of the diverse positions taken by different countries while assessing prior art are discussed hereafter. TRIPS, Article 29.2. 37 Code of Federal Regulations (CFR) Section 1.56 also provides that “the Office encourages applicants to carefully examine: (1) Prior art cited in search reports of a foreign patent office in a counterpart application, and (2) The closest information over which individuals associated with the filing or prosecution of a patent application believe any pending claim patentably defines, to make sure that any material information contained therein is disclosed to the Office.” The same provision specifies that information is material to patentability “when it is not cumulative to information already of record or being made of record in the application, and (1) It establishes, by itself or in combination with other information, a prima facie case of unpatentability of a claim; or (2) It refutes, or is inconsistent with, a position the applicant takes in: (i) Opposing an argument of unpatentability relied on by the Office, or (ii) Asserting an argument of patentability.” [Secretariat footnote, not in original text]. 170 171 64 The two broad approaches to assess prior art are represented by the European and the American laws. While the European standards of novelty encompass any information which has been ‘made available to the public’, the American IPR system, recognizing only documented usages and knowledge in other countries, adheres to a narrow approach, or what has also been called the ‘mixed novelty approach’.172 Section 102 (b) of the US Patent Act considers an invention to be novel unless “the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for patent.”173 The American patent system recognizes documented knowledge from anywhere in the world but oral knowledge and usages prevalent only in the US as prior art.174 The European Patent Convention175 in Article 54(2) defines prior art or state of the art “to comprise everything made available to the public by means of a written or oral description, by use, or in any other way, before the date of filing of the European patent application”.176 The expression ‘made available to the public’ has been clarified by Aldous J. in P.L.G. Research Ltd. v. Ardon International Ltd.177 where he held, “Thus to form part of the state of the art, the information given (by the user) 172 GEORGE WEI, Fitting Biological Products within the Intellectual Property Framework: Challenges Facing the Policy Makers, in INTELLECTUAL PROPERTY AND BIOLOGICAL RESOURCES, (Burton Ong ed. 2004) 28. 173 Section 102 (b), U.S. Patent Act (Title 35 of the United States Code). 174 Unlike some countries like United Kingdom, EPC, Singapore, Australia; the priority date at which the novelty of invention is assessed under the US law is the date of invention, as opposed to the date of filing. 175 European Patent Convention (referred to as EPC in the instant thesis) is a Convention entered into in 1973 for the grant of European patents. The text is available at (last accessed on 7 September 2005) . 176 Article54, European Patent Convention, see id. 177 P.L.G. Research Ltd. v. Ardon International Ltd. [1993] F.S.R. 197 at 226. 65 must have been made available to at least one member of the public who was free in law and equity to use it”.178 The view is similar to the observation made earlier by Justice B.J. Wadia , Bombay High Court, that “The inventor is entitled to ask his friends confidentially to help him to advise him, provided they are not so many that they may be regarded as a portion of public”.179 The best interpretation of this case is that if the inventor imposes bars of confidence on the recipients, then even if they are numerous, the disclosure will not be treated as disclosure to the public. The Australian Patent Act originally practiced the narrow approach to novelty. The Australian prior art base would include printed publication anywhere in the world and usages within Australia. This stand has hence been amended by the Patents amendment Act 2001 to include acts which take place beyond Australia.180 The change applies to applications filed after 1 April 2002.181 The Singapore Patent Act182 178 This stand follows the position taken in the Fomento case where it was held that the gift of a single pen with a special characteristic invisible or of no interest to the common man constituted user, though it was distributed by way of a gift to an ordinary person with no interest, and that there was no evidence that any knowledge derived from that particular pen was utilised in any way. Fomento Industrial S.A. Biro Swan Ltd.v. Mentmore Mfg. Co. Ltd. (1956) RPC 87 at 106. 179 Lallubhai Chakubhai v. Chimanlal & Co. (1935) A.I.R. 1936 Bombay 99 at 107. 180 Act No.160 of 2001. 181 The words “in the patent area” have been removed from Section 7, specifically, sections 7(1) (b); 7(3) and 7(5)(b), dealing with novelty and inventive step in the Australian Patent Act 1990. Section 7 ((1)(b) now reads: “For the purposes of this Act, an invention is to be taken to be novel when compared with the prior art base unless it is not novel in the light of any one of the following kinds of information, each of which must be considered separately: … (b) prior art information (other than that mentioned in paragraph (c)) made publicly available in 2 or more related documents, or through doing 2 or more related acts, if the relationship between the documents or acts is such that a person skilled in the relevant art would treat them as a single source of that information”. Section 7(3) now reads: “The information for the purposes of subsection (2) is: (a) any single piece of prior art information; or (b) a combination of any 2 or more pieces of prior art information; being information that the skilled person mentioned in subsection (2) could, before the priority date of the relevant claim, be reasonably expected to have ascertained, understood, regarded as relevant and, in the case of information mentioned in paragraph (b), combined as mentioned in that paragraph”. Section 7(5)(b) now reads: “For the purposes of subsection (4), the information is of the following kinds: …(b) prior art information made publicly available in 2 or more related documents, or through doing 2 or more related acts, if the relationship between the documents or acts is such that a person skilled in the relevant art would treat them as a single source of that information”. 66 recognizes a world wide definition of novelty. According to Section 14183 of the Act, state of the art would comprise of any information available to the public by oral and written description in Singapore or beyond before the priority date.184 Prior art or the term “state of the art” is not defined in the Indian Patents Act. According to Narayanan, the law of patents in India is modeled largely on the lines of the Patent Act, 1949 of United Kingdom.185 The early English Patent Act used a limited understanding of novelty allowing patents which were known and practiced elsewhere but new in United Kingdom.186 The 1977 amendment of the UK Patent Act changed the position. As per section 2(2) of UK Patent Act, 1977, prior art would include “all matter (whether a product, a process, information about either or anything else) which has at anytime before the priority date of the invention been made available to the public187 (whether in United Kingdom or elsewhere) by written or oral description, by use or in any other way.”188 In the case of Lallubhai v. Shamaldas189, 182 Amended by Act 19 of 2004. Section 14, Singapore Patents Act (Chapter 221). (1) An invention shall be taken to be new if it does not form part of the state of the art. (2) The state of the art in the case of an invention shall be taken to comprise all matter (whether a product, a process, information about either, or anything else) which has at any time before the priority date183 of that invention been made available to the public (whether in Singapore or elsewhere) by written or oral description, by use or in any other way. 184 The ‘priority date’ of a patent is the date on which a patent application is tested against the state of the art. For United Kingdom (UK), European Patent Convention and a Paris Convention country including Singapore, the date of filing the patent application is the priority date. They follow the ‘first to file’ rule. However US follows the ‘first to invent’ rule. Priority date for a patent application in US is the day when the claimed invention was invented. See, UK Patents Act, 1977, Sections 5(1), (2); EPC, Article 7(1)-(3); Singapore Patent Act (Chapter 221) Section 17; Clause 101 of US Code 35. 185 Narayanan, supra note 24 at 7. 186 United Kingdom is hereinafter also referred to as UK. 187 The implications of the term ‘made available to the public’ would be similar to the provisions of the English law whereby this would be mean information available to atleast one member of the public who was free in law and equity to use it. However a mosaic of publications from which the information could be extracted would not be sufficient to invalidate the patent. See supra note 24 at 309. Also, see, Fomento Industrial S.A. Biro Swan Ltd.v. Mentmore Mfg. Co. Ltd. (1956) RPC 87. 188 The exceptions when prior publication or prior use would not constitute anticipation are when the invention was published without the consents of the applicant, or where the invention was communicated to Government to investigate the invention, its merits or anything done in consequence thereof, or whether the invention was displayed at an industrial or other exhibition approved by the Central government, or published in a paper read by the inventor before a learned society, or if 183 67 Justice Rangnekar of the Bombay High Court, while clarifying public use, held “..the doctrine of public user is that the patentee could not give any consideration to the public for the grant nor does he add to the knowledge of the public, if the invention which he claims to be new was either known to the public or used in public before the application for the patent, that is if the public already possessed everything that he could give…Public use does not mean use by public but use in a public manner and not secretly”. Initially Indian patent regime, following the UK Patent Act 1949, followed the limited novelty system, but under the newly introduced Section 2(l),190 India follows the worldwide novelty system.191 The PCT provides a common facility to conduct international searches of prior art for patent applications. All patents in the world are national documents granted under national rules and procedures. PCT allows patentees to shortcut some of that process, if they wish to seek protection internationally, by allowing for preliminary examination of the application. If the application is held valid, the inventor proceeds with national filing. The countries in which the application is filed have the liberty to evaluate the patent independently or accept the findings of WIPO's examiners. invention was publicly worked for the purpose of a reasonable trial. See Section 64(3) Patents Act 1970 as amended by the Act of 2005. 189 A.I.R. 1934 Bombay 407 at 417. 190 Section 2(l), Patent Amendment Act, 2005: “new invention” means any invention or technology which has not been anticipated by publication in any document or used in the country or elsewhere in the world before the date of filing of patent application with complete specification, i.e., the subject matter has not fallen in public domain or that it does not form part of the state of the art. 191 Prior art is difficult to establish for inventions relating to traditional knowledge, The Patent Act 1970, as amended by Act 38, 2002 (w.e.f. 20-5-2003) has prohibited patentability for inventions relating to traditional knowledge. Under Section 3(p): “an invention which is an aggregation or duplication of known properties of traditionally known component or components” would not be patentable. 68 However, Articles 15(1) and (2) of the PCT state that international applications would be subjected to international search to determine the relevant prior art192. The prior art would include “everything which has been made available to the public anywhere in the world by means of written disclosure (including drawings and other illustrations) and which is capable of being of assistance in determining that the claimed invention is or is not new and that it does or does not involve an inventive step (i.e., that is or is not obvious), provided the making available to the public occurred prior to the international filing date”193. Here too, a narrow description of prior art has been accepted, the search excluding unwritten knowledge and practices. 2.2.2 Recommendations and Conclusion a) Uniform internationally recognized definition of ‘prior art’ The restricted definition of using relative novelty standards is one of the means by which bad patents based on existing usages and practices are granted. It can be further interpreted to display a lack of respect to the traditional knowledge systems and the indigenous people across the globe. TRIPS is by far is the broadest multilateral treaty in the area of intellectual property rights. A world-wide novelty assessment approach should be mandated in the TRIPS for evaluation of prior art in the member states.194 192 Article 15, Patent Cooperation Treaty (PCT). Rule 33.1, Regulations under the PCT. 194 Professor Correa has held that novelty requirement should be defined so as to exclude patentability for any subject matter which was made available to the public, by means of written description, by use or in any other way, in any country before the date of filing, including use by local and indigenous communities and deposit of a material in a germplasm bank or other deposit institutions where such material is publicly available.” See, CARLOS CORREA, Access to Plant Genetic Resources and Intellectual Property Rights, in, PERSPECTIVES ON INTELLECTUAL PROPERTY: IP IN BIODIVERSITY AND AGRICULTURE (2001), 129. Dutfield has held that the mixed novelty system followed by US to evaluate prior art could legalize biopiracy. He has considered the world wide novelty evaluation system of EU fairer. See, GRAHAM DUTFIELD, Indigenous Peoples, Bioprospecting and the TRIPS Agreement: Threats and Opportunities, in, PERSPECTIVES ON INTELLECTUAL PROPERTY: IP IN BIODIVERSITY AND AGRICULTURE (2001), 143-144. 193 69 The member states should be required to include a corresponding absolute novelty provision in their patent laws, so as to avoid conflict with the TRIPS.195 b) Prior art should be construed broadly A fundamental difficulty vis-à-vis traditional knowledge search is that a lot of such knowledge is not codified. Non-codification is primarily due to three reasons. Firstly, traditional knowledge is transmitted through generations to by word of mouth and method of memorizing. Secondly, usages are automatically practiced across generations in communities and thus are often not codified and lastly traditional knowledge is often bound by religious rituals and practices. In such cases, communities are secretive about the knowledge.196 The possibility of such traditional knowledge being exposed in prior art searches undertaken by patent offices is remote unless the search is extensive. It is necessary that prior art should be construed broadly and flexibly for inventions which are likely to involve traditional resources. It is improbable that the prior art would be described exactly in the same language as would be disclosed in the invention. Interpretation of what prior art discloses must be sensitive to differences in knowledge systems and means of description.197 For instance, in case of the neem patent controversy, the pesticide sold by the bioprospector could not have been exactly the same compound as the decoction of the neem seeds traditionally used by the farmers in India as pesticide. The patented product was more value-added and had 195 See supra note 29 at 122. The CIPR has advocated application of an absolute standard of novelty such that “any disclosure anywhere in the world can be considered prior art.” 196 See, Foster v. Mountford, supra note 135. 197 See generally, VANDANA SHIVA, PROTECTING OUR BIOLOGICAL AND INTELLECTUAL HERITAGE IN THE AGE OF BIOPIRACY (1996). Dr. Shiva has held that to avoid bad patents, more importance should be given to non-western knowledge systems. 70 a longer shelf life than the version used by the Indian farmers. The pertinent question is how does the patent examiners evaluate prior art in this instance to opine whether the claimed product is worth intellectual property protection, or is that a mere tinkering of a known practice. In such cases, prior art should be evaluated in reference to the practical scope of the claims made in a particular patent application.198 What also needs to be keenly assessed is whether inventive step over the existing prior art, broadly construed, is significant to merit patent protection.199 Thus even if the neem invention crept over the novelty threshold, its proximity to the prior art raises doubts about the obviousness of the invention. In the case of Societe Technique De Pulverisation Step v. Emson Europe,200 Lord Hoffman held that the question of inventive step is a qualitative consideration based on a judgement as to whether grant of the patent would be innately fair. The patentability of a natural product in a purified and more stable form is an issue which was dealt with in the Merck case.201 Chao Hick Tin JA held that, “There was no blanket rule that either endorsed or prohibited the patentability of differences in the 198 See supra note 26. Referring to “magic spirit of the bark” as an alternative way to describe quinine, Lord Hoffman has supported that interpretation of prior art should be sensitive to cultural differences. 199 The cases clarifying the importance of non obviousness for patentability are Catnic Components Ltd and Another v. Hill & Smith Ltd. [1982] RPC 183 and Improver Corporation v. Remington Consumer Products Ltd [1990] FSR 181. In both these cases, it was held that the claims of a patent should be given a purposive construction rather than a purely literal one. Lord Hoffman, in the Improver case, formulated three questions which the court should ask if an alleged infringement falls outside the scope of the claims on a strictly literal interpretation. These questions, also called the Protocol questions, are: -Does the variant have a material effect upon the way the invention works? If yes, the variant is outside the claim. If no,- Would this have been obvious at the date of publication of the patent to a reader skilled in the art? If no, the variant is outside the claim. If yes, - Would the reader skilled in the art nevertheless has understood from the language of the claim that the patentee intended that strict compliance with the primary meaning was an essential requirement of the invention? If yes, the variant is outside the claim. See Cornish, supra note12, at 209-210, ¶¶ 6-05, 6-06. 200 (1993) RPC 513 (CA). Lord Hoffman held that the most important criteria for judging patent eligibility is that of ‘nonobviousness’ or ‘inventive step,’ this involves a question of fact and degree and is to be answered in accordance with the general policy of the Patents Act to reward and encourage invention without inhibiting improvements of existing technology by others. 201 Merck & Co Inc v. Pharmaforte Singapore Pte Ltd, [2000] 3 SLR 717. 71 degree of purity of a compound. Whether differences in purity of a compound were patentable would depend on the type of invention and the circumstances of each case.”202 However, the Indian Patent Act holds that a mere discovery of a new form of a known substance or the mere discovery of a new use of a known substance would not be patentable.203 c) Public examination The procedural variations in various patent regimens need to be reconciled for a harmonious patent system.204 USPTO allows patent specifications to be made public 202 Id. ¶ 30. Facts of the case: The appellant pharmaceutical company held a patent on Lovastatin with a dimer impurity level of less than 0.2%. The respondent company imported and distributed the pharmaceutical products product called `Apo-Lovastatin`. The appellant claimed infringement since Apo-Lovastatin possessed dimeric impurity levels of less than 0.2%. The respondents claimed that since purification did not alter the efficacy of the product, the appellants’ patent was invalid, for want of novelty and inventive step. The trial judge found that the appellants` patent was invalid as their product Lovastatin lacked both novelty and inventive step. It was also held that `Apo-Lovastatin` did not infringe since the process used to produce Apo-Lovastatin was different from that used by the appellants to produce Lovastatin. The issue of purification was dealt with in contexts of novelty and inventive step. On novelty the court of appeal held that a purer form a known compound was novel and hence patentable. However on facts the appellate court agreed with the trial judge that the appellants’ product did not produce any new advantage and hence held that purification was obvious and lacked inventive step (¶¶ 50-65). 203 This is in consonance with the recommendations of the Commission of Intellectual Property Rights (CIPR) In the Report of September, 2002. CIPR has advocated avoidance of “patenting of new uses of a known product.” See, supra note 29 at 122. Section 3(d) inserted by the 2005 amendment to the Indian Patent Act, with retrospective effect from 1.1.2005. The neem patent, under this Section may also be considered unpatentable. However, it may be queried whether inventions, which do not claim patents to the traditional knowledge but are a modified or a more stable form of what has been taught by traditional knowledge, can be patented. The complaint here is more the lack of inventiveness than lack of novelty. However, it is upto the patent examining offices to decide whether the invention is inventive enough to be considered novel if it is based on traditional knowledge. In such situations, it should be reconsidered if the invention may be granted a patent provided the knowledge was accessed according to provisions in national laws and fair benefit sharing arrangements has been made with the knowledge sharer community. As per the Section 3(p) of the Indian patent Act, however such an invention is umpatentable. See, supra note 316. 204 Since June 2000, WIPO has initiated a bid to harmonize patent procedures among the member states by way of a draft Substantive Patent Law Treaty (SPLT). Article 8 of SPLT offers two options while defining ‘prior art’, both providing for a worldwide novelty system. Alternative A reads: “The prior art shall consist of everything which, before the filing date or, where priority is claimed, the priority date of the application claiming the invention, has been made available to the public anywhere in the world, as prescribed in the Regulations.” Alternative B reads: “Subject to Articles 9 and 10, the prior art with respect to a particular claim shall consist of all information which has been made available to the public anywhere in the world, as prescribed in the Regulations, before the filing date or, where priority is claimed, the priority date of the application which discloses the subject matter of the claim.” In the last meeting of the Committee on Patents (SCP) held in June 2005, the members were divided on how 72 after the grant of patent. Hence a patent can only be disputed post-grant. This not only increases litigation expenses, but is also time consuming. A pre-grant public examination of the specifications relating to the biological sources, the prior art referred to, country of origin and the traditional knowledge used would allow the countries with possible claims as the country of origin to make submissions before the patent is granted. A universal definition of prior art should be adhered to recognizing not only international written or documented knowledge but also usages, unwritten knowledge and oral traditions.205 In the present era of globalization and electronic transfer of information, difficulties in locating undocumented prior art can not be an excuse to cling on to regional novelty system. Infact, it has encouraged researchers from states with absolute novelty system to obtain patents on inventions based on undocumented traditional knowledge in jurisdictions where a regional novelty system is practiced.206 future work of the committee should proceed. While some member, mostly the developed countries suggested that the four issues of prior art, grace period, novelty and inventive step be initially taken up for discussion, and the specifically want the issues relating to sufficiency of disclosure and genetic resources be taken up at the Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC). The developing countries are opposed to separation of the issues and want the draft Treaty to be disc used as whole. While it seems unlikely that the Treaty would be finalized soon, one looks forward to a harmonized international document plugging the existing lacunae specially in areas of rights of protection of traditional knowledge and related resources. Substantive Patent Law Harmonization, available at (last accessed on 5 July 2005). 205 At the Intellectual Property and Biological Resources Conference in Singapore in December 2003, Professor Charles R. McManis, Thomas and Karole Green Professor of Law and Director of the LLM Program in Intellectual Property and Technology Law had said that the United States had adhered to a local definition of patents to encourage innovation at a stage when they were a developing nation and needed to boost the local industries. The rationale, though might have been relevant at the time of the first enactment of intellectual property law, is of hardly any relevance now since the relative novelty standard use by United States allows people to copy undocumented foreign knowledge and obtain patent rights over the same. Charles R. McManis, Fitting Traditional Knowledge Protection and Biopiracy Claims into The Existing Intellectual Property and Unfair Competition Framework, in INTELLECTUAL PROPERTY AND BIOLOGICAL RESOURCES, (Burton Ong ed. 2004) 425 at 451. 206 For instance see discussions on patenting of turmeric and neem at USPTO in Chapter I sections 1.3.1 and 1.3.2 above. 73 Countries that only include domestic use in their definition of prior art, should give equal treatment to users of knowledge in other countries. In addition, the unwritten nature of traditional knowledge should be borne in mind in any attempt to further develop the patent system internationally. Efforts are being made to codify traditional knowledge and maintain databases of such information so that it prevents granting of bad patents. Some of such efforts are discussed in the next section. 2.3 DATABASES Compilations of traditional knowledge databases have been effected for a number of purposes apart from preventing biopiracy. Documented traditional knowledge could be made available to patent examiners around the world so that prior art in the case of inventions based on such traditional knowledge and genetic resources referred therein, is readily traceable. Further, documentation should facilitate identification of communities with whom benefits of commercialisation of such materials/knowledge have to be shared. It would also prevent the extinction of such knowledge due to intrusion of urban lifestyle in traditional societies.207 A WIPO Report has held that “Documenting TK208 includes recording it, writing it down, taking pictures of it or filming it - anything that involves recording your traditional knowledge in a way that preserves it and could make it available for others to learn about your knowledge. It is different from the traditional ways of preserving 207 Once documented, information would fall in the written public domain of knowledge and would be recognized as novelty defeating prior art even by patent offices which do not recognize undocumented foreign traditions, usages and local knowledge as prior art for evaluating novelty of a patent claim. CIPR has said that documentation of traditional knowledge will, other than restricting biopiracy, contribute to “preservation, promotion and possible exploitation of traditional knowledge”. CIPR, supra note 29 at 82. 208 Traditional knowledge is also referred to as “TK” or “tk”. 74 and passing on knowledge within the community. Documentation is especially important because it is often the way people beyond the traditional circle get access to traditional knowledge…. In some cases, documentation could mean putting TK into new media or new languages.”209 During the third session of WIPO in 2002, it was decided to devise a ‘toolkit’ for guiding the preparation of databases.210 The proposed toolkit is to act as a guide to compilers particularly in regard to the intellectual property implications of recording information in databases and educating the traditional communities about the pros and cons of adopting such measure.211 The toolkit takes the documentation process as a starting point for a more advantageous management of traditional knowledge as a community’s intellectual and cultural asset.212 It also enumerates measures for educating the traditional communities about the consequences of documentation of their knowledge.213 209 See, World Intellectual Property Organization, Report on The Toolkit For Managing Intellectual Property When Documenting Traditional Knowledge and Genetic Resources, WIPO/GRTKF/IC/5/5, page 4 Annex, WIPO, Geneva, 1 April 2003. 210 WIPO recognised that documentation of traditional knowledge was a defensive protection against biopiracy. Supra note 165. 211 The toolkit suggests that documentation can be effected by the use of a variety of mediums including audio-visual tools. The toolkit proposes a three-tier system for recording traditional knowledge information. The kit advises that before documentation, the traditional knowledge holding community should be fully aware of the consequences of such documentation, and the individuals involved should be apprised about the pros and cons. Documented prior informed consent may be obtained to avoid disputes. During documentation, all information regarding a piece of knowledge should be included. This should comprise of data regarding individual efforts for promotion and preservation of the knowledge and list of individual claimants in case of probable benefits. Documentation is not synonymous to making the knowledge public, and the knowledge must be documented keeping in mind whether the knowledge has to be kept secret. After documentation, possibilities of protecting the database with IP and other laws should be evaluated, and as per the goal of the knowledge holder society, the knowledge compilation may be publicized or kept secret. To maintain secrecy, the knowledge holders may use confidentiality agreements and other contracts with the persons or bodies they are sharing their knowledge with, even if for documentation purposes. See, supra note 209. 212 For a draft of the proposed toolkit, see, Maria Thereza Wolff, Report of the meeting of the Intergovernmental Committee of Intellectual Property and Genetic Resources Traditional Knowledge and Folklore, 5th Session, July 2003, available at (last accessed on 23 July 2004). 213 Supra note 209. 75 Some countries have developed databases of traditional knowledge and related practices.214 Such exercises have been undertaken by various nations not only to check biopiracy, but also to respond to the growing need of recording information which stand the risk of elapsing into oblivion, and further, to live up to the demands of the rapidly developing information dissemination technologies around the world.215 Some jurisdictions protect databases through copyright laws. However copyright protects the expression only and not the contents of the database. While database producers would want broader protection for their databases, for traditional knowledge database holders, it is more important to protect the contents of the database. An analysis of the database protection in some countries follows. It is seen 214 WIPO has published samples of traditional knowledge databases from China, India, and Venezuela, to demonstrate the knowledge available and to illustrate examples of intellectual property issues that have arisen from traditional knowledge databases. See, World Intellectual Property Organization "Inventory of existing online databases containing traditional knowledge documentation data", Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore, WIPO/GRTKF/IC/3/6, WIPO, Geneva, 2002. Further, The American Association for the Advancement of Science has launched a project, viz. TEKPAD for the preparation of electronic databases to establish prior art. TEKPAD is the acronym for “Traditional Ecological Knowledge Prior Art Database.” The database launched in 2001, is at < http://ip.aaas.org/tekindex.nsf> (last accessed on 13 July 2005). APINMAP, launched by UNESCO, is a network of organizations who are working to create traditional knowledge databases in Asia-Pacific countries. APINMAP is the acronym for Asian Pacific Information Network on Medicinal and Aromatic Plants. It is located at the The APINMAP Secretariat Secretary-General APINMAP, c/o Ministry of University Affairs, 328 Sri Ayutthya Road, Bangkok 10400, Thailand. The APINMAP member countries include: Australia, People's Republic of China, India, Indonesia, The Republic of Korea, Malaysia, Nepal, Pakistan, Papua New Guinea, Philippines, Sri Lanka, Thailand and Vietnam. See, Dr. Susan Macarthy, APINMAP-An Asian Medicinal Plants Database, at (last accessed on 13 July 2005). TradiMed is a Korean government supported database development project aiming to integrate the ancient knowledge of oriental medical traditions with modern science and technology. TradiMed has been developed at the Natural Products Research Institute, in Korea since 1992. The database is at http://www.tradimed.com (last accessed on 13 July 2005). China is modernizing its traditional medicine industry in the hope of cornering the fast growing world market for natural medicines. In China, an herbal medicine gene database project was launched in April 2002 that is expected to combine traditional Chinese medical science with gene pharmaceutical technology. See, Gene Technology set to decode Traditional Chinese Medicine, Xinhuanet, 16 April 2002 ,at http://www.checkbiotech.org (last accessed on 13 July 2005). The Malaysian government has built the "Sarawak Biodiversity Centre," whose purpose is to help develop national policy and guidelines, and to document indigenous medicinal practices. Malaysia established a National Biodiversity Policy in 1997. The “Sarawak Biodiversity Centre” has been established by this policy. More about the Centre is at Sarawak Biodiversity Centre, at < http://www.sbc.org.my> (last accessed on 13 July 2005). 215 The Indian government developed Traditional Knowledge Database Library (TKDL) is discussed in Chapter II Section 2.3.2 of the thesis. 76 that while most jurisdictions protect the industry behind the creation of a database, the protection for the contents is thin. 2.3.1 Legal Protection of Databases The WIPO has suggested that traditional knowledge be protected by means of a combination of measures including conventional IP laws.216 Traditional knowledge databases therefore should be protected by general database protection laws. Various national regimes have endeavoured to protect the databases using basic intellectual property, namely, copyright laws. The following discussion of some of the copyright regimes highlights the inadequacy of standard copyright laws in protecting the contents of a database. Sections 102 and 103 of the US Copyright Act, 1976 provide that “compilation” would be entitled to copyright protection if they qualify as “original work of authorship.”217 Facts and mere data are excluded from the scope of copyright.218 In Bellsouth Advertising & Publishing Corp v. Donnelly Information Publishing Inc and 216 See, World Intellectual Property Organization, Revised Version of Traditional Knowledge Policy and Legal Options, Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore, WIPO/GRTKF/IC/6/4, WIPO, Geneva, March 2004. 217 Section 102, US Copyright Act, 1976, 17 U.S.C.: Subject matter of copyright: In general (A) Copyright protection subsists, in accordance with this title [17 USCS Sects. 101 et seq.], in original works of authorship fixed in any tangible medium of expression, now known or later developed, from which they can be perceived, reproduced, or otherwise communicated, either directly or with the aid of a machine or device. Works of authorship include the following categories: (1) literary works; (2) musical works, including any accompanying words; (3) dramatic works, including any accompanying music; (4) pantomimes and choreographic works; (5) pictorial, graphic, and sculptural works; (6) motion pictures and other audiovisual works; (7) sound recordings; and (8) architectural works. (B) In no case does copyright protection for an original work of authorship extend to any idea, procedure, process, system, method of operation, concept, principle, or discovery, regardless of the form in which it is described, explained, illustrated, or embodied in such work. Section 103: Subject matter of copyright: Compilations and derivative works: (a) The subject matter of copyright as specified by section 102 [17 USCS Sect. 102] includes compilations and derivative works, but protection for a work employing preexisting material in which copyright subsists does not extend to any part of the work in which such material has been used unlawfully. (b) The copyright in a compilation or derivative work extends only to the material contributed by the author of such work, as distinguished from the preexisting material employed in the work, and does not imply any exclusive right in the preexisting material. The copyright in such work is independent of, and does not affect or enlarge the scope, duration, ownership, or subsistence of, any copyright protection in the preexisting material. 218 Section 103 , US Copyright Act, 1976. 77 another it was quoted from Feist219 that "[t]he primary objective of copyright is not to reward the labor of authors, but '[t]o promote the Progress of Science and useful Arts.'…To this end, copyright assures authors the right to their original expression, but encourages others to build freely upon the ideas and information conveyed by a work."220 This holding overruled numerous lower courts that adopted a "sweat of the brow" or "industrious collection"221 test of copyrightability.222 The Supreme Court expressly stated that this "sweat of the brow"223 analysis was faulty, and that copyright extended only to the original selection, coordination, and arranging of data, and not to any unprotected facts contained within the compilation.224 219 Facts of the case: Feist copied information from Rural's telephone listings to include in its own, after Rural refused to license the information. Rural claimed a collection copyright in its directory and sued for copyright infringement. The Court clarified that the intent of copyright law was not, as claimed by Rural to reward the efforts of persons collecting information, but rather "to promote the Progress of Science and useful Arts" (U.S. Const. 1.8.8), that is, to encourage creative expression. The Court ruled that Rural's directory was nothing more than an alphabetic list of all subscribers to its service, and that no creative expression was involved and therefore Rural's phone directory was not copyrightable,. The fact that Rural spent considerable time and money collecting the data was irrelevant to copyright law, and Rural's copyright claim and allegation of infringement were dismissed. Feist Publications Inc. v. Rural Telephone Service Company Inc, 111 S Ct. 1282; 113 L Ed 2d 358; 20 IPR 129 (US Supreme Court, 1991). 220 Bellsouth Advertising & Publishing Corp v. Donnelly Information Publishing Inc and another 999 F2d 1436 (11th Cir. 1993) at 1445. 221 Industrious collection: This term implies that there has been sufficient work involved and expenses occurred in gathering the data in a compilation. Copyright protection could be given as a reward for the author’s investment of time and money. Telstra Corporation Limited v. Desktop Marketing Systems Pty Ltd [2001] 51 I.P.R. 257 at 269-270. See, note 231 hereafter. 222 Under this test, if a compilation was created as a result of a great deal of effort, copyright protection would extend to the compilation regardless of the creativity or originality in the selection, coordination, or arrangement of the facts. In fact, under this overruled doctrine, copyright protection extended to each fact contained within the compilation--no extraction of facts from a compilation was allowed. 223 The "sweat of the brow" doctrine, holds that copyright for a compilation is a reward for the hard work that went into compiling the facts, regardless of originality of selection and arrangement. 224 In the recent past, the two Second Circuit decisions in Matthew Binder & Co. v. West Publishing Co. (158 F.3d 674, 48 U.S.P.Q. 2d (BNA) 1560 (2d Cir. 1998); 158 F. 3d 693, 48 U.S.P.Q. 2d (BNA) 1545 (Cir.1998)) signaled a reinforcement of the Feist conclusion that “originality, not ‘sweat of the brow’, is the touchstone of copyright protection in directories and other fact-based works.” Also see, Warren Publishing Inc. v. Microdos Data Corp and others, where copyright a massive extraction of data from a printed directory for compiling another database was allowed. [1992] CCH Copyright Law Decisions 26928; 3 CCH Computer Cases 46,683 (Dist., Northern District Georgia, Atlanta Division, 1992). 78 US has endeavoured to legislate toward protecting the data in a database.225 Among the latest legislative efforts is H.R.3261, Database and Collections of Information Misappropriation Act. Under this Act, a person, who appropriates information from a database complied by another, and commercially uses the same, other than being prevented from doing so, is to be held civilly liable to pay damages to the database owner. The Bill was introduced to the House of the 108th Congress in 2003 and is yet to be passed.226 The Berne Convention for the Protection of Literary and Artistic Works227 is the oldest international instrument regarding copyright covering scientific, literary and artistic productions and through subsequent amendments, specially in 1967, has a very wide scope. The TRIPS has expressly provided for protection of computer 225 The H.R. 354, Collections of Information Antipiracy Act considered by the 106th United States Congress gave database owners the right to prevent certain acts of extraction of information from their database for uses of information into down-stream products, whether or not they compete with the database. Section 1402 on prohibition of copying from the database read: `(a) MAKING AVAILABLE OR EXTRACTING TO MAKE AVAILABLE- Any person who makes available to others, or extracts to make available to others, all or a substantial part of a collection of information gathered, organized, or maintained by another person through the investment of substantial monetary or other resources, so as to cause material harm to the primary market or a related market of that other person, or a successor in interest of that other person, for a product or service that incorporates that collection of information and is offered or intended to be offered in commerce by that other person, or a successor in interest of that person, shall be liable to that person or successor in interest for the remedies set forth in Section 1406. `(b) OTHER ACTS OF EXTRACTION- Any person who extracts all or a substantial part of a collection of information gathered, organized, or maintained by another person through the investment of substantial monetary or other resources, so as to cause material harm to the primary market of that other person, or a successor in interest of that other person, for a product or service that incorporates that collection of information and is offered or intended to be offered in commerce by that other person, or a successor in interest of that person, shall be liable to that person or successor in interest for the remedies set forth in section 1406. The bill was placed on the Union Calendar, Calendar No. 212 on 10th August 1999. However the bill was not enacted. Space constraints in the instant thesis do not permit a detailed discussion of the arguments raised for and EU styled database laws. 226 For more information, see, the summary and status of the bill at the THOMAS website, at (last accessed on 1 July 2005). 227 Berne Convention for the Protection of Literary and Artistic Works, Paris Act of July 24, 1971, as amended on September 28, 1979 79 programs, as a type of literary work under the provisions of the Berne Convention.228 Article 2(8) of the Convention states, “The protection of this Convention shall not apply to news of the day or to miscellaneous facts having the character of mere items of press information.” As per the Convention, copyright protection is only available for expression but not for mere facts or the contents of the protected subject matter. The provision is also reflected in Article 9(2) of the TRIPS which states that “Copyright protection shall extend to expressions and not to ideas, procedures, methods of operation or mathematical concepts as such”.229 This credo is adhered to in copyright legislation of some countries.230 Other countries have taken a more robust position and have accepted that copyright protection can extend to the effort of collection. A case in point is the Australian 228 TRIPS AGREEMENT, Article 10, Computer Programs and Compilations of Data: 1. Computer programs, whether in source or object code, shall be protected as literary works under the Berne Convention (1971). 2. Compilations of data or other material, whether in machine readable or other form, which by reason of the selection or arrangement of their contents constitute intellectual creations shall be protected as such. Such protection, which shall not extend to the data or material itself, shall be without prejudice to any copyright subsisting in the data or material itself. 229 Article 10(2) of TRIPS Agreement also provides that: “Compilations of data or other material, whether in machine readable or other form, which by reason of the selection or arrangement of their contents constitute intellectual creations shall be protected as such. Such protection, which shall not extend to the data or material itself, shall be without prejudice to any copyright subsisting in the data or material itself.” TRIPS Agreement text has been accessed from WTO website available at (last accessed on 1 July 2005). 230 An instance of legislative compliance of Article 10(2) of TRIPS Agreement is Section 7A of Singapore Copyright Act : “Literary works include compilation and computer program - (1) For the purposes of this Act, “literary work” includes — (a) a compilation in any form; and (b) a computer program. (2) Any copyright subsisting in a compilation by virtue of Part III — (a) is limited to the selection or arrangement of its contents which constitutes an intellectual creation; and (b) is in addition to, and independent of, any right subsisting by virtue of Part III, IV or XII in any relevant material or data contained in the compilation. (3) For the purposes of this section — “compilation” means — (a) a compilation, or table, consisting wholly of relevant materials or parts of relevant materials; (b) a compilation, or table, consisting partly of relevant materials or parts of relevant materials; or (c) a compilation, or table, of data other than relevant materials or parts of relevant materials, which, by reason of the selection or arrangement of its contents, constitutes an intellectual creation; “relevant material” means — (a) a work, including a computer program; (b) a sound recording; (c) a cinematograph film; (d) a published edition of a work; (e) a television or sound broadcast; (f) a cable programme; or (g) a recording of a performance within the meaning of Part XII”. 