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PATENTS AND MEDICAL
BIOTECHNOLOGY: AN
EMPIRICAL ANALYSIS OF
ISSUES FACING THE
AUSTRALIAN INDUSTRY
DIANNE NICOL AND JANE
NIELSEN
CENTRE FOR LAW AND
GENETICS
OCCASIONAL PAPER No. 6
All rights reserved
Copyright ©2003 University of Tasmania, Dianne Nicol and Jane
Nielsen
Apart from fair dealing for the purposes of study, research, criticism
or review, as permitted under copyright law, no part of this
publication shall be reproduced by any process without written
permission of the owners of copyright. Inquiries should be made to
the authors or publisher.
National Library of Australia Cataloguing-in-Publication Data
ISSN 1445-2766
This issue may be cited as:
Centre for Law and Genetics Occasional Paper No. 6 (2003).
Published by
Centre for Law and Genetics Printed by
Faculty of Law UniPrint
University of Tasmania University of Tasmania
Private Bag 89 Private Bag 15
Hobart Tasmania 7001 Hobart Tasmania 7001
Australia Australia
i
TABLE OF CONTENTS
Preface viii
Abstract x
PART 1: CONTEXTUALISING THE ISSUES
Context Chapter 1: Aims of this Study 3
Context Chapter 2: Background 6
The Role of Patents in the Australian Medical
Biotechnology Industry 6
Medical Biotechnology Research in Australia 12
Other Empirical Studies 16
Context Chapter 3: Patenting of Biotechnology
Inventions in Australia 20
Patentability Requirements 20
Use Of Patents 34
Patent Activity in Australia 38
Context Chapter 4: Impact of Patents on Medical Biotechnology
Research and Development 50
Patents and Public Sector Research 50
Restrictions on Access to Upstream Patents 53
The Tragedy of the Anticommons 56
ii
The Consumer Perspective – Restrictions on Access to
Biotechnology-Related Products 57
Context Chapter 5: Study Methods 64
Surveys 64
Interviews 67
PART 2: RESULTS OF THE EMPIRICAL STUDY
Results Chapter 1: Research And Patent Issues 75
Patent Activity 76
Views On Patents 81
Results Chapter 2: Transfer of Technology 93
Survey Data on Collaborative Activity 94
Survey Data on Licensing-out Activity 100
Licensing, Assignment and Mergers 103
Technology Transfer Issues for Research Institutions 105
Technology Transfer from Upstream to Downstream
Industry Sectors 110
Licensing-in 114
Licence Terms 115
Summary 122
Results Chapter 3: Impact of Patents on the Research Sector 124
Changing Attitudes towards Commercialisation of
iii
Biotechnology Research 125
Effect of Patents on Publication 126
Quantum and Quality Issues 130
Ownership and Clean Title 132
Under- and Over-Valuing 134
Summary 136
Results Chapter 4: Restrictions on Access to Upstream
Patents 137
Blocking Patents 140
Refusals to Licence 145
Exclusivity 150
Costs and Delays Associated with Licensing Patents 156
Restrictive Terms 160
Failure to Exploit Patents 168
Summary 172
Results Chapter 5: Anticommons Issues 174
Preconditions to an Anticommons in Australia 176
Patent Searching Obligations 178
Survey Data on Number of In-Licences 184
Number of In-licences and Project Abandonment 186
Royalty Stacking 191
Reach-through Right Stacking 193
Summary 194
iv
Results Chapter 6: Supply to End Users 196
Pharmaceuticals 196
Devices 198
Diagnostics 198
Summary 205
Results Chapter 7: Market Solutions 208
Collaborations and Licensing 208
Inventing Around 211
Patent Enforcement 214
Research Exemption 218
Challenges to Validity 222
Summary 224
PART 3: OUTCOMES OF THIS STUDY: THE WAY
FORWARD
Outcomes Chapter 1: The Legal Landscape And Options
For Reform 229
Excluding Gene Sequences 231
Excluding Diagnostic Tests 233
Public Interest Provision 233
Increasing The Stringency Of Patent Invention and
Disclosure Requirements 234
Exemptions From Infringement 236
v
Compulsory Licensing / Government Use Provisions 236
Fair Use And Automatic/ Statutory Licensing 239
Collective Rights Organisations 242
The Role Of Competition Law 244
Summary 248
Outcomes Chapter 2: Conclusions 250
Study Findings 250
Reform Options 258
Bibliography 261
vi
LIST OF TABLES
Table 1: Patents linked to cessation of tests in the US
and equivalent Australian patents 62
Table 2: Interview respondents 68
Table 3: Numbers of patents held 78
Table 4: Types of patents held 79
Table 5: General views on the impact of patents on
research 83
Table 6: Views on the impact of types of patents on
research 83
Table 7: Collaborative activity: research institution
survey respondents 95
Table 8: Types of collaborators and their geographical
location: research institution survey
respondents 95
Table 9: Types of collaborators: company survey
respondents 96
Table 10: Types of collaborators: diagnostic facility
survey results 97
Table 11: Number and types of out-licences: research
institution and company results 100
Table 12: Company and research institution respondents
with patents but with no out-licences 101
Table 13: Views on the impact of patents on publication
in the research institution and diagnostics
sectors 127
Table 14: Numbers and types of in-licences 184
vii
Table 15: Location of laboratory 199
Table 16: Types of tests 200
Table 17: Cost of tests 200
Table 18: Payment of licence fees or royalties 201
Table 19: Notifications 201
Table 20: Views on the impact of patents on diagnostic
tests 202
viii
PREFACE
We are most grateful to all the people who participated in this study,
particularly those people who agreed to be interviewed. Thank you
for giving up so much of your valuable time and for your candour,
patience and good humour.
