Source: https://pl.b-ok.org/book/2467943/ee89bf
Timestamp: 2020-04-03 18:04:19
Document Index: 8981598

Matched Legal Cases: ['Art. 27', 'Art. 27', 'Art. 27', 'Art. 27', 'sui generis', 'sui generis', 'Art. 1', 'Art. 2', 'Art. 3', 'Art. 2', 'Art. 1']

Biotechnology and Intellectual Property Rights: Legal and Social Implications | Kshitij Kumar Singh (auth.) | download
Strona główna Biotechnology and Intellectual Property Rights: Legal and Social Implications
Kshitij Kumar Singh (auth.)
In the context of examining and analyzing the legal and social implications arising from the recent conjunction of biotechnology and intellectual property rights, the book particularly focuses on human genes and gene variations. Emphasis is placed on “patent law,” as a considerable percentage of genetic inventions are covered by patents. The book presents a comparative and critical examination of patent laws and practices related to biotechnology patents in the United States, Canada, European Union and India, in order to gather the common issues and the differences between them. The international patent approach regarding biotechnology is also analyzed in light of the constant conflict between differentiation and harmonization of patent laws. The book highlights the potential gaps and uncertainties as to the scope of numerous terms such as invention, microorganisms, microbiological processes, and essential biological processes under TRIPS. Also analyzed are the social and policy implications of patents relating to genetic research tools and genetic testing. The intricacies involved in providing effective intellectual property protection to bioinformatics and genomic databases are also examined. Bearing in mind the collaborative nature of bioinformatics and genomic databases, the book evaluates the pros and cons of open biotechnology and assesses the implications of extending intellectual property rights to human genetic resources, before explaining the ownership puzzle concerning human genetic material used in genetic research.
978-81-322-2059-6
patent1295
genetic668
research637
patents575
biotechnology547
human477
ibid463
supra note368
court298
invention297
rights296
law296
property286
protection270
patentability248
inventions241
patentable241
countries228
patenting226
intellectual property212
trips207
subject matter199
dna170
application165
biological165
process152
development150
genetic material149
resources148
human genetic146
decision143
laws140
claims137
commercial135
regarding132
patentability of biotechnology132
agreement129
bioinformatics127
researchers116
sequence114
genetic resources110
plant110
developing countries108
genetic research105
patent act103
implications102
Naveen Kumar Arora (eds.)
Ena Ray Banerjee (auth.)
Legal and Social Implications
ISBN 978-81-322-2058-9    ISBN 978-81-322-2059-6 (eBook)
DOI 10.1007/978-81-322-2059-6
Springer New Delhi Heidelberg New York Dordrecht London
Library of Congress Control Number: 2014948601
being entered and executed on a computer system, for exclusive use by the purchaser of the work. Duplication of this publication or parts thereof is permitted only under the provisions of the Copyright Law
of the Publisher’s location, in its current version, and permission for use must always be obtained from
or omis; sions that may be made. The publisher makes no warranty, express or implied, with respect to
Recent conjunction of biotechnology and intellectual property rights has long-term
implications for law and society. Intellectual property laws that were framed in
industrial age have proved to be insufficient in the current information age. In the
present age, modern biotechnological inventions, particularly genetic inventions
differ markedly from chemical and mechanical inventions that have been the traditional subject matter of patents. With the development of human genomics and success of Human Genome Project, gene becomes more important because of its informational content rather than its material qualities (physical attributes). Moreover,
the emergence of bioinformatics and genomic databases has changed the face of
biotechnology from lab-based technology to computer-based science, posing new
challenges for intellectual property laws. In addition to legal implications, patents
on gene and gene fragments have significant social and policy implications. Overbroad patent claims on genetic research tools and diagnostic genetic testing and
aggressive licensing practices relating to them have serious implications for genetic
innovation, health policies, patients’ rights and society at large. In genetic research,
increased extension of intellectual property rights to human genetic material may
have an adverse impact upon the interests of research subjects from whom the human genetic material is extracted. Against this backdrop, the book analyses the legal
and social implications arising from the conjunction of biotechnology and intellectual property rights, focussing particularly on human gene and genetic variations.