80 decision in Telstra Corporation Limited v. Desktop Marketing Systems Pte Ltd 231 . The primary issue in this case concerned the standard of originality required for a compilation of data to qualify as a copyright work. The court reviewed the approaches taken in different countries, particularly the US decision in the Feist232 case which held against copyright in the white page entries per se. The Australian Court differed and found that under the Australian Copyright Act, a compilation might well be original by reference to industrious collection. Countries that apply an industrious protection approach would provide broader copyright protection that might be attractive to traditional knowledge database producers. Nevertheless, the trend is very much against this as TRIPS and WIPO Copyright Treaty233 clearly support protection limited to original arrangement or selection of facts. The European Union (EU) directive has enumerated provisions for protection of databases.234 Directive 96/9 concerning the Legal Protection of Databases may also be used to protect traditional medicinal knowledge and folklore collection. Article 1, paragraph 2 defines the concept of database in these terms: “A collection of independent works, data or other materials arranged in a systematic or methodical way and individually accessible by electronic or other means.” The protection provided by the Directive is at two levels. Firstly it provides for database protection 231 Facts of the case: Telstra published white and yellow pages directories. Telstra also produced "heading books" which contain the categories for yellow pages directories. Desktop Marketing Systems produced three different CD-ROM computer software products. Each product used data from Telstra's white and yellow pages directories and contained headings similar to those used by Telstra. Telstra sued for infringement of copyright by Desktop. It was held that copyright subsisted in Telstra’s White Pages and Yellow pages directories and that Desktop infringed the copyright by its production of a CDROM form of directory, which utilized the entries in the White Pages. The decision was unsuccessfully appealed to a Full Court and special leave to appeal to the High Court was refused. [2001] 51 I.P.R. 257. The Full Court appeal decision is cited at [2002] F.C.A.F.C. 112. 232 See, supra note 219. 233 WIPO Copyright Treaty (WCT), adopted in 1996, in force from 6 March 2002. 234 Directive 96/9/EC of the European Parliament and of the Council of March 11, 1996, on the legal protection of databases Official Journal L 077 , 27/03/1996 P. 0020 - 0028 81 through means of national copyright acts. Copyright protection would be available for “databases which, by reason of the selection or arrangement of their contents constitute the author’s own intellectual creation”.235 This “copyright protection of databases […] shall not extend to their contents and shall be without prejudice to any rights subsisting in those contents themselves.”236 As the latter provision indicates, the protection in question does not directly apply to the expressions of folklore but only to their publication and presentation in the form of a collection, anthology or compilation. The EU has attempted to standardize the copyright protection laws in the member states and has insisted on the reciprocity of treatment amongst the member states. Since such protection is targeted towards protecting author’s own intellectual creation or what may be called the expression only and would not extend to their contents and shall be without prejudice to any rights subsisting in those contents themselves, it does not benefit the community that is at the origin of the traditional knowledge, but rather the person who has made the said collection. The only criterion for protection is that, as a literary work, the compilation must be “original”237 in order to qualify for protection. The views of Peterson J. in University of London Press v. University Tutorial Press238 evinces that the requirement for originality in this context has been held by courts to be satisfied if it could be shown that some degree of “labour, skill and judgement” had been applied in the “selection and arrangement” of the contents of the work. 235 Article 3 paragraph.1 of the EU Directive 96/9/EC. Article 3 paragraph 2 of the EU Directive 96/9/EC. 237 Section 1(1)(a) Copyright, Designs and Patents Act 1988, United Kingdom. 238 [1916] 2 Ch. 601. 236 82 EU further provides for the creation of a sui generis right of the database owner in the contents of a non original database. This provision is for the benefit of the database maker who has made a substantial investment in the endeavour.239 The database owner was effectively granted an exclusive property right in the contents of the database to prevent unauthorized extraction and reutilization of the whole or substantial part of the contents of the database. Unlike the copyright protection duration, which is for life time of the author plus 70 years, the sui generis protection is available for fifteen years.240 The accrual of a sui generis right to the database maker does not require the showing of a creative achievement or a novel contribution to the prior art; rather it accrues on merely showing that there has been qualitatively and/or quantitatively a substantial investment in the obtaining, verification or presentation of the contents.241 From the British Horseracing Board Ltd v William Hill Organisation Ltd242 it seems that for countries wanting to encourage setting up of traditional knowledge databases, 239 Article 7(1) of the EU Directive 96/9/EC.: “Member States shall provide for a right for the maker of a database which shows that there has been qualitatively and/or quantitatively a substantial investment in either the obtaining, verification or presentation of the contents to prevent extraction and/or reutilization of the whole or of a substantial part, evaluated qualitatively and/or quantitatively, of the contents of that database”. 240 Article 10(3) of the EU Directive 96/9/EC provides that “Any substantial change, evaluated qualitatively or quantitatively, to the contents of a database, including any substantial change resulting from the accumulation of successive additions, deletions or alterations, which would result in the database being considered to be a substantial new investment, evaluated qualitatively or quantitatively, shall qualify the database resulting from that investment for its own term of protection.” Therefore a fresh term of 15 years apply where the database is substantially changed. Given that most databases, including a traditional knowledge database will be dynamic and evolving, the possibility of ever renewing terms of protection would be attractive to database producers. While giving her opinion on this provision in the case of British Horseracing Board Ltd v William Hill Organisation Ltd , the Advocate General has considered this phenomenon as not the extension of the term of protection of the database, but the creation of a new database right. 241 Legal protection: databases, at (last accessed on 14 August 2004). 242 Case C-203/02. The bookmaker William Hill had copied part of British Horseracing Board’s database , namely the names of horses and jockeys on William Hill's website. While the UK High Court and the Appeal Court had ruled in favour of the board, and decided that the use of the names of horses and jockeys on William Hill's website was an infringement of the board's database rights, the 83 aside from copyright which might only provide thin protection for original selection and arrangement, there is a need to consider the desirability of stronger database rights.243 After the adoption of the European Database Directive, a Draft Treaty for the protection of databases was tabled at the Diplomatic Conference of WIPO.244 The Treaty extends protection to the expression of the database and not to the contents, or “the data or the material itself.”245 The proposals of the Treaty have not gone far and WIPO is yet to be able to gather momentum on this issue. There is no legislation in India dealing singularly with databases. The Indian Copyright Act, 1957 provides an inclusive definition of “literary works” so as “to include computer programmes, tables and compilations including computer European Court of Justice (ECJ) took a narrower view on infringement and held that by using a small part of the Board’s database, William Hill was not violating the board’s database rights. 243 But then there might be the disadvantage that such rights are a severe impediment to freedom of information especially when crafted as a full property right. Dissemination of traditional knowledge is one of the ways that the knowledge has been preserved through generations. Proper dissemination of traditional knowledge is also an aim of CBD. A full property right might therefore not be synergetic to traditional knowledge. 244 In November 1996, soon after the adoption of the European Database Directive, a Draft Treaty for the protection of databases was put to the Diplomatic Conference of WIPO. The Draft WIPO Database Treaty incorporated a sui generis right approach, containing two alternative proposed terms of protection (Article 8), for 15 or 25 years. Any substantial change to the database, evaluated qualitatively or quantitatively, including substantial change resulting from the accumulation of successive additions, deletions, verifications, modifications in organization or presentation or other alterations, which constitute from such investment, would qualify the database resulting from such investment for its own term of protection (Article 8 (3)).However, any new substantive investment in the database would mean a new term of protection for the whole of the database, and not only for the new material. Therefore, the Draft Treaty was explicit in aiming at the implementation of a perpetual protection of databases. So, though the term of protection of a database was stipulated to 15 or 25 years, in fact, the Draft Treaty meant a protection forever. On exceptions, individual countries were to be allowed to provide for exceptions and limitations to rights, but not if these exceptions and limitations conflicted with the normal exploitation of the database or unreasonably prejudiced the legitimate interests of the rightholder. The Treaty is yet to be finalised. 245 Article 5 of the WIPO Database Treaty states that: ““Compilations of data or other material, in any form, which by reason of the selection or arrangement of their contents constitute intellectual creations, are protected as such. This protection does not extend to the data or the material itself and is without prejudice to any copyright subsisting in the data or material contained in the compilation”. 84 databases”.246 The Indian copyright law thus specifically recognizes copyright protection for compilations and computer databases as literary works but does not stipulate the content of a compilation. The author in relation to a database would either be the creator, or, if the database is computer-generated, then under Section 2(d)(vi), the person who causes the database to be created. This would include the person who takes the initiative and responsibility for creating the database. Databases, in India, are protected through the provisions of the Copyright Act, 1957 and the Information Technology Act, 2000. It is pertinent to mention that India, being a commonwealth country, follows the “sweat of the brow” doctrine. The level of originality required for a compilation to be considered as a work, and the “sweat of the brow” in gathering data have been the subject of some cases before the Indian courts. The Indian courts have therefore protected compilations involving minimal originality as has been held, in the case of V.Govindan v. E.M.Gopalakrishna and Anr., that “no man is entitled to steal or appropriate for himself the result of another’s brain, skill or labor even in such works.”247 In Burlington Home Shopping v. Rajnish Chibber,248 it was held that a compilation of addresses developed by any one by devoting time, money, labour and skill though the source may be commonly situated amounts to a ‘literary work’ wherein the author has a copyright. In the recent decision 246 Section 2(o) of the Indian Copyright Act, 1957. AIR 1955 Madras 391. Facts of the case: The original plaintiff, respondent in the instant appeal case, had compiled an English-English Tamil dictionary in 1932. The appellant, the original defendant, had published another English-English Tamil dictionary under a different name in 1947. In the suit for infringement, the defendant claimed that the dictionary, being a “mechanical thing” was not capable of having copyright. The Trial Court and the Appeal Court disagreed saying that the defendant’s publication was infringing and the plaintiff was entitled to damages and injunction. AIR 1955 Madras 391. 248 1995 PTC (15) 278 247 85 of Eastern Book Company v. Navin J. Desai,249 however a doubt has been cast on whether the “sweat of the brow” doctrine would continue to hold sway.250 For nonoriginal databases, the compiler’s discretion and skill have been recognised as relevant criteria while extending copyright protection.251 Section 13 of the Copyright Act, 1957 provides for copyright protection to original literary works, which include compilations.252 Section 14 specifies the exclusive 249 Facts of the case: The case involved a database of copy-edited judgments along with head-notes published by the plaintiff on CD-ROM, which it alleged, the defendant had copied. The Plaintiff/ Appellant had argued that it had expended great skill in the collection, selection and correction of judgments. The Court did not give any finding on the aspect of protecting the copyright in the collection and selection of judgments. It relied on Section 52 (1) (q) (iv) of the Copyright Act, 1957 which states that it is not an infringement of copyright to reproduce or publish judgments of Courts. The Court held and stated that a genuine abridgment of judgments of the Court was an original work and could be the subject-matter of infringement of a copy right even if the amount of originality is very small, but by merely correcting such judgments, the Plaintiff was not able to establish that such judgments had become original literary works which would take them out of the realm of the public domain. Further, when the head-notes were verbatim extracts from the judgments of the Courts, there was no amount of skill or labour involved in preparing the head-notes and no person could claim a copyright therein. It would seem therefore that by implication, the Court rejected the claim that the database of judgments collected and selected by the Plaintiff was not copyrightable as a compilation or computer database. A.I.R. 2001 Delhi 185. 250 It was held that “it is the product, skill and capital of one man which must not be appropriated by another, not the elements, the raw material, if one may use the expression, upon which labour and skill and capital of the first have been expended. The (sic) secure copyright for this product it is necessary that the labour, skill and capital of the first have been expended should be sufficient to impart to the product some quality of character which the raw material did not possess and which differentiates the product from the raw material…What is the precise amount of the knowledge, labour, judgement or literary skill or task which the author of any book or other compilation must bestow upon its composition in order to acquire copyright in it within the meaning of the Copyright Act cannot be defined in precise terms. In every case it must depend largely on the special facts of that case, and must in each case be very much a question of degree.” id at 210. 251 This seems to be in parity with the approach taken by the Canadian Supreme Court in CCH Canadian Ltd. v. Law Society of Upper Canada [2004] S.C.C. 13. Canada seems to be adopting a position which is in between the sweat of the brow doctrine and the creativity requirement for database protection. At page 16 of the judgement, the Chief Justice has held that: “..the correct position falls between these two extremes. For a work to be ‘original’ within the meaning of the Copyright Act, it must be more than a mere copy of another work. At the same time, it need not be creative in the sense of being novel or unique. What is required to attract copyright protection in the expression of an idea is an exercise of skill and judgement. By skill, I mean the use of one’s knowledge, developed aptitude or practiced ability in producing the work. By judgement, I mean the use of one’s capacity for discernment or ability to form an opinion or evaluation by comparing different possible options in producing the work…the exercise of skill and judgement required to produce the work must not be so trivial that it could not be characterized as a purely mechanical exercise”. 252 Section 13, Indian Copyright Act, 1957 (1) Subject to the provisions of this section and the other provisions of this Act, copyright shall subsist throughout India in the following classes of works, that is to say,- (a) original literary, dramatic, musical and artistic works; (b) cinematograph films; and (c) 10 [sound recording]. (2) Copyright shall not subsist in any work specified in sub-section (1), other than a work to which the provisions of section 40 or section 41 apply, unless,- (i) in the case of a published 86 rights that subsist in a literary work, being, inter alia, the right to reproduce or store it, to issue copies to the public, to perform or communicate it to the public, to make a translation or adaptation etc.253 The term of copyright is specified in Section 22 of the Act,254 and lasts for 60 years from the beginning of the year following the death of the work, the work is first published in India, or where the work is first published outside India, the author is at the date of such publication, or in a case where the author was dead at that date, was at the time of his death, a citizen of India; (ii) in the case of an unpublished work other than 12[work of architecture], the author is at the date of the making of the work a citizen of India or domiciled in India; and (iii) in the case of a 12[work of architecture], the work is located in India. Explanation : In the case of a work of joint authorship, the conditions conferring copyright specified in this sub-section shall be satisfied by all the authors of the work. (3) Copyright shall not subsist- (a) in any cinematograph film if a substantial part of the film is an infringement of the copyright in any other work; (b) in any sound recording made in respect of a literary, dramatic or musical work, if in making the 1sound recording, copyright in such work has been infringed. (4) The copyright in a cinematograph film or a sound recording shall not affect the separate copyright in any work in respect of which or a substantial part of which, the film, or as the case may be, the sound recording is made. (5) In the case of a work of architecture, copyright shall subsist only in the artistic character and design and shall not extend to processes or methods of construction. 253 Section 14, Indian Copyright Act, 1957: For the purposes of this Act, "copyright" means the exclusive right subject to the provisions of this Act, to do or authorise the doing of any of the following acts in respect of a work or any substantial part thereof, namely,- (a) in the case of a literary, dramatic or musical work, not being a computer programme,- (i) to reproduce the work in any material form including the storing of it in any medium by electronic means; (ii) to issue copies of the work to the public not being copies already in circulation; (iii) to perform the work in public, or communicate it to the public; (iv) to make any cinematograph film or sound recording in respect of the work; (v) to make any translation of the work; (vi) to make any adaptation of the work; (vii) to do, in relation to a translation or an adaptation of the work, any of the acts specified in relation to the work in sub-clauses (i) to (vi); (b) in the case of a computer programme,- (i) to do any of the acts specified in clause (a); (ii) to sell or give on commercial rental or offer for sale or for commercial rental any copy of the computer programme: PROVIDED that such commercial rental does not apply in respect of computer programmes where the programme itself is not the essential object of the rental. (c) in the case of an artistic work,- (i) to reproduce the work in any material form including depiction in three dimensions of a two dimensional work or in two dimensions of a three dimensional work; (ii) to communicate the work to the public; (iii) to issue copies of the work to the public not being copies already in circulation; (iv) to include the work in any cinematograph film; (v) to make any adaptation of the work; (vi) to do in relation to an adaptation of the work any of the acts specified in relation to the work in sub-clauses (i) to (iv); (d) in the case of a cinematograph film,- (i) to make a copy of the film, including a photograph of any image forming part thereof; (ii) to sell or give on hire or offer for sale or hire, any copy of the film, regardless of whether such copy has been sold or given on hire on earlier occasions; (iii) to communicate the film to the public; (e) in the case of a sound recording- (i) to make any other sound recording embodying it; (ii) to sell or give on hire, or offer for sale or hire, any copy of the sound recording regardless of whether such copy has been sold or given on hire on earlier occasions; (iii) to communicate the sound recording to the public. Explanation: For the purposes of this section, a copy which has been sold once shall be deemed to be a copy already in circulation. 254 Section 22, Indian Copyright Act, 1957 - Except as otherwise hereinafter provided, copyright shall subsist in any literary, dramatic, musical or artistic work (other than a photograph) published within the lifetime of the author until 17[sixty] years from the beginning of the calendar year next following the year in which the author dies. Explanation : In this section the reference to the author shall, in the case of a work of joint authorship, be construed as a reference to the author who dies last. 87 author.255 The Indian Copyright Act, in parity with the ubiquitous position, does not protect the data since the focus is on expression of the form but not the contents. Some amount of protection to the contents of a database is rendered by the Information Technology Act, 2000. Under Section 43(b)256 of the Act, insubstantial amounts of information are protected. Computer databases257 and data258 have been broadly defined in the Act. There is no precondition that a substantial amount of the work should be downloaded, copied or extracted. 255 As per Section 2 (d) (vi), Indian Copyright Act, 1957, the author of a computer-generated work (compilation) is the person who causes the work to be created. 256 Section 43 of Information Technology Act, 2000, India: Penalty for damage to computer, computer system, etc.: If any person without permission of the owner or any other person who is incharge of a computer, computer system or computer network, (a) accesses or secures access to such computer, computer system or computer network; (b) downloads, copies or extracts any data, computer data base or information from such computer, computer system or computer network including information or data held or stored in any removable storage medium; (c) introduces or causes to be introduced any computer contaminant or computer virus into any computer, computer system or computer network; (d) damages or causes to be damaged any computer, computer system or computer network, data, computer data base or any other programmes residing in such computer, computer system or computer network; (e) disrupts or causes disruption of any computer, computer system or computer network; (f) denies or causes the denial of access to any person authorised to access any computer, computer system or computer network by any means; (g) provides any assistance to any person to facilitate access to a computer, computer system or computer network in contravention of the provisions of this Act, rules or regulations made thereunder; (h) charges the services availed of by a person to the account of another person by tampering with or manipulating any computer, computer system, or computer network, he shall be liable to pay damages by way of compensation not exceeding one crore rupees to the person so affected. Explanation - For the purposes of this section, -(i) "computer contaminant" means any set of computer instructions that are designed: a. to modify, destroy, record, transmit data or programme residing within a computer, computer system or computer network; or b. by any means to usurp the normal operation of the computer, computer system, or computer network; (ii) "computer data base" means a representation of information, knowledge, facts, concepts or instructions in text, image, audio, video that are being prepared or have been prepared in a formalised manner or have been produced by a computer, computer system or computer network and are intended for use in a computer, computer system or computer network; (iii) “computer virus” means any computer instruction, information, data or programme that destroys, damages, degrades or adversely affects the performance of a computer resource or attaches itself to another computer resource and operates when a programme, data or instruction is executed or some other event takes place in that computer resource; (iv) “damage” means to destroy, alter, delete, add, modify or rearrange any computer resource by any means. 257 Id. Explanation (ii) to Section 43. 258 Data, defined in Section 2 (1) (o) of the Indian Information Technology Act 2000 means “a representation of information, knowledge, facts, concepts or instructions which are being prepared or have been prepared in a formalized manner, and is intended to be processed or has been processed in a computer system or computer network, and may be in any form (including computer printouts magnetic or optical storage media, punched cards, punched tapes) or stored internally in the memory of the computer”. 88 According to Vandrevala259, Himalaya Drug Company v. Sumit is the first case, in India, relating to copying of databases. The matter appeared before the Delhi High Court when the plaintiff’s online herbal database was copied by the defendant, an Italian infringer onto its website. The Court issued an injunction against the infringer and in compliance with the interim order; the American service provider removed the infringing content on its own accord and furnished the complete details of the infringer, who had rented space on the website.260 A person who damages a computer database is liable to pay up to INR 1,00,00,000 261 under Section 43(d) of the Information Technology Act, 2000. Under Section 43(b), a person who downloads, copies or extracts any data, computer database262 or information from such computer, computer system or computer network including information or data held or stored in any removable storage medium without the permission of the database owner or any other person who is in charge of a computer, computer system or computer network is liable to similar punishment. It is pertinent to mention that not only is there no requirement under the Information Technology Act, 2000 for the databases to be original but also, the Act does not contain any ‘fair dealing’263 exception to infringement as provided in the Copyright Act 1957. 259 PHIROZ VANDREVALA, A Study On The Impact Of Protection Of Unoriginal Databases On Developing Countries: Indian Experience, available at ( last accessed on 1 July 2005). 260 Suit No.S-1719 of 2000. To the best of my knowledge the matter is yet to be disposed off. See, Delhi High Court Website available at (last accessed on 1 July 2005). 261 Approx. USD 220,000. 262 Supra note 257 263 The expression ‘fair dealing’ is found in Section 52 of the Indian Copyright Act , 1957, enumerating the exceptions to copyright. Section 52(1) states that the following acts shall not constitute an 89 2.3.2 Endeavours in India The first endeavor to document traditional knowledge was made by the SRISTI in Ahmedabad, India.264 SRISTI has been developing databases of traditional knowledge and practices in close collaboration with local community members and institutions in India. Anil Gupta, Director, SRISTI, advocates the establishment of global registration system of local innovations along the lines of SRISTI’s local innovations database. Such documentation was started through People’s Biodiversity Registers Programme coordinated by the Centre for Ecological Sciences of the Indian Institute of Science, and the Foundation for Revitalization of Local Health Traditions (FRLHT) based in Bangalore, in Karnataka, a state in India.265 The objectives of the Programme were: infringement of copyright namely:- a. fair dealing with a literary, dramatic, musical or artistic work not being a computer programme for the purposes of-- i. private use including research; ii. criticism or review, whether of that work or of any other work; aa. the making of copies or adaptation of a computer programme by the lawful possessor of a copy of such computer programme from such copy-iii. in order to utilise the computer programme for the purpose for which it was supplied; or iv. to make back-up copies purely as a temporary protection against loss, destruction or damage in order only to utilise the computer programme for the purpose for which it was supplied; b. a fair dealing with a literary, dramatic, musical or artistic work for the purpose of reporting current events-- i. in a newspaper, magazine or similar periodical, or ii. by broadcast or in a cinematograph film or by means of photographs. The term ‘fair dealing’ has not been defined in the Act. Black’s Law dictionary defines the term as “a reasonable and limited use of a copyrighted work without the author’s permission.” This is a defense to an infringement claim depending on the purpose and character of use, the nature of the copyrighted work, the amount of material used and the economic impact of the use. 264 SRISTI is the acronym for Society for Research and Initiatives for Sustainable Technologies and Institutions. Professor Anil Gupta is the founder and a director of SRISTI. Available at (last accessed on 1 July 2005). 265 Professor Madhav Gadgil of the Centre for Ecological Sciences delineated ten genre of information which should be kept in mind while incorporating traditional knowledge in the People’s Biodiversity Registers. They are as follows: (iii) Identifying different user groups in accordance with their use of local biological resources. (iv) Mapping the mosaic of ecological habitats of the study site. (v) Documenting the ecological history of the study site. (vi) Investigating the extent and distribution of local collective and individual knowledge about different species of plants and animals and their uses recording the abundance, scarcity and distribution of living organisms. (vii) Recording patterns of economic (subsistence and commercial) utilization of living resources. (viii) Documenting efforts to regulate uses of living resources or to conserve them, both by the government agencies and local communities. (ix) Recording the development aspirations of local communities and how these relate to local biodiversity. (x) Documenting divergences and agreements among the various local groups concerning management of natural resources. (xi) Documenting the emerging options for managing the natural resources of the study site, with particular focus on biodiversity conservation. Documents 90 (i) To provide a record of local knowledge for the use of present and future generations of village community people. (ii) To promote the revitalization of local knowledge by recognizing the range of such knowledge; rewarding outstanding knowledge, skills, techniques and conservation practices; validating and promoting sound local knowledge and resource management traditions; and promoting inter-community transfer of knowledge for capacity enhancement. (iii) To alert conservationists about the need for action concerning the threatened resources and the need for protection of local resource rights. (iv) To protect local biodiversity and knowledge from misappropriation by companies such as through patenting of modified products, processes and biological resources.266 In 1996-97, the villagers of Pattuvam, a village in the state of Kerala, undertook to register all their natural resources and related knowledge in a database.267 The register was created with the philosophy that no monopoly claim of life forms would be accepted by them. The register has been kept secret to prevent undue commercial exploitation of the information therein and it is shared only in exceptional cases. Such a register would be useful to prove the existence of a practice or usage in case of a following the aforesaid lines were prepared with the collaboration of local educational institutions and voluntary organizations and the first People’s Biodiversity Register was completed and released in 1997. See, M. Gadgil, Conserving India’s Biodiversity: Let People Speak, 1998, at www.etfrn.org/etfrn/workshop/ biodiversity/documents/gadgil/hinsur98.pdf (accessed on 1 July 2005). 266 Foundation for Revitalization of Local Health Traditions (FRLHT), available at (last accessed on 3 September 2005). 267 The Pattuvam database, was among the first of its kind. Under Section 13 of the Indian Copyright Act of 1957, the compilation would be protected as an original literary work by reference to its selection, arrangement and co-ordination of contents. 91 Neem like dispute. The aim of such documentation is to prevent assertion of intellectual property rights on prior local knowledge.268 For easier dissemination and search of traditional medical knowledge, the Government of India decided to set up a digital library of every known and codified form of traditional treatment in India. It was launched in 2002 in four languages. This state of the art storehouse of information, named the Traditional Knowledge Database Library269 is an effort to provide essential traditional information in a language likely to be known to the International Patent Examiner, in a retrievable form. The ayurvedic formulations can presently be decoded in English, French, German, Hindi, Japanese and Spanish. The Department of Indian System of Medicine and Homoeopathy constituted an interdisciplinary task force.270 The task force devised a unique methodology271 for creating 268 S.K.Verma, Access to Biological and Genetic Resources and their Protection, 43 JILI (2001) 1 at 21. 269 Traditional Knowledge Database Library is hereinafter referred to as TKDL in the thesis. 270 The task force consisted of consisting of Ayurveda experts from Central Council of Research in Ayurveda and Siddha (CCRAS), Banaras Hindu University (BHU), Department of ISM&H, patent examiners from the Office of the Controller General of Patent, Design and Trade Marks (CGPDTM), information technology experts from National Informatics Centre (NIC), and scientists from Council of Scientific and Industrial Research (CSIR), under the Chairmanship of Mr. V K Gupta, Director, National Institute of Science Communication (NISCOM), New Delhi. 271 Methodology used for TKDL - The methodology used for TKDL involved a unique classification system for arrangement, retrieval and dissemination of traditional knowledge resources. Slokas or Sanskrit verses from Ayurvedic texts were first identified. Each verse was then converted into structured language using Traditional Knowledge Resource Classification (TKRC), a classification system for arrangement, retrieval and dissemination of traditional knowledge resources. The TKRC classification has been evolved for about 5,000 subgroups as against one group in file International Patent Classification (IPC) for traditional knowledge and has been claimed to be suited for classification of non Indian traditional knowledge as well. The TKDL portal is based on XML standards and would be platform-independent. The codes for each sloka were fed into a data entry screen and also saved on the database. Computer-savvy ayurveda experts carried out the data entry. These were then decoded in different languages. The ayurvedic formulations can be presently decoded in English, French, German, Hindi, Japanese and Spanish. In future, it would be available in 20 foreign languages and all Indian languages. The decoded format of the formulation is easy to read and understand, even by the layman. The web version of TKDL includes a web-based search interface providing for a full text search and retrieval of traditional knowledge information on International Patent Classification Union (IPC) and keywords in multiple languages. TKRC is an integral part of TKDL, provides a background on ayurvedic concepts, definitions and scientific basis of Indian systems of medicine. In addition, it carries information on practitioners, hospitals and dispensaries. There are 92 TKDL based on fifteen well-known Ayurvedic books. The TKDL has received wide acceptance and support internationally.272 India's TKDL database has been selected for a pilot study by 170 member states of WIPO.273 The Indian databases are limited to the codified traditional knowledge systems of South Asia. The data contained in the Indian databases is limited primarily to Ayurvedic medicinal knowledge, fully disclosed in writing in twelfth century B.C.274 Nevertheless, importance of the TKDL is that though the entries therein are compilation of codified information, which have already been in the public domain, the TKDL, being an electronic database in English, and other common languages used in the world, presents the data in a far more conveniently searchable and comprehensible mode and hence, facilitating prior art search.275 several search features incorporated in the format. According to V. K. Gupta, Director of National Institute of Science Communication, the TKDL software developed in-house does not do transliteration but it does smart translation. Once abstracted, data from the slokas are converted into several languages using Unicode meta data methodology. The software developed can perform smart translation of botanical names and ayurvedic descriptions from traditional terminology into modern terminology. Examples of this are 'Kumari' to 'Aloe Vera', or 'Mussorika' to 'small pox', etc.” The system, named Traditional Knowledge Resource Classification (TKRC), has been evolved for about 5,000 subgroups as against one group in file International Patent Classification (IPC) for traditional knowledge and has been claimed to be suited for classification of non Indian traditional knowledge as well. See, Nirupa Sen, TKDL- A safeguard for Indian traditional knowledge, Current Science 82 (9): 1070-71. The International Patent Classification (IPC) is an internationally recognised classification system, which is controlled by the WIPO and assigned to patent documents by Patent Offices. Most patent examiners around the world use the IPC during patent examination. Although the IPC has more than 1,00,000 sub-groups for retrieving information on modern scientific inventions, it has only one such sub-group for retrieving information on “medicinal plants.” Since the Indian TKDL will have information on 5000 subgroups, their inclusion in the IPC will enhance the quality of patent examination substantially. For further details see, International Patent Classification, at (last accessed on 2 March 2005). 272 World Intellectual Property Organization, Special Union for the International Patent Classification (IPC Union): Committee of Experts, IPC/CE/31/6, WIPO, Geneva, 18 February 2002. 273 id. 274 World Health Organization, TRADITIONAL MEDICINE IN ASIA (R.R. Chaudhury & U.M. Rafei eds., 2002), 3. 275 The TKDL qualifies for intellectual property protection as an original database since the TKRC system used is a unique arrangement formulated exclusively for TKDL. Besides it can be protected through the provisions of the Information Technology Act, 2000 against unauthorized extraction of data therefrom. However since the data stored in the TKDL has already been present in the public domain, the database is highly a subject of copyright protection for its expression. The WIPO, in its portal containing the online databases, specifies the terms of use. It adjudges that though the databases 93 2.3.3 Advantages of traditional knowledge databases The utility of a database is to present information in some systematic arrangement like chronology or genre or the first alphabet of the entry. Traditional knowledge databases, being libraries of information available in the public domain, become part of the written prior art. As written knowledge, they are recognized by most legal regimes of the world. It prevents the grant of any individual proprietary right in such knowledge. Further being part of documented prior art, they prevent granting of patents which are not novel or are obvious. The patent examiner, while conducting prior art searches, can pitch the claimed invention against the body of knowledge available in such databases and determine the novelty. It is also that such databases help in bringing information in the public domain. Such knowledge can be further used for research and development purposes.276 2.3.4 Criticism of the traditional knowledge databases Firstly, though databases would stop patents like turmeric277 from being granted, it can not be confidently proclaimed that they would prevent all kinds of biotechnological patents from traditional knowledge inputs being granted. The Indian TKDL presents already documented information in a more user friendly and searchable form. The problem of protecting known but unpublished traditional are subjected to copyright reservations, the data might be copied, downloaded or printed for “personal, non-commercial purposes” and the user should “acknowledge their source”. See, Health Heritage Database: Terms of Use, at (last accessed on 14 September 2004). 276 Traditional medicine, often being administered through very simple procedures, can be used by patients. For instance, a treatment for ‘dry eyes’, in the Indian literature, is to take few leaves of aloe vera (or Kumari), wash these in clean water and then crush the leaves, and apply some drops of the solution extracted from the leaves into the eye. 277 See, Chapter I section 1.3.1. 94 knowledge is not remedied by the TKDL since such unpublished information would not be recorded in the TKDL as well. Secondly, while the databases would prevent others from claiming patent rights on the knowledge, the farmers and the indigenous communities also lose their rights on the knowledge since that piece of information is now a part of the public domain. New property rights in favour of the first knowledge holders are yet to be worked out. Thirdly, Dr. S.K.Verma has suggested that it is not necessarily true that the conservers of a piece of traditional knowledge information are the creators or the owners of the knowledge, therefore the right to transact the knowledge is questionable.278 Fourthly, there is no specification regarding how a traditional knowledge entry would have to be described to constitute novelty destroying prior art. The national and regional patent laws also vary with respect to how information or material in the public domain should be described to constitute novelty-defeating prior art. Some regimes would consider mere knowledge as novelty destroying while some other regimes, as Japanese patent laws, warrant that the “novelty-defeating disclosure…has to be enabling, i.e. it teaches those skilled in the art how to make and use the claimed invention.”279 If the disclosure fails to provide such information, the disclosure will not be considered to be novelty-defeating. This implies that if a published traditional knowledge is not disclosed in a way that would teach how to work the invention exactly as described in the specification and claims of the actual patent, the latter’s validity would not be threatened. 278 Verma, supra note 268. M.A. Morneault & B.F. Rademaker (2001), A maze of laws and exceptions: examples of novelty around the world, Journal of World Intellectual Property 4(1): 27-32 at 28. 279 95 Interested parties and bioprospectors would be able to obtain relevant information from the database and obtain patent protection for an invention based on such information, after making minor alterations or changes to the product or process recorded in the database, without any intimation to or negotiation or benefit sharing with the holder of the knowledge. The latter concern is certainly more valid if the traditional knowledge databases are made available not only to patent offices but to the general public. They would become a valuable resource to the industry which would otherwise have to conduct far more time-consuming literature searches to acquire the same quantity of information. It has been held by Dutfield that “if the purpose of the database is to present published information to examiners so they do not grant patents in error, then unrestricted access is likely to give rise to further abuses”.280 Keeping the registers closed or secret would again defeat some of the purposes for which the documentation had been effected, viz. knowledge extraction, its documentation, dissemination and abstraction into theories, institutions or technologies. The Pan American Health Organization adviser Jorge Luis Prosperi said, “I don’t doubt that scientists could visit the Amazon to extract the active properties of some plants to make millions out of patented medicines. But it is correct and fair that legitimate research takes place. Just as I believe indigenous groups have a right to access the breakthroughs and knowledge of the modern world, I believe that Western society has a right to learn about these medicinal plants. They can’t be solely the property of the indigenous community or the shaman”.281 To avoid such disputes, India has refused patents on an invention “which in effect, is traditional knowledge or 280 Graham Duttfield, “Protecting Traditional Knowledge and Folklore: A review progress in diplomacy and policy formulation”, UNCTAD/ICTSD Capacity Building Projects on IPRs, October 2002. 281 Quoted from, Owain Johnson, A Marriage of Medicine, Perspectives in Health Magazine: The Magazine of the Pan American Health Organization (2002), Volume 7(3), at (last accessed on 13 August 2004). 96 which is an aggregation or duplication of known properties of traditionally known component or components”.282 Fifthly, a traditional knowledge database can never be exhaustive. There are varieties of traditional knowledge which are based on religious rituals and which are confined within a particular community. For instance, healers use rituals as part of their traditional healing methods, despite disclosure of the phyto-chemical products or techniques used, it would not be possible to accurately document such knowledge. The plethora of undisclosed information relating to traditional practices should, by no means, find place in the databases since that would amount to the violation of privacy of the traditional communities. In all likelihood, the database would be of an inclusive nature. It is unlikely that documentation would emerge to be a fool-proof method for defeating novelty as well. Since the proposed databases are likely to be inclusive, it would not prevent a bioprospector to physically visit a biodiverse country, interact with the local healers, obtain information and resources, some of which are distributed by the healers or sold in the markets or grown ubiquitously, and finally research the collected resource on the basis of the information obtained. His claim to a patent would not be rejected on grounds of unsatisfying the novelty criteria, specially by patent regimes which recognize relative novelty, and do not consider foreign usages, practices or undocumented knowledge as part of patent claim defeating prior art. The chief concern relating to the traditional knowledge databases is regarding the protection of the data incorporated in the database. Not many jurisdictions except EU 282 Section 3(p), Patents (Amendment) Act, 2005. 