This research was supported by a University of Tasmania
Institutional Research Grant (N0012490). Funding was also provided
from grant DP0208258 from the Australian Research Council
Discovery Grant Scheme. The study was approved by the Southern
Tasmania Social Sciences Human Research Ethics Committee.
We would like to thank Bruce Newey, Tim Graham, Rebecca Keep,
Brendan Gogarty and Liz Sharp for research assistance. We also
thank Rhys Edwards for assisting us in the design of our surveys and
for other advice during the course of this study. We are grateful to
both Mildred Cho and John Walsh for visiting us and generously
providing us with their insight and guidance.
We thank Donald Chalmers, Lynden Griggs, Matthew Rimmer,
Andrew Christie, Joshua Gans, Amanda Lim, John Walsh, Tim
Caulfield, Margaret Llewelyn and the Australian Law Reform
Commission commissioners and staff involved in the gene patenting
reference for commenting on drafts of this Report.
Some of the material in this Report has previously been published.
Where necessary, permission has been granted to use this material.
See particularly:
D. Nicol ‘The Impact of Patents on the Delivery of Genetic
Tests in Australia’ (2003) 15(5) Today’s Life Science22-27
D. Nicol ‘Patents and Access to Genetic Tests’ Centre for
Law and Genetics Symposium Breaking the Code Murdoch
Children’s Research Institute And Walter And Eliza Hall
Institute, Melbourne 28 and 29 November 2002. In: Centre
for Law and Genetics Occasional Paper No 5 (2003)
D. Nicol ‘Patents and Access to Drugs’ Centre for Law and
Genetics Symposium Regulating the New Frontiers: Legal
Issues in Biotechnology, University of Tasmania 10
December 2001. In: Centre for Law and Genetics Occasional
Paper No 4 (2002) 52.
[...]... examining these issues Particular challenges facing the Australian industry make these issues relevant, and a number of other issues may confront the industry. 25 We have identified these challenges as being: • • the need for Australian companies to seek foreign investment and enter into alliance activity with international companies; and the fact that most Australian patents falling into the biotechnology... research programs and on the capacity of diagnostic facilities to continue to offer diagnostic tests The GTG example provides a snapshot of the complex issues involved in finding the right balance in protecting the rights of both the holders and the users of patented technology It is only when we have an understanding of how the industry is operating and the true extent of the social benefits and costs associated... commercialise; the extent of collaborations, assignments and licensing-out of patents held by the Australian industry and the nature of the arrangements; the general terms and conditions contained in licences entered into by the Australian industry for the purposes of commercialising research (licensing-out); the extent to which the Australian industry needs to obtain authorisation from other patent holders... challenges facing the Australian industry in mind This Report will generally consider the issues raised in the studies outlined above Our initial focus when commencing the study was an analysis of whether there is any evidence of restricted access to upstream patents having a consequent effect on downstream research in Australia, and whether there is any evidence of an “anticommons” within the Australian medical. .. companies, necessitating the need for Australian companies to negotiate access deals with these companies.26 The impact of gene patenting and licensing on the development of the Australian biotechnology industry has not yet been assessed, although there is now some recognition of the need for examination of these issues During the course of conducting this study, the Australian Law Reform Commission announced... AIMS OF THIS STUDY To date, there has been little or no analysis of the impact of patents and technology transfer on the commercial success of the Australian biotechnology industry, on the capacity of Australian research institutions to continue with their world-class research and on consumer access to the products of biotechnology research, particularly health care products The challenge is whether the. .. Similar patents have been granted to Myriad in Australia, for example patent AU691958, which is entitled “17q-linked breast and ovarian cancer susceptibility gene” What Myriad has obtained, through these and other patents, is broad claims over mutant BRCA 1 gene sequences and their use in diagnosis and prognosis of breast, ovarian and other cancers, therapies and drugs The patents include claims... its research and commercialisation, specifically focusing on the types of patents that are being enforced in Australia and the quantum of in-licensing; the general terms and conditions contained in licences entered into by the Australian industry for the purposes of obtaining access to patents held by others; the particular issues faced by the research institution, diagnostics and private industry sectors... the extent to which they have an effect on other socially desirable goals Patents grant patent holders and their licensees a period of market exclusivity, which enables them to charge monopoly prices on the sale of their products for the life of the patent and prevent others from using the patented technology for the life of the patent Although the justification for patents is that they enable innovations... nationally and internationally In addition, the expertise of members of the Centre for Law and Genetics lies primarily in the area of medical law and ethics and to date the research work conducted within the Centre has been focused primarily in these areas For these reasons, the study reported herein focuses primarily on the Australian medical biotechnology industry, although some data are included from other
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