97 have devised sui generis protection which might be extended to protect the data contained in the databases as well.283 2.3.5 Recommendations There are certain other aspects which should be taken care of before compilation of any piece of information in a database. These form the basis of the following recommendations. Firstly, any information should be incorporated in the database only after receiving assent from the knowledge holder. In situations where such knowledge is not already in the public domain, governments would need to ensure that the disclosure of traditional knowledge is voluntary. Also, much traditional knowledge that is currently in the public domain may be there without the consent of the concerned communities. There is no consensus at the WIPO that only published databases should be available to patent examiners. The knowledge holders should have the right to veto the inclusion of their knowledge in databases and to have their views respected on how or 283 To respond to the issue of protection of traditional knowledge databases, Nuno Pires de Carvalho, Head, Industrial Property Law Section, Cooperation for Development (Intellectual Property Law) Department, WIPO, has suggested special database rights for protection of traditional knowledge databases. His proposal is based on Article 39.3 of TRIPS, reproduced below, which deals with test and other data that must be submitted to the government authorities as a condition of approving the marketing of pharmaceutical or agrochemical products. The Article requires government to protect such data against unfair commercial use and disclosure. This allows for the protection of certain information against unfair commercial use though that information has been disclosed to the public. The suggested framework would retain the following three features from Article 39.3 of TRIPS: the establishment of rights in data; b. the enforceability of rights in the data against their use by unauthorized third parties; c. non-fixation of a predetermined term of protection. Carvalho suggests that such databases be registered with national patent offices for facilitating novelty searches. Article 39.3 TRIPS Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use. Nuno Pires de Carvalho, “From the shaman’s hut to the patent office: how long and winding is the road?” 41 Rev. ABPI [Brazilian Association of Intellectual Property] 3 (1999). 98 whether access to the databases be regulated. The traditional knowledge holders should be involved in the management of such databases. Since unrestricted access is prone to give rise to further abuses, access to such databases should be restrictive. Access should be controlled through modes of user fees, valuation of the information collected, possible claims of intellectual property over the databases themselves and the recovery of operational costs of these databases. Access to the databases can be regulated through two means. Firstly, the database owners can be made to sign forms revealing their interests in the database, and access to the database could only be granted after the database owner authority approved the same. Such forms could also contain stipulations for sharing of pecuniary benefits in case the data accessed is used for economic gains by the prospector. These agreements can be made under the aegis of the national contract laws and violation of the terms and conditions could be subjected to redress through termination of the contract and payment of damages. Secondly, encryption methods may be used for locking the databases and only those who have been allowed access would be able to enter the databases through passwords or similar modes. However both the processes of protecting the databases, in the hard and especially in electronic version are expensive as they call for the use of sophisticated software not very easily found in the developing countries. These are beyond the means of the members of the traditional communities. It is only possible if the traditional groups are supported by some other body in these endeavours.284 284 For instance, the indigenous knowledge of Venezuela have been incorporated in a database called the Biozulua Database to record food and agricultural information based on ancestral technology, and native medicine from indigenous peoples which are at risk of being lost due to the impacts of western civilization. The database, owned by the government of Venezuela, has been kept confidential and is protected as a trade secret. Discretionary access is granted after the incumbent has signed a confidentiality agreement. World Intellectual Property Organization, Report, Intergovernmental 99 Secondly, the description of the creation of the Indian TKDL also indicates that such projects involve substantial investments, which are beyond the means of the traditional knowledge holders. It is generally much beyond the means of the traditional knowledge holding communities to finance the compilation of databases. Converting them to digital form would be more expensive. Such compilation may either be made through government funding or through corporate sponsorship. Academic institutions involved in research might also be interested in sponsoring the database expenses, though they should not have dominant control on the data contained in the databases, and regulating access to the databases remain in the hands of the government or the communities whose information have been stored in the databases or with an elected body comprising the members of the various indigenous communities, scientific workers and lawyers for proper dissemination of information through the databases. Access to the databases can be regulated through two means. Firstly, the database owners can be made to sign forms revealing their interests in the database, and access to the database could only be granted after the database owner authority approved the same. Such forms could also contain stipulations for sharing of pecuniary benefits in case the data accessed be used for economic gains by the prospector. These agreements can be made under the aegis of the national contract laws and violation of the terms and conditions could be subjected to redress through termination of the contract and payment of damages. Secondly, encryption methods may be used for locking the databases and only those who have been allowed access would be able to enter the databases through passwords or similar modes. However both the processes Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore, , WIPO/GRTKF/IC/3/17, WIPO, Geneva, 21 June 2002. 100 of protecting the databases, in the hard and especially in electronic version are expensive as they call for the use of sophisticated software not very easily found in the developing countries. These too are beyond the means of the members of the traditional communities. It is only possible if the traditional groups are supported by some other body in these endeavours. 2.3.6 Conclusion Admittedly the documentation of traditional knowledge may in some cases be the only way to ensure that it does not disappear. However in the plea of protecting traditional knowledge the individual and collective rights of the traditional knowledge holders and their communities should not be sacrificed. Whether widely known, or secret, once traditional knowledge is recorded and publicly disseminated, its use and application is beyond the control of the original knowledge providers. The intellectual property laws do not prevent a researcher from investigating a piece of public traditional knowledge, improvising it in a practical way and claiming a patent for the final product which the researcher can call his own invention outside India. While keeping the databases secret would lessen the possibility of such misappropriation of information, it may not serve as a defensive protection since a prospector, who had acquired the knowledge or resource from an indigenous community, can acquire a patent on the same. Depending on how prior art is defined in the jurisdiction where the patent has been granted, the researcher can claim ignorance on the plea that the knowledge was recorded in a private data base and was not disseminated to the public. Moreover, the traditional farmers and breeders make various contributions towards conservation, augmentation and development of agrobiodiversity of a region. It is 101 therefore imperative that they do not lose the right to in situ practices on the knowledge and the resources. The WIPO has admitted that “Depending on how documentation is carried out, it can promote a community’s interests or damage those interests. This is because important intellectual property rights may be lost or strengthened when traditional knowledge is documented”. 285 The aims of documentation can be fully met if it is proclaimed that no intellectual property right would be granted on any invention based on traditional knowledge or genetic resources occurring naturally, keeping them free for exploitation for all. While the latest Indian Patent Act has such a provision, the efficacy would be limited if such stance is not taken by the international agreements.286 The WIPO287 and other forums, while drafting regulations for protection of databases, or states drafting sui generis database laws, should keep in mind that in traditional societies of India and other developing countries, it is a while before the internet age sets in. The communities here are financially challenged as well as unexposed to modern trainings. Factually it is almost impossible for them to handle the act of documentation, access to the databases, get immediate information of illegal patenting and finally protesting against such patents on the ground of violation of prior art. On the other hand, some communities would not object to bioprospecting of its knowledge or resources through mutual benefit sharing. The time period of protection 285 See, WIPO/GRTKF/IC/5/5, supra note 209 at 9. Section 3(p), Patent (Amendment) Act, 2005,see supra note 77. 287 According to Kamil Idris, Director General of WIPO, WIPO is working toward an all inclusive intellectual property protection system that is “widely accessible, and that provides an appropriate balance between the rights of inventors and creators and the public interest in general”. See, Interview with Kamil Idris, The Courier ACP-EU n˚ 201 November-December 2003 at 24, available at, (last accessed on 13 August 2004). 286 102 of databases also need to be stipulated. Though it would be in the best interests of the world intellectual property regime harmonization process to fix a common time period of protection that might not be just to the traditional knowledge holders. Such misgivings make it unlikely that same policies functioning for a general database would be effective to protect a traditional knowledge compilation. With such handicaps, it is impossible for the traditional knowledge documentation procedure to actually assist the indigenous communities unless international regimes standardize the norms and rules for documentation to be accepted as prior art and initiate national governments to work with the communities explaining to them the full implications of sharing their knowledge with all outsiders including themselves. One aspect of protection of databases is securing the investment made on compiling the database. While there is not much precedent of violation of a traditional knowledge database in India, in an effort to circumspect the probable view which might be taken by the courts in case of such a dispute, the Indian enactments being based on English laws, the “sweat and brow” philosophy is expected to dominate.288 But with changing times, some courts might prefer a Feist like approach, deciding in favour of creativity than only investment of labour and capital for a database to qualify for copyright protection. Due to the dearth of a guideline for evaluating creativity for databases, it is presumed that, as has been held in the Eastern Book Company v. Navin J. Desai case, the decision would depend on the facts of a case.289 With regard to protection of the data, the terms of agreement of accessing the TKDL holds that the database can only be use for non-commercial and academic purposes, 288 289 But see Himalaya Drug Company v. Sumit, supra note 260. See supra note 249 at 210 ¶ 50. 103 there is not much remedy to prevent misuse of the database. While the Patent Act prohibits patents on inventions based on traditional knowledge in India, measures need to be formulated to prevent illegal patenting of inventions based on information accessed from the databases. The only drawback of extensive protection would be the problem of access to these works by the academic/scientific community. The problem of potential non-access could be solved by carving out specific exceptions in favor of the academic and research community. The law of contracts complements copyright law in so far as database protection is concerned. With the advent of online databases, it is possible to make the end-user agree to the contractual obligations as deemed fit by the database provider. Thus, if the end-user infringes any of the obligations stipulated in the contract, it could amount to breach of contract under the Indian Contract Act, 1872. 2.4 COMPULSORY DISCLOSURE OF ORIGIN The biopiracy instances described in the Chapter I justify the outcry in the developing nations against patenting laws in the developed nations. The developing countries have demanded that the reviewed version of Article 27(3)(b) of the TRIPS should include provisions for mandatory submission of a certificate disclosing the origin of the genetic material, the prior informed consent290 of the genetic resource owner or the knowledge holder allowing the use of the knowledge or genetic resource and the copy of the material transfer agreement, if that is a part of the arrangement between the knowledge sharing community and the bioprospector.291 290 291 Prior informed consent is referred to as PIC hereinafter in the instant thesis. An invention derived from the use of genetic resources that have been illegally extracted from their in situ environment has been compared by De Carvalho to the situation of an invention that has been developed with the assistance of a stolen microscope. The inventor might have been liable under criminal law but would still be entitled to the patent if the invention was new, inventive and capable of 104 The suggestion of compulsory disclosure of origin of genetic resources or the traditional knowledge used first appeared in an article by Frederic Hendrickx, Veit Korester and Christian Prip292 wherein they proposed certain additions in national patenting legislation. They suggested that while filing patent applications the applicant should have to retrace the genetic material used, to indicate to what extent it was used and to state the conditions under which it had been acquired. The authors recommended that only in cases where sufficient information and proof of compensation to the source country are submitted along with the patent application, the genetic material should be made patentable. Many genetic resource providing countries have established access and benefit sharing legislation and national enactments requiring patent applications to be accompanied by documents relating to the disclosure of the origin of genetic resources used and certification that the resources have been legally procured. Forerunners in this field are the Andean Community, the OAU, Costa Rica, India and Brazil.293 However these regulations conflict with the international patent laws, specially the TRIPS Agreement which sets out that the criteria of patentability would include novelty, inventive step and usefulness of the invention.294 Some WTO Members have proposed to create a direct interface between the TRIPS and CBD by incorporating a requirement into the TRIPS that patent applicants should industrial application. See, Nuno Pires De Carvalho, “Requiring Disclosure of the Origin of Genetic Resources and Prior Informed Consent in Patent Applications Without Infringing the TRIPS Agreement: The problem and the Solution”, (2000) Washington University Journal of Law and Policy, Vol. 2, 371 at 380, available at ( last accessed on 13 August 2004). 292 Frederic Hendrickx, Veit Korester and Christian Prip, “Convention on Biological Diversity, Access to Genetic Resources: A Legal Analysis”; Environmental Policy and Law, 23/6 (1993), 250 at 253. 293 Some of the new regulations are, available at http://www.grain.org/brl/ (last accessed on 15 July 2005). 294 Article 27 of the TRIPS Agreement. 105 disclose the geographical source and origin of the genetic material and the related traditional knowledge used, and produce an official certificate or evidence that domestic laws on access and benefit-sharing of the source country have been respected. According to Dutfield, there are three forms of the disclosure, namely, “the weak, medium and strong forms”.295 The weak form entails that the disclosure requirement be kept optional and non-disclosure should not invalidate the patent. The middle form proposes a mandatory disclosure of origin. The strong form prescribes that the patent application is accompanied with official documents from the genetic resource provider country, or the country prescribing the relevant traditional knowledge that the applicant has complied with the access benefit sharing regulations as provided in Articles 15 and 16 of the CBD.296 These would include submitting certificates regarding compliance of PIC and access benefit sharing between the claimant inventor and the community holding the traditional knowledge or the country providing the genetic resource. The relevance of the term ‘strong form’ is that applications unaccompanied by such documents would be returned to the applicant for resubmission with the relevant documents. The medium and the strong forms would seem to conflict TRIPS if failure to conform would result in rejection of the patent application. The Indian led paper at WTO reiterated a previous proposal from the signatory countries for amending the TRIPS to require patent applicants to disclose the source of origin of the biological resource and associated traditional knowledge; and 295 Graham Duttfield, Protecting Traditional Knowledge and Folklore: A review in diplomacy and policy formulation, October 2002, available at (last accessed on 5 July 2005). 296 See, supra note 24. 106 provides evidence of PIC and benefit-sharing while applying for patents.297 In 1997, the Indian government proposed the incorporation of a provision in the TRIPS Agreement establishing that patents inconsistent with Article 15 of CBD should not be granted. The Indian delegation at the WTO was concerned about the two main contradictions relating to TRIPS and CBD: first, the lack of a patentability condition to disclose the origin of the biological or genetic resources or traditional knowledge used in the invention, and second, the lack of provisions in the TRIPS concerning PIC of the country of origin and the knowledge holder of the biological raw material.298 In 1999, India suggested that such obligations could be incorporated through inclusion of provisions in Article 29299 of the TRIPS, which dealt with conditions on patent applicants, requiring a clear mention of the biological source material and the country of origin.300 It was further suggested that the part of the patent application containing declarations regarding the disclosure of origin should be open to full public scrutiny upon filing of the application. This would permit countries with possible opposition claims to examine the application and state their claims well in time.301 In July 1997 the European Parliament discussed a proposal for a directive on the legal protection of biotechnological inventions where the applicant was obligated to indicate the geographical origin of the material and provide evidence to the patent 297 See, IP/C/W/403, supra note 122. Also see, World Trade Organization, Secretariat, Minutes of the Meeting of 7-8 July 1999, IP/C/ M/24, WTO, Geneva, 17 August 1999 at ¶ 81. 298 See, World Trade Organization, “The Relationship Between the TRIPS Agreement and the Convention on Biological Diversity: Communication from Indian Delegation”, WT/CTE/W/65 ¶¶ 7, 12-14 and 16 WTO, Geneva, 29 September 1997. 299 Art 29, TRIPS Agreement: 1. Members shall require that an applicant for a patent shall disclose the invention in a manner sufficiently clear and complete for the invention to be carried out by a person skilled in the art and may require the applicant to indicate the best mode for carrying out the invention known to the inventor at the filing date or, where priority is claimed, at the priority date of the application. 2. Members may require an applicant for a patent to provide information concerning the applicant's corresponding foreign applications and grants. 300 A contrasting view was expressed by Singapore by not supporting benefit sharing arrangements be incorporated in the TRIPS. It is assumed that Singapore will not be in favour of disclosure of origin requirement as a requirement for the grant of a patent. See, Non-Paper by Singapore, supra note 30. 301 See, IP/C/ M/24 ¶ 81, supra note 298. 107 authority that the material was used in accordance with the regulations regarding access and export applicable in the place of origin.302 Though these suggestions were rejected, the preamble to the approved Directive303 and in particular Recital 27, lays down that, “if an invention is based on biological material of plant or animal origin, or if it uses such material, the patent application should, where appropriate, include information on the geographical origin of such material, if known; this is without prejudice to the processing of patent applications or the validity of rights arising from granted patents”. The aforesaid being a Directive, creates no obligation in international intellectual property laws. It also does not provide punitive measures for non disclosure of origin of the genetic material. Nor does the failure to provide such information has, as such, any legal consequence on the processing of patent applications, or on the validity of rights arising from granted patents. The Swiss proposal to the WTO suggested an amendment to PCT that would enable countries to implement a disclosure requirement for the source of both genetic resources and traditional knowledge.304 Switzerland proposed to enable national patent legislation to require the declaration of the source of genetic resources and traditional knowledge in patent applications. Switzerland also proposed amendment of the PCT Regulations so as to enable the PCT Contracting Parties to require patent applicants to declare the source of genetic resources and/or traditional knowledge 302 Joseph Straus, “Biodiversity and Intellectual Property”, AIPPI Yearbook 1998/IX, 105, available at (last accessed on 13 August 2004). 303 Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions. 304 PCT, supra note 20 108 used upon or after entry of the international patent application into the national phase of the PCT procedure. In case an international patent application did not contain the required declaration, national laws would be allowed to foresee that in the national phase, the application was not processed any further, until the patent applicant had furnished the required declaration.305 The African group felt that any process of protection of genetic resources and traditional knowledge would not be effective unless international mechanisms are found and established within the framework of TRIPS. They suggested that although CBD has provisions relating to traditional knowledge and genetic resources protection, TRIPS should address the questions unilaterally as well and work out solutions by way of rights which should protect genetic resource and traditional knowledge from misappropriation. TRIPS obligations should obligate every member to take steps in this regard. They further prescribed measures like requirements for disclosure of source of genetic resource used or the traditional knowledge involved in the claimed invention and for demonstration of the compliance of the domestic procedures of the member state from where the genetic resource or the traditional knowledge has been acquired. The African Union, alike India, felt that Article 29306 of the TRIPS was an appropriate provision for setting out the measures for protection of traditional knowledge and genetic resources and for incorporation of the rights and obligations such as requirements for equity, disclosure of the origin of the genetic resource and traditional knowledge involved, and compliance of the domestic laws and procedures of the source country. They advocated an amendment enumerating the 305 World Trade Organization. Review of Article 27.3(b) - The Relationship Between the TRIPs Agreement and the Convention on Biological Diversity, and the Protection of Traditional Knowledge: Communication from Switzerland, Council for Trade-Related Aspects of Intellectual Property Rights, IP/C/W/400, WTO, Geneva, 15 June 2001. 306 Supra note 299. 109 conditions for patentability by way of an additional third paragraph to Article 29, which should read as: “3. Members shall require the applicant for a patent to disclose the country and area of origin of any biological resources and traditional knowledge used or involved in the invention and to provide confirmation of compliance with all access regulations in the country of origin.”307 The US stated that since the aim of an intellectual property regime is to promote invention, intellectual property rights should not be related to regulation of access to genetic resources or for controlling the terms and conditions for bio prospecting. US suggested using unilateral contracts and agreements between the authorities controlling access to the genetic resource or the traditional knowledge and the prospector intending to use the same for ensuing disclosure of origin. Requirements for conclusion of such contracts could be made part of the national legislation. US prescribed civil or criminal punishments for violations or breaches of obligations and disputes could be litigated in prefixed international jurisdictions.308 However an opponent to the US submission, Peru,309 has held that the US prescription did not address the problem where bioprospecting was being committed without the authorization of the competent authority in the country of origin so without conclusion of any contract. Such actions might be illegal under the law of the country of origin, but there might be little remedy when the genetic resource is being used 307 Supra note 119. World Trade Organization, Council for Trade-Related Aspects of Intellectual Property Rights, Minutes of Meeting held from 5th to 7th March 2002, IP/C/M/35, WTO, Geneva, ¶¶ s 230-232 and 241242. 309 Peru, IP/C/M/35, see id. ¶ 236. 308 110 outside the national jurisdiction. Brazil submitted that specific intellectual property legislation on the contrary would apply even in the absence of contracts.310 Pakistan has also submitted that the local indigenous communities often suffering from lack of literacy and awareness would not be at even footing while negotiating contracts with bioprospecting companies.311 The incorporation of a mandatory disclosure of origin obligation in the TRIPS Agreement and its enforcement through the dispute settlement system in WTO would provide a mechanism to help ensure compliance of prior informed consent and the access benefit rules enumerated in Article 15 of CBD.312 310 World Trade Organization, Secretariat, Minutes of the Meeting of 18-22 June 2001, IP/C/ M/32, WTO, Geneva, 23 August 2001, ¶ 128. 311 World Trade Organization, Secretariat, Minutes of the Meeting of 21-22 September 2000, IP/C/ M/28, WTO, Geneva, 23 November , 2000, at ¶ 157. 312 Article 15, CBD: 1. Recognizing the sovereign rights of States over their natural resources, the authority to determine access to genetic resources rests with the national governments and is subject to national legislation. 2. Each Contracting Party shall endeavour to create conditions to facilitate access to genetic resources for environmentally sound uses by other Contracting Parties and not to impose restrictions that run counter to the objectives of this Convention. 3. For the purpose of this Convention, the genetic resources being provided by a Contracting Party, as referred to in this Article and Articles 16 and 19, are only those that are provided by Contracting Parties that are countries of origin of such resources or by the Parties that have acquired the genetic resources in accordance with this Convention. 4. Access, where granted, shall be on mutually agreed terms and subject to the provisions of this Article. 5. Access to genetic resources shall be subject to prior informed consent of the Contracting Party providing such resources, unless otherwise determined by that Party. 6. Each Contracting Party shall endeavour to develop and carry out scientific research based on genetic resources provided by other Contracting Parties with the full participation of, and where possible in, such Contracting Parties. 7. Each Contracting Party shall take legislative, administrative or policy measures, as appropriate, and in accordance with Articles 16 and 19 and, where necessary, through the financial mechanism established by Articles 20 and 21 with the aim of sharing in a fair and equitable way the results of research and development and the benefits arising from the commercial and other utilization of genetic resources with the Contracting Party providing such resources. Such sharing shall be upon mutually agreed terms. 111 One of the controversies in the negotiation of the Patent Law Treaty313 was whether or not disclosure of the country of origin of genetic material or traditional knowledge, and proof of prior informed consent in their acquisition, would be required for grant of a patent. These issues were brought into the discussion by developing countries, which are keen to implement CBD in the context of patent law. Developed countries held that the abovementioned issues pertained to the substance of patent law, and not procedure. They said that the CBD provisions should not be construed as criteria for patentability and incorporation of the disclosure of origin and related provisions would be an administrative burden. In the face of such dichotomy, various arrangements have been suggested to make disclosure requirements compatible with TRIPS. One of the options which have been suggested by some of the WTO member states, and which has been discussed above is amending Article 29 of TRIPS so as to keep the substantive requirements of patentability undisturbed, yet introducing disclosure of origin as a compulsory stipulation under the conditions of patentability.314 De Carvalho suggested that 313 The Patent Law Treaty ( also and hereinafter referred to as PLT) was adopted by WIPO members in Geneva in June 2000. Its aim is to harmonise the formal requirements set by patent offices for granting patents, and to streamline the procedures for obtaining and maintaining a patent. PLT signatories have agreed to a single internationally standardised set of formal requirements for national and regional offices, standardised forms to be accepted by all offices, filing date requirements, and procedures to avoid a loss of the filing date because of a failure to comply with formalities, simplified procedures before the patent office, basic principles for the implementation of electronic filing, and mechanisms to avoid unintentional loss of rights as a result of failure to comply with time limits. The Treaty has been ratified by ten states: Moldova, Kyrgyz Republic, republic of Slovania, Slovak Republic, Federal Republic of Nigeria, Ukraine, Estonia, Denmark, Croatia and Romania, and is in force since 28 April 2005. The full text of the Treaty is available at the WIPO website at (last accessed on 5 July 2005). 314 In the present form, Article 29 of TRIPS sets out that the disclosure of invention has to be clear and complete for the invention to be carried out by a person skilled in the art. Patent legislation have historically developed for mechanical and chemical inventions. Specifications requirements for inventions relating to biological material have started evolving recently. The indication of the origin of the genetic material and the means of acquisition is not related to the ways that a person skilled in the art can carry out the invention and so, in the present form, is outside the purview of Article 29 which only requires the disclosure of how the invention works. The Article however may be amended, as suggested by the African group, to provide for the disclosure requirement. 112 conditions relating to disclosure of origin could be incorporated in Article 62 of the TRIPS Agreement which deals with patent procedure and formalities consistent with the TRIPS. Article 62 paragraph 1 states that “Members may require, as a condition of the acquisition or maintenance of the intellectual property rights provided for under Sections 2 through 6 of Part II, compliance with reasonable procedures and formalities. Such procedures and formalities shall be consistent with the provisions of this Agreement”. Though there is a link between the reasonable procedures admitted by Article 62 of TRIPS and conditions of patentability established in Articles 27 and 29 of TRIPS, Article 62 can be amended making the disclosure requirement a compulsory procedure for applying patents. Section 25 of the Indian Patents Amendment Act 2005 which deals with grounds for revocation claims, has been amended with two more grounds for revocation being incorporated,315 viz. that the complete specification does not disclose or wrongly mentions the source or geographical origin of biological material used for the invention; and that the invention so far as claimed in any claim of the complete specification is anticipated having regard to the knowledge, oral or otherwise, available within any local or indigenous community in India or elsewhere.316 The Conference of the Parties, CBD has invited its Parties and Governments “to encourage the disclosure of the country of origin of genetic resources in applications for intellectual property rights, where the subject matter of the application concerns or 315 Sections 25(j) and (k) of Patents Amendment Act 2005. Sections 25(j) and (k) of Patents Amendment Act 2005 also have to be read with Section 3(p) of Patents Amendment Act 2005. In Section 3(p) “an invention, which in effect, is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known component or components” has been precluded from the definition of inventions in the Act. 316 113 makes use of genetic resources in its development, as a possible contribution to tracking compliance with prior informed consent and the mutually agreed terms on which access to those resources was granted” and “to encourage the disclosure of the origin of relevant traditional knowledge, innovations and practices of indigenous and local communities relevant for the conservation and sustainable use of biological diversity in applications for intellectual property rights, where the subject matter of the application concerns or makes use of such knowledge in its development”.317 2.4.1 Challenges in Disclosure of Origin An elementary problem of disclosure of the origin is what is meant by the term ‘origin’. It needs to be clarified whether origin refers to the country of origin. If origin has the meaning of “country of origin” in the sense of the CBD, the disclosure of origin would be impractical and very often not possible. In many cases it might be impossible to trace the origin of a biological resource. For instance, detection of the origin of the neem tree, being ubiquitously found in various south east Asian countries318, would lead to discrepancies. Moreover, it is also very difficult to determine when and where biological materials, in the form received, have developed their distinctive properties. This problem may be solved by providing information on the “source” of the biological material, that the applicant should be obliged to declare from where the biological resource has been obtained with possible exceptions in cases where the resource received is in the frame of a confidential contract and the disclosure of the origin would be a breach of that contract.319 317 The Conference of the Parties (COP) is the governing body of the CBD. See, Convention on Biological Diversity, Access and Benefit-Sharing as related to Genetic Resources, COP Decision VI/24. 318 Neem is a common tree in south east Asian countries specially India, Pakistan and Bangladesh. 319 CIPR, supra note 29 at 85. The CIPR Report states that while uncertainty of the geographical origin of a resource might be a problem in making compulsory disclosure of origin an obligation for patent grant, “it is difficult to judge how real any such uncertainty would be. Where a company is interested in 114 Another issue which needs to be addressed is the distinction between disclosure of origin of genetic resource and that of traditional knowledge. The need arises because though the two concepts are often used interchangeably, traditional knowledge rarely can be attributed to a single community. Often the knowledge would be regional, or even, national. Thus, disclosure of the source of the traditional knowledge would be difficult. It would perhaps be easier to disclose the source of a genetic resource. The CBD320 has recognised the sovereign rights of the state on the natural resources. Therefore a genetic resource can be acquired with the certification from the state government or any other authorised body. In case of multi-states providing the same genetic resource, it would not be logical for a foreign bio-prospector to obtain the same resource from all these states and in all likelihood the bio-prospector would have the option of choosing the source of the genetic resource which he would then disclose in the patent application. In cases where traditional knowledge can not be allocated to a single community, a nationally authorised body should be established to clarify who the community holder is, and for purposes of disclosure, all such communities should be jointly credited to be the holder of the traditional knowledge. Any subsequent pecuniary benefit from the commercial exploitation of the knowledge would be divided among the communities claiming ownership to that particular piece of knowledge. Disclosure of origin of a particular genetic resource, it seems likely that it would endeavour to discover as much information about the material as possible because of its relevance to its possible utility”. 320 CBD Article 2: “…"Country of origin of genetic resources" means the country which possesses those genetic resources in in-situ conditions. “Country providing genetic resources” means the country supplying genetic resources collected from in-situ sources, including populations of both wild and domesticated species, or taken from ex-situ sources, which may or may not have originated in that country. As per CBD, any benefit acquired from bioprospectorship of genetic resources or traditional knowledge is to be shared with the country providing the resource irrespective of whether the actual resource originated in the country. 115 inventions developed from the genetic material obtained ex-situ from repositories, and agricultural research centres has posed another problem. The Consultative Group on International Agricultural Research (CGIAR), set up in 1971, with the mission of increasing crop yields to meet the banes of scarcity of food across the world has been accused of being party to a number of biopiracy issues. Under the terms of the 1994 agreement between the Consultative Group on International Agricultural Research and the UN Food and Agriculture Organization, “in trust” germplasm is maintained in the public domain and is not allowed to be included in any intellectual property claim. However the controversial Enola Bean Patent321 has been alleged to violate this provision. The patent has been challenged and USPTO is yet to decide on the matter. With biotechnology allowing for engendering of desirable genetic traits from more than one species, disclosure should involve origin details of all the species used. The species stored in the agricultural research centres are mostly not subjected to patent 321 The Enola bean patent: The USPTO had granted Larry Proctor, the president of Pod-Ners seed company (Colorado, USA) a patent described as a “new field bean variety that produces distinctively yellow coloured seed which remain relatively unchanged by season.” Proctor also obtained a U.S. Plant Variety Protection Certificate on the bean variety. He filed a lawsuit on 30 November 2001 against 16 small bean seed companies and farmers in Colorado, claiming that they are violating the patent by illegally growing and selling his yellow “Enola” bean. The patent was challenged by an international plant breeding institute in Cali, Colombia, the International Center for Tropical Agriculture (CIAT). CIAT pointed out the yellow beans were “misappropriated” from Mexico, and Proctor’s patent violated Mexico’s sovereign rights over its genetic resources, as recognized by the CBD. The issue is how Proctor disclosed the origin of the grains in the patent application, and if it is presumed that the disclosure was sufficient, why was the patent granted for a non-novel claim. The CGIAR has since responded that no intellectual property claim would be allowed to be claimed by the research centre on the materials held by them unless it is extremely important to do so to ensure access to new technologies and products by developing countries. Such intellectual property claim would not preclude access by developing countries to “knowledge, technology, materials and plant genetic resources”. See, MICHAEL BLAKENEY, “ Intellectual Property Aspects of Traditional Agricultural Knowledge,” in IP IN BIODIVERSITY AND AGRICULTURE: REGULATING THE BIOSPHERE, (Peter Drahos & Michael Blakeney eds., 2001) 29 at 37. For full text of the patent, see, USPTO Patent Full-Text and Image Database, at (last accessed on 2 July 2005). For CGIAR’s response, see, ‘CGIAR Working Document on Genetic resources and Intellectual Property,’ CGIAR Mid term Meeting. In: Summary of Proceedings and Decisions, Istanbul. World Bank, Washington, DC (1992). From a posting by Paul Gepts (Department of Agronomy and Range Science, University of California), it seems that the matter has not been decided yet. This has also been verified by a personal communication from ETC. Group. See, Knowporse.com website at (last accessed on 2 July 2005). 116 rights directly. In case of an improvement, the disclosure requirement can be fulfilled by quoting the information about the origin as recorded with the research centre. If the research involves a traditional resource, the terms or the purpose for which the resource holding state has deposited the material at the centre should be adhered to. Though the resources in the research centers are freely accessible, if it appears that the research activity has not been approved by the resource origin state, or they have not waived the procedure of granting consent, the researcher must approach for consent from the state. Ensuing benefit accrued by commercial exploitation of the invention should be proportionately shared with these states and also with the research centre from where the germplasm originated. The fact that it might be inconvenient to disclose the origin of a resource, can not be a ground for nondisclosure since, in the profit driven business arena, seeds and drugs developed from traditional genetic resources yield staggering financial gains. 2.4.2 Conclusion Disclosing the origin of the genetic resource used, on its own, is perhaps a morality issue.322 It is firstly imperative to be truthful about the claimed invention. Secondly it is acknowledgement to the resource holders for nurturing and preserving the resources over periods of time. Though some national legislatures with the disclosure requirement have been cited above, without mandatory international sanction, it can not lead to firstly, the process of harmonization of patents; secondly preservation of biodiversity; and thirdly equitable treatment to the traditional communities. Along 322 It has been argued that before the grant of a patent the “extent of prior existing knowledge” that has been used and the inventiveness involved in the invention need to be verified. The Brazilian submission, as an example, states that in case of microorganisms, it is necessary to that they are deposited prior to the grant of the patent. See, Brazilian submission, IP/C/W/228, supra note 125 ¶ 3. According to Professor Wei, the disclosure requirements can also be justified on the basis that the information provided is necessary to evaluate whether any objection on morality grounds can be raised. Wei, supra note 172 at 105 note 119. 117 with the prior informed consent rule, the international forum should include the mandatory disclosure requirement in the multilateral agreements binding the developed, the developing nations, the multi national corporations, the research institutes and all other stake holders. 2.5 PRIOR INFORMED CONSENT Another defensive measure of protection of traditional knowledge is that the granting of patents on inventions involving biological resources should require proof that the inventor had obtained prior informed consent to develop the material or to use the knowledge from the country or indigenous community holding the knowledge or the resource. Such consent should be given by the knowledge holder community after they are apprised about the probable developments for their knowledge or resource, what it was to be used for, the expected consequences, the financial prospects, and safety issues if any together with the community approval of all such exploitations.323 The importance of PIC may be justified due to different concerns. The first concern might be whether access to the traditional knowledge or genetic resource was legitimate, whether consent was given to permit the initial access to occur. Secondly, even if physical access to the resource had been consented to, the research process leading to the invention needs to be approved by the resource or knowledge holder. For instance, an access contract may allow medical research but prohibit cosmetic research. A contract in the WIPO Genetic Resources Contracts database included the 323 The prior informed consent (PIC) principal was first applied within the field of environmental instruments in the United Nations Environment Program (UNEP) London Guidelines for the Exchange of Information on Chemicals in International Trade. It was hereafter incorporated in the 1989 Basel Convention on the Control of Transboundary Movements of Wastes and Their Disposal and in the FAO International Code of Conduct on the Distribution and Use of Pesticides. In the aforesaid arenas, the prior informed consent procedure emphasizes the shared responsibility of importing and exporting countries in a different context. States here ensure that prior informed consent is obtained for any export, before the potentially harmful activity, namely, international trade of chemicals, transboundary movements of hazardous wastes or the distribution and use of pesticides, is undertaken. 118 proviso: “the (biological) materials will not be used for testing in or treatment of humans, and shall not be used, directly or indirectly, for commercial purposes.”324 Thirdly, whether all the uses of the invention were consented to needs to be ascertained. An invention may have multiple uses, for instance, as a food item and also as a cosmetic. It might infringe a traditional custom if the invention using the traditional resource, is consumed internally. Consent also should be acquired for filing a patent application since an access contract for certain genetic resource may specify that no IPR may be established on products derived from that genetic resource. In other words, the access to the traditional knowledge or genetic resource may itself be entirely legitimate, but it may create contractual or other legal constraints that limit the directions and extent of research based on the traditional knowledge or genetic resource, or restrict the entitlement to apply for a patent in all or in particular jurisdictions. An example is available in a research agreement contained in the WIPO Genetic Resource Contracts Database provides for “patent rights on metabolites with Recipient except for joint patents in the territory of provider”325. One more instance of a stipulation to access to genetic resources is found in Article 7 of the Amapá State Law on Access to Genetic Resources326 where it is stated that research subsequent to the access of the genetic 324 See, World Intellectual Property Organization, Traditional Knowledge: Contracts Database , (last accessed on 13 August 2004). This precondition would allow the recipient, Syngenta Crop Protection AG of Switzerland to apply singly for patent for the referred metabolite in any jurisdiction, except in the territory of the provider, Hubel Academy of Agricultural Science, China, where the recipient must apply for joint patent right with the provider. See, Research Agreement between Syngenta Crop Protection AG, Basel, Switzerland and HUBEL Academy of Agricultural Science, Wuhan, China, November 1997, available at (last accessed on 2 July 2005). 326 The full text of the Amapá State Law on Access to Genetic Resources can be accessed from Lewis and Clark Law School website at (last accessed on 3 July 2005). 325 119 resources of the Territory of Amapá, Brazil, shall require the participation of a Brazilian technical and scientific institution known in the area of the research, designated by the competent authority. To ensure transparency in case of patents related to biological resources, Article 15(5)327 of the CBD has provided that access to genetic resources must be subject to the prior informed consenting of the contracting party providing such resources. As required by Article 15(2), parties must endeavour to facilitate access, thereby ensuring the continued exchange of genetic resources. Though in Article 15(5), the CBD is fairly unambiguous that the authority to determine access to genetic resources rests with the national governments and informed consent has to be sought from national governments prior to such access, the nuances relating to obtaining prior informed consent have not been enumerated in the CBD and have been left to the legislation in the member states.328 Sarah A. Laird has suggested two extreme means through which the national governments can discharge their responsibilities. They can either be party to each commercial agreement regarding the access to genetic resources or the traditional knowledge, or they might enact laws guiding the development of access and benefit sharing arrangements. The agreements in the second instance may be entered into by private bodies in compliance with the national laws.329 Consequently the biotechnology companies searching for new genetic resources will need to respect the domestic legislation, including legislation protecting the rights of the indigenous 327 Art 15(5) CBD: 5. Access to genetic resources shall be subject to prior informed consent of the Contracting Party providing such resources, unless otherwise determined by that Party. 328 Art 15(1) CBD: Recognizing the sovereign rights of States over their natural resources, the authority to determine access to genetic resources rests with the national governments and is subject to national legislation. 329 Kate & Laird, supra note 27 at 28. 120 people, in the country of origin of genetic germplasm. The sovereignty, to determine how rights in those resources would be allocated, belongs to the host country. Some regimes resort to a local level consent requirement where the indigenous knowledge communities are required to approve the access to the genetic resources or the traditional knowledge within their territory. Some jurisdictions advocate obtaining the consent of other individuals and organizations. Section 2 of the Philippines Implementing Regulations includes in its definition of prior informed consent both local communities and private land owners.330 In Philippines, President Executive Order (PEO) No. 247 was issued in 1995 for regulating biodiversity prospecting which is defined as “the research, collection and civilization of biological and genetic resources for purposes of applying the knowledge derived there from to scientific and/or commercial purposes”. The PEO required that all biodiversity prospecting should be subject to the PIC of local and indigenous communities.331 Article 7 of the Andean Community Commission, Decision 391 dealing with Common Regime on Access to Genetic Resources holds that the five member states of the Andean Commission recognize and value the rights of the decision making capacity of indigenous Afro-American and local communities with regard to their traditional practices, knowledge and innovations related to their genetic resources and 330 It states, “Prior informed consent refers to the consent obtained by the applicant from the Local Community, Indigenous Cultural Communities or Indigenous Peoples (IP), protected Area Management Board (PAMB) or Private Land Owner concerned, after disclosing fully the intent and the scope of the bioprospecting activity, in a language and process understandable to the community, and before nay bioprospecting activity is undertaken”. See, Manila, Prescribing Guidelines and Establishing a Regulatory Framework for the Prospecting of Biological and Genetic Resources, their By-Products and Derivatives, for Scientific and Commercial Purposes, and for other purposes, Executive Order No. 247 (1995), available at (last accessed on 13 August 2004). 331 See, id. 121 the derivatives from such resources.332 Article 26(b) puts the onus of locating the supplier of the ‘intangible component’333 on the applicant of the patent for product based on that genetic resource or derivatives with an intangible component and negotiates access contracts with them. The US and the EU hold a unique position regarding obtaining informed consent prior to obtaining the genetic resources. While not opposing the practice in principle, they have proposed that the submission of proof of PIC be made an enforcement requirement rather than a substantive criterion for patentability. They have also opposed the idea of non grant or cancellation of patents for lack of production of PIC evidence. They have held that though CBD speaks about prior informed consent, it does not obligate that the provision be made mandatory. US has not supported the use of TRIPS as a suitable means to ensure prior informed consent and benefit sharing. US has held that contracts would be more effective.334 US has said that there is no conflict between TRIPS and the CBD, and that WIPO should be the governing agency on this issue. The EU has proposed the establishment of further mechanism for PIC and disclosure of origin requirements outside the purview of TRIPS so as not to affect the patentability of the invention.335 In a WIPO report, the US delegation, while recognizing the necessity for obtaining prior informed consent, did not consider that 332 Andean Community Commission, DECISION 391: Common Regime on Access to Genetic Resources, 1996. 333 ‘intangible component’: any knowledge, innovation or individual or collective practice of actual or potential value associated with the genetic resource, its derivatives or the biological resource containing them, whether or not it is protected by intellectual property systems. Andean Community Commission, DECISION 391. 334 See, Martin Khor, TRIPS Council debates patents on Life, TK & Art 27.3(b), at (last accessed on 13 August 2005). 335 European Commission: Director General for Trade: "Communication by the European Communities and their Member States to the TRIPS Council on the review of Article 27.3(b) of the TRIPS Agreement, and the relationship between the TRIPS Agreement and the Convention on Biological Diversity (CBD) and the protection of traditional knowledge and folklore - A Concept Paper" available at (last accessed on 15 August 2005). 122 to be a “natural right” and sought the implementation of prior informed consent procedure through ‘permits, contract systems and other national laws.’336 The Bonn Guidelines were recognized as a useful first step of an evolutionary process in the implementation of relevant provisions of the CBD related to access to genetic resources and benefit-sharing.337 The Guidelines suggest that PIC be discharged by the government through a competent national authority.338 The key issue is the prior informed consent of stakeholders in the providing country, which means that clear information has to be given in advance on the intended purposes of resource utilization. The Guidelines stipulate that procedures legally regulated at the national level should facilitate the involvement of all relevant stakeholders from the community to the governmental level particularly including indigenous and local populations.339 Furthermore PIC should include information about the specific uses for which the consent is to be granted. Thus users of genetic resources and related knowledge will have to seek PIC not only from the government (as represented by a 336 See, World Intellectual Property Organization, Disclosure Requirements Related to Genetic Resources and Traditional Knowledge, Report, WIPO/GRTKF/IC/6/14, WIPO, Geneva, March 2004, ¶ 76. 337 Bonn Guidelines have been discussed in Chapter III section 3.3.1 of the thesis. 338 Article 26, Bonn Guidelines provides that prior informed consent should include the consent of the relevant competent national authority(ies) in the provider country. It further states that the consent of relevant stakeholders, such as indigenous and local communities, as appropriate to the circumstances and subject to domestic law, should also be obtained. The applicant must supply the best scientific and commercial information and the providers must be free to seek further clarification. The information provided should also disclose the foreseeable risks involved. The consent should state whether the applicant is free to transfer the material to third parties. An alternate method that has been suggested is that a two tier mechanism be established involving the processes of public notification and national assessment of the views democratically expressed by the stake holders. See, generally, Stephen Tully, The Bonn Guidelines on Access to Genetic Resources and Benefit Sharing, Review of European Community and International Environmental Law, Vol.12 , Issue1, 89 at 93. 339 See, Convention of Biological Diversity, Report of the Ad Hoc Open-ended Working Group on Access and Benefit-Sharing, Doc. UNEP/CBD/COP/6/6, Hague, 31 October 2001, ¶ 28. 123 designated authority), but from an indigenous or local community, or an authority nominated or established to represent it.340 The Brazilian laws for access to genetic resources mandate obtaining permission from government approved biotechnology research institutions prior to access of the genetic resource.341 The State of Amapa has also entrusted the Government to issue 340 The draft ASEAN Framework Agreement On Access To Biological And Genetic Resources proposed that ASEAN shall not allow the patenting of plants, animals, microorganisms or any parts thereof and traditional knowledge. In Article 10, it is provided that prior informed consent of the resource holder nation would be essential for gaining access to the resource. Such consent should honour the customary laws, practices and protocols of the indigenous people and the local communities. This, however, is not the official position of ASEAN but is a proposal by the non government organisation SEARICE (www.searice.org.ph) for consideration by the ASEAN Working Group for Nature Conservation and Biodiversity in June 2000. It does not seem that the proposals made in the draft would be adopted since all the members might not agree. For instance Singapore does not prohibit patents of either plants or animals or microorganisms. Further from the Non-Paper (supra note 29), it seems Singapore shall not support the inclusion of PIC requirement and certification of compulsory disclosure of origin as requirements for patentability. The full text of the draft ASEAN Framework Agreement On Access To Biological And Genetic Resources is at (last accessed on 15 December 2004). Association of Southeast Asian Nations (ASEAN) is an association of nations dedicated to economic and political cooperation in southeastern Asia. Presently ASEAN has ten member countries which are Brunei Darussalam, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, and Vietnam. More about ASEAN is at < www.aseansec.org> (last accessed on 15 December 2004). 341 Provisional Measure on Access to Genetic Resources and Traditional Knowledge has been in force Brazil since 2001. This provides: Article 16: Access to components of the genetic heritage existing in situ within the national territory, on the continental shelf or in the exclusive economic zone, and to associated traditional knowledge, shall be had by collection of samples and information respectively, and authorization shall only be given to a national institution, whether public or private, that carries on research and development activities in the biological and related fields by prior authorization, as provided in this Provisional Measure. Section 1: The person responsible for the expedition to collect samples shall, at the end of his work in each area accessed, sign with the owner or representative thereof a declaration listing the material accessed, as provided in the regulations. Section 2: In exceptional cases, where the owner of the area or his representative was not identified or located when the expedition to collect samples took place, the declaration listing the material accessed shall be signed by the person responsible for the expedition and sent to the Management Council. Section 3: A representative sub-sample of each accessed population constituting a component of the genetic heritage shall be deposited ex situ with an accredited depositary, described in Article 11.IV(f) of this Provisional Measure, as provided in the regulations. Section 4: When there is a prospect of commercial use, in situ access to samples of components of the genetic heritage and to associated traditional knowledge may only occur after the Contract for Use of the Genetic Heritage and Benefit-Sharing has been signed. Section 5: If potential for economic use has been identified in either a product or a process, whether or not it qualifies for intellectual protection on the basis of a sample of a component of the genetic heritage and information derived from associated traditional knowledge, accessed by virtue of authorization that did not establish that hypothesis, the benefiting institution is obliged to communicate with the Management Council, or the institution with which the process of access and dispatch originated, for execution of the Contract for the Use of the Genetic Heritage and BenefitSharing. Section 6: Participation of a foreign legal entity in an expedition to collect samples of components of the genetic heritage in situ and to gain access to associated traditional knowledge shall only be authorized when it is to be in conjunction with a national public institution, which shall compulsorily be responsible for the coordination of activities, and provided that all institutions involved carry out research and development activities in biological and other related fields. Section 7: Research on components of the genetic heritage shall preferably be done on the national territory. 124 permission for access of genetic resources after guarantee of involvement of local communities and full knowledge about the aims of such access.342 The aforesaid enactments and regulations demonstrate the earnest endeavours of some biodiverse nations for incorporating PIC as a method of protecting biodiversity and regulating applications for IPRs. The latest WIPO reports likewise uphold the need for implementing prior informed consent procedures.343 However TRIPS has yet to move on this issue and the national laws and rules summarised have not yet been entrenched into the international IP regime. 2.5.1 Challenges in obtaining PIC Section 8: The Authorization of Access to and Dispatch of samples of components of the genetic heritage in the case of species that are strictly endemic or threatened with extinction shall be dependent on the prior consent of the competent body. Section 9: Authorization of Access and Dispatch shall be granted with the prior consent of: I. the indigenous community involved, the views of its official representative body having been heard where access occurs on indigenous territory; II. the competent body where access occurs in a protected area; III. the owner where access occurs on private land; IV. the National Defense Council where access occurs in an area indispensable to national security; V. the maritime authority where access occurs in Brazilian territorial waters, on the continental shelf or in the exclusive economic zone. Section 10: The holder of an Authorization of Access and Dispatch under Section9.1 to V of this Article is responsible for indemnifying the owner of the area for any damage or harm that has been duly proved. Section 11: An institution holding a Special Authorization of Access and Dispatch shall send to the Management Council the consents referred to in ¶ s Section8 and Section9 of this Article before or on the occasion of collection expeditions to be carried out during the period of validity of the Authorization, and failure to do so shall result in its cancellation. Brazil, Provisional Measure on Access to Genetic Resources and Traditional Knowledge, available at (last accessed on 3 July 2005). 342 The Amapá State Law on Access to Genetic Resources, Article 1(III): “Entrusts the Executive Power to preserve the diversity, integrity, and the defensible utilization of genetic resources located in the State of Amapá, and to inspect the entities dedicated to the resource as well as manipulation of genetic material, by taking in consideration the following principles: (I)…(III) participation of the local communities and indigenous people in social and economic benefits resulting from the activities of access to the genetic resources located in the State of Amapá”. Article 6: The survey activities and gathering of biological diversity resources performed in the Territory of Amapá requires the prior approval of the competent authority, after presentation by natural person or legal entity of a petition, which includes at least: I. detailed and specific information to the resources research for which they want access, including the resource's present and potential use, its sustainability and risks that may result from access, II. detailed description of the methods, techniques, gathering systems and the tools to be used, III. precise location of the areas of access to the resource, IV. indication of the destination of the material gathered and its probable later use. 343 World Intellectual Property Organization, Preliminary submission by Assembly of First Nations, Call of the Earth, the Aboriginal and Torres Strait Islanders Commission (ATSIC), Foundation for Aboriginal and IslanderResearch Action (FAIRA), Canadian Biodiversity Network, Coordinating Body of the Indigenous Organizations of the Amazon Basin (COICA), Hokotehi Moriori Trust, Rekohu, Aotearoa (New Zealand), Indigenous Peoples Caucus of the Creators Rights Alliance, the Kaska Dena Council, the Saami Council and the International Indian Treaty Council:Objectives, principles and elements of an international instrument, or instruments, on intellectual property in relation to genetic resources and on the protection of traditional knowledge and traditional cultural expressions, DRAFT, Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore, WIPO, Geneva, March 15 to 19, 2004, 1. 125 The prior informed consent procedure poses some underlying difficulties. Article 15 of the CBD confers the ownership of the genetic resources to the various nations. Certain genetic resources are endemic to a number of countries. In such circumstances obtaining the consent to access a resource from only one such country may lead to allegations of infringement from the other countries possessing the resource.344 It is further a challenge for the collector to identify, at the local level, exactly whose consent is required. While it may be possible to identify the local landowners, it is often quite a challenge for scientists from foreign countries, who are not acquainted with local languages and cultures, to identify who to seek permission from, which local and indigenous communities consent is needed, and who can negotiate on their behalf. This raises a number of pertinent questions. It is relevant to know how many communities are involved and whether the legal system of the country grants rights to individuals or collective rights to the communities. Also important is the issue whether consent being given by the community is a total agreement or the views of a proportion of the members of the community. 2.5.2 Case Study: The Jeevani experience The Kanis are a small nomadic community based in the state of Kerala, in southwestern India. Kanis used a concoction made of the local Arogyapachha plant to cure liver ailments.345 A detailed scientific investigation of the plant was conducted, 344 But see note 319. CIPR has felt that the bioprospector would take the initiative to trace the origin of the resource or the knowledge. 345 A team of scientists from the Regional Research Laboratory at Jammu, under the leadership of Dr Pushpangadan (who is currently the Director of the National Botanical Research Institute, India) were surveying ethno-botanical knowledge of the Kani community in the forests of Thiruvananthapuram, Kerala. While the scientists felt fatigued climbing the mountains and walking long stretches, they noticed that Shri Mallan Kani and Shri Mathan Kani, two tribal guides accompanying them, were quite agile and not tired. The guides constantly ate some fruits, which were apparently the source of their 126 including chemical screening to isolate the active principles. Two national patents were filed by The Tropical Botanical Garden and Research Institute346 on 4 June 1996, on its immuno-enhancing, anti-fatigue, anti-stress, hepato-protective properties along with a process of making the drug. A license was given to an Ayurvedic company347 for a period of seven years for commercialising the drug called Jeevani. The benefits were shared with the tribal community by putting 50 per cent of the licence fee i.e., INR 500,000348 in a trust established under their control. Individual information providers were given special incentives from the trust. Kanis in different areas of Tiruvananthapuram district have different opinions on the arrangement of TBGRI which has interacted primarily with Kanis from the Kuttical Gram Panchayat area.349 This section of the Kanis has been appreciative of TBGRI’s role. However Kanis in other Panchayat areas have expressed annoyance at the fact that TBGRI had not been working with Kanis from the other areas. Some feel the benefit sharing arrangement is a superficial exercise since the Kanis have neither been consulted nor involved. In September 1995, a group of nine Kani medicine men called energy. After much persuasion, Shri Mallan and Shri Mathan revealed the identity of the plant, Arogyapacha (scientific name: trichopus zeylanicus) from which the fruit was obtained. It was said that for many years, when allopathic medicines failed to cure critical liver diseases, the local population in and around Thiruvananthapuram used to get cured with a concoction that the Kani elders and local doctors prepared out of Arogyapacha. See, Convention On Biological Diversity, Benefit Sharing Model Experimented By Tropical Botanic Garden And Research Institute (TBGRI), A National Center Of Excellence On Tropical Plant Diversity, Ministry Of Environment & Forests, Government Of India, at (last accessed on 12 August 2004). 346 Hereinafter referred to as TBGRI. 347 Arya Vaidya Pharmacy – Coimbatore Ltd., also known as CAVP, at < www.avpayurveda.com> (last accessed on 13 August 2004). 348 Approximately USD 12,000. 349 The traditional system of governance among the Kanis has been eroded, and their day –to –day activities and system of governance is now linked to that of non-tribal local communities, rather than governed by local chief. This system of governance, referred to the Panchayati Raj system is based on the principle of devolution of administrative powers to the local village level and has been institutionalized under the Constitution of India. Each Panchayat area consists of a number of wards with assemblies of all the adult members called the Gram Sabha (village council). There are 1,000 to 2,000 members in each Gram Sabha, inclusive of both tribal and non-tribal members, but predominantly non-tribals. Members of the Panchayat’s decision-making body are elected by members of all the Gram Sabhas constituting the Panchayat. 127 Plathis wrote a letter to the Chief Minister of Kerala objecting to the sale of their knowledge to private companies. TBGRI has acknowledged that it has not communicated with all the members of the Kani tribe but has hoped that the trust established for benefit sharing arrangement would involve and benefit more Kanis.350 2.5.3 Recommendations and conclusion In essence, prior informed consent is about transparency and respect. It is a form of recognition to the authority of the knowledge holders. The present legal regimes create domestic laws for prior informed consent but though it is enumerated in the CBD, it is yet to obtain a substantive requirement status with United States choosing to opt for a voluntary disclosure of origin rather than a mandatory disclosure. The TRIPS, in Article 29.1 (i.e. disclosure in order to allow reproduction of the invention) may accommodate origin disclosure requirement if that is essential for reproduction of the invention, but would not, in the present form, advocate prior informed consent. Article 62 of TRIPS which allows WTO countries to require, as a condition of acquisition of an IPR, compliance with reasonable procedures and formalities, can also be extended to mandate prior informed consent. Some nations have mandated a prior informed consent requirement, pinning the right to the state governments or governmental bodies, as has been done in the Indian Biodiversity Act.351 This might lead to further alienation of the indigenous community, access for whose knowledge permission is being sought. It is therefore 350 Anil K. Gupta, Rewarding Conservation of Biological and Genetic Resources and Associated Traditional Knowledge and Contemporary Grassroots Creativity, January 2003, available at (last accessed on 14 August 2004). 351 See the powers of the National Biodiversity Authority and State Biodiversity Boards in the discussion on the Biological Diversity Act in Chapter III, section 3.2.3. 128 appropriate if a two tier system can be designed where the indigenous community sharing the knowledge has a right to grant or refuse consent for sharing the knowledge. The prospector must obtain consent not only form the related government body but also from the indigenous community. The national government or the authorized body should have a role to play since the indigenous communities may not have an even footing with the prospector by way of communication hazards due to lack of common language and bargaining power. Further the government body can object if a particular agreement could be detrimental to the interests of any other community, or the nation as a whole. Such a mechanism would also be in consonance to the provisions of the CBD which, though bestows the ownership of traditional and genetic resources to the holder state, also advocates the involvement of the indigenous communities in the sustenance and the exploitation of biodiversity. The emerging national legislation and the CBD have only gone so far as to determine that access to traditional resources should be subject to the consent of the indigenous communities.352 Indigenous groups have called upon governments to recognize their free prior informed consent as a fundamental right for protecting traditional knowledge, innovations and practices.353 It is increasingly being acknowledged that the communities are not mere stake holders, but are right holders in allusion to their traditional knowledge and genetic resources. Presumably, without international 352 Convention on Biological Diversity, Article 8(j) and Related Provisions, COP Decision V/16 (2000). 353 International Indigenous Forum on Biodiversity, Closing Declaration of the Sixth COP at CBD (Hague 19th April 2002), available at < (last accessed on 14 August 2004). 129 sanction the obligation of prior informed consent would often be bypassed by the prospectors. To ensure more transparency in biotechnology patents, specially for ones based on genetic resources, it is extremely important that documents disclosing the origin of a genetic resource and also showing prior informed consent be made mandatory requisites for filing patent applications. 2.6 CONCLUSION The measures discussed above are some of the modes by which traditional knowledge can be protected.354 The mode of protection must be decided by a state’s philosophy, ideals and priority. This should be supported by a desire to evolve a win-win situation where both the traditional communities and the developed populace gain from the knowledge and the experiences of each other. In the following Chapter positive measures for protection of traditional knowledge and resources have been discussed. An ideal protection system would be a combination of the defensive measures and the positive measures, the rivet being on the traditional communities’ rights and interests 354 As the TRIPS Agreement contains no provisions allowing a members claim to enforce ‘fair and equitable sharing of benefits’ from the patenting of its own genetic resources abroad, in IP/C/W/429/Rev.1, on 27th September, 2004 Brazil, Cuba, Ecuador, India, Pakistan, Peru, Thailand and Venezuela proposed to implement a legally binding obligation to (i) disclose the source and country of origin of biological resources and/or traditional knowledge used in the invention, (ii) provide evidence of prior informed consent through approval of authorities under the relevant national regimes, and (iii) provide evidence of fair and equitable benefit sharing under the relevant national regimes. This will serve the following purposes: (i) helping patent examines determine whether the claimed invention constitutes an invention that is excluded from patentability under Articles 27(2) and (3) of the TRIPS Agreement, (ii) enhancing the ability of countries to track bad patents and in the instances where they are granted and challenge the same, (iii) reducing instances of bad patents and (iv) improving compliance with their national laws on Prior Informed Consent and fair and equitable benefit sharing prior to accessing a biological resource/associated traditional knowledge. Article 29 already obliges members to require that patent applicants disclose the invention in a manner sufficiently clear and complete for the invention to be carried out by a person skilled in the art and may require the applicant to indicate the best mode to carry out the invention known to the inventor. An obligation to disclose source and country of origin of biological resources and/or traditional knowledge used in an invention would play a crucial role in ensuring patent quality. World Trade Organization, Elements of the obligation to disclose the source and country of origin of the biological resources and/or traditional knowledge used in an invention, Council for Trade-Related Aspects of Intellectual Property Rights, IP/C/W/429/Rev.1, WTO, Geneva, 27 September 2004. 130 as well as advancement of sciences, technology, and biotechnology by way of new solutions to problems faced by mankind. 131 CHAPTER III: POSITIVE PROTECTION OF TRADITIONAL KNOWLEDGE 3.1 INTRODUCTION The difference between positive protection and defensive protection is obscure. The PIC requirement, disclosure of origin measures, and similar steps, which do not create any new right but are used to discourage biopiracy, are defensive measures which have featured in sui generis acts to extend protection to traditional knowledge and resources used by traditional communities through intellectual property rights. Sui generis laws are pieces of legislation which endeavour to cover the shortfalls of standard intellectual property laws in protecting unconventional fields like traditional knowledge. This chapter sets out a general review of sui generis rights. Access benefit sharing355 system and the Indian laws facilitating the same are discussed thereafter. Finally, the Chapter describes the global biocollecting society356 idea propounded by Professor Peter Drahos and the probable problems of its implementation in India. 3.2 SUI GENERIS RIGHTS ‘Property’ has been defined in the dictionary as ‘the right to possession, use, etc.’ or, ‘possessions collectively’.357 Black’s Law Dictionary358 qualifies this and defines property as ‘the right to possess, use and enjoy a determinate thing’. Neither of these two definitions however highlights the economic aspect of property. Property, in the IP sense, can be considered as the right of commercial exploitation of one’s possession. This explains the definition of ‘intellectual property’ in Black’s Law Dictionary wherein intellectual property has been defined as “a commercially 355 Also referred to as ABS hereinafter. Also referred to as GBS hereinafter. 357 THE CONCISE OXFORD DICTIONARY, (9th ed., 1995) 1097. 358 Seventh Edition, West Group, St. Paul, MN, 1999, 1233. 356 132 valuable product of the human intellect,” or “a category of intangible rights protecting commercially valuable products of the human intellect.”359 Thus a creation, or an invention, which can be commercially exploited360 is an intellectual property.361 Though natural products have long formed an integral part of drug discovery, a study by Laird362 reveals that 42 percent of sales of the 25 top-selling drugs world-wide are either biological, natural products or entities derived from natural products. This has led to two major concerns particularly in biodiversity rich developing countries. First is the concern for protection of biological resources from over exploitation. Second is the tendency of certain pharmaceuticals to research genetic resources based on leads from traditional knowledge and obtain patents for such products without compensating or even acknowledging the source of the information. The neem, turmeric, basmati, enola bean and the other biopiracy cases described earlier in the thesis363 show that without effective protection, traditional knowledge and culture are open to pillage and erosion. Thus has risen the necessity to extend some form of legal protection to traditional knowledge so that, firstly it is not alienated from the local community or the nation holding this knowledge, secondly, it is not exploited without the consent of the knowledge holder country or community, and leading from the second concern, thirdly, the source countries and local communities obtain financial benefit from the use of traditional knowledge. While genetic resources can be protected with 359 Seventh Edition, West Group, St. Paul, MN, 1999, page 813. Also see, Chapter I section 1.4 of the thesis. 361 For instance, poetry as a creation of a poet; or a machine as an invention of an engineer; if viable for economic exploitation, would merit intellectual property right recognition and protection. 362 Supra note 27 at 333. 363 See, Chapter I section 1.3 of the thesis. 360 133 environment protection laws or even criminal laws364, the associated traditional knowledge relating to their attributes make them a subject matter of some other protection in addition to criminal laws.365 Since knowledge is an intangible subject, and also, since traditional knowledge has proved to be commercially viable, efforts have been made to protect traditional knowledge through intellectual property rights.366 However traditional knowledge has a number of unique properties alien to the standard concepts of knowledge.367 Though traditional knowledge is synonymously called indigenous knowledge, it is not restricted in its use and evolution to the indigenous communities only but is utilised by all having access to the information and the resources referred to in the information.368 A recent report reveals that experts from Kings College, London are studying the diabetes controlling properties of the Indian curry leaf.369 It is a possibility that such research would eventually yield a vendible product in the form of a patentable new drug, notwithstanding that the information triggering the research was held by some other nation. 364 For instance, theft of an expensive indoor plant, with aesthetic value but no viable biochemical property would be the subject matter of criminal laws of the land and would not come under the fold of intellectual property right protection. Also see supra note 163. 365 Protection of traditional knowledge is discussed in Chapter I section 1.6 of the thesis. 366 The endeavours of protecting traditional knowledge through standard intellectual rights laws have been discussed in Chapter I section 1.4 and Chapter iii section 3.2. 367 It is mostly the genre of information which has evolved over ages through the living experiences of people across the globe. Unique cultural customs, beliefs and practices, as well as specific environmental conditions have influenced the different indigenous peoples over centuries. Some of them have traditional ways of living while others have more or less adopted Western cultures. The characteristics of traditional knowledge have been dealt in detail in Chapter I sections 1.2, 1.4 and 1.5 of the thesis/ 368 A home remedy made of warm lime and turmeric is still used even by the city bred in various parts of India as a wound healing ointment . Source:A. K. NADKARNI, INDIAN MATERIA MEDICA : WITH AYURVEDIC, UNANI-TIBOI, SIDDHA, ALLOPATHIC, HOMEOPATHIC, NATUROPATHIC & HOME REMEDIES, APPENDICES & INDEXES, Bombay : Popular Book Depot , [1954]. 369 Herbal remedies 'do work', at < http://news.bbc.co.uk/2/hi/health/3698348.stm > (last accessed on 14 December 2004). 134 Certain limitations in intellectual property laws have hindered protection of traditional knowledge through standard legal regime. Traditional knowledge, often being noncodified, is difficult to establish as novelty defeating, since certain legal jurisdictions do not recognize unwritten information as novelty defeating prior art.370 Traditional knowledge databases are being compiled to remedy the situation. Such efforts in India have been discussed in Chapter II. Though there is a strong copyright protection for databases based on selection, arrangement and industrious collection theories; what is being protected is the labour and capital invested in the database as opposed to the traditional knowledge data. Thus while the labour and capital of the compiler is being rewarded with copyright protection, the actual knowledge holders are still insecure.371 Further, copyrights are meant to benefit society through the granting of exclusive rights to natural and .juridical persons, not collective entities such as, indigenous people. Copyright normally requires works to be documented. However, this is not so with folkloric expressions as they are usually passed on orally from one generation to the next. Hence copyright laws are inadequate in protecting traditional knowledge.372 A disparity between traditional knowledge and modern concept of intellectual property is the issue of ownership.373 To qualify for intellectual property protection there should be a specific inventor who should be granted the exclusive right of exploitation of his creation. This would permit the inventor to prevent others from 370 United States Patent and Trademark Office does not recognize non documented information as novelty defeating prior art. A detailed discussion can be found in Chapter II section 2.2.1 of the thesis. 371 Databases and copyright are discussed in Chapter II section 2.3 of the thesis. Also, Article 10 of TRIPS provides “ Compilations of data or other material … which by reason of the selection or arrangement of their contents constitute intellectual creations shall be protected as such, Such protection, which shall not extend to the data or material itself, shall be without prejudice to any copyright subsisting in the data or material itself”. 372 To remedy the thin protection copyright laws provide to databases, EU has created sui generis rights on the contents of the database. This protects database holders from unauthorized copying of the database. See Chapter II section 2.3.1 of the thesis. 373 Supra note 125. 135 using the same without the inventor’s permission. It is based on notions of individual property ownership, a concept that is often alien and can be detrimental to many local and indigenous communities. Traditional knowledge is collective in nature and is often considered the property of the entire community, and not belonging to any single individual within the community.374 Hence any assigned right should be collective in nature.375 Incase of traditional knowledge shared by more than one community, any right can not just be attributed to a single community, or in cases of information which have emanated from neighbouring nations, the rights might have to be shared by such nations.376 Further, intellectual property protection on inventions or creations is for a specific period of time. For instance US grants patent rights for a period of twenty years from when the right is granted. The standard copyright protections protect works during the 374 There are some traditional crafts which are practiced by a single family in the community. One instance is the Dashabatar playing cards made in Bishnupur, a small town in the state of West Bengal, India. These cards are used in a unique card game played by the kings of the Malla dynasty in around 800 A.D. The cards are adorned with colourful miniature paintings of Hindu deities. While the actual game is almost an extinct practice, the cards are in great demand for their aesthetic appeal. However the supply of these cards is very low since only the Fauzdar family in the community produces these cards. The researcher had the opportunity to meet a member of the family and learnt that the production was a family effort since it involved various steps from making the base of the cards to painting them. In such instance the single family would be entitled to an intellectual property right arising from the practice. PRABHAS SEN, CRAFTS OF WEST BENGAL, (1994) 18. More about the cards can be found at the Handicrafts website of Government of West Bengal at (last accessed on 3 July 2005). 375 However according to Cleveland and Murray, the concept of individual property rights is not alien to indigenous communities. David A. Cleveland & Stephen C. Murray, The World’s Crop Genetic Resources and the Rights of Indigenous Farmers, Current Anthropology, Volume 38, Number 4, August-October 1997, 477-516 at 483. 376 The issues of common origin of a traditional knowledge have been discussed in Chapter II section 4 herein before. Neem is a tree which is common to the Indian subcontinent and its uses applied in day to day life by the people there. Thus any property right on the knowledge associated with the neem tree may be claimed by all the nations using such knowledge, and would not be attributable to a single nation. The Indian subcontinent is the peninsular region of larger South Asia in which the nations of India, Bangladesh, Pakistan, Sri Lanka as well as parts of Nepal, Bhutan and Myanmar are located. 136 lifetime of the author and a period of fifty years after his demise.377 But traditional knowledge being developed through generations requires perpetual protection from piracy or any other kind of misuse. Further, modern inventions, being subject matters of intellectual property laws, are under enacted legal sanctions. Traditional knowledge is mostly protected by community social systems and sanctions. They might actually not adhere to the present standards of intellectual property protection.378 The incompatibilities between traditional knowledge and intellectual property rights have surfaced with the rapid global acceptance of western concepts and standards for intellectual property.379 Even in instances where intellectual property protection could 377 Some countries have extended copyright protection for a period of 70 years after the death of the author. For instance, the Copyright Act of Singapore, under Sections 28 and 29, protects the work till 70 years after the death of the author or creator. Section 28 , Copyright Act: (1) This section shall have effect subject to sections 27 (2) and 29. (2) Subject to this section, where, by virtue of this Part, copyright subsists in a literary, dramatic or musical work, or in an artistic work other than a photograph, that copyright shall continue to subsist until the expiration of 70 years after the expiration of the calendar year in which the author of the work died. (3) If, before the death of the author of a literary, dramatic or musical work — (a) the work had not been published; (b) the work had not been performed in public; (c) the work had not been broadcast; (d) the work had not been included in a cable programme; and (e) records of the work had not been offered or exposed for sale to the public, the copyright in the work shall continue to subsist until the expiration of 70 years after the expiration of the calendar year in which the work is first published, performed in public, or broadcast, or included in a cable programme, or records of the work are first offered or exposed for sale to the public, whichever is the earliest of those events to happen. (4) A reference in subsection (3) to the doing of an act in relation to a work shall be read as including a reference to the doing of that act in relation to an adaptation of the work. (5) If, before the death of the author of an engraving, the engraving had not been published, the copyright in the engraving shall continue to subsist until the expiration of 70 years after the expiration of the calendar year in which the engraving is first published. (6) Copyright subsisting in a photograph by virtue of this Part shall continue to subsist until the expiration of 70 years after the expiration of the calendar year in which the photograph is first published. Section 29 of the Copyright Act: (1) Subject to subsection (2), where the first publication of a literary, dramatic or musical work, or of an artistic work other than a photograph, is anonymous or pseudonymous, section 28 shall not apply in relation to the work but any copyright subsisting in the work by virtue of this Part shall continue to subsist until the expiration of the period of 70 years after the expiration of the calendar year in which the work was first published. (2) Subsection (1) shall not apply in relation to a work if at any time before the expiration of the period referred to in that subsection, the identity of the author of the work is generally known or can be ascertained by reasonable inquiry. The Copyright Act has been accessed from the Singapore Statutes Online website at (last accessed on 3 August 2005). 378 See, Chapter I sections 1.2 and 1.4 of the thesis. 379 Problems experienced in trying to protect traditional knowledge under intellectual property laws stem mainly from the failure of traditional knowledge to satisfy requirements for intellectual property protection or for the intellectual property regime to accommodate the diversities of traditional knowledge. Id. and Chapter 3 section 3.2. 137 potentially apply to such knowledge, the prohibitive costs of registering and defending a patent or other IP right may curtail effective protection. Such drawbacks of the intellectual property system have prompted the demand for recognizing sui generis or unique rights of the indigenous communities for protection of their knowledge. In the following section, views of various nations and authorities regarding protection of traditional knowledge via sui generis laws are mentioned; geographical indications as a kind of sui generis right and the Biodiversity Act 2002 of India as a sui generis legislation is discussed. It will be argued that the present intellectual property rights regime can be adapted to protect traditional knowledge instead of a new sui generis right. 3.2.1 Sui Generis protection systems-legal sanctions The TRIPS Agreement, adopted two years after the CBD, created some specific challenges for protecting genetic resources and traditional knowledge. With the ratification of TRIPS at Marrakesh in 1994, as per Article 27.1380, WTO member countries found themselves under the obligation to provide some form of intellectual property protection for inventions in all fields of technology including plant varieties. TRIPS Article 27(3)(b) required that members of the WTO, do this either through patents or some "effective sui generis system" or a combination thereof at the national level. Sui generis literally means “of its own kind” and consists of a set of nationally recognized laws and, in the context of TRIPS, implies ways of extending plant variety 380 Article 27.1, TRIPS-Subject to the provisions of ¶ s 2 and 3, patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application. Subject to ¶ 4 of Article 65, ¶ 8 of Article 70 and ¶ 3 of this Article, patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced. 138 protection381 other than through patents. TRIPS itself did not define what a sui generis system is or should be. Potentially, a sui generis system could be defined and implemented differently in different countries. In addition, a sui generis system might be defined to create legal rights that recognize any associated traditional knowledge relating to genetic resources and promote access and benefit sharing. Since TRIPS provides for protection of plant varieties through sui generis rights other than patents in Article 27(3)(b), according to Wei, on the basis of Article 1(1), which allows WTO members to adopt higher standards of protection than what is enumerated in the TRIPS, the Member states may be able to introduce new intellectual property rights so long as these are consistent with the general TRIPS provisions.382 Hence the governments of the member states may choose to extend protection to genetic resources and/or knowledge to a community in the form of patents, trade secrets, copyrights, farmers’ and breeders’ rights, or any other right not currently established in the intellectual property regime. The proposal from Kenya on behalf of the African Group before the 1999 WTO Ministerial Conference held that the Article 27(3)(b) of TRIPS be reviewed to include, as a foot note, a statement that any sui generis law should provide for the protection of the “innovations of the farming communities in developing countries”. 383 In 2002, the COP of CBD requested the Ad Hoc Open-ended Inter-Sessional Working Group on Article 8(j) and Related Provisions of the Convention on Biological 381 Plant variety protection is also referred to as PPVFR in the thesis. Wei, supra note 172 at 88. 383 See, supra note 119, WT/GC/W/302, ¶ 23. 382 139 Diversity to address the issue of sui generis systems for the protection of traditional knowledge, focusing in particular on the following issues: (a) Clarification of relevant terminology; (b) Compiling and assessing existing indigenous, local, national and regional sui generis systems; (c) Making available this compilation and assessment through the clearing-house mechanism of the Convention; (d) Studying existing systems for handling and managing innovations at the local level and their relation to existing national and international systems of intellectual property rights, with a view to ensure their complementarity; (e) Assessing the need for further work on such systems at the local, national, regional and international levels; (f) Identifying the main elements to be taken into consideration in the development of sui generis systems; (g) The equitable sharing of benefits arising from the utilization of traditional knowledge, innovations and practices of indigenous and local communities.384 India’s Plant Variety Protection and Farmer’s Rights Act, 2001385 has been enacted following the aforesaid principles. The Act, drafted in response to the sui generis option provided for in Article 27(3)(b) not only bestows plant breeders rights, inter alia to produce, sell, market, distribute, import or export the plant variety bred by him by way of a certificate; but also upholds the rights of a farmer to save, use, resow, exchange, share, or sell his farm produce including a seed variety protected under the 384 Convention of Biological Diversity, Report of the Sixth Meeting of the Conference of the Parties to the Convention on Biological Diversity, UNEP/CBD/COP/6/20, Hague, 27 May 2002, 157, ¶ 34. 385 India’s Plant Variety Protection and Farmer’s Rights Act, 2001 is discussed in detail in Chapter III section 3.2.3 of the thesis. 140 Act. The only exception provided is that the farmer is prohibited from selling branded seed of a variety sold under the Act.386 This ensures that the breeders are rewarded for their innovations, but at the same time are unable to threaten the farmers’ conventional methods of sustenance.387 A sui generis system may also adopt measures of protection specific to traditional knowledge in order to nullify inappropriate patents. For example, the Andean Community’s Decision 486 states that patents granted on inventions obtained or developed from genetic resources or traditional knowledge, of which any member state is the country of origin, without presentation of a copy of the proper access contract or license from the community shall be nullified.388 Further, the Indian Patent Act prohibits inventions using traditional knowledge from patentability. The Costa Rican Biodiversity Law, 1998, expressly recognizes and protects, under the common denomination of sui generis community intellectual rights, the knowledge, practices and innovations of indigenous peoples and communities related to the use of components of biodiversity and associated knowledge. This right exists and is legally recognized by the mere existence of the cultural practice or knowledge related to genetic resources and biochemicals; it does not require documentation, prior 386 Section 39(1)(iv) India’s Plant Variety Protection and Farmer’s Rights Act, 2001. The act has evoked mixed reactions. Suman Sahai, on of the activists in the field of farmers’ rights has said that this legislation is “the first in the world to grant formal rights to farmers in a way their self reliance is not jeopardized”. Suman Sahai, Protecting farmers, freeing the breeders, May 2003 at (last accessed on 15 December, 2004). However Vandana Shiva has held that the Act undermines the concept of farmers’ rights inter alia, as farmers here are envisaged to be conservers but not breeders of seeds (section 2(k)(iii) of the Act) thus negating their role as innovators. Vandana Shiva, Creating Seed Monopolies: proposed Indian Plant Variety Legislation, at (last accessed on 14 December 2004). 388 Article 75 (g) & (h) of Andean Community’s Decision 486. 387 141 declaration, explicit recognition or official registration; therefore it can include practices which in the future acquire such status.389 Though TRIPS posits sui generis rights only for plant variety protection, as has been discussed before, the WTO member states are free to adopt any form sui generis rights to protect their traditional knowledge and the related genetic resources. Since traditional knowledge has various forms,390 the same sui generis law might not be appropriate to protect all such variations.391 Further, countries disagree on the question of the necessity of sui generis legislation as means to protect traditional knowledge.392 One representative view is that of Brazil, one of the biodiversity rich countries of the world, which has held that intellectual property laws are improper tools to protect traditional knowledge relating to genetic resources. It has said that “they (intellectual property) are systems from which and not by which TK (traditional knowledge) should be protected”.393 389 It has advocated such rights that firstly, would ensure However, pertinent to note is that the ambit of the Law, under Article 4, Costa Rican Biodiversity Law, 1998, excludes “the exchange of biochemical or genetic resources among the indigenous people and local communities, nor to the associated knowledge resulting from their non-profit making practices, uses or customs”. Such practice is guided by the customs of the indigenous communities. 390 The basic forms of traditional knowledge have been mentioned in Chapter I Sections 2.1. 391 Some form of sui generis protection at WIPO dates back to 1982 when WIPO and UNESCO had jointly convened an expert group who had designed the sui generis ‘Model Provisions for National Laws on the Protection of Expressions of Folklore against Illicit Exploitation and Other Prejudicial Action.’ But traditional knowledge became a subject of negotiation only in the last decade, particularly with the signing of CBD in 1992. See, Michael Blakeney, Australian Reconciliation Convention 1997: Human Rights and Indigenous Australians - Cultural and Intellectual Property Rights, at (last accessed on 14 December 2004). 392 The current reports of the WIPO meetings reveal that the member states are divided regarding the need for sui generis rights for protection of traditional knowledge. See, generally, WIPO/GRTKF/6/14 supra note 336; WIPO/GRTKF/6/4 supra note 216. 393 WIPO/GRTKF/IC/6/14, supra note 336 at 31, ¶ 69. 142 inalienability of the rights of the indigenous people on their resources, and secondly, would not be restricted by time.394 The Indian delegation has opted for a strong internationally binding sui generis system of protection alongwith intellectual property protection for securing traditional knowledge. Emphasis has been given for procedures to facilitate prior art searches and access to traditional knowledge by patent offices. The delegation said that since there was a fair consensus toward the necessity to protect traditional knowledge, a system for its protection should be devised using ‘multi legal doctrines’, which would mean the relevant legal positions from the different jurisdictions should be incorporated in the system.395 The Indian sui generis acts for protection of traditional knowledge are discussed later in this section. Another representative view is that of the US delegation who has expressed reservations toward new intellectual property laws for protection of traditional knowledge vis-à-vis the existing traditional intellectual property laws. The delegation has not supported the advent of new intangible laws to protect traditional knowledge and genetic resources and has held that traditional knowledge could be protected under the existing intellectual property law regime. The idea of according protection in perpetuity to traditional knowledge has also not been accepted by the American delegation. The delegation has rather proposed a combination of the conventional 394 Brazil has enacted the ‘Provisional Measure for Access to genetic Resources and Traditional Knowledge’, 2001 and ‘Law on Plant Variety Protection’ in 2002. In the former provisions, Article 8(IV), it is stated that “The protection hereby instituted shall not affect, prejudice or limit rights pertaining to intellectual property.” Therefore Brazil has resorted to a combination of intellectual law rights, and sui generis laws for protecting its resources. 395 WIPO/GRTKF/6/14, supra note 337 at 37, ¶ 81 . 143 intellectual property laws alongwith contractual obligations as effective means to protect traditional knowledge.396 The European Community has been supportive of the sui generis option of protection. They have incorporated the sui generis option for protection of databases in the Directive 96/9 for protecting databases as well as the data contained therein. The database owner has been effectively granted an exclusive property right in the contents of the database to prevent unauthorized extraction and reutilization of the whole or substantial part of the contents of the database. Unlike the copyright protection duration, which is for life time of the author plus 70 years, the sui generis protection is available for fifteen years.397 However the European Union has expressed reservations about formulating sui generis options at the WTO, and has preferred WIPO, being the forum for handling intellectual property matters, as appropriate for such purpose.398 Certain pieces of legislation have been enumerated in TRIPS, which, though do not provide intellectual property protection directly, help to protect certain traditional creations and technologies from infringement. Since these do not offer any intellectual property right, they can be called sui generis provisions. The protection for geographical indications is such a provision enumerated in the TRIPS and is discussed hereunder. 396 WIPO/GRTKF/6/14, supra note 337 at 34-35, ¶ 76,. The EU Directive 96/9 is discussed in Chapter II section 2.3.1 of the thesis. 398 EUROPEAN COMMISSION Directorate-General for Trade, Communication by the European communities and there member states to the TRIPS Council on the review of Article 27.3(b) of the TRIPS Agreement, and the relationship between the TRIPS Agreement and the Convention on Biological Diversity (CBD) and the protection of Traditional Knowledge and Folklore: “A Concept Paper,” available at (last accessed on 13 July 2004). 397 144 3.2.2 Geographical Indications (GI) The geographical indications399 system provides protection to traditional products, specially genetic produces and handicrafts unique to certain areas from similar replicated products in other areas. These are distinctive signs identifying products of several producers located in the same geographical area. GIs are not absolute rights like trademark laws but are unique or sui generis rights since these do not distinguish the product as to the source or the enterprise of the origin but as to the geographical territory of origin. These are also a form of collective rights since no single entity owns this distinctive sign. All undertakings located in a specific geographic area are allowed to use the GI on the specified products produced by them provided they comply with the characteristics associated with such products under the geographical origin. Geographical indications400 is defined under Article 22.1 of TRIPS as “indications which identify a good as originating in the territory of a member, or a region or locality in that territory, where a given quality, reputation and other characteristic of the good is essentially attributable to its geographic origin”. However, under Article 24.9, TRIPS does not require a member to protect GIs unless they are protected in their country of origin. Further TRIPS Article 22.2 requires members to “provide the legal means for interested parties to prevent the use of any 399 Also referred to as GI. The GIs originate from the Paris Convention, 1883. Even though the Convention did not use the said expression Article 1(2) of the Convention used the expressions ‘appellation of origin’ and ‘indications of source’. The scope of the aforesaid expression has been delineated in Lisbon (1958) and Madrid Agreements (1979). The former delineates the appellation of origin to mean: geographical name of a country, region, or locality, which serves to designate a product originating therein, the quality and characteristics of which are due exclusively or essentially to the geographic environment, including natural and human factors. The country of origin is the “country whose name, or the country in which is situated the region or locality whose name, constitutes the appellation of origin which has given the product its reputation”. The latter defines the expression ‘indications of source’ to mean: Goods bearing a false or deceptive indications by which one of the countries to which this agreement applies, or a place situated therein, directly or indirectly indicated as being the country or place of origin. 400 145 name in the designation or presentation of a good that indicates or suggests that the good in question originates in a geographical area other than in a true place of origin in a manner which misleads the public as to the geographical origin of that good.”401 Such protections are available since many years in US402 and European countries. Although it is very difficult to enforce the protection in every corner of the world, France and Scotland have protected their geographical appellation rights for their most popular “Champagne Sparkling Wine” and “Scotch Whisky” from the Champagne District of France and Scotland respectively.403 401 It has been argued whether basmati rice (Chapter I section 1.3.3 of the thesis) could be protected by a geographical indications act. The issue is debatable since basmati, not being the name of a place, is not a geographical indication. However if it could be proved that basmati was not a generic name but its uniqueness inherently depended not only on the characteristics but also the region where it originated along with the local know-how, there could have been a claim in favour of basmati being established as a geographical origin. 402 The United States offers robust protection for geographical indications, generally through registration as a certification mark (a type of trademark). Examples of geographical indications protected as certification marks in the United States include: U.S. Registration No. 571,798 (‘ROQUEFORT" for cheese - France); U.S. Registration No. 2,685,923 ("DARJEELING" for tea India); U.S. Registration No. 2,014,628 ("PARMA HAM" for ham products - Italy); U.S. Registration No. 1,570,455 ("SWISS" for chocolate - Switzerland); and U.S. Registration No. 1,959,589 ("STILTON" for cheese – United Kingdom). Information regarding these and all other U.S. trademark registrations is available from the United States Patent and Trademark Office’s (USPTO) Internet website through the Trademark Application Information Retrieval system. The United States provides protection for geographical indications, whether of domestic or foreign origin. For example, “ROQUEFORT,” “STILTON,” and "COGNAC," are European Community geographical indications protected in the United States as certification marks while "DARJEELING" is a geographical indication from India. In addition, the United States protects geographical indications that are not registered. For example, the Trademark Trial and Appeal Board (an administrative appeal body within the USPTO) recently held that "COGNAC" is protected as a common-law (unregistered) certification mark in the United States. Institut National Des Appellations v. Brown-Forman Corp., 47 USPQ2d 1875, (TTAB 1998)("Cognac" is a valid common law regional certification mark, rather than a generic term, since purchasers in the United States primarily understand the "Cognac" designation to refer to brandy originating in the Cognac region of France, and not to brandy produced elsewhere, and since opposers control and limit use of the designation which meets certain standards of regional origin). 403 Thus ‘champagne style sparkling wine, made in USA’ or ‘Scotch Whisky, made in Holland’ would be prohibited since the products would not made in France or Scotland and though there is no deception to the consumer, the products would be prohibited to be sold under the same names. The TRIPS Agreement also provides for an “enhanced” minimum level of protection for GIs that identify wines and spirits. WTO Members are required to provide the legal means for interested parties to prevent the use of GIs even if they do not imply that the wines or spirits originate in a place other than the true place of origin. It is thus possible to deny protection in some countries where the indication has become generic in the country where protection is claimed. This is permitted by Article 24.6 of TRIPS. 146 An important issue that has been raised at the TRIPS meetings is the difference in the level of protection extended between Article 22 and Article 23,404 GIs for wines and spirits. Article 23.1 of the TRIPS states, “Each Member shall provide the legal means for interested parties to prevent use of a geographical indication identifying wines for wines not originating in the place indicated by the geographical indication in question or identifying spirits for spirits not originating in the place indicated by the geographical indication in question, even where the true origin of the goods is indicated or the geographical indication is used in translation or accompanied by expressions such as “kind”, “type”, “style”, “imitation” or the like.” Wines and spirits are granted a stronger level of protection under Article 23. Many developed and developing countries including India have demanded the removal of the inequality between GI protection for wines and spirits, on one hand, and all other products, on the other.405. They have suggested expansion of scope of protection available under Article 23 to products other than wines and spirits. The philosophy behind seeking extension of Article 23 protection to all other products is that GIs can be used to promote the export of valuable products while preventing misappropriation. 404 TRIPS Article 22 provides for protection of GI products other than wines and spirits and Article 23 provides for protection of GIs for wines and spirits. 405 Bulgaria, Cuba, the Czech Republic, Egypt, Iceland, India, Liechtenstein, Mauritius, Nigeria, Sri Lanka, Switzerland, Turkey and Venezuela jointly submitted a paper demanding expansion of Article 23. World Trade Organization, Proposal from Bulgaria, Cuba, the Czech Republic, Egypt, Iceland, India, Liechtenstein, Mauritius, Nigeria, Sri Lanka, Switzerland, Turkey and Venezuela, Council for Trade-Related Aspects of Intellectual Property Rights , IP/C/W/247, WTO, Geneva, 29 March 2001. 147 The concept of GIs as developed and applied by Indian courts is evident in Imperial Tobacco Co. v. Registrar, Trademarks406 where the Calcutta High Court explained the “geographic term” as following: “Geographical terms and words in common use designate a locality, a country, or a section of country which cannot be monopolised as trademarks; but a geographical name not used in geographical sense to denote place of origin, but used in an arbitrary or fanciful way to indicate origin or ownership regardless of location, may be sustained as a valid trademark.” India enacted The Geographical Indications of Goods (Registration and Protection) Act, 1999 to offer TRIPS compliant stronger protection to appellations for goods which have become distinctive in terms of quality or uniqueness by virtue of it being available only from a particular geographical area.407 The Act, discussed here after, is relatively new, it is only with time that its efficacy would be tested in legal forums. 406 AIR 1977 Cal 413 at 422. A survey of decided cases reveals that Indian courts have maintained the action of passing off to protect GIs. Scotch Whiskey Association v Pravara Sakhar Shakar Karkhana Ltd (AIR 1992 Bom 294) is a leading case on this subject. In this case the plaintiff the Scotch Whisky Association a company incorporated under the Companies Act of the United Kingdom instituted the passing off action against the defendants; a manufacturer of various brands of Indian whisky known as ‘Blended Scotch Whisky’ or ‘Blended with Scotch’, under various brands, namely, ‘Drum Beater’ and ‘God Tycoon’. On these facts the Bombay High Court held: (i) The plaintiffs have sufficient interest and locus standi to prevent passing off of Indian whisky manufactured by defendant as ‘Scotch whisky’ and to prevent damage to reputation and goodwill of Scotch whisky. (ii) The plaintiffs have made out a strong prima facie case that the defendants are passing off their goods as Blended Scotch Whisky or goods closely and substantially associated with Blended Scotch Whisky when in fact they are not. The plaintiffs have, therefore, made out a case for grant of an interim injunction on merits of the case. (iii) The defendants are deliberately and intentionally passing off their product as if ‘Blended Scotch’ although as a matter of law, even unintentional misrepresentation is also actionable. It is unfortunate that the defendants have resorted to unfair device by using the words ‘Blended with Scotch’ and indulged in colorable imitation and unfair trading in an attempt to reap harvest by appropriation of plaintiff’s goodwill in Scotch whisky trade. The attempt of the defendants to justify the use of the words ‘Blended with Scotch’ has totally failed. The balance of convenience is in favour of the plaintiffs and not in favour of the defendants. (iv) The defendant is restrained from advertising or offering for sale or distributing in any country whisky which is not Scotch Whisky with the description ‘Blended with Scotch Whisky’ or ‘Blended Scotch Whisky’ or ‘Blended with six year Old Scotch’ or ‘Blended with six year Old Vatted Malt Scotch’ or the word ‘Scotch’ or the impugned labels or the impugned carton which bear the mark ‘Gold Tycoon’ containing the word ‘Scotch’ or the description ‘Blended Scotch Whisky’ or ‘Blended with six year’. From the aforesaid decision it is evident that the judiciary in India afforded protection to 407 148 3.2.2(a) The Geographical Indications of Goods (Registration and Protection) Act, 1999, India The Geographical Indications Act, 1999 confers legal protection to geographical indications in India and to Indian Geographical Indications abroad. Section 2(e) of the Act defines a geographical indication as: “an indication which identifies such goods as agricultural goods, natural goods or manufactured goods as originating, or manufactured in the territory of a country, or a region or locality in that territory, where a given quality, reputation or other characteristic of such goods is essentially attributable to its geographical origin and in case where such goods are manufactured goods one of the activities of either the production or of processing or preparation of the goods concerned takes place in such territory, region or locality, as the case may be”. 408 Any association of persons, producers, organisation or authority established by or under the law could apply for a geographical indication provided that:409 a. The application should be in writing in the prescribed form along with the prescribed fee b. The applicant must represent the interest of the producers. The application for registration would be examined to check whether it meets the requirements of the Act and Rules. Once objections raised by the Registrar are GIs even during the absence of any legislation in force. It is significant to note that such protection was afforded much before the TRIPS Agreement came into force. 408 See basmati patent case discussed in Chapter I Section ---. Basmati, being a long grain aromatic rice grown in Himalayan foothills, may be considered for qualification as a GI under Section 2(e) of the Geographical Indications Act. See supra note 401. 409 Section 11 of the Indian Geographical Indications Act, 1999. 149 clarified, the geographical indication shall be entered in the Geographical Indication Register kept at the Head office of the Geographical Indications Registry. Unauthorized parties may not use geographical indications if such use is likely to mislead the public as to the true origin of the product. Applicable sanctions range from court injunctions preventing the unauthorized use to the payment of damages and fines or, in serious cases, imprisonment. A person would be deemed to falsify a geographical indication if he makes the indication without the consent of the authorised user, or makes a deceptively similar indication.410 The penalty for falsifying an indication or falsely applying a geographical indication would be punished with imprisonment from 6 months to 3 years and/or a minimum fine of INR 50,000 to a maximum of INR 2,00,000.411 The registration of a geographical indication is valid for a period of 10 years and it can be renewed from time to time for a further period of 10 years each.412 3.2.3 Other sui generis Indian Acts Two other sui generis Acts passed in India for the protection of traditional knowledge and resources are the Protection of Plant Variety and Farmers’ Rights Act, 2001 and the Biological Diversity Act 2002. The Acts are briefly described below. 3.2.3(a) Protection of Plant Variety and Farmers’ Rights Act, 2001413 India chose to utilize the flexibility offered by TRIPS in Article 27.3(b).414 Plant varieties were excluded from patentability in the Indian Patent Act.415 A sui generis 410 Section 38(1) of the Indian Geographical Indications Act, 1999. Section 39(f) of the Indian Geographical Indications Act, 1999. 412 Section 18 of the Indian Geographical Indications Act, 1999. 413 Act no. 53 of 2001. 414 TRIPS Article 27.3(b) requires members to protect plant varieties either by patents or by an effective sui generis system. See discussion in Chapter I section 1.4.1 of the thesis. 411 150 Protection of Plant Variety and Farmers’ Rights Act, 2001416 was legislated to provide rights for plant breeders417 and farmers.418 Seeds are a very necessary input to the agrarian economy of India. The MNCs419 still dominate the seed industry in India since the local seed manufacturing corporations are yet to emerge as a sole actor in the Indian markets. However, 85% of the over 60 lakh tons of seed required by Indian agriculture annually is produced by the farming community making them the largest seed producers in the country.420 To protect the rights of the farmers, specially to breed and propagate new plant varieties and to continue traditional practice of saving and sowing seeds, the Act incorporates strong farmers’ rights.421 The Act also extends 415 Section 3(j) was inserted by the 2002 amendment of the Indian Patent Act with effect from 20-052003. Section 3(j) provides that “plants and animals in whole or in part thereof or microorganisms, but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals” would not be considered as patentable inventions. 416 Act 53 of 2001. Also referred to as PPVFR Act in the thesis. 417 UPOV 1961, in Article 5(1) defined PBRs as an exclusive right over the commercial production and marketing of reproductive or vegetative propagating material of the protected variety. This right was less stringent than patents as it allowed for, first, under research exemption, Article 5(3), which was that a protected variety might have been used in competing breeding programs as long as subsequently derived varieties did not require the repeated use of the protected variety for its production; second, under Article 5(1), the use and exchange of saved seeds was not prohibited but sale of seeds was not allowed. Under Section 28(1) of the PPVFR Act, PBR is an exclusive right on the breeder or his successor, his agent or licensee, to produce, sell, market, distribute, import or export the plant variety. Adcock has called such rights as softer IPRs than patents. Thus this unique or sui generis right is a feasible option for protecting plant varieties for nations who are against patenting of plants. See, Mike Adcock, Farmer’s Right or Privilege, [2001/2002] 3 BSLR 91. 418 While the Act is primarily based on the UPOV Convention providing a sui generis system for protecting plant breeder’s rights, it recognizes the role of farmers as cultivators and conservers and the contribution of traditional, rural and tribal communities in the country’s agrobiodiversity by making provisions for benefit-sharing and compensation and protecting traditional rights of farmers. 419 Multi National Corporations. 420 Further, the seeds produced by the farmers are well adapted seeds for local agriculture and hence are often more productive than the seeds produced by MNCs (see id.) since MNCs have centralized production and such seeds are not attuned to regional variations. See, Suman Sahai, Right to Food, at (last accessed on 3 September 2005). 421 Farmers’ rights were incorporated in the International Treaty on Plant Genetic Resources for Food and Agriculture 2001. The Commission on Genetic Resources for Food and Agriculture is a permanent forum within the Food and Agricultural Organization (FAO) where governments discuss and negotiate matters relevant to genetic resources for food and agriculture. The FAO Conference established the Commission in 1983, mandate of which was broadened in 1995 to cover all components of biodiversity of relevance to food and agriculture. The FAO adopted an International Undertaking on Plant Genetic Resources in 1983. The Undertaking was revised with the aim of working in harmony with the CBD. It is known as the International Treaty on Plant Genetic Resources for Food and Agriculture, 2001(hereinafter referred to as the FAO Treaty). The Treaty incorporates the following objectives 151 protection to plant breeder’s rights to stimulate investment for research and development of new plant varieties.422 Under Section 15 of the Act, a plant breeder can register a plant variety for protection if it is novel, distinct, uniform and stable.423 On registration, the breeder would have rights of commercialization for the registered variety either personally or through anyone he designates. These rights include the right to produce, sell, market, distribute, import or export a variety, in short, the breeder can exercise full control l. Conservation and sustainable use of plant genetic resources for food and agriculture; 2.Fair and equitable sharing of benefits arising out of their use. Apart from the objectives stated above, the Treaty acknowledges the contribution of farmers and their rights in the area. It further emphasises on the need to develop synergy among agriculture, environment and commerce to achieve the objectives. Part three, Article 9 enumerates the farmers’ rights. The treaty recognises the enormous contribution of local, indigenous and farming community for the conservation and development of plant genetic resources throughout the world (Article 9 ¶ 1). The responsibility for realising farmers rights vests with the national governments. Hence, each contracting party has to adopt suitable measures in this direction, which include protection of traditional knowledge, equitable participation in benefit sharing, and the right to participate in the decision-making at the national level on matters related to conservation and sustainable use of the resources. As per Part 3, the Article shall not be interpreted to limit the rights of farmers to save, use, exchange and sell farm-saved seed/propagating material. This provision is subject to national law as appropriate. 422 Under Section 30(a) of the PPVFR Act, researchers are allowed free and complete access to protected materials for research use in developing new varieties of plants. Proviso to Section 30(b) states that authorisation of the breeder is required where repeated use of a registered plant variety is necessary for commercial production of the newly developed variety. 423 Under Section 15(3)(a) of the PPVFR, plant variety would be considered novel if it has not been sold in India, earlier than one year, or outside India in the case of trees or vines earlier than six years, or in any other case, earlier than four years; before the date of filing such application. It has been provided that a trial of a new variety which has not been sold or otherwise disposed of shall not affect the right to protection. Under Section 15(3)(b) the criteria of distinctiveness would be fulfilled if the plant variety is clearly distinguishable by at least one essential characteristic from any other variety whose existence is a matter of common knowledge in any country at the time of filing of the application. Under Section 15(3)(c), a variety would be considered uniform if subject to the variation that may be expected from the particular features of its propagation it is sufficiently uniform in its essential characteristics and under Section 15(3)(d) stable, if its essential characteristics remain unchanged after repeated propagation or, in the case a particular cycle of propagation, at the end of each such cycle. Novelty has a more restricted meaning than the absolute novelty requirement of patent law since a plant variety not sold in India for a certain time period in the past would be considered novel for registration under the PPVFR Act. This provision has been adopted from UPOV wherein a variety is deemed new if , at the filing date of the registration application, the propagated or harvested material of the variety has not been sold or disposed of by or with the consent of the breeder for purposes of exploitation in the territory of the Contracting Party in which the application has been filed earlier than one year before that date. In case of territories other than the Contracting party, the period is extended to four years, and for trees and vines, six years. See, Article 6, UPOV 1991. 152 over formal marketing.424 To protect the breeders from infringement,425 the Act enumerates punishment by way of damages, imprisonment and share of profit.426 Under Section 39, a farmer can register any new plant variety developed by him. Further, under Section 39(4), a farmer is entitled to save, sow, resow, exchange, share or sell his farm produce including seed of a variety protected under this Act. This is a limited right since the farmer is not entitled to sell “branded seeds” of a variety protected under this Act.427 To encourage protection and propagation of traditional varieties alongside new plant varieties, the Act also provides that a farmer who is engaged in “conservation of genetic resources of land races and wild relatives of economic plants” would be rewarded.428 Section 41 of the Act ensures community rights of the people.429 On behalf of a village or a community contributing to the 424 Section 28 of the PPVFR Act enumerates breeder’s rights. Under Section 24(6) of the PPVFR Act, protection is accorded for nine years in the case of trees and vines and six years in the case of other crops and may be reviewed and renewed for remaining period on payment of such fees as may be fixed by the rules made in this behalf subject to the condition that the total aggregate period of validity of protection shall not exceed in the case of trees and vines, eighteen years from the date of registration of the variety; and fifteen years in case of other varieties. 426 Sections 64 to 67 of the PPVFR Act deal with infringement. A suit for infringement should be brought to a forum not lower than a District Court. Under Section 66, relief to the breeder would be provided by way of allotment damages fro infringement and share or profits. If a person applies the exact or a deceptively similar denomination of a plant variety registered under the Act or uses any package bearing a denomination which is identical with or deceptively similar to the denomination of such variety registered under this Act shall be held to be infringing and, as per the provisions of Section 70, would be imprisoned for a period of minimum three months to maximum two years; and/or would be fined minimum INR 50,000 (USD 1,095.53 approx). The maximum fine that may be levied under this Act is INR 5,00,000 (USD 10.955.30 approx). 427 Proviso to Section 39(1)(iv) of the PPVFR reads “Provided that the farmer shall not be entitled to sell branded seed of a variety protected under this Act.” An explanation to Section 39(1)(iv) states that “For the purpose of clause (iv) branded seed means any seed put in a package or any other container and labelled in a manner indicating that such seed is of a variety protected under this Act”. 428 Section 39(1)(iii) reads “the farmer who is engaged in the conservation of genetic resources of land races and wild relatives of economic plants and their improvement through selection and preservation shall be entitled in the prescribed manner for recognition and reward from the National Gene Fund”. Section 45(1) provides for the establishment of a National Gene Fund out of, inter alia, the benefits accrued from plant breeders through benefit sharing arrangements and donations. Under Section 45(2)(c), the Fund would be expended for inter alia, “the conservation and sustainable use of genetic resources including in-situ and ex-situ collections”. 429 Under Section 44 of PPVFR Act, a farmer or a group of farmer shall not be liable to pay any fee in any proceeding before the Authority or Registrar or the Tribunal or the High Court under this Act or the rules made there under. Section 42 of the Act protects a farmer if he has committed innocent infringement of a right established under this Act. 425 153 evolution of a plant variety, any individual or a group from the village or the community can stake claim attributable to the contribution of the people of that village or local community. The PPVFR Act has done more than perfunctorily complying to the TRIPS obligation under Article 27(3)(b) by introducing legislation to protect the indigenous genetic resources, and preserve traditional farming practices and knowledge and the custodians of such knowledge, the farmers. The Act has provided a balance between the rights of farmers and plant breeders.430 In such circumstances, the Indian Government’s decision to seek accession to UPOV 1978 in May 2002431 has evoked strong criticism nationally.432 The PPVFR Act, deviates from UPOV significantly and it is apprehended that UPOV may ask for changes in the PPVFR Act if India joins UPOV.433 The main area of contention between UPOV and PPVFR Act would be the issue of farmer’s rights. Though UPOV 1978 allows for farmer’s rights by way of saving and 430 See, supra note 417 at 91. Adcock states, “...the PPVFR Act goes further than any other existing or proposed legislation in trying to allow for greater equity and balance between the plant breeder and the farmer.” He feels that many Asian and African countries may consider enacting legislation like PPVFR as alternative to join UPOV. Also see, Suman Sahai, India’s Plant Variety Protection and Farmers’ Rights Act, 2001, Current Science, Vol. 84, No. 3, 10 February 2003 at 407. Sahai notes that the PPVFR Act “has been hailed as a progressive, pro-developing country legislation” with notable features. 431 India’s decision to join UPOV 1978 has raised the issue that since the UPOV has been amended in 1991, it is too late to join UPOV 1978. Adcock has explained that an extraordinary meeting held in the UPOV Council in 1997 allowed interested states with legislation in parity with the 1978 UPOV to deposit an instrument of accession before 24 April 1994. Additional time was granted to India to deposit the instrument. The UPOV might have been flexible since it felt that the membership of a large developing country, with an agrarian economy, like India would influence other Asian countries to join UPOV other than designing sui generis rights. See, id. 432 See, amongst others, GRAIN, Sprouting up: UPOV continues to influence, available at (last accessed on 3 July 2005); Suman Sahai, India’s Plant Variety Protection and Farmers’ Rights Act, available at (last accessed on 3 July 2005). 433 Adcock, supra note 417 at 92. 154 sowing seeds and exchanging seeds with fellow farmers,434 the rights granted in the PPVFR Act are broader.435 The Indian Government’s decision to accede to UPOV stemmed from the inclination of according international recognition to India’s sui generis system. An internationally recognised system would encourage more investment and transfer of technology from foreign investors.436 However it is unlikely that UPOV would agree to the PPVFR Act without diminution of farmer’s rights.437 3. 2.3(b) Biological Diversity Act 2002 Responding to the new international regime of national sovereignty over biological resources ushered in by the CBD, the Indian Government formulated the Biological Diversity Act, 2002.438 The Act has two broad aims: • Access/benefit sharing; and • Conservation/sustainable usage of biological resources. 434 UPOV 1991 has been amended to increase breeders’ rights by including the notion of essentially derived variety and making the farmers’ privilege optional. Accordingly as per Article 14(5), UPOV 1991, an essentially derived variety, that is, a variety that is predominantly derived from the initial variety itself, and which fulfilled the normal protection criteria of novelty, distinctness, uniformity and stability, could be the subject of protection but could be exploited without the authorization of the breeder of the protected variety. Further Article 15(2) of UPOV 1991 was in sharp contrast to the earlier system under which farmers were allowed to re-use protected material without paying any royalty to commercial breeders. The new provisions allow farmers to reuse protected material only if the "legitimate interests of the breeder" are taken care of. 435 See, Section 39(1)(iv) of PPVFR Act. It is stated that a farmer “Shall be deemed to be entitled to save, use, sow, resow, exchange, share or sell his farm produce including seed of a variety protected under this Act in the same manner as he was entitled before the coming into force of this Act.” Also see, amongst others, Sections 41, 42 which provide for more farmers’ privileges. 436 K.S. Jayaraman, Indian Seed Bill Forges New Ground, NATURE BIOTECHNOLOGY, Oct. 2001, available at (last accessed on 17 July, 2004). 437 Gene Campaign, a non government organization opposed Indian Government’s decision to accede to UPOV and filed a public interest litigation at the Delhi High Court in October 2002. Due to lack of information regarding the outcome, it is presumed that the case is yet to be decided. Till the matter is sub judice, India will not be able to join the UPOV. Interview with Dr. Sumna Sahai, India needs a Biotechnology Policy, Frontline, May 08-21, 2004, available at (last accessed on 7June, 2004). 438 Hereinafter also referred to as the Biodiversity Act. 155 A three-tier administrative structure comprising of the National Biodiversity Authority (NBA)439, the State Biodiversity Board (SBB)440 and the Biodiversity Management Committee (BMC)441 has been established by the Act to achieve the goals. The Act proposes to set-up ‘Biodiversity Funds’ at central442, state443 and local levels.444 The monetary benefits, fees and royalties received as a result of approvals 439 National Biodiversity Authority (NBA): The authority headquartered at Chennai since 2003, has, under Section 18 of the Biodiversity Act, the responsibility of regulating access to biological resources for commercial purposes by foreigners/ non-resident Indians/ MNCs. Research Projects for academic purposes, which are approved by the Central Government, are exempt from this Access Regime. This process of granting access involves the issuance of a prospecting license to the would-be bioprospector concomitant upon an adequate benefit sharing regime with the local communities that possesses knowledge about the resource. The authority also has the right to penalise persons / institutions in case of non-compliance. The authority has the responsibility also to take steps that it deems to be adequate to conserve biological diversity including the notification of threatened / endangered species as the case may be. The NBA may also advice the Central Government on biodiversity related issues. It also has to ensure that environmental impact assessments are carried out in the case of projects that may have an impact on biodiversity conservation. 440 State Biodiversity Board (SBB): These boards, which are to be constituted at the state level under Section 22 of the Biodiversity Act, are supposed to perform virtually all the functions of the NBA at the state level. The functions are moefully enumerated in Section 23 of the Biodiversity Act. In case of the NBA, access was about regulating foreigners using Indian resources and in case of the SBB, is to regulate the access of Indians both individuals and companies, who are interested to commercially access biological resources. The benefit-sharing regime concomitantly has to be overseen by the SBBs. The conservation function is probably a bit better developed in comparison to the NBA. In this regard it is the SBB, which have the authority to declare biodiversity heritage sites taking into account the biological importance of these areas. This is indeed very significant and in many ways should be the fulcrum of the conservation initiatives that should be put in place after the passage of this legislation. These biodiversity heritage sites should ideally cover large landscapes and may emerge as an important category of protected area for conservation of biological diversity. 441 Biodiversity Management Committee (BMC): This is the lowest rung of the three-tier hierarchical set up envisaged under this Act. Established by the provisions of Section 41 of the Biodiversity Act, these would be local bodies defined by the Constitution or other relevant legislation including appropriate Central or State Legislation. The BMC can levy an amount from bio prospectors in their jurisdiction. The BMC is also entrusted with the job of actually managing / conserving biological diversity in the geographical area under their jurisdiction and probably it is the most important function that has been entrusted to any of these three bodies. 442 See, Sections 26, 27 of the Biodiversity Act. The National Biodiversity Fund shall be funded by way of grants and loans from the Central Government; all charges and royalties received by the NBA under the Biodiversity Act; and all sums received by NBA from other sources as decided by the Central Government. As per Section 27, this fund shall be used for channeling benefits to the benefit claimers, conservation and promotion of biological resources and development, as well as socio-economic development, of areas from where such biological resources or knowledge associated has been accessed, in consultation with the local bodies concerned. 443 See, Sections 31 and 32 of the Biodiversity Act. Under Section 31, State Biodiversity Funds are proposed to be constituted for every state in India. According to the provisions in Section 32, these shall primarily be funded by the NBA and other sources as decided by the State Governments and these shall be used for management and conservation of heritage sites, compensation or rehabilitation of any 156 by NBA will be deposited in the ‘National Biodiversity Fund’. The Fund will be used for conservation and development of areas from where resources have been accessed, including management and conservation of heritage sites wherever applicable. Sections 3 to 7 of the Biodiversity Act enumerate regulations for access to biological resources in India. As per Section 3 of the Act, foreign individuals, companies or associations can not access any biological resource occurring in India or knowledge associated thereto for research, commercial exploitation, bio-survey or bio-utilization without the prior approval of the NBA.445 Section 4 provides conditions for transfer of results of research related to biodiversity.446 It states that transfer of results of research based on Indian genetic resources to a non India individual, company or a corporate with non-Indian participation in its share capital or management would be subject to approval of NBA.447 Exemption to provisions of Sections 3 and 4 has been provided in Section 5.448 section of people economically affected by the notification of biodiversity heritage sites1 conservation and promotion of biological resources and socio-economic development of areas from where such biological resources have been accessed. 444 See, Sections 42, 43 and 44 of the Biodiversity Act. The Local Biodiversity Fund would be funded by grants from the National Biodiversity Fund and the State Biodiversity Funds. The Local Biodiversity fund would be spent for conservation of biodiversity in areas within the jurisdiction of the particular local body and for the benefit of the community involved with the conservation of biodiversity in the area. 445 Section 3 of the Biodiversity Act: (1) No person referred to in sub-section (2) shall without previous approval of the National Biodiversity Authority obtain any biological resource occurring in India or knowledge associated thereto for research or for commercial utilisation or for bio-survey and bio-utilisation. (2) The persons who shall be required to take the approval of the National Biodiversity Authority under sub-section (1) are the following, namely:- (a) a person who is not a citizen of India; (b) a citizen of India, who is a non-resident as defined in clause (30) of section 2 of the Income-tax Act, 1961; (c) a body corporate, association or organisation- (i) not incorporated or registered in India; or (ii) incorporated or registered in India under any law for the time being in force which has any non-Indian participation in its share capital or management. 446 Publication of research papers or dissemination of knowledge in any seminar or workshop, if such publication is according to the guidelines issued by the Central Government of India have not been considered as transfer as per Section 4 of the Biodiversity Act . 447 Section 4 of the Biodiversity Act: No person shall without the previous approval of the National Biodiversity Authority, transfer the results of any research relating to any biological resources occurring or obtained from India for monetary consideration or otherwise to any person who is not a citizen of India or a body corporate or organisation which is not registered or incorporated in India or which has any non-Indian participation in its share capital or management. 157 Under Section 6449, applications for IPRs, on inventions based on genetic resources in India, have been subjected to permission granted by NBA. Section 7 enumerates provisions regarding prior intimation to the SBBs for obtaining biological resources for commercial purposes.450 Traditional doctors and local people have been exempted from obtaining such permission. The penalties imposed for violations of the provisions of the Act, by way of fine and/or imprisonment, have been enumerated in Section 55.451 The Act acknowledges the importance institutions of local governance, such as Panchayats, in managing biodiversity and affecting benefit sharing.452 Explanation.--For the purposes of this section, "transfer" does not include publication of research papers or dissemination of knowledge in any seminar or workshop, if such publication is as per the guidelines issued by the Central Government. 448 Section5 of the Biodiversity Act: (1) The provisions of sections 3 and 4 shall not apply to collaborative research. projects involving transfer or exchange of biological resources or information relating thereto between institutions, including Government sponsored institutions of India, and such institutions in other countries, if such collaborative research projects satisfy the conditions specified in sub-section (3). (2) All collaborative research projects, other than those referred to in sub-section (1) which are based on agreements concluded before the commencement of this Act and in force shall, to the extent the provisions of agreement are inconsistent with the provisions of this Act or any guidelines issued under clause (a) of sub-section (3), be void. (3) For the purposes of sub-section (1) collaborative research projects shall- (a) conform to the policy guidelines issued by the Central Government in this behalf; (b) be approved by the Central Government. 449 Section 6 of the Biodiversity Act: (1) No person shall apply for any intellectual property right by whatever name called in or outside India for any invention based on any research or information on a biological resource obtained from India without obtaining the previous approval of the National Biodiversity Authority before making such application: Provided that if a person applies for a patent, permission of the National Biodiversity Authority may be obtained after the acceptance of the patent but before the sealing of the patent by the patent authority concerned. Provided further that the National Biodiversity Authority shall dispose of the application for permission made to it within a period of ninety days from the date of receipt thereof. (2) The National Biodiversity Authority may, while granting the approval under this section, impose benefit sharing fee or royalty or both or impose conditions including the sharing of financial benefits arising out of the commercial utilisation of such rights. (3) The provisions of this section shall not apply to any person making an application for any rights under any law relating to protection of plant varieties enacted by Parliament. (4) Where any right is granted under law referred to in sub-section (3), the concerned authority granting such right shall endorse a copy of such document granting the right to the National Biodiversity Authority. 450 Section 7 of the Biodiversity Act: No person who is a citizen of India or a body corporate, association or organisation which is registered in India shall obtain any biological resource for commercial utilisation or bio-survey and bio-utilisation except after giving prior intimation to the State Biodiversity Board concerned: Provided that the provisions of this section shall not apply to the local people and communities of the area, including growers and cultivators of biodiversity, and vaids and hakims, who have been practising indigenous medicine. (Vaids are traditional doctors mostly practicing Indian Ayurvedic medicine. Hakims are traditional doctors practicing the Unani or the Sidhha form of medicine). 451 For Section 3 of the Biodiversity Act, see id. For Section 4, see supra note 447, for Section 6, see supra note 447, Section 7, see id. Section 55 of the Biodiversity Act: (1) Whoever contravenes or attempts to contravene or abets the contravention of the provisions of section 3, section 4, or section 6 shall be punishable with imprisonment for a term which may extend to five years, or with fine which 158 The Act, though a commendable effort as a pioneer legislation in the field of conservation and sustainable use of biodiversity, suffers from shortcomings. The Act aims to regulate the use of biological resources throughout India. According to Gadgil, “This would be a stupendous task anywhere in the world; it is quite impossible in a biomass-based civilisation such as ours”.453 Gadgil has suggested that instead of trying to bring all activities within the ambit of the Act, the most common end uses be identified and collection of resources for such uses should be regulated.454 Further in Section 7 of the Act, exemptions have been allowed to “local people and communities of the area”.455 However, it does not define what constitutes local people and local communities.456 This is a critical question that needs to be clarified.457 may extend to ten lakh rupees and where the damage caused exceeds ten lakhs such fine may be commensurate with the damage caused, or with both, gh(2) Whoever contravenes or attempts to contravene or abets the contravention of the provisions of section 7 or any order made under subsection (1) of section 24 shall be punishable with imprisonment for a term which may extend to three years, or with fine which may extend to five lakh rupees, or with both. Section 24: (1) Any citizen of India or a body corporate, organisation or association registered in India intending to undertake any activity referred to in section 7 shall give prior intimation in such form as may be prescribed by the State Government to the State Biodiversity Board. (2) On receipt of an intimation under sub-section (1), the State Biodiversity Board may, in consultation with the local bodies concerned and after making such enquires as it may deem fit by order, prohibit or restrict any such activity if it is of opinion that such activity is detrimental or contrary to the objectives of conservation and sustainable use of biodiversity or equitable sharing of benefits arising out of such activity: Provided that no such order shall be made without giving an opportunity of being heard to the person affected. 452 “Local bodies” has been defined in Section 2(h) of the Biodiversity Act as “(h) “local bodies" means Panchayats and Municipalities, by whatever name called, within the meaning of clause (1) of article 243B and clause (1) of article 243Q of the Constitution and in the absence of any Panchayats or Municipalities, institutions of self-government constituted under any Central Act or State Act”. The Indian Panchayati Raj system is based on the principle of devolution of administrative powers to the local village level and has been institutionalized under the Constitution of India. Each Panchayat area consists of a number of wards with assemblies of all the adult members called the Gram Sabha (village council). There are 1,000 to 2,000 members in each Gram Sabha, inclusive of both tribal and non-tribal members, but predominantly non-tribals. Members of the Panchayat’s decision-making body are elected by members of all the Gram Sabhas constituting the Panchayat. References to local bodies are found in Sections 21(1), 24(2), 27(2)(c), 32(d) and 37(1) of the Biodiversity Act. 453 Madhav Gadgil, Defining Biodiversity Resources, Current Science, Vol. 79, No. 3, 10 August 2000 at 280, available at (last accessed on 3 July 2004). 454 Gadgil has identified some of the most common end uses of genetic material. These are uses as “drugs, industrial enzymes, food flavours, fragrances and cosmetics, emulsifiers, dyestuffs, plant growth regulators and pesticides, oleoresins, and genes used for improving crops and livestock through breeding and genetic intervention.” Id. at 282. 455 Section 7, Biological Diversity Act, 2002, supra note 450. 456 National Biodiversity Rules 2004 also do not define who would be considered “local people and communities”. This might be a problem since, India is a single citizenship country and hence it is 159 A major drawback is probably the very high level of centralization that has been envisaged in this Act. The NBA has been assigned with far too much responsibility and power which may lead to the creation of another bureaucracy, which may not yield the desired results. The Act does not lay down detailed guidelines for assessing and assigning IPRs related to biological resources and traditional knowledge. These tasks are left to the NBA, which will be required to establish detailed rules and regulations in this regard. To be really effective, the Act must assign property rights in a manner that protects the rights of all those who have contributed to the development of a commercially significant product. Further decisions regarding the grant to access to resources being taken by the NBA, the local communities non-commercial rights are sacrificed. The OAU recognizes the non-commercial interests of their people and acknowledge that receiving monetary returns is not the only force that drives innovations. In case the local communities fear that the given access would be detrimental to their socio-economic life, or their natural or cultural heritage, then the law allows them to withdraw consent or restrict activities related to such access.458 The local communities have not been granted a similar right in the Biodiversity Act. The Act brings the country’s biodiversity and associated traditional knowledge under the regulation of the NBA. difficult to distinguish the local people from non locals. The status of settlers from other regions of the country would also be a contentious issue while identifying local people. 457 Further, the status of people not being defined, Gadgil has apprehended that taking advantage of the exemption in Section 7 of the Biodiversity Act, foreign bioprospectors in a bid to bypass the access permission requirement under Section 3 of the Act, might employ local people to collect genetic resources for them. Gadgil, supra note 453 at 281. 458 Article 20, African Model Legislation For The Protection Of The Rights Of Local Communities, Farmers And Breeders, And For The Regulation Of Access To Biological Resources: Local communities shall have the right to withdraw consent or place restrictions on the activities relating to access where such activities are likely to be detrimental to their socio-economic life, or their natural or cultural heritage. 160 This neglects the fact that traditional knowledge has been conserved, researched and expanded by the local communities The Act should specify localities in accordance with the administrative limits and vigil should be maintained when genetic resources are removed from that area, not withstanding the nationality of the collector.459 The Biodiversity Act seems to be chiefly concerned about access to biological resources with some measure of regulations for conservations juxtaposed along with it. It is to be ensured that conservation is of equal importance as conservation of the biological material is the real issue, it is after all the raw material and all the other issues like access / benefit sharing are of secondary importance. 3.2.4 Recommendations and Conclusion The Indian sui generis enactments do not bestow any new or unique right to the traditional knowledge holders on their knowledge. The Acts described above primarily use defensive measures to protect traditional knowledge related genetic resources. They establish authorities to oversee the interests of the traditional communities and equitable use of the genetic resources of India and formalized procedures, rules and regulations for handling the genetic germplasm in India and protecting the traditional communities from illegal use of their knowledge.460 459 Gadgil, supra note 453. The Biodiversity Act confers no right to traditional communities for dealing with traditional knowledge owned by them since all rights are vested in the authorities set up under the Act. See discussion on the Biodiversity Act in Chapter III section 3.2.3 of the thesis. 460 161 An effective sui generis regime for protecting biodiversity and traditional knowledge and upholding the interests of the knowledge holders should provide for rights with the following characteristics: • Proprietary rights need to be established for all parties involved in biodiversity management. Instead of protecting only the interests of corporate biotechnology firms, it should also uphold the interests of indigenous communities who have maintained the biological resources and also hold knowledge associated with it.461 This would involve assigning proper rights both for the resource held as well as associated knowledge. • Non-monopoly rights that recognise that biodiversity related innovations are the handiwork of various actors and each needs property rights over his inventions. So while firms can commercialise products produced using traditional knowledge associated with biological resources, the knowledge provider community shall get a share of the benefits. This allows different property rights systems to exist simultaneously. • The non-commercial interests of the parties, specially the traditional communities should be recognized. This should include the recognition of the option of the communities to refrain from commercializing their knowledge if they so desire. It recognizes that not all communities see monetary gains as the sole driving force behind the use of biological resources and traditional knowledge. • The rights should be such that they can be effectively implemented. This takes into account the broader context of a nation’s interests as well as its international 461 Cleveland & Murray, supra note 375. Cleveland and Murray have said that the concept of individual ownership of property is well known among indigenous communities. They enumerate instances of intellectual property rights in indigineous communities. 162 obligations and requires that policy is effective not just on paper, but in actual practice. Cleveland and Murray462 hold that the indigenous communities are not unaware of intellectual property rights. Further, individual right over property is also a concept recognized among the indigenous groups. Unless the sui generis law brings about a vanguard change, such set of laws would amount to aimless addition to the already saturated plethora of legislation with no effective role to play in protecting traditional knowledge. An international sui generis right is a utopian idea since it is almost impossible to create a right which would cater to all the traditional knowledge holder communities of the world.463 National level sui generis laws may be enacted but their international acceptance and applicability would remain questionable since they would be comprising of local thoughts and beliefs which would be alien, if not, unacceptable to others. On the contrary, formal intellectual property laws are based on the common concepts of intellectual property recognized by all. Sui generis legislation may also turn out to be documents to assist the intellectual property laws. India’s Biodiversity Act, for one, mostly is a legislation enumerating rules and procedures for access to genetic resources. Subject to the approval of the NBA, the invention resulting out of such access would be protected by standard IPRs 462 Id. at 483. For instance, the UPOV Convention, while aiming to create a universally acceptable sui generis option to patenting of plant varieties, has been criticised for being pro developed countries. UPOV has also been criticised as being against farmers’ rights and India’s decision to join UPOV was vehemently opposed by various fora. Supra notes 381 and 382. Also supra note 417 at 91, Adcock has stated that the developing Asian and African countries are wary about joining UPOV. See page 93.He has also opined that India’s joining UPOV may be disadvantageous for Indian farmers. 463 163 and not a new right. The Act, in that case, plays an assisting role to chiefly the Patent Act of India. Hence, efforts may be made such that instead of creating further laws, the intellectual property enactments should be amended to include prior informed consent provisions, disclosure of origin procedures, and benefit sharing rules and should be used to protect traditional knowledge and genetic resources. 3.3 ACCESS AND BENEFIT SHARING (ABS) “Access and Benefit Sharing”, that is equitable sharing of benefits for utilization of genetic resources of a country, is one of the objectives enumerated in Article 1 of the CBD. The COP to the CBD agreed in its fifth session in 2000 that members would assess systematically their policies and legislation regarding access to genetic sources and benefit sharing arrangements, and provide an overview of collections of genetic resources maintained in the country. It was also agreed to establish international guidelines concerning access to genetic resources, international exchange and the promotion of equitable benefit sharing arising out of the utilization of genetic resources. The result of such agreement was the adoption of the Bonn Guidelines to Access and Benefit Sharing in 2002.Though there have been several meetings thereafter in various international fora, the Bonn Guidelines is by far the best document in regard to sharing of benefits accrued due to use of genetic resources. The WIPO member states, at the WIPO meeting held in April 2004, also expressed their approval of the Bonn Guidelines and the delegation of Venezuela submitted that the same should be adopted by WIPO as well.464 In the instant section the ABS provisions of the Bonn Guidelines, and the provisions of the Indian Contract Act which can be used to ensure equitable sharing of benefits have been mentioned. 464 See, WIPO/GRFTK/IC/6/14, supra note 336 at 53. 164 3.3.1 The Bonn Guidelines465 The Bonn Guidelines are a voluntary agreement to facilitate access to genetic resources and to ensure the benefits of commercialization, or research or development derived from those resources are rightfully shared with their owners. It is based on a bilateral approach between the parties that would provide the resources and the parties that would use them. As per the provisions in Paragraphs 34 and 16(b)(viii) of the Guidelines, a third party intending to use a genetic resource, must apply afresh to the provider. The Guidelines, in its section on benefit sharing, particularly in Paragraph 9, has included “all the benefits derived from all genetic resources and associated traditional knowledge466, innovations and practices covered by the CBD.” It therefore covers both in situ and ex situ conservation of biodiversity. The Guidelines further, in Appendix II, distinguishes between the monetary and the non-monetary benefits which may be shared by the prospectors to the resource providers. The scope of benefit covers a variety of options, ranging from licensing fees and joint ventures, to capacity building and simple recognition. The report of CBD’s first expert committee for evaluating access and benefit sharing measures enumerates different types of benefits that were possible and provides an exhaustive list.467 It appears that the dominant thinking in the panel was that common benefit sharing arrangements would not be conducive due to their diverse nature. Many experts and parties submitted that 465 Full text of the Bonn Guidelines is available at (last accessed on 14 August 2004). 466 Discussion on definitions of traditional knowledge can be found in Chapter I section 1.1. 467 Convention of Biological Diversity, Report of the Panel of Experts on Access and Benefit-Sharing, UNEP/CBD/COP/5/8, Hague, 2 November 1999, ¶ 98. 165 the benefit sharing arrangements should be some type of ‘consistent national system.’ A similar approach is used in Australia where the system is agreed upon through negotiations involving both the users and genetic resources’ owners.468 A binding legal instrument might not allow for such regional variations. The Guidelines provide a flexible approach whereby partners agree on arrangements suited to their particular circumstances. These arrangements would be legally recognized in material transfer agreements or some form of contractual arrangement that set out “mutually agreed terms”.469 Material transfer agreements (MTAs) are the engine of the Guidelines through which the arrangements between the providers and the users would be legally defined. These agreements governing the transfer of intangible material as the knowledge and the associated tangible material, the genetic resources, would set up terms on the uses of the materials and the rights of the users and providers. Such agreements would also cover the use and commercialization of the derivatives of the resources. The CBD states that access should be granted on mutually agreed terms (MATs).470 A distinction can be made between MTAs and MATs. The providers and the users must agree on certain terms viz. confidentiality, recognition of sovereign rights for accessing and using the resources for commercial or other use.471 Such agreed terms would be the provisions in the MTAs. Though the Guidelines make several observations about what these terms should entail, the MATs would execute and embody such terms. 468 Convention of Biological Diversity, Report of Second Expert Panel on Access and Benefit-Sharing Arrangements, UNEP/CBD/WG-ABS1/2, Hague, 9 April 2001, ¶17. 469 Bonn Guidelines, paragraphs. 41 and 42(g). See supra note 471. 470 Articles 15(4) and (7) of CBD. 471 A list of probable mutually agreed terms is incorporated in para.44. 166 The Bonn Guidelines were followed while enactment of the Biological Diversity Act 2002 in India. The Act strives for conservation and sustainable use of biodiversity and related traditional knowledge in India and equitable sharing of benefits arising out of the use of biological resources.472 The Act provides that foreigners and non-Indian bioprospectors should obtain permission from the NBA before accessing genetic material and related knowledge. Indian bioprospectors have to access genetic resources and relevant traditional knowledge after intimating the SBB. Benefit sharing measures enumerated in Section 21 of the Act include grant of joint ownership of IPR to NBA or where benefit claimers are identified to be such benefit claimers; transfer of technology; establishment of production, research and development units in such areas which will facilitate better living standards to benefit claimers; association of Indian scientists, benefit claimers and local people; setting up of venture capital fund for aiding the cause of benefit claimers; and payment of monetary or other compensation.473 472 The Biological Diversity Act, ,2002, India (also referred to as the Biodiversity Act in the thesis) is discussed in Chapter III, section 3.2.3 of the thesis. 473 Section 21 of the Biodiversity Act: (1) The National Biodiversity Authority shall while granting approvals under section 19 or section 20 ensure that the terms and conditions subject to which approval is granted secures equitable sharing of benefits arising out of the use of accessed biological resources, their by-products, innovations and practices associated with their use and applications and knowledge relating thereto in accordance with mutually agreed terms and conditions between the person applying for such approval, local bodies concerned and the benefit claimers. (2) The National Biodiversity Authority shall subject to any regulations made in this behalf determine the benefit sharing which shall be given effect in all or any of the following manner, namely:-- (a) grant of joint ownership of intellectual property rights to the National Biodiversity Authority, or where benefit claimers are identified, to such benefit claimers, (b) transfer of technology; (c) location of production, research and development units in such areas which will facilitate better living standards to the benefit claimers; (d) association of Indian scientists, benefit claimers and the local people with research and development in biological resources and biosurvey and bio-utilisation; (e) setting up of venture capital fund for aiding the cause of benefit claimers; (f) payment of monetary compensation and other non-monetary benefits to the benefit claimers as the National Biodiversity Authority may deem fit. (3) Where any amount of money is ordered by way of benefit sharing, the National Biodiversity Authority may direct the amount to be deposited in the National Biodiversity Fund: Provided that where biological resource or knowledge was a result of access from specific individual or group of individuals or organisations, the National Biodiversity Authority may direct that the amount shall be paid directly to such individuals or group of individuals or organizations in accordance with the terms of any agreement and in such manner as it deems fit. 167 3.3.2 Relevant provisions in other Indian Legislation The mechanism of benefit sharing for plant genetic resources and the traditional knowledge has been taken care of at the national level in the following Acts as well: Section 26 (1) of Protection of Plant Varieties and Farmers’ Rights Act 2001 states that wherein the Authority shall publish and invite claims of benefit sharing for the applicant variety to be registered, in the manner as may be prescribed. As per section 10(4)(d) of Patent (Amendment) Act 2005, if the patent applicant mentions a biological material in the specification, the application shall be supported by deposition of the material to the authorized depository institutions and by documents proving compliance of conditions such as the disclosure of the source and geographical origin of the biological material used. The biological material is to be deposited not later than the date of the patent application. As per Section 11(A)(6) of the 2005 Act, depository institution would make the biological material available to public after publication of the patent. Contract legislation can also be used for ensuring compliance of access benefit sharing agreements. In this section certain provisions of the Indian Contract Act, 1872 474 which could be used for ensuring equitable sharing of benefits by way of securing the access agreements chiefly from misrepresentation and breach are enumerated. Section 10 of the Contract Act makes a distinction between agreements and contracts. It says that an agreement in order to be a contract must be made for a lawful object and consideration. An agreement may be unlawful when it is prohibited by law and (4) For the purposes of this section, the National Biodiversity Authority shall, in consultation with the Central Government, by regulations, frame guidelines. 474 Act 9 of 1872. Hereinafter referred to as the Contract Act. 168 made punishable. It is further stated that the acceptee must express free consent to the offer made by the offerer. Free consent, as defined in Section 14 of the Contract Act would mean, consent given without fraud, coercion, misrepresentation, undue influence or mistake.475 As per Section 19 of the Contract Act, contracts entered into without free consent are voidable at the option of the party who did not render free consent. Hence if an access to genetic resources is as per the approval of the NBA and is compliant with the other provisions of the Biological Diversity Act, then the benefit sharing agreement would act as a binding contract on the parties, breach of which would be subjected to payment of damages and other redressal measures enumerated in the statutes including the ones mentioned in Chapter VII sections 73 to 75 of the 475 Indian Contract Act, section 15 "Coercion" defined “Coercion” is the committing, or threatening to commit, any act forbidden by the Indian Penal Code (45 of 1860) or the unlawful detaining, or threatening to detain, any property, to the prejudice of any person whatever, with the intention of causing any person to enter into an agreement. Section 16 "Undue influence" defined (1) A contract is said to be induced by "under influence" where the relations subsisting between the parties are such that one of the parties is in a position to dominate the will of the other and uses that position to obtain an unfair advantage over the other. (2) In particular and without prejudice to the generally of the foregoing principle, a person is deemed to be in a position to dominate the will of another - (a) where he hold a real or apparent authority over the other, or where he stands in a fiduciary relation to the other; or (b) where he makes a contract with a person whose mental capacity is temporarily or permanently affected by reason of age, illness, or mental or bodily distress. (3) Where a person who is in a position to dominate the will of another, enters into a contract with him, and the transaction appears, on the face of it or on the evidence adduced, to be unconscionable, the burden of proving that such contract was not induced by undue influence shall be upon the person in a position to dominate the will of the other. Nothing in the sub-section shall affect the provisions of section 111 of the Indian Evidence Act, 1872 (1 of 1872) Section 17 “fraud” defined "Fraud" means and includes any of the following acts committed by a party to a contract, or with his connivance, or by his agents, with intent to deceive another party thereto his agent, or to induce him to enter into the contract; (1) the suggestion as a fact, of that which is not true, by one who does not believe it to be true; (2) the active concealment of a fact by one having knowledge or belief of the fact; (3) a promise made without any intention of performing it; (4) any other act fitted to deceive; (5) any such act or omission as the law specially declares to be fraudulent. Section 18 “Misrepresentation” defined “Misrepresentation” means and includes (1) the positive assertion, in a manner not warranted by the information of the person making it, of that which is not true, though he believes it to be true; (2) any breach of duty which, without an intent to deceive, gains an advantage to the person committing it, or anyone claiming under him; by misleading another to his prejudice, or to the prejudice of any one claiming under him; (3) causing, however innocently, a party to an agreement, to make a mistake as to the substance of the thing which is subject of the agreement. 169 Contract Act. These include payment of pecuniary damages as well as rescindment of the contract. Besides, under Section 124 of the Act, the accessor can be asked to sign an indemnity contact to indemnify the community against probable loss caused to the community by any act of the prospector. 3.3.3 Indian benefit sharing instance The Jeevani case of India476 was accepted by the UN Environment Programme and the WTO as a global model in benefit sharing and recognizing IPRs of indigenous people in accordance with the guidelines of the UN Convention on Biodiversity Treaty.477 The unique model for Jeevani, developed in partnership with the Kani tribes in interior Thiruvananthapuram is reputed to be the first world model of benefitsharing that implements Article 8(j) of CBD. TBGRI shared the license fee and royalty obtained for Jeevani with Kani, the tribal community on a 1:1 basis. It received INR.1,000,000/-478 as license fee and 2 per cent royalty on ex-factory sales from the CAVP479. The Kerala Kani Samudaya Welfare Trust, specially formed for the purpose of receiving the money and utilizing the same for the benefit of the Kanis, received half the licence fee480 and received a share of the royalty. The trust funds were used for welfare activities for the Kanis.481 476 Jeevani is discussed in Chapter II, section 2.5.2 of the thesis. T. Nandakumar, Kerala project to draw global attention at Earth Summit, The Hindu, August 23, 2002. 478 USD 21,867.43 (approx.) 479 CAVP, supra note 347. 480 INR 500,000/- equivalent to USD 10,950.50 approx. 481 Vinson Kurian, TBGRI meet to take stock of `Jeevani' trademark breach, The Hindu Business Line, March 08, 2004. 477 170 3.3.4 Suggestions and conclusion While the Indian Acts specify provisions for benefit sharing, there is no stipulation about what information a benefit sharing agreement must contain. Though the Bonn Guidelines enumerate some conditions, following are some of the provisions which a benefit sharing agreement should include: • The agreement should contain unambiguous details about all the parties to the agreement viz. the individual owner of the traditional knowledge or the community which owns the traditional knowledge, the institution/company contracting with the community; and the state authorized representative representing the state, if the state chooses to be a party to the agreement. • The agreement should clearly state all the purposes of the research and/or intended final product; and should disclose any bi-product obtained during the research. • The elements and quantification of the samples collected, alongwith the exact location of the collection site should be stated in the agreement. • The community name and the scientific name for the sample should be stated with a list of uses that the community has used the genetic resource; • The method for fair and equitable sharing of benefits should be clearly stated with exact stipulations of the financial obligations of the parties. Further any obligation regarding transfer of technology, training the members of the knowledge 171 holder community or providing employment to members of the community should also be clearly enumerated. • The causes for termination of the contract and stipulations relating to redressal to the affected party due to such termination should be clearly defined. • The agreement may contain contingency provisions for consequences should the research not result into a saleable product. • Conditions regarding non-disclosure of the traditional knowledge, if used, acceptor to people who are directly involved in the research should be included. The researchers and any other person to whom this knowledge is disclosed by the person accessing the resource may be made to sign non-disclosure agreements. • The jurisdiction of the agreement should be clearly defined. It is desirable that the agreement be subjected to the jurisdiction of the courts in the country where the traditional knowledge is found and the indigenous community located. This clause is vital because the community must avoid litigating, at huge expense, in a foreign court. India is the current president of eighteen Likeminded Megadiverse Countries482, set up on 19 February 2004 during the seventh COP meeting of the CBD at Kuala Lumpur.483 India is taking the lead in evolving an international treaty to regulate 482 Also known as LMMC. The other member countries are China, Brazil, Colombia, Mexico, Ecuador, Peru, Venezuela, Costa Rica, Bolivia, Kenya, Zaire, South Africa, Democratic Republic of Congo, Madagascar, Indonesia, Malaysia and the Philippines. See (last accessed on 14 August 2004). 483 172 access to genetic resources while ensuring that benefits arising from them are shared equitably. The treaty will work on a global regime on the marketing of natural produce while taking care of conserving resources and indigenous knowledge. The access and benefit sharing regime would not just explore the marketing of indigenous herbs and plant material, thus preventing blatant exploitation, but also assure the country of origin and the local people of their rights.484 At the January 2005 meeting, the LMMC member countries signed the Delhi Declaration emphasizing the necessity of providing for protection of traditional knowledge and genetic resources in the international IP regime and making disclosure and PIC requirements mandatory for patent applications.485 If finalised, the regime would be an important step in harmonization of traditional knowledge protection laws in the international arena, and would command a stronger voice in the international scenario. The developed and the developing nations have had a consensus on the concept of ABS486 as a measure to fight biopiracy by pharmaceuticals. Thus one hopes that an international protocol on standard ABS norms can be reached within or outside the purview of the WIPO so that the research and development can continue unhindered, while the traditional communities are also acknowledged for their contribution. 3.4 GLOBAL BIOCOLLECTING SOCIETY (GBS) In the quest for suitable paradigm to protect and promote traditional knowledge, related genetic resources, folk arts, crafts and culture; various options have been 484 Asha Ramachandran, India wants to be sheikh of biodiversity, The Statesman, October 10, 2004. Discussions, Outcomes and Way Forward, Expert Meeting of the Likeminded Group of Megabiodiverse Countries on Access and Benefit Sharing and the International Regime 17-19 January 2005, New Delhi, India, available at http://www.biodiversityasia.org/docs/LMMCreportnologos.pdf (accessed on 2 March 2005). 486 See, generally, Convention of Biological Diversity, Report on the Open-ended Expert Workshop on Capacity Building for Access to Genetic Resources and Benefit Sharing, UNEP/CBD/ABS/EWCB/1/3, Hague 16 December 2002. 485 173 considered. Professor Peter Drahos in 2000487 proposed formation of a biocollecting society in the style of copyright societies for authors and performing artists. According to Narayanan, the premise to formation of copyright societies is that, “Ordinarily the authors of creative works are not business minded and they have seldom the financial resources or the business skill to exploit their work themselves. Further, it is extremely difficult for the owner of the work to prevent infringement of the work anywhere in India or abroad. To overcome this difficulty owners of copyright works have formed societies to license their works for performance.”488 Professor Drahos has propounded the global biocollecting society concept with a similar view. He has commented that the partnership between the indigenous communities and the modern biotechnology companies is, “an intriguing and potentially unstable combination—some of the world’s most globalised and hypermodern companies seeking deals with some of the most local and traditional people. Finding ways in which to encourage mutually satisfactory contractual arrangements between life sciences companies and indigenous groups over the use of indigenous knowledge has become a major regulatory challenge.”489 It has been extensively discussed that the indigenous communities do not subscribe to the western idea of knowledge. Indigenous knowledge is based on experience to cope with the challenges of life in contrast to modern knowledge which is acquired through academic research pursued to attain goals of recognition. The communities usually are not very secretive about their medical knowledge and often do not understand all the implications of their sharing the knowledge with others, including bioprospectors. Though benefit sharing contracts are an effective way of ensuring returns to the 487 P Drahos, Indigenous Knowledge, Intellectual Property and Biopiracy. Is a Global BioCollecting Society the Answer? E.I.P.R. 22 (6), (2000), 245–252. 488 Narayanan, supra note 24 at 311-312. 489 Supra note 487at 245. 174 knowledge holder communities, Professor Drahos has felt that the knowledge sharing community “will conclude ex post that their integration into the commerce in biodiversity was not worth the resulting changes to their traditional social world.” Further there may be misgivings about their discussion making process since as per the Rational Choice theory, an actor’s decision is also influenced by the amount of information he has access to.490 Professor Drahos has suggested the establishment of an international collecting society which would be a repository of knowledge relating to genetic resources. Unlike copyright societies, voluntary membership to the biocollecting society would not be restricted to the traditional knowledge holder communities, and the prospector companies would also be free to join the society. He enumerates two other distinctions between a copyright society and a biocollecting society. Firstly, instead of having many national biocollecting societies, Professor Drahos suggests the formation of a single global biocollecting society to ensure easier monitoring and better transparency while serving the ends of the indigenous knowledge holder communities. Secondly, while copyright societies protect the interests of the copyright holder member alone, the GBS would not only champion the interests of the indigenous communities by way of equitable benefit sharing, but also would serve the broader goals of conservation and sustainability of biodiversity envisaged in CBD. 490 The Rational Choice theory proposes that individuals or actors make their choice based on their aims and the sacrifice he has to make to achieve the aim. Access to the amount of information he has influences his choice. More about this theory can be found, amongst others, in the following papers: M. Hechter, and S Kanazawa, Sociological Rational Choice Theory, Annual Review of Sociology (1997), 23, 191-214. D. FRIEDMAN & M. HECHTER, The Contribution of Rational Choice Theory to Macrosociological Research, READINGS IN CONTEMPORARY SOCIOLOGICAL THEORY : FROM MODERNITY TO POST-MODERNITY, (Donald McQuarie ed., 1995) 294-303. 175 This reflected in to Professor Drahos’s statement that, “the protection of indigenous knowledge by a GBS would be a primary rather than absolute duty”.491 Professor Drahos has stated that the establishment of the GBS should be made outside the purview of an international treaty due to the time lag in reaching a consensus in international multilateral agreements. He has felt that the World Bank would be interested in funding the GBS since it is recognizing the role of knowledge in economic development. He has also mentioned possible incentives why the indigenous communities and the prospector organizations would be interested in joining the GBS. Members of the biotechnology industry would be interested in joining the GBS for chiefly three reasons. First, the GBS being a storehouse of traditional information would act as a steady source of such knowledge for the prospectors. This would lower the particular organizations costs to search for traditional resources; costs incurred to access such knowledge and further, since the activities would be overseen by a third international forum. Secondly, Professor Drahos mentions an instance where a particular community’s knowledge is accessed by a prospector company under the auspices of the GBS. Subsequently a second community claims right to that knowledge which has been accessed by the prospector company. The prospector company has a defense against such claim since it had accessed the knowledge through the established procedure of the GBS. Further if the pecuniary benefit is transacted through the GBS, the second community claiming a right on the knowledge can approach the GBS for a share of the benefits. Thirdly, government imposed 491 Supra note 487 at 248. 176 regulations might be overtly onerous for prospectors finally discouraging them from utilizing traditional resources. The GBS, being a neutral forum would make access terms easier for prospectors. Professor Drahos enumerates five distinct services the GBS could provide to the members. First, the GBS would act as a repository of the community registers documenting the traditional knowledge of the various communities. The registers would be kept under strict confidentiality and interested prospectors or researchers would have to negotiate with a particular community before accessing the register. Third parties would only be able to find out that a particular community has deposited a register with the GBS. Second, the GBS, if approached, would provide assistance during the negotiations between the indigenous community and the interested accessor of information. Third, the GBS would monitor the use of the particular indigenous knowledge after it has been accessed by a prospector. Professor Drahos mentions the necessity of such monitoring in the long time period between the filing of a patent application and the ultimate grant of the patent. In the interim period the GBS would check the status of the patent applications and also check whether the traditional knowledge is being misused. It is difficult for a community to perform such checks on its own. Fourth, the GBS would further provide an impartial dispute settlement forum regarding disputes between any traditional community and the prospector organization. The unbiased stance of the GBS in the dispute settlement would augment its credibility among the prospector company as well as the indigenous body. Punitive measures could include expulsion from the GBS which would be a form of “global 177 shaming”.492 Fifth, Professor Drahos has envisaged that the GBS would establish some paradigm of standard practices regarding bioprospecting activities and benefit sharing. The standards would be set by agreement between the indigenous communities, bioprospecting companies and the state. The GBS model is yet to obtain a definite shape. Though it has been acknowledged to be an interesting idea, the Society is yet to be formed. India is among the most biodiverse countries of the world. The probable effects of the GBS arrangement on knowledge management in India are suggested hereinafter. 3.4.1 GBS in India India has been keen to provide protection as well as convenient dissemination of the vast repertoire of traditional knowledge that has been accumulated by the various indigenous societies in India. After the biopiracy episodes493 the Indian government has introduced provisions in the laws to combat illegal access to the genetic resources. Other measures such as documenting of indigenous knowledge have also been initiated. Besides the TKDL494, certain private organizations such as SRISHTI and the Honeybee have created databases of traditional knowledge. India is an extremely biodiverse country with many cultural and ethnic groups, castes and tribes and the introduction and implementation of any new idea is a time consuming and tedious process. On the other hand, due to such obstacles, this is a 492 Supra note 487 at 248. See, Chapter I section 1.3 of the thesis. 494 TKDL and some other Indian traditional knowledge databases have been discussed in Chapter II section 2.3.2 of the thesis. 493 178 good base to implement the efficacy of an idea. The implementation of Professor Drahos’s GBS paradigm in India might lead to interesting consequences. Under Section 14 of the Indian Copyright Act of 1957, the copyright holders have been ensured certain rights regarding their artistic or literary works. The owner of a copyright in any work can derive monetary benefit from his work only by exercising some or all of the rights conferred under Section 14 or by authorizing others to do so for a consideration. Alternatively, owners of copyright works form societies to license their work for performance or communication to the public or issue copies of the work to the public. Thus the copyright societies are authorized to license the works of owners of copyrights to those interested in the reproduction, performance or communication to public of the works. In turn the copyright society retains a small share of the royalty received by a particular copyright owner, or charges the copyright owner some fees for rendering this service. The Preamble to the Indian Constitution has ensured equality for all citizens in the eyes of law. Further in Part III, Articles 12 to 35 of the Constitution, certain Fundamental Rights of the citizens of India are enumerated wherein there are provisions for protection of interests of the minority sections.495 However, other than these provisions the traditional knowledge holders and the indigenous communities have not been granted any special right in relation to the protection and promotion of the knowledge they hold. 495 Articles 29 and 30 of the Constitution of India (ninety-second amendment in 2003). 179 The modern acts viz. the Biological Diversity Act 2002 and The Plant Variety Protection and Farmer’s Rights Act 2001 do not offer any special right to the traditional societies on their knowledge. Hence there is very little legal right that the indigenous communities in India can actually authorize the GBS to handle. Though documentation of traditional knowledge and creation of traditional knowledge registers can be deposited to the GBS, there would arise disputes about the handling of knowledge without any defined set of rights.496 For such purpose also, it is extremely important to define traditional knowledge, and the specific rights the knowledge holder has on the knowledge.497 Further since Professor Drahos proposes the establishment and functioning of the GBS outside the purview of a multilateral treaty, the authority commanded by such an arrangement is questionable. Without proper legal sanction, the arrangement may become a mere expression of good intentions. Implementation of the GBS may prove to be a problem. Because of the magnitude and the diversity of the India, depositing all information to one global body might prove to be confusing. As has been stated earlier, the traditional societies often do not have any notion about the developments made in fields of information and technology. But, to make them part of the global movement, the use of the internet is inevitable. The communities would, atleast for the present, have to remain dependent 496 For instance, community A submits a register of their traditional knowledge with the GBS. A prospector company B is interested in researching particular information noted in that register. B, with such intention enters into a prospectorship agreement with A and accesses the resources. The issue is whether that prevents A to share the same information with another interested bioprospector. If we assume that in the aforesaid example, A further shares the same knowledge with another research institute C, intellectual property right can be claimed by either B or C, depending on who is the first to claim an intellectual property. Again, this might go against any other policy of the GBS. 497 It is important that the rights of traditional knowledge holders be defined. For instance, there may be an issue questioning if the traditional knowledge holder would have the right to commit waste to the knowledge or resources under his possession. Article 8(j)(1) of CBD establishes the right of the state on its natural resources. Would such right go against the right of the traditional communities or would they be superior to their rights should be the issue in this illustration. 180 on external agencies for such assistance. Without a formal legal regime and with the present literacy level, the communities may be exposed to further exploitation from third parties. Secondly, the scope of the GBS needs to be adequately delineated. What kind of information would be considered under the purview of the GBS should be clearly defined. From Professor Drahos’s proposal it seems that GBS would be a repository of traditional knowledge related to genetic resources only. In that case, an issue might be what kind of information relating to the genetic resources would be considered for inclusion in the GBS.498 3.4.2 Conclusion Due to the lack of homogeneity, even at national levels, the world may not be prepared for a common GBS. However, national GBS may be formed which might be linked to a common international organization, viz. either the United Nations or some other new international body formed with representatives of major biodiverse nations and other interested parties which could harmonise the functioning of the various 498 A genetic resource might be also used as a component for traditional handicrafts. Most of the latest updates in Indian law deal with genetic resources and related knowledge. Let us consider a situation where a traditional society in India weaves a special kind of dried grass carpet. One of the weavers of the society creates a different pattern on the same variety of carpet. This is more of a traditional cultural expression. Should this fall under the scope of GBS? The issue here is whether his creation, which is unique from the regular designs, merits special mention in the register. A lifestyle store desirous of manufacturing such carpets approaches the community through the GBS. If the community, as a consequence of a benefit sharing agreement, reveals the technology of weaving the carpets, would the new manufacturer suo moto have the right to replicate all the patterns including the unique pattern created by one of the community members? Most traditional handicrafts in India are still almost unprotected. The tag “Made in India”, though announces a geographical indication, is not effective in curbing replication of the traditional handicrafts, prints and designs. Such handicrafts are far easily available and accessible than the genetic resources and related knowledge. The craftsmen of such handicrafts do not get protection, legal or otherwise, against unauthorized reproductions of their works. 181 GBS and work toward a standard but flexible set of norms guiding access and benefit sharing procedure internationally. The international body should have a two fold function. Firstly it should work toward protection of traditional knowledge and furthering the interests of the traditional society. Secondly it should promote proper dissemination of information through conducive sharing regimes between the traditional societies and the prospector organizations. The organization should work towards alleviating the differences between the traditional societies and the corporate so that an environment based on mutual trust and concern is created between the two quarters, and hence do away terms like “biopiracy” and “bad patents” from the biotechnology law lexicon. 3.5 CONCLUSION The instant chapter aimed to describe some positive measures in protection of traditional knowledge. However it has been felt that in the guise of ‘positive protection’, most legislation have incorporated defensive measures to prevent biopiracy. These stipulations basically are an extension to the provisions present in most intellectual property regimes and they could have been incorporated in the intellectual property regime. Admittedly there are gaps in existing legal and non-legal techniques and mechanisms with regard to the recognition and the protection of the knowledge and innovations derived from traditional knowledge systems and traditional knowledge. Further, elements of a new and common law concerning the protection of the traditional knowledge are beginning to emerge; the elaboration of farmer's rights provides an example: These rights are defined as being those “arising from the past, present and future contribution of farmers in conserving, improving and making available Plant Genetic Resources, particularly those in the centers of 182 origin/diversity. These rights are vested in the International Community, as trustees for present and future generations of farmers, for the purpose of ensuring full benefits of farmers and supporting the continuation of their contributions”. 499 But the importance of modern biotechnology can not be undermined. An over protective sui generis system of laws might add to the multiplicity of enactments and over protection might actually lead to hindrance in the research and development of knowledge in the world. Hence efforts should be focused on evaluating the potential of existing intellectual property rights regimes to provide protection for traditional knowledge systems, traditional knowledge and indigenous innovations alongwith the relevant issues and problems posed by modern biotechnology specially in developing countries like India. 499 Food and Agriculture Organization of the United Nations, Conference Resolution 5/89: Farmers'Right, Twenty-fifth Session of the FAO Conference, Rome, 11-29 November 1989 ¶ 3 available at (last accessed on 14 August 2004). 183 CHAPTER IV: PATENTABILITY OF MODERN BIOTECHNOLOGY INVENTIONS IN INDIA 4.1 INTRODUCTION The growth of technology is challenging established legal principles, which are struggling to adapt to rapid technological advances. Developing nations are responding to these challenges of balancing demands for western-style intellectual property protection while further consolidating indigenous capacities. They are establishing regimes that not only encourage the transfer of technology but also allow for control over genetic resources and prevent biopiracy. Unlike western models, where grant of IPRs is seen as sufficient to promote technological innovations, these are unique in the sense that they seek to protect biological resources, traditional rights and indigenous knowledge in addition to granting IP protection. India is one such developing country that is working towards necessary changes in the IP regime to balance new and traditional rights. Biotechnology involves intervening in nature through varied scientific techniques to achieve a desired result. In this respect, it is markedly different from automobile and electronic technologies and, consequently, far more controversial. It also presents a wide variety of challenges to the patent law. While patenting encourages the pharmaceutical industry to invest in research and development of new technologies for improvement of the quality of life, many universities today are actively pursuing research collaborations with pharmaceutical companies. Research results are now more often subjected to patent rights as part of the on going trend to commercialize 184 research output. Richard R. Nelson, a professor,500 has said, “Universities have become extraordinarily greedy and aggressive in prosecuting there patents and, in the process, have backed away from their responsibilities as defenders of open science”.501 Perhaps the most hotly contested spheres of modern biotechnology are biomedical and biopharmaceutical research and applications, which depend primarily on plant, animal, and human genetic materials. First there is the problem of plant and animal genetic resource control and access, which predominates the trade and political discourse. Second, biomedical research and clinical applications raise ethical, moral, and legal issues posed by gene patenting, human genetic sourcing, ownership and theft of genetic materials or body parts, genetic discrimination, genetic screening and confidentiality, stem cell research, and human cloning. These opportunities are also coupled with controversies that not only challenge the laws within which society functions, but also the ethical and religious beliefs. Indian prowess in the field of biotechnology research dates back to early 1980s.502 Today it boasts of a very competent biotechnology industry with a turnover of USD 5.5 billion per year. The biotechnology sector, unlike the information technology sector is highly regulated. The recently passed Patents Amendment Act, 2005 governs patent law in India. 500 Richard R. Nelson is a professor of International and Public Afffairs and an expert in the economics of technological advances at Columbia University, in New York. 501 Harry Goldstein & Ronil Hira, R+D 100, IEEE Spectrum INT, November 2004 at 43. 502 India Biotechnology, at (last accessed on 3 September 2004). 185 4.1.1 Classification of modern biotechnology Modern biotechnology has various classifications. One way of classifying is delimiting the inventions in terms of their time of invention. Dutfield, in a recent publication has classified biotechnology into three generations. In the first generation biotechnology, he has included the ancient biotechnology processes of brewing beer and fermenting the dough for making bread. The second generation biotechnology has been conceived to commence from the nineteenth century studies of microbes by Louis Pasteur and includes modern plant and animal breeding techniques. This generation culminates in the mass production of antibiotics.503 The third generation biotechnology includes the techniques of isolating DNA from one living organism to another for expressing desired traits in the transferee life form.504 503 Antibiotics are drugs which kill or retard the growth of bacteria. The term originally described only those formulations derived from living organisms, but is now applied also to synthetic compositions. More information can be found at John C. Brown, What the Heck is Antibiotic?, 1995, at, (last accessed on 3 September 2004). 504 The use of microscopes by early scientists led to the discovery of cells in both plants and animals. Cells are the factories of life that encode the vital reproductive information of plants and animals. “Chromosomes” were identified as the likely carriers of this reproductive information. They are “threadlike” in nature and reside in the nucleus of the cell. Scientists soon discovered that "genes" were actually located on chromosomes, and are made from deoxyribonucleic acid (“DNA”). It subsequently became clear that DNA is the carrier of hereditary information in plants and animals. In 1953 two Cambridge University scientists, James Watson and Francis Crick, finally deciphered the structure of DNA. They described the structure as having “two helical chains each coiled round the same axis” and observed that each DNA molecule comprised two sugar-phosphate backbones that entwined one another. This shape is known as the “double helix" This discovery of the structure of DNA facilitated useful insights into how DNA reproduces itself when a cell divides, and in that process, passes on a complete copy of hereditary information to both “daughter” cells. Scientists soon revealed the process by which hereditary information in the DNA code was converted to proteins, the complex chemicals that do most of the work of the cell. This process involves copying DNA into ribonucleic acid (“RNA”), a related chemical slightly different in composition. Unlike DNA, RNA is mobile and moves from the cell nucleus to the rest of the cell. There, the RNA shepherds the assembly of amino acids into a protein molecule in accordance with the original DNA specifications and instructions. In other words, genes are instructions for making various proteins. According to Grace, “every process and product in living cells depends on proteins. They do everything from activating essential chemical reactions, to carrying messages between cells, to fighting infections, to making cell membranes, tendons, muscles, blood, bone, and other structural materials”. A defective or missing protein molecule is known as “genetic mutation”. Genetic mutations may be rectified by “gene therapy”. The ultimate genetic technology is “genetic engineering”. Genetic engineering may be used to introduce a desirable trait into plants or animals to cure a particular genetic disease in a person, or for experimental purposes in animals. See, ERIC S. GRACE, BIOTECHNOLOGY UNZIPPED: PROMISES & REALITIES (1997), 1 to 52 at 21. 186 It is the third generation biotechnology identified in the Dutfield time-line which is raising difficult questions.505 This is not surprising since the precise scope and extent of new biotechnology applications that have been recently opened up is unclear. The third generation technology is very new and it is often times hard to predict the consequences of the practical applications. It can only be assumed that biotechnology has numerous applications and that the modern research in biotechnology, ideally targets to achieve ends for betterment of life. India has been involved in conventional biotechnology for several decades but modern biotechnology is currently in its nascent stage. Products manufactured by the use of genetic engineering, immunological techniques, cell culture methods have increasingly been used during the last five years and local research in these areas has intensified.506 There is little doubt that the applications of modern biotechnology will increase rapidly in India and around the world. It holds great potential for providing solutions to improve the health of people and their quality of life, significantly improving agricultural productivity along with supplying more nutritious food and improving the quality of environment by ensuring sustainable development. An 505 Genetically modified animals have always been the centre of debates. An instance of such transgenic creature is the baby monkey named 'ANDi', the first ever genetically modified non-human primate. This rhesus monkey was born on 2 October 2001 at the Oregon Regional Primate Research Centre. ANDi carries a gene that codes for GFP (green fluorescent protein) which was isolated from glowing jelly fish. Rhesus monkeys and human beings being structurally similar, both being primates, transgenic monkeys represent a potentially powerful research tool to investigate the causes of diseases such as cancer and Parkinson's disease, opening the possibility of new vaccines and therapies. Ohsu Researchers Produce First Genetically Modified Monkey, 11 January 2001, at http://www.ohsu.edu/news/archive/2001/011001monkeyfaq.shtml html (last accessed on 17 December 2004). Another example of genetic engineering is ‘geep’ which is a chimera of a goat and a sheep. The advantage of this transgenic animal is that further research could allow embryos from severely endangered species to be carried by recipient mothers from other species. Mosaicism and Chimersim, at http://arbl.cvmbs.colostate.edu/hbooks/genetics/medgen/chromo/mosaics.html (last accessed on 17 December 2004). 506 P.K.GHOSH, Future of Biotechnology in India in INDIAN CHEMICAL INDUSTRY OPPURTUNITIES UNLIMITED (Kamal Khokhani ed. 2000). 187 example of a modern controversial research process is stem cell, particularly, embryonic stem cell research. Stem cell research is an emerging area in India and the scientists are looking forward to develop prowess in this area.507 This chapter discourses questions of patentability of some such third generation modern biotechnology in India. Issues as to the scope of rights and infringement whilst important and significant will not be discussed in any detail. The much discussed biotechnology cases: Diamond v. Chakrabarty508, Howard Florey /Relaxin509 and the Harvard Oncomouse510 cases are used as test cases to evaluate India’s preparedness to tackle the modern biotechnology era. 507 In the wake of the ethical issues, the US government, since August 2001 has limited funding on embryonic stem cell research only to the 64 existing stem cell lines that have already been derived or were already in existence as of the date of the announcement. Some Indian research agencies have approached the US institutes involved in embryonic stem cell studies for collaborative projects since there is neither any restriction against stem cell research in India, nor a public outcry regarding the ethical issues involved. Though stem cell therapy has been used to treat degenerative corneal disease in the L.V. Prasad Eye Institute in Hyderabad, India, the use of adult stem cells has made it non controversial. Embryonic stem cell research is still a new phenomenon in India, and it is yet to affect the masses to evoke a public reaction. There already is a sanction under Section 3 of the Medical Termination of Pregnancy Act, 1971, for terminating pregnancy if the birth of the child causes physical or mental anguish to the mother, or the child in the womb if born, would suffer from physical and mental abnormalities. Unless there is a strict law, embryos may be transacted for the sake of obtaining embryonic stem cells. Indian Council of Medical Research (ICMR), under the Ministry of Health and Family Welfare, Government of India, has formulated a guideline for stem cell research in India and has suggested the establishment of an apex regulatory body to “examine the scientific, technical, ethical, legal and social issues in the area of cell based research and therapy” in India. Under Section 2(j), Patent (Amendment) Act 2005, a patentable invention means a new product or process involving an inventive step and capable of industrial application. In case of a patent application of a stem cell line, Section 3(i) prohibits patents on processes relating to medical treatment. But, since 1 January 2005, products developed for use in medical treatment being made patentable, the cell line developed can be patented if it has industrial applicability. Industrial applicability not being defined in the Act, patentability will depend on the utility of a particular claimed product. Patentability would also depend whether embryonic stem cell is considered to be morally offensive, in which case the invention would not be patentable as per Section 3(b) of the Act. However embryonic stem cell research in India being at a nascent stage is yet to be debated by the public and issues resolved at the Courts. In page 10 of the Guidelines, it is stated that issues relating to patenting of such cell lines need to be sorted out through public debate. K. S. Jayaraman, India forges ahead with stem cells for eye repair, 20 February 2004, at (last accessed on 5 July 2005). Indian Council of Medical Research, Draft Guidelines for Stem Cell Research/Regulation in India, available at (last accessed on 5 July 2005). 508 Diamond v. Chakrabarty, 447 U.S. 303 (1980) 509 [1995] EPOR 541 510 Commissioner of Patents v. President and Fellows of Harvard College and Ors. 2002 SCC 76 188 4.2 DIAMOND V. CHAKRABARTY The Diamond v Chakrabarty dispute is a watershed decision in the history of biotechnology patents. Chakrabarty, the respondent, had filed a patent application for the invention of bacteria, pseudomonas that degraded oil. The carbon containing genes for hydrocarbon degradative pathways are not found naturally in pseudomonas in the environment. This invention was designed for bioremediation of oil spills. The USPTO511 verdict in the case established that human intervention, leading to a novelty in expression, could be patented. The Court held that: "the respondent's microorganism plainly qualifies as patentable subject matter. His claim is not to a hitherto unknown natural phenomenon, but to a non-naturally occurring manufacture or composition of matter - a product of human ingenuity having a distinctive name, character and use...... His discovery is not nature's handiwork, but his own..." In other words, it was held that a genetically engineered microorganism was not a creation of nature, but rather a product of a person's work, and thus was patentable subject matter. In dismissing the argument that the invention would adversely affect the environment, the Court held, “We are told that genetic research and related technological developments may spread pollution and disease, that it may result in a loss of genetic diversity, and that its practice may tend to depreciate the value of human life . . . . It is argued that this court should weigh these potential hazards in considering whether respondent's invention is patentable subject matter . . . . We disagree . . . . We are without competence to entertain these arguments--either to brush them aside as fantasies generated by fear of the unknown, or to act on them. The choice we are urged to make is a matter of high policy for resolution within the 511 See supra note 68. 189 legislative process after the kind of investigation, examination, and study that legislative bodies can provide and courts cannot . . .” It is evident from the ruling that the American courts had prioritized the advancement of biotechnology over ethical and environmental issues. Such issues had been considered beyond the jurisdiction of the court to pass rulings unless a policy was framed by the legislature that could perhaps be implemented by the courts. The Indian courts are yet to face a similar litigation and hence the position in Indian law in this regard is not very clear. However on the basis of the existing provisions in the Indian patent laws, the Patent Act 1970, as subsequently amended, and the Guidelines laid down by the Department of Biotechnology512, a forecast to a likely outcome may be attempted. Section 3513 of the Patent Act lists inventions that have been held unpatentable. The 2002 amendment of the Act has prolonged this list. The process for producing the oil 512 Also known as, and hereinafter referred to as DBT. This is a unit under the Ministry of Science and Technology, Government of India, at http://dbtindia.nic.in (last visited on 15 August 2005). 513 Under Section 3 the following are not inventions within the meaning of the Patent Act, 1970: (a) an invention which is frivolous or which claims anything obviously contrary to well established natural laws; (b) an invention the primary or intended use of which would be contrary to law or morality or injurious to public health; (c) the mere discovery of a scientific principle or the formulation of an abstract theory; (d) the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant; (e) a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance; (f) the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way; (g) a method or process of testing applicable during the process of manufacture for rendering the machine, apparatus or other equipment more efficient or for the improvement or restoration of the existing machine, apparatus or other equipment or for the improvement or control of manufacture; (h) a method of agriculture or horticulture; (i) any process for the medicinal, surgical, curative, prophylactic or other treatment of human beings or any process for a similar treatment of animals or plants to render them free of disease or to increase their economic value or that of their products. The 2002 amendment to the Indian Patent Act has revised the section to include, inter alia: (a) The mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non- living substance occurring in nature. (b) Plants and animals other than microorganisms in whole or any part thereof including seeds varieties and species and essentially biological processes for production or propagation of plants and animals. (c) An invention which, in effect, is a traditional knowledge or which is an aggregation or duplication of known properties of traditionally known component or components. 190 degrading bacteria for which patent had been sought in USPTO falls under the category of microorganism which is not used for “medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings or any process for a similar treatment of animals or plants”.514 Hence such a process also solitarily would not be patentable in India. Providing the exclusion of plant and animals as patentable subject matter in the second amendment to the Act, the legislators have expressed tacit encouragement to patenting of microorganisms. With regards to the Act, Section 3(b) provides that an invention, the primary or intended use or commercial exploitation of which could be contrary to public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment, is not to be regarded as an invention at all, in other words, is not patentable. The Act also excludes from patentability plants and, animals in whole or any part, other than microorganisms.515 There is no legal bar in patenting the microorganism unless that is against morality or is harmful for animal and plant life or health or environment. The DBT enumerates guidelines for undertaking biotechnology activities and subject to Environment Protection Act, 1986, the bacteria would be eligible for patent under the present Indian Act.516 514 Id. Under Section 3(i) of the Patent Act, the referred processes are unpatentable. Section 3(j), Patents Act, 1970 as amended by Patent Amendment Act 2005. 516 Department of Biotechnology in India, Regulatory Reforms in Biotechnology, available at (last accessed on 5 July 2005). 515 191 Further, the definition of ‘invention’ was amended in 2002517 in accordance with the TRIPS to mean a new product or process involving an inventive step and capable of industrial application.518 The amendments were made to incorporate an allencompassing definition of invention and to broaden the horizon of patentability in India. Under the 2005 Act, the scope of patentable inventions has been expanded, beyond the purview of process, to mean a patent for ‘any invention,’ that is either product or process.519 “Inventive step”, in the 2002 Amendment of the Patent Act, 1970, was defined as a feature that makes the invention not obvious to a person skilled in the art. The definition has been qualified to “a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art.”520 While ‘Technical advance as compared to the existing knowledge’ and ‘economic significance’ are terms subject to judicial interpretation, it can be surmised that the Indian patent regime is taking a pro-patent stance. On January 15, 2002 Calcutta High Court delivered a landmark judgment in Dimminaco AG v. Controller of Patents and Designs. & Others,(Aid No.1 of 2002)521 which set out to change the landscape of patents and life forms in India, just as the Diamond v. Chakrabarty did in US. Dimminaco AG522 had filed a patent application 517 Section 2(1)(j) of the Patents Act, 1970 defined an invention as follows: “Invention means any new and useful-(i) art, process, method or manner of manufacture, (ii) machine, apparatus or other article, (iii) substance produced by manufacture, and includes any new and useful improvement of any of them, and an alleged invention”. 518 The 2002 amended definition is also valid under the 2005 amendment of the Patent Act of 1970. Section 2(1)(ja) of the Patents (Amendment) Act 2005. 519 Section 2(1)(m) of the Patents (Amendment) Act 2005. 520 Section 2(1)(ja) of the Patents (Amendment) Act 2005. 521 IP World Online, Case Comment–India: Patentability of biotechnology, at (last accessed on 16 December 2004). The proper citation to the case, even after employment of best efforts, could not be obtained. 522 Dimminaco AG is a subsidiary of American Home Products Inc. 192 for the process of manufacture of a live vaccine for protecting poultry from infectious Bursitis. The end product contained living organisms in the form of a virus. Indian Patent Office rejected the application on several grounds, the most prominent of which was that the statutory definition of ‘manufacture’ did not include a process leading to a living organism.523 The Court held that merely because the end product contained a live virus did not inhibit the process of manufacture from being patented. It was further held that there is no statutory bar to accept a manner of manufacture as patentable even if the end product contains a living organism.524 The appellant stated that since there was no statutory definition of the word ‘manufacture’ the dictionary meaning should be attributed to the word. Taking this into account, Mr. Justice Asok Kumar Ganguly observed that “if the end product is a commercial and vendible entity, and for that, presence of living virus/microorganism in the end product cannot be a bar to its patentability”.525 On April 10, 2002 the Controller of Patents finally accepted Dimminaco’s application.526 Subsequently, the Government decided against filing an appeal against the Calcutta Judgment. This should provide a breakthrough for the filing of patents by the biotech industry and will be a crucial factor for the growth of the biotechnology sector. There is yet no means to decide what ordre public is in India. It remains to be seen how the 523 Section 5, Patent Act, 1970. This section has been since omitted in the 2005 Amendment. Supra note 521. Also see, Ella Cheong Mirandah & Sprusons, Rejection of Vaccine Patent Application Quashed, April 15 2002, at http://www.internationallawoffice.com/ld.cfm?Newsletters__Ref=4868 (last accessed on 17 December, 2004). 525 Mohan Padmanabhan, Govt not to appeal against ruling on biotech patent, 25 April 2002, at (last accessed on 5 July 2005). 526 According to Thambisetty, the denial of the patent was based on an internal circular of the patent office according to which there was no bar on processes that involved the use of a living organism , rather the bar appeared when the invention was a product in the form of a living organism. This made the claim for a process using living organisms patentable. Sivaramjani Thambishetty, Patenting Research Tools in Human Genome Studies: View from a Technologically Proficient Developing Country (2003), 8, available at (last accessed on 3 September 2005). 524 193 courts would decide a case where the morality issue of a particular invention is in question. Some indications emerge from the communication of India to the TRIPS Council regarding review of provisions of Article 27(3)(b) of the TRIPS.527 Under the heading microorganisms, the probable criteria for patenting a microorganism are said to be novelty, non-obviousness and usefulness. In the same communiqué, it has been mentioned that “a man-made genetically engineered bacterium, would meet the test of patentability.” Since the bacteria in question satisfies the three patentability conditions, it would, in all likelihood be patented under the prevalent laws in India. 4.3 RELAXIN In the Howard Florey case, the European Patent Office528 had allowed a patent for the encoding for a protein, H2-relaxin that was produced in the body of a pregnant woman.529 Aside from the objection that this did not amount to an invention, morality based objections that this was patenting human life and the pregnant woman, whose tissues were being used for isolation of the gene, was being reduced to slavery were also raised.530 The Opposition Division of the EPO dismissed the objections on the 527 World Trade Organization, Review of the Provisions of Article 27.3(b): Communication from India, Council for Trade-Related Aspects of Intellectual Property Rights, IP/C/W/161, WTO, Geneva, 3 November 1999. 528 European Patent Office is commonly and in the instant thesis referred to as EPO. 529 The protein H2-relaxin caused the pelvic ligaments to relax in a pregnant woman. 530 The patent claims included claims to the gene and the protein. The claim was opposed, inter alia, on the ground that the claim was a discovery and not an invention. It was argued that gene sequences, since they are present in the body of the organism, could only be discovered and not invented. The EPO Opposition Division disagreed. The Guidelines for Examination in the EPO, Guideline C-IV stated that while finding a substance “freely occurring in nature” would be a discovery; isolating a substance from the state in which it is found in nature and developing it through a process would not be so. The process of isolation and development, if novel, would be patentable. Further, if the substance can be characterized either “by its structure, by the process by which it is obtained or by other parameters, and it is new in the absolute sense having no previously recognised existence,” the substance would be patentable. In case of Relaxin, the gene claims were for complementary DNA, a version not found in nature. Relaxin , in these senses, was new since it has no “previously recognised existence”. Further a method was developed by the applicants fro obtaining the protein, and the protein was charaterised by the chemical structure. The applicants also had found a use for their product. Relaxin was therefore held patentable. This decision was confirmed by the Technical Board of Appeal. See, S. J.Botsyn, The 194 grounds, inter alia, that DNA was not "life," but rather substance carrying genetic information for the production of medically useful protein.531 The patent on the gene and the protein did not confer a right on the donor.532 Further, since the tissues were obtained with the donor’s consent and since tissue had been used earlier for research related to human health, the patentability bar in Article 53(a) of EPO Guideline could not be invoked.533 Article 53(a) was restricted to those inventions that would be universally considered unconscionable.534 The EPO’s views are symptomatic of the increasing tensions and conflicts between ethical or moral considerations and the Prodigal Son: The Relationship Between Patent Law and Health Care, [2003] Medical Law Review 11, 67 at 76. 531 In dismissing the slavery contention, the EPO found, “[A]s for the opponent's assertions concerning slavery and dismemberment of women, these are considered to betray a fundamental misunderstanding of the effects of a patent. It can not be overemphasized that patents covering DNA encoding human H2-relaxin, or any other human gene do not confer on their proprietors any rights whatever to individual human beings any more than do patents directed to other products such as proteins, including human H2- relaxin. No woman is affected in any way by the present patent--she is free to live her life as she wishes and has exactly the same right to self- determination as she had before the Patent was granted . . . . [T]he exploitation of the invention does not involve dismemberment and piecemeal sale of women. The whole point about gene cloning is that the protein encoded by the cloned gene--in this case human H2-relaxin--is produced in a technical manner from unicellular hosts containing the corresponding DNA; there is therefore no need to use human beings as a source for the protein. The only stage at which a woman was involved was at the beginning of the making of the invention, as a (voluntary) source for Relaxin mRNA.” Howard Florey, [1995] E.P.O.R. at 550. 532 WILLIAM R. CORNISH, INTELLECTUAL PROPERTY: PATENTS, COPYRIGHT, TRADEMARKS AND ALLIED RIGHTS (4th ed. 1999) 117-118. 533 Article 53(a) of the EPO Guideline states that: European patents shall not be granted in respect of: (a)inventions the publication or exploitation of which would be contrary to "ordre public" or morality, provided that the exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the Contracting States… 534 During trial, the opponents had requested that a referendum be conducted on the issue. In rejecting the proposition the Opposition Division declared: [T]he opponents requested that the EPO carry out a referendum . . . . This request is refused since in opposition proceedings the burden of proof lies with the opponent--if they felt that such a survey might assist their case, it was up to them to carry it out. In any case, the Opposition Division wishes to point out that even if such a Referendum were feasible, there is no provision in the EPC that only those inventions actively approved by the public should be patented. If such a provision existed, it is arguable that the number of patents Grants would be decimated . . . . [O]nly in those very limited cases in which there appears to be an overwhelming consensus that the exploitation . . . of an invention would be immoral may an invention be excluded from patentability under Article53(a). The holding did not clarify what constitutes an "overwhelming consensus," and how it could be fairly ascertained. The Opposition felt that the opinion of the society regarding patenting of genes had not crystallized. Further since patents were not to be granted only for inventions approved by the public, Article 53(a) was not applicable here. The questions of morality should be decided by the society, and unless there was an “overwhelming consensus” about immorality, the invention must not be excluded from patentability on the ground of Article 53(a). This stance reflects a pro-patent policy at the EPO. Supra note 531 at 553. 195 commercialization of biotechnology where ethical and moral influences are comparatively weak. Section 5(a) of the Indian Patent (Amendment) Act, 2002 prohibited patents on products capable of being used as food, medicine or drug. Thus Relaxin, being a medicine, would fall under inventions where only methods of manufacture were patentable but not the product itself and hence would not be a patentable invention. The Patent Amendment Act passed by the Indian Parliament in December 2004 alters this position of Indian patent laws and allows for product patents in the fields of medicine and drugs as well. As per the latest Act, Relaxin is a patentable subject matter under the Indian law. Since the process of manufacture of Relaxin involves obtaining genetic material from a pregnant woman, ethical issues relating to biomedical research would also need to be addressed. The EPO’s views imply that ethical issues, being subject matters for continual assessment, should be addressed outside patent law. The justification for EPO’s stance might be that patent offices only can address the public order issues at the time of granting the patent, when often the consequences of the invention are not clear.535 While there is no precedent in India regarding the ethical stance, some of the aspects have been dealt with in the policy declaration of the DBT. In formulating the policy, 535 An external regulatory authority granting manufacturing licenses for drugs can withdraw permission when ill effects of the patented invention are reported. Such a provision of post grant opposition may be introduced in the patent act so that while the patentee has the right to further develop the product or remedy the ill effects, the public is not affected. 196 the DBT has adhered to standard international ethical norms.536 These include practices like obtaining the informed consent of the subject and maintaining the privacy of the subject. However the reaction to obtaining DNA from a pregnant woman in a conservative social environment as in India is extremely uncertain. Going by the latest government initiatives to support modern science and technology and investment in such fields; and to upgrade Indian laws to support the most modern scientific and biomedical research, it is likely that the ethical issues would be dealt with so as to effectively prohibit the grant of the patent to Relaxin in India. 4.4 ONCOMOUSE In May 1992 the EPO granted a patent to a 1985 application by President and Fellows of Harvard College, Cambridge, Massachusetts, USA, in respect of “non-human mammalian animals” for eleven member states of the EPO.537 The USPTO had already granted the patent to the aforesaid claim in 1988. Seventeen oppositions filed against the patent, at EPO led to the decision in November 2001 to maintain the patent in respect of “transgenic rodents”. The Technical Board of Appeal overruled the Examining Division's refusal to grant 536 The Bioethics Advisory Committee (BAC) of Singapore has issued 24 proposals for guarding the rights of the subjects for biomedical research. Genetic tests should be consented to and the outcome of such tests should not be disclosed to third parties including employers and insurers. Obtaining samples for testing, for instance “by picking up a used toothpick for DNA samples – without the person’s knowledge or consent ” has been held illegal. Chang Ai-Lien, Illegal to get genetic material without consent: proposal, The Strait Times, April 6 2005, 1. 537 The principal claims were: The patent's principal claims were: 1. A method for producing a transgenic non-human mammalian animal having an increased probability of developing tumours, said method comprising introducing an activated oncogene sequence into nonhuman mammalian animal at a stage no later than the eight-cell stage. 2. A transgenic non-human mammalian animal whose germ cells and Somatic cells contain an activated oncogene sequence introduced into said animal, or an ancestor of said animal, at a stage no later than eight-cell stage, said oncogene optionally being further defined according to any one of claims 3 to 10. See Harvard/Onco-Mouse, [1990] E.P.O.R. at 6. 197 the patent on various grounds, but required the Division to consider further whether exploitation of the invention would be contrary to "ordre public" or morality under Article 53(a) of the EPC538. On remand, the Examining Division concluded that the invention could not be considered immoral or contrary to public order539. It was further noted that the test animal was useful in cancer research, and therefore beneficial to mankind. Finally, on November 7, 2001, the EPO Opposition Division ruled that the patent claim must be limited to “transgenic rodents containing an additional cancer gene”,540 instead of a transgenic non-mammalian animal. The ruling considerably narrowed the scope of the claim, not on ethical or moral grounds, but to encourage competition and facilitate the patentability of subsequent inventions in the field. Six opponents appealed the 2001 decision to the Technical Board of Appeal. On 6 July 2004, the Board handed down its decision to maintain the patent but to restrict its application even further, to ‘transgenic mice’.541 The decision to maintain the 538 Harvard/Onco-Mouse, [1990] E.P.O.R. 501at 504. Harvard/Onco-Mouse, [1991] E.P.O.R. 525. 540 Press Release, European Patent Office, "Oncomouse" Opposition Proceedings Resume at EPO, 5 November 2001, available at (last accessed on 2 January 2005). 541 Press Release, European Patent Office, Technical Board of Appeal restricts 'Oncomouse' patent, July 6, 2004 available at (last accessed on 2 January 2005). The EPO Board of Appeal framed the issues involved as whether the EPC allows the patentability of the particular animal invention in question and, if so, how broadly that invention may be claimed (page 79). The Board dealt with the first question in light of Article 53(a) EPC, Rule 23d(d) EPC. The Rule reads: "Under Article 53(a) European patents shall not be granted in respect of biotechnological inventions which, in particular, concern the following:...(d) processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes". While there was a definite likelihood that the animal would suffer, the invention would help in advancing cancer research. The Board stated that there was no credible non-animal alternative which could be used for this purpose. According to the Board, the invention passed the “balancing test” since the benefits of the invention outweighed the concern for suffering to the animal. (page 116). Regarding probable environmental hazards, the Board held that there was no sufficient evidence to substantiate the existence of a threat to the environment such as to represent a bar to patentability under Article 53(a) EPC (page 117). Regarding the issue whether the invention fell under the animal exclusion in Article 53(b), the Board held that the issue was whether the technical feasibility of the invention is not confined to a particular animal variety. The patent clearly concerned a taxonomic category of animals higher than "species" which represents the widest definition which could be given to the animal exclusion in Article 53(b) EPC. The invention was thus beyond the exclusion. Regarding public view the Board held that while there was a major concern regarding animal suffering in Europe, such “unease” could not regarded as a “moral disapproval” in Europe towards use of animals for medical research. However, the Board felt that all rodents are not so different that each would contribute 539 198 patent suggests that the philosophy regarding patentability of animals generally has not changed. Instead, it seems likely that the decision reflects even more weight being given to moral considerations. If this is the case, it heralds an even deeper divide between Europe and the US in terms of the patentability of biotechnological inventions. Canada has all along taken a unique stand. In early 2002, Canadian Supreme Court rejected the patent for the Harvard Oncomouse. In denying the patent, the Court ruled that Canadian law did not support the patenting of "higher life forms" like mice and other animals.542 The Canadian Court’s decision was in marked contrast to the granting of corresponding transgenic mouse patents in most industrialized countries, including the United States, France, Germany, Britain, and Japan. The Canadian Supreme Court decision has resurrected arguments against animal patents being differently to cancer studies (page 109). Thus the invention was outside the purview of exclusions in Article 53(a) (page 127). The Board therefore allowed the “claims limited to "mice"”(page 136). The request for a referral to an Enlarged Board of appeal was disallowed. Due to space restriction, the decision of the EPO Board of appeal is not being discussed in detail. Boards of Appeal of the European Patent Office, Decision T 315/03 of 06.07.2004 - Transgenic animals/HARVARD ("Oncomouse"), at , http://legal.european-patent-office.org/dg3/updates/2005_03_29.htm (last accessed on 14 July 2005). 542 The Canadian Supreme Court decided that the terms "manufacture" and "composition of matter" excluded higher life forms. The Supreme Court’s decision was by barest majority with a strong dissenting minority. The majority decided Oncomouse on a relatively narrow interpretation of law. As a matter of statutory interpretation, the Canadian Parliament could not have intended “composition of matter” to include inventions based on higher life forms as this was not something that was achievable when the patent law was drafted. It appears that the majority felt that it was for the Parliament to decide whether higher life forms should be patented, and if the inclination was pro-patent,, then draft exclusions that would be needed to deal with human life forms. It does not seem that the majority decided the case on policy grounds as such, and hence, were not necessarily holding the view that as a matter of policy, higher life form based inventions should not be regarded as patentable subject matter. The minority view was that patent law, by definition, is concerned with the future and encourages useful advances in the art. That being so, the fact that modern biotechnology was not available at the time the law was drafted, does not mean that the Parliament did not intend these to be covered. Canadian Biotechnology Advisory Committee (CBAC) have however been pro-patent. While they have held that human body should not be patentable at any stage of development, plants and nonhuman animals which meet the criteria of novelty, non-obviousness and utility, should be made patentable. Wei has stated that CBAC’s stand may be the harbinger of change in Canada’s patent policy. George Wei Sze Shun, Mus Muscukus and Homo Sapiens: Murine Metaphysica and the Canadian Supreme Court, Singapore Journal of Legal Studies [2003] 38-79 at 76. 199 considered to be the teething steps toward patenting humans.543 Ironically, in the United States, although the courts make no distinction between lower and higher life forms, human patents are proscribed.544 In contrast, the Canadian Supreme Court does acknowledge a distinction between lower and higher life forms, yet Canada has no express ban on patenting humans. The European Union prohibits patents on "the human body," but allows patents on "an isolated element of a human body." Further reflecting unsettled international biotechnology related patent law, human cloning is unlawful in the United Kingdom, but patents do cover the cloning and growing of a human embryo. The question of morality is also vital for the human society where the society still detects a divine design in the act of procreation. However the Oncomouse patent would be barred under other provisions of Indian law as well since Section 3 of the Patent Act 1970,545 since the 2005 amendment has barred patenting of plants and 543 However the Canadian Supreme Court took a more pro-patent view in the case of Monsanto Canada Inc. v. Schmeiser, [2004] 1 S.C.R. 902, 2004 SCC 34 (CanLII). In March 2001, Monsanto, a multinational agro-biotechnology company, successfully sued Saskatchewan farmer in Canada, Percy Schmeiser, for patent infringement. The company contended that the farmer had illegally planted and sold harvested seed containing the gene and cells covered by Monsato's patent on Roundup Ready Canola. Monsanto Canada, Inc. v. Schmeiser, [2001] F.C. 256, available at http:/decisions.fctcf.gc.ca/fct/2001/2001fct256.html (last accessed on 12 February 2005) . The Federal Court affirmed the decision. Schmeiser appealed to the Supreme Court. The issue was whether Monsanto had a patent right on the plants which were allegedly grown from seeds manufactured by Monsanto. The Court held that patent claims disclosing genetically modified genes and cells which, when inserted into plants, increased tolerance to glyphosate herbicides, could also be extended to the “the genes and the modified cells that make up the plant”. This distinction was clarified by the Bench (dissenting in part) stating that “the gene claims and the plant cell claims should not be construed to grant exclusive rights over the plant and all of its offspring.” Hence the patent was held valid. However since Schmeiser did not make any profit from the crop out of Monsanto’s seeds, that would not have made from a crop grown out of his won seeds, and since Monsanto had opted for a share of profit rather than damages, Schmeiser was held not liable to pay. The singularity of this decision is that while, plants as higher life forms, were considered unpatentable, the modified genes and the plant cells that composed the plant were held patentable. But, this did not give the patentee a right on the plant or its progeny. 544 U.S. Patent and Trademark Office, Manual of Patent Examining Procedure (Revised February 2003), Sec. 2105: “Patentable Subject Matter--Living Subject Matter”: · “If the broadest reasonable interpretation of the claimed invention as a whole encompasses a human being, then a rejection under 35 U.S.C. 101 must be made indicating that the claimed invention is directed to nonstatutory subject matter”. 545 The Patent Act, 1970 did not have an express prohibition regarding patenting of biotechnology. Probably, the legislators did not foresee the rapid progress of biotechnology in the following years and hence did not feel to provide for biotechnology inventions. According to Bhattacharya, “The Act also 200 animals except micro organisms. Though the Oncomouse is a genetically manufactured creature, and similar to the oil-degrading bacteria in that score, it is a higher life form and hence is not liable for a patent as per Section 3(j) of the Indian Patent Act. Oncomouse could have also been refused a patent under Section 3 of the Act on grounds of being injurious to public health and environment.546 Not much documented research is being undertaken in India toward creating higher life forms and in all likelihood the Oncomouse patent would have been an extremely controversial invention. Assuming the absence of the aforesaid legal bars, the Indian courts might have, for sakes of advancement of scientific research and also, to encourage investment in biotechnology, allowed patenting of the Oncomouse restricting in to a very narrow claim to balance public sentiments and scientific zeal. A major consideration would have been whether the Oncomouse would have satisfied the definition of “invention”. Under Section 2(j) of the Act, “invention” means a new product or process involving an inventive step and capable of industrial application. In that score, since the Oncomouse results into a hitherto not known product involving an inventive step and capable of industrial application, it would qualify as an invention. However Dutfield has said that “admittedly it is very difficult to consider does not mention anything about patenting biotechnology, and so in practice India does not grant patent in plants, animals and human beings.” See, Swapan K. Bhattacharya, TRIPS, Indian Patents (Amendment) Act and India’s Agendas in the Next Ministerial Meeting at Mexico, 2002. 546 Till the latest amendment in 2005, Section 5 of the Indian Patent Act disallowed patents of drugs and medicinal products. Medicine, under Section 2(l) is very broadly defined and includes: “all medicines for internal or external use of human beings or animals; all substances untended to be used for or in the diagnosis, treatment, mitigation or prevention of diseases in human beings or animals; all substances intended to be used or in maintenance of public health, or in prevention or control of any epidemic disease among human beings or animals; insecticides, germicides, fungicides, weedicides and all other substances intended to be used for the protection or preservation of plants and all chemical substances which are ordinarily used as intermediates in the preparation or manufacture of any of the medicines or substances above referred to.” According to Wei, the Oncomouse would have qualified as a medical product and would have been ineligible for a patent. Supra note 172 at 51. The 2005 amendment has deleted Section 5, and hence, currently, this would not have been a bar to patenting of Oncomouse in India. 201 an animal as a human invention”.547 The issue would be whether the insertion of a gene in an animal, albeit through an extremely sophisticated and vanguard process, entail the patent applicant monopoly right on the whole organism and also on the progeny. Further the behaviour of the new creature is fundamentally uncontrollable by the “inventor” except in some predictable ways which can be partially maneuvered by the inventor as expressions to certain stimuli. On the other hand though the Oncomouse is not a complete “invention”, the inventor deserves some form of applaud and encouragement for devising the innovative process leading to the invention which, by way of being used as a cancer research tool, will be beneficial to mankind. The Oncomouse is not a process of treatment to human beings or animals, but is a research tool. So, while patent of a process used to treat humans or animals is not patentable under Section 2(j) of the Act, a patent in this respect could have been obtained for products used in the process. Further, genetic engineering processes which are not specifically linked to treatment for humans or animals should be patentable if all the other requirements are met. Of course, under the Indian Act patents patents for essentially biological processes are prohibited.548 But where there is significant human intervention in the process, the process will not be essentially biological. This is the view taken by the EPO. The artificial insertion of a gene into the genome of a mouse is a significant technological intervention. 547 GRAHAM DUTFIELD, INTELLECTUAL PROPERTY RIGHTS AND THE LIFE SCIENCE INDUSTRIES: A TWENTIETH CENTURY HISTORY (2003) 164. Also see, Burton Ong, “Patenting the Biological Bounty: Re-examining the Status of Organic Inventions as Patentable Subject Matter,” Marquette Intellectual Property Law Review [Vol. 8:1, 2004] 33. “His or her claim to the “authorship” and ownership of the intellectual property is weakened by the fact that the inventive process, which led to the development of organic invention, is essentially characterized by the identification and subsequent replication under controlled circumstances of potentially useful pre-existing natural functions or properties of living organisms, organic substances, or their particular constituent components”. 548 Section 3(j), Patent Act 1970, as amended by the Patent Amendment Act 2005. 202 4.5 ETHICAL ISSUES OF BIOTECHNOLOGY PATENTING IN INDIA Article 27(2) of the TRIPS Agreement allows Member States to bar the patenting of inventions when the commercial exploitation conflicts with ordre public or morality. Neither TRIPS nor other international agreements define these terms although reference to the protection of human, animal and plant life provides some direction.549 According to Dutfield, ordre public or morality exclusions are interpreted narrowly in Europe.550 EPO Technical Board of Appeal has approached the ordre public and morality exclusions as exclusions on the commercial exploitation of publication of the invention, rather than the invention itself.551 In view of the non-availability of case law on the question of ethics and morality and patent law, decisions of the EPO under the EPC might be helpful in providing nonbinding guidance. In Plant Genetic Systems case, the Technical Board of Appeals stated that: 549 According to Correa, “the concept of ordre public [may be interpreted as being narrower that ‘public order’ or ‘public interest.’ [There is] no generally accepted notion of ordre public: member countries have therefore a certain degree of flexibility to define which hypotheses are covered, depending on their own conception of the protection of public values. Article 27(2), itself indicates that the concept is not limited to ‘security’ reasons; it also relates to the protection of ‘human, animals or plant life or health’ and may be applied to inventions that may lead to ‘serious prejudice to the environment’.” CARLOS M. CORREA, Patent Rights, in INTELLECTUAL PROPERTY AND INTERNATIONAL TRADE- THE TRIPS AGREEMENT (Carlos M.Correa & A.Yusuf eds., 1998). 550 Dutfield, supra note 105 at 76. 551 Technical Board of Appeal, EPO, “The wording of Article 53(a) EPC is clear: "European patents shall not be granted in respect of: (a) inventions the publication or exploitation of which would be contrary to "ordre public" or morality...". (4.2) It is, in the Board's opinion, only possible to read the words "contrary to "ordre public" or morality" as qualifying "publication or exploitation". The same is true of the text in the other official languages. Accordingly, the Article raises no question of the morality of patenting a particular invention or of the morality of that invention per se. This conclusion, of course, applies to the particular animal invention claimed in the patent in suit: this case is concerned neither with the morality of genetically manipulating a mouse nor with the morality of the oncomouse thereby produced nor with the morality of patenting either the oncomouse or the genetic manipulation method but only with the morality of publication or exploitation of the oncomouse or that method. The same is of course true of "ordre public": it must be the publication or exploitation of the invention (in this case, the oncomouse or the method of producing it) which is contrary to "ordre public". Decision of 6 July 2004, supra note 541 at 68-69. 203 “5. It is generally accepted that the concept of 'ordre public' covers the protection of public security and the physical integrity of individuals as part of society. This concept encompasses also the protection of the environment. Accordingly, under Article 53(a) EPC, inventions the exploitation of which is likely to breach public peace or social order (for example, through acts of terrorism) or seriously to prejudice the environment are to be excluded from patentability as being contrary to 'ordre public'. 6. The concept of morality is related to the belief that some behaviour is right and acceptable whereas other behaviour is wrong, this belief being founded on the totality of the accepted norms which are deeply rooted in a particular culture. For the purposes of the EPC, the culture in question is the culture inherent in European society and civilisation. Accordingly, under Article 53(a) EPC, inventions the exploitation of which is not in conformity with the conventionally-accepted standards of conduct pertaining to this culture are to be excluded from patentability as being contrary to morality”.552 However while deciding whether there is a possibility of sufficient harm to the environment, the EPO generally requires this to be established on the basis of present evidence and not speculation. It does not adopt a precautionary measure since that is something EPO is not equipped to handle. 4.5.1 India and Article 27(3)(b) Indian views on patentability of life forms are evident in her proposals for review of Article 27(3)(b)553 of the TRIPS. While the review still continues, some of India’s 552 553 Plant Genetic Systems/Glutamine Synthetase Inhibitors (T356/93) [1995] E.P.O.R. 357 at 366. IP/C/W/161, supra note 527. 204 views about the aforesaid Article have been incorporated in the TRIPS compatible laws Indian subsequently legislated. India, with a host of other nations, has suggested more flexibility under Article 27(3)(b), following are two areas which deserve mention. (a) Patenting of life forms The issue of patenting of life forms has been addressed at two levels by India. The first is the ethical stand regarding whether patenting of life form leads to monopoly on life. If so, the extent to which patent on life forms may be granted. 554 The Indian patent offices are yet to face the issue of granting patent to a higher life form or a product derived from research based on a human organ.555 The Dimminaco case556 has 554 World Trade Organization, Minutes of the Meeting of 7-8 July 1999, IP/C/M/24, WTO, Geneva, 17 August 1999 ¶ 80. The Indian representative at WTO had advanced a hypothetical example where a firm were to patent a particular tribe for having discovered and isolated genes responsible for strength, immunity from disease, ability to withstand natural climatic pressures or any other characteristic. While this example is a highly improbable possibility, what the Indian representative was trying to highlight was the consequence in case of such a monopoly, would that tribal have any right on their own lives, if so how far would that extend and could there be any possible compensation for the tribe. Also see, Issues For Discussion Under The Review Of The Provisions Of Article 27.3(b) of the TRIPS Agreement: Non-paper by India, Council for Trade-Related Aspects of Intellectual Property Rights, JOB(00)/6091, 5 October 2000 at 3, “What would happen, for example, if a firm were to patent a particular tribe on the strength, immunity from disease, ability to withstand natural climatic pressures or something else?” 555 A similar issue was dealt with in Moore v. Regents of the Univ. of Cal., 793 P.2d 479 (Cal. 1990), James Moore had been diagnosed to suffer from hairy cell leukemia and was prescribed a splenectomy. Moore granted permission for the splenectomy but was not informed that his spleen was to be used for subsequent medical research. Moore’s doctors subsequently established a cell line from Moore's Tlymphocytes and a patent was obtained by the institute conducting the research with the names of the doctors as the inventors to the cell line. It assigned the patent to the Regents of the University of California and named Golde and Quan as the inventors. The patent was on a cell line known as Mo. Moore subsequently did not challenge the validity of the patented "Mo cell line," but claimed a share in the proceeds of the invention derived from his cells. His claim was declined by the Supreme Court of California on the ground that Moore did not own his body tissues once they had been removed and he could not prevent the research and development of the patented invention and the patented cell line was "both factually and legally distinct from cells" originally taken from his body. The Court held that there was a breach of fiduciary duty or lack of informed consent based on allegations that a physician concealed his economic interest in postsplenctomy takings of blood and other samples for use in research when the physician failed to disclose that he had begun to investigate and initiate procedures for obtaining a patent on cell line developed from the patient's cells. It is unlikely that the Indian Courts would take such a catholic on the issue of access to human cells and other genetic materials for basic research and clinical trials. See, Jayashree Watal, Intellectual Property Rights in the WTO and Developing Countries Kluwer Law International. Hague. 2001, at page 141. Also see, GEORGE WEI, AN INTRODUCTION TO GENETIC ENGINEERING, LIFE SCIENCES AND THE LAW, (2002) 250. 205 revealed that while the patent authorities might be conservative in granting patent to living organisms557 the Calcutta High Court was anachronistic in its views in allowing the patent on the virus.558 The judgment being yet uncontested proves that the Government is interested in furtherance of research in modern biotechnology. The Indian society is however conservative and religion often plays a role in formation of public opinion. The Department of Biotechnology has formulated policy guidelines559 but those guidelines do not adequately address the ethical issues of patenting of materials derived from animates. Faced with the issue of granting patent for a higher life form, the courts may not resort to a public referendum.560 Rather, they may refer to a committee set up with scientists, environmentalists and even religious leaders561 for assistance about coming to an opinion about public morality. Further, India felt that economic motives might supersede environment issues and she was not supportive of patenting plants and specially animals. India hence chose to 556 Dimminaco AG v. Controller of Patents and Designs. & Others, morefully discussed in Section 2.1 above. 557 Dimminaco AG v. Controller of Patents and Designs. & Others is based on Patent Act, 1970, before the 2002 amendment. Under the present Act, micro organisms are patentable subject matters. 558 According to Thambisetty, there exists “an institutional rift between the courts and the patent office in India.” He states a case where, while the Biotechnology Committee appointed by the Government of India opined in favour of patenting a process of production of a mushroom, the Controller General of Patents in India denied the patent. See, supra note 526 at 7. 559 Department of Biotechnology of India, Ethical Policies on the Human Genome, Genetic Research & Services, available at (last accessed on 13 March 2005). 560 The Technical Board of Appeal, EPO declined from associating a lot of importance to the results of public opinion polls conducted by the parties in the matter. At page 124 the Board has held, “it does not consider opinion pol9ls (sic.) as reliable tools for assessing public perception. The respondent's objection that in order to answer poll questions meaningfully those questioned would need a certain level of education in several fields is to much the same effect.” Decision of 6 July 2004, supra note 541. The Indian population lacks adequate awareness to pass sound comments regarding the subject of patenting of life forms. Hence the outcome of a public referendum may not be a reliable gauge to measure morality about patenting of life forms in India. 561 Shankaracharya Jayendra Saraswati, one of the leading Hindu pontiffs has stated, “Abortion, artificial insemination or even test tube babies are sinful acts and not acceptable.” Quoted from, Thambishetty ,supra note 526 at 8. 206 adhere to the sui generis option to protect plant life and has prohibited patents on plants and animals in the patent laws. India’s other concern was relating to the practice of some countries to only recognize formalized or codified knowledge. India’s shruti (knowledge through hearing) or smriti (knowledge through memory) modes of transmission of knowledge in such cases would not be recognized by the industrialized knowledge systems. Such knowledge being intangible in nature was albeit problematic to justify to the western world. Although intangibles were protected in legal regimes, including patents, and even goodwill, that was possible only because they were found assessable as to their commercial value. As to natural wealth in biodiversity, as acquired through traditional knowledge of indigenous communities, such an assessment was very difficult. It is difficult to evaluate the pecuniary worth of a potion made from substances found in an Indian kitchen. Till such issues are clarified, India suggested an outright exclusion of patent on all life forms. If this was not possible, India suggested exclusion of patents based on traditional/indigenous knowledge and essentially derived products and processes from such knowledge; or at the least make disclosure of the country of origin of the biological resource and associated knowledge mandatory, and obtain consent of the country providing the resource and knowledge, to ensure equitable sharing of benefits. What should constitute invention as per Indian Patent Act has been guided by the aforesaid concerns. While inventions relating to higher life forms have been held 207 unpatentable,562 under Section 3(d),563 ‘mere discovery’ of a new form of a substance or a mere new use has been made unpatentable. The 2004 Ordinance had introduced the word “mere” in the erstwhile "new use", which, as per Dipak Basu564 allows an applicant to claim a patent by just adding a new chemical reactant instead of inventing new chemical entities or NCE in drug industry parlance, that is, completely new drugs.565 The 2005 Amendment Act has deleted the word “mere” to narrow the scope of patenting.566 The efficacy of the provisions introduced to prevent biopiracy and protect traditional knowledge is questionable since without an international protocol, these provisions would remain confined in local boundaries while bad patents are issued by other jurisdictions where compulsory disclosure of origin and proof of obtaining prior informed consent is not part of the requirement for obtaining patent protection. (b) Micro organisms Living things such as unicellular organisms like microorganisms are liable for protection in most countries provided such microorganisms satisfy the cardinal 562 Section 3(j) of the Patent Amendment Act 2005, also, supra note 415. Section 3(d) of the Patent Amendment Act 2005 reads: The following are not inventions within the meaning of this Act: …(d) the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant. Explanation.—For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy…The replaced Section 3(d) of the Patent Amendment Ordinance 2004 read: The following are not inventions within the meaning of this Act: …(d) The mere discovery of any new property or [mere] new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs atleast one new reactant. Section 3(d) of the Patents Act, 1970 read: The following are not inventions within the meaning of this Act: …(d) The mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs atleast one new reactant. 564 Dipak Basu, is a senior advocate at the Calcutta High Court, India. 565 Dipak Basu, Patent Laws: Developing Countries Suffer the Most, The Statesman, 31 December, 2004. 566 Section 3(d) Patent (Amendment) Act, 2005, supra note 563. 563 208 requirements of the patent law. For example, if a microorganism is isolated from nature by the application of human intellect and if such a microorganism is not known prior to the date of filing of the application for patent, such a work is considered an invention and not a discovery. Since such a microorganism is not known prior to the filing of the application for patent it is treated as novel. India has suggested that what comprises micro organisms be left open to interpretation by national patent regimes. The Patent Amendment Act 2005 has not clarified what would be included in the genre of micro organisms. It seems that an inclusive definition would perhaps develop on a case by case basis with the passage of time.567 Suman Sahai of the NGO Gene Campaign has argued that India’s strength in secondgeneration biotechnologies like fermentation and tissue culture provides a firm foundation for better exploitation of India’s biological wealth.568 Recently there has been some movement in augmenting third generation biotechnology research. Regarding stem cell research, Dr. Anbumani Ramadoss, the Union Minister for Health has recently held, ‘‘Institutes in the UK are doing some of the best research work in the world; Korea and China are also doing a lot of good work and so is Singapore. India has one of the finest researchers and we have the potential to achieve a lot.’’569 The Minister has also promised that guidelines regarding stem cell research have been created and an enactment would be legislated within a year. The draft guidelines570 referred to has held that embryos should not be generated for the 567 See, IP/C/W/161, supra note 527. Suman Sahai, India’s Position on Intellectual Property Rights, Journal of Intellectual Property Rights, vol 3 pages 1-8. 569 Toufiq Rashid, Next month, India in US to push for stem cell research, 26 May 2005, The Indian Express 26 May 2005.. 570 Draft Guidelines for Stem Cell Research/Regulation, supra note 507. 568 209 purpose of stem cell research. Surplus embryos from fertility centres may be used for stem cell research with the consent of the embryo donating parent.571 The present Indian view towards ethical issues can be evidenced from the list of patentability exclusions enumerated in Section 3 of the Patent Act. Section 3(c) excludes from patentability “discovery of any living thing or non-living substance occurring in nature.”. This is in consonance to the UNESCO issued Universal Declaration on the Human Genome and Human Rights where in Article 4 it was stated, “the human genome in its natural state shall not give rise to financial gain.” The DBT Guidelines572 echo this in respect of its intellectual property stance. However the Guidelines also say that human genome may be patented as per international laws. From the pro research attitude of the current regime, and the acceptance of international trends regarding patenting, it appears that isolation of substances from living organisms with proven function may be patentable. Notwithstanding the propatent attitude of the India government, patenting of higher life forms is still considered against the sensibilities of the public. Standing at such a cross road, patenting of higher life forms be it plants or animals, is prohibited by the Patent Act of India. Further an examination of the DBT indicates there is unlikely to be any change in this position in India in the immediate future. Genetically modified animals are excluded though microorganisms would remain patentable under Indian laws. 571 572 Id. at 10. Ethical Policies on the Human Genome, Genetic Research & Services, supra note 559. 210 4.6 INDIA’S PATENT POLICY PRIOR TO TRIPS AND SUBSEQUENT DRIVERS FOR CHANGE India’s patent policy focused on balancing developmental concerns with the need for promoting innovations. India viewed patents as a tool for economic development and restricted the scope and term of patents.573 The Indian patent system sought to balance the need for public interest with encouraging innovation. This was in tune with the science and technology mission of developing indigenous technology and fostering R&D activities in areas of national significance. The main aim in India was to ensure that patents did not lead to monopoly by foreign companies nor lead to high prices for medicines and food items. The original Patent Act of 1970 restricted the field of patentability, only granted process and not product patents in food, pharmaceutical and chemical fields, restricted the term of patents and had an elaborate system of licenses to ensure that patents are worked in India.574 India was one of the most vociferous opponents of revising patent laws according to the TRIPS Agreement of the WTO, and refused to comply with its provisions. To conform to TRIPS, India had to revise one of the main aspects of her patent policy that only process and not product patents would be granted in pharmaceuticals and agrochemicals. By 1995 India had to establish legislation that would allow for 573 For Mrs.Indira Gandhi’s views regarding patents in India see supra note 162. The original Indian Patent Act was based on the recommendations of two expert committees that were established to provide advice on the type of patent system India should set up. The reports concluded that foreigners held 80-90% of the patents in India and were exploiting the system to achieve monopolistic control of the market. The Ayyangar Committee (1957-59) noted that foreign patentees were acquiring patents not “in the interests of the economy of the country granting the patent or with a view to manufacture there but with the object of protecting an export market from competition from rival manufacturers particularly those in other parts of the world”. Thus India “is deprived of getting, in many cases, goods…at cheaper prices from alternative sources because of the patent protection granted in India.” The committees therefore suggested that a patent system that focused on access to resources at lower prices would be beneficial to India. Sources: Jain & Biswas, supra note 24 at ¶ 1.1; Patent reform in India, available at (last accessed on 3 July 2005). 574 211 applications for agrochemical and pharmaceutical product patents and grant EMRs575, a transition to product patents that gives the firm the exclusive right to sell the product for five years. Domestically and internationally India resisted conforming to TRIPS. The government’s attempt to pass an Ordinance576 in 1994 on reforming India’s law to conform to TRIPS, failed to be passed by the Upper House of Parliament when it was introduced as a bill.577. From 1995-1998, inspite of external pressure, India did not revise its patent laws as required by TRIPS. India’s resistance to patent reform in the initial years following TRIPS was led by Industry and NGO groups who protested against change. While Industry stressed the losses and price rises in drugs that would occur if TRIPS was adhered to, NGOs pointed out the negative implications on farmers, access to medicines and the appropriation of traditional knowledge. A marked shift in India’s policy occurred around 1998-99. The policy shift in India was initiated when a bill to conform to TRIPS by allowing for EMRs for drugs and agro-chemical products, was passed by the Parliament in March 1999. The bill was passed in the Upper House of Parliament in December 1998 and in the lower house in March 1999. The Parliament also passed a second amendment act in May 2002. The Patents (First Amendment) Act 1999 and the Patents (Second Amendment) Act of 2002 allowed for applications on product patents in pharmaceutical and agrochemical 575 Article 70 of TRIPS ¶ 9, provides for a transitory arrangement under which members who do not grant patent protection on the date of entry of the WTO agreement into force, are required to grant Exclusive Marketing Right (EMR), that is, the exclusive right to sell or distribute the article or substance, to applicant companies till the patent is either granted or rejected. No examination of the patent application is also required for a period of 5 years. See, Jain & Biswas, supra note 24, ¶ 1.45. 576 An Ordinance did not require immediate assent by the legislature but had to be passed in six months. 577 Dasgupta, an economist and a member of the Upper House in the Indian Parliament said that the government was heavily criticized for issuing the Ordinance. Biplab Dasgupta, Patent Lies and Latent Danger: A Study of the Political Economy of Patent in India, Economic and Political Weekly, April 17-24, 1999. 212 fields, increased the term of patents to 20 years, and restricted the system of licenses found in the original Act. India’s joining the Paris Convention and the PCT in 1998 marked a turnaround in India’s earlier decades of refusal to be a member of these treaties. There was thus a clear shift in policy from opposition to patent reform towards a revision of India’s patent policy. The changing nature of actors’ interests was a major factor in promoting this policy shift. The chief lobbies that were involved in deciding the patent regime change were the pharmacists and the non government organizations578 representing the interests of the general public. India’s Patent Act with a provision for granting only process and not product patents in pharmaceuticals enabled domestic companies to produce drugs through cheaper alternative processes. The gains that Indian pharmaceutical companies have been able to accrue due to this provision along with other measures have been documented579. In 1991 Indian firms accounted for 70% of the bulk drugs and 80% of the formulations produced in the country. In 1996, out of the top ten companies in pharmaceutical sales, six were Indian firms. Indian companies resisted moves to amend India’s laws according to TRIPS as this could harm their interests in generic manufacturing. The opposition to patent reforms underwent a change within industry. Industry bodies and various groups shifted their position and became vocal on the need to grant product patents prior to the introduction of bill to amend patent laws in Parliament in 1998-99. The Confederation of Indian Industry (CII) took the position in its 578 Commonly called “NGOs” Keshab Das, The Domestic Politics of TRIPS: Pharmaceutical Interests, Public Health, and NGO Influence in India Linking the WTO to the poverty-reduction agenda, July 2003, at (last accessed on 7 July 2005). 579 213 statements before the Gujral Committee580 that India was not able to get relevant technology due to the absence of product patents.581 The CII emphasized that India needed to raise patent standards. Along with WIPO, the International Institute of Intellectual Property Development (IIPD) and the Ministry of Industry have organized various conferences on intellectual property management, the PCT, and interactive sessions between Indian and foreign firms on intellectual property. India’s joining of the Paris Convention and Patent Cooperation Treaty appeared to have broad support by industry, media and lawyers.582 The drivers for change in thoughts regarding the TRIPS compatibility of patent laws in India came from pressure from both international and domestic sources. The US exerted both bilateral and multilateral pressure on India to change its patent laws. One form of trade pressure came with the Special 301 legislation of US Trade Act. The United States had filed a case with the Dispute Settlement Body for India’s failure to implement TRIPS and the WTO had ruled that India must reform its laws by April 1999. In 1992, the US also placed a sanction on India for not changing its IPR policy. In 1992, the US suspended GSP583 benefits to India on pharmaceutical and chemical products. The action meant that duty-free treatment of USD 60M worth of imports from India was suspended. This certainly was a major impediment to the functioning of pharmaceutical companies. In addition, the US effectively utilized the ‘piracy’ argument against Indian industries. Domestic firms in India found it difficult to refute 580 Gujral Committee, or the Rajya Sabha-Department Related Parliamentary Standing Committee on Commerce (1993-94) was established by the Indian Parliament to solicit views and prepare a report on the impact of the WTO Agreement on India. Rajeev Dhawan, A Patent Mistake, at (last accessed on 15 January 2005). 581 CII’s Wish List for the Government, at (last accessed on 15 January 2005). 582 No More Stiff Upper Lip: India Finally Joins the Paris Convention, Economic Times, August 13, 1998; Patently Correct, Hindu Business Line, August 19, 1998; India Agrees to Sign Two Patent Treaties, Financial Express, October 15, 1998. 583 Generalised System of Preferences. 214 US accusations that Indian companies were not innovators but were copying US technology and ideas. Pharma, the association that represents US based pharmaceutical held that India had become a haven for bulk pharmaceutical manufacturers who pirate the intellectual property of the world’s research-based pharmaceutical industry.584 India boasts of over USD 5 billion drug industry, consisting of 24,000 large, small, and very-small manufacturers, about 500,000 chemists, and over one billion plus people using the medicines. The industry is expected to grow at a compounded annual growth rate of 19% and touch USD 25 billion in revenue by 2010. However the Indian drug industry mostly consists of generic drug manufacturers who, due to the process patent policy of India would reverse engineer and produce a drug manufactured and patented in another country, by using a slightly different process and would supply them to the consumers at a much cheaper price. Since there was more than one manufacturer deploying the reverse engineered or the generic version of the same drug, the drugs are competitively priced and there was no dearth of supply of the drug in the market. Once a product patent was introduced, such reverse engineering would be considered illegal and the drugs produced by such methods would be considered infringement of the patented product. The generic drug manufacturers would therefore be prohibited from manufacturing such drugs and would only be allowed to manufacture the drugs patented by them. Hence the Indian pharmaceutical industry was against introduction of TRIPS compatible provisions, specially product patent for drugs, in the patent legislation. 584 India: Intellectual Property Protection, 98/india.html> (last accesses on 17 January 2005). at [...]... involve minor tinkering of the naturally occurring organisms • Even if the patent represents a genuine invention, however defined, no arrangement had been made to obtain prior informed consent from the communities holding the knowledge or resource which was the origin to the invention, and for sharing the benefits of commercialization of the invention with the knowledge holder community.63 A number of cases... for breeding or propagation, comprising the steps of: a) preparing rice grains from rice seeds; b) determining i) the percent amylose (PA), and ii) the alkali spreading value (ASV) of samples of said grains; c) summing said PA and said ASV to obtain the starch index (SI) of said grains; d) cooking a sample of said grains and determining the percent elongation of cooked grains; e) identifying a rice... authorization, from making, using, offering for sale, selling or importing for these purposes the patented product This is in conformity with Article 28(1)(a) of the TRIPS Agreement In the case of the grant of a patent for a method or process of manufacture, this right extends to the ‘product obtained directly by the patented process See, Section 48(b), the Patents act, 1970 as amended in 2002 This is in conformity... to the knowledge holder group The prevalent types of biopiracy are as follows: a) The granting of invalid patents These are patents granted for inventions which are either not novel or are not inventive having regard to the traditional knowledge already in the public domain Such patents may be granted either due to oversight of the patent examiner or because the examiner did not have access to the. .. determining i) the percent amylose (PA), and ii) the alkali spreading value (ASV) of samples of said grains; c) summing said PA and said ASV to obtain the starch index (SI) of said grains; d) determining the burst index of a sample of said grains; e) identifying a rice plant which produces grains having an average PA of about 22 to about 29, an average ASV of about 2.9 to about 7, an average SI of about... from these countries The government of Indian applied for re-examination of the patent at the USPTO The attorneys for the Indian government stated: "Rice Tec has got a patent for three things: growing rice plants with certain characteristics identical to Basmati, the grain produced by such plants, and the method of selecting rice based on a starch index (SI) test devised by Rice Tec, Inc.”.80 The challenge... crops from being destroyed by fungal infections The Indian government filed a complaint in the USPTO accusing W.R Grace of copying an Indian invention A complaint was also made to European Patent Office73 to revoke the European patent The patent has been struck down by the EPO after it was proved that neem had been used as insecticide through similar methods for a very long time by the Indian farmers.74... Patent In 1997, Rice Tec, a Texas company, acquired a patent in a novel method of breeding a long grain of aromatic rice, in a novel method of preparing and cooking the rice, and in the grains themselves.79 Rice Tec's claims are for a a specific rice plant (Claims 1-11, 78 The word “basmati” in, Hindi, the official language of India, means fragrant The Basmati rice is so named because of its distinctive... those of good quality Basmati rice Another aspect of the invention relates to novel rice lines produced from novel rice lines The invention provides a method for breeding these novel lines A third aspect relates to the finding that the starch index (SI) of a rice grain can predict the grain's cooking and starch properties, to a method based thereon for identifying grains that can be cooked to the firmness... patent aspirants of contracting states of PCT can simultaneously obtain priority for their inventions without having to file separate application in their countries of interest In addition the system provides much longer time for filing patent application in member countries The time available under Paris Convention for securing priority in other countries is 12 months from the date of initial filing