The book locates emerging legal, social and policy issues pertaining to biotechnology and intellectual property laws and suggests some meaningful solutions to
them. The discussion in the book is streamlined to respond to few important questions: whether existing intellectual property laws at national and international levels can cope up with the challenges posed by biotechnology (especially genetic
technology); whether aggressive assertion of intellectual property rights to genetic
research tools, fundamental genetic research and human genetic resources stands in
conflict with the rights of patients, independent researchers and research subjects;
and whether open and collaborative biotechnology promotes genetic research and
innovation. There are numerous books on intellectual property rights which deal
with biotechnology, however, the present book provides a comprehensive overview
of biotechnology and intellectual property rights and connects various aspects of
the topic in an integrated manner, providing a fresh insight of law–biotechnology
interface in tune with the current information age. It is aimed at providing basic
and comprehensive knowledge pertaining to the topic to a wide range of audience
comprising legal practitioners, law students, researchers and scholars interested in
interdisciplinary research, policymakers and others interested in biotechnology and
The book is divided into seven chapters. Chapter 1 introduces the theme of the
book and contains the background of the book, the concepts of biotechnology and
intellectual property rights and the framework of the book. In Chap. 2, the book
analyses the patent approaches of the USA, European Union, Canada and India on
the basis of patent laws, administrative decisions and case law, bringing common
points and differences among and between them. The book concludes that the selected countries for the study vary significantly in their approach to biotechnology
in degree of patent protection and patent exclusions; however, all of them recognise
patenting of biotechnology invention, given its commercial potential. In Chap. 3,
the book analyses the international patent regime dealing with biotechnology, highlighting the potential gaps and uncertainties as to the scope of numerous terms such
as invention, microorganisms, microbiological processes, essentially biological
processes under TRIPS. It also discusses the impact of such uncertainties on developing countries given their relatively slow pace of scientific and technological
development and the persistent conflict between developed and developing countries regarding the harmonisation of patent laws. Chapter 4 of the book undertakes
the analysis of the social and policy implications of patents on genetic research
tools and genetic testing and comes up with the conclusion that these concerns
cannot be adequately addressed only by making changes in the patent systems as
patent law is not expected to provide solutions to broad social and policy issues. It
insists upon formulating policies and making legislations specific to genetic patents
to regulate the patent practices such as patent licensing in order to provide viable
solutions to such issues. The book analyses the ill effects of Myriad Genetics’ patent
claims on BRCA1 and BRCA2 gene, which prevents patients from taking a second
opinion and verification testing. It concludes that in diagnostic field, exclusive licensing of genetic tests often obstructs the accessibility of genetic innovation or
diagnostic genetic testing and advocates for non-exclusive licensing. In Chap. 5, the
book examines the intricacies involved in providing effective intellectual property
protection to bioinformatics and genomic databases and suggests a comprehensive
review of existing intellectual property laws in the light of present information age.
Keeping in view the collaborative nature of bioinformatics and genomic databases,
the book evaluates the pros and cons of open biotechnology. The book analyses the
extension of intellectual property rights to human genetic resources in the light of
benefit sharing and informed consent in Chap. 6. It explains the ownership puzzle
of human genetic material used in genetic research and suggests that ownership
rights of research subjects in their extracted genetic material must be recognised.
The book insists upon a careful application of intellectual property rights to human
genetic resources. The concluding observations and possible way outs are provided
in Chap. 7.
Author’s Preface
Despite the complex nature of the topic, the book approaches the issues pertaining to the topic in a clear, integrated and meaningful way. Though the analysis of the
patentability of biotechnology in the book is limited to four jurisdictions, it gives
fresh insights of biotech patent trends in different social, political and economic
setups. It would be helpful in striking a balance between harmonisation and differentiation of patent laws. The analysis of social and policy implications of genetic
patents is limited to available literature and supporting data. Since the science involved in biotechnology is of evolving nature, it is difficult to come up with definite
solutions, however, the book provides an insight of law–biotechnology interface,
highlighting emerging issues and providing some possible solutions to the existing
In the process of writing this book, the support provided by the individuals and
institutions is noteworthy. In this context, I most sincerely convey my deep sense
of gratitude to my supervisor and guide in LL.M. and Ph.D., Prof. G. P. Verma,
Law School, Banaras Hindu University (BHU), India, for his remarkable guidance
and academic support during my work. As a supervisor, he has always encouraged
me to produce quality work with his scholarly inputs. I am grateful to Prof. M. P.
Singh, Law School, BHU, for igniting my thought process to cover some vital issues pertaining to my topic by his critical observations. I wish to express my sincere
gratitude to Prof. Ali. Mehadi and Prof. R. K. Murali of Law School, BHU, for their
encouragement and support they offered me during the work. I am grateful to Mr.
Vinai Kumar Singh, Indian Society of International Law, New Delhi, for his great
cooperation and support extended during the preparation of the book.
I take this opportunity to express my sincere regards to one of the most eminent
scientists of India and great visionary, Dr. Lalji Singh, Vice Chancellor, BHU, who
has always been a great source of inspiration for me regarding my academic pursuit. He encouraged me to work on law–technology interface. I am highly obliged
to Prof. Mark Perry, who provided me an excellent environment to hone my research skills during my visit to Faculty of Law, University of Western Ontario,
Canada, which helped immensely while writing my book. It was his guidance that
broadened and advanced the level of my research and enabled me to develop global
understanding of the subject. I am thankful to my friend Dr. Thomas Margoni, Institute of Information Law, Faculty of Law, University of Amsterdam, for sharing his
thoughts over the topic of my book and encouraging my work. I am also thankful to
my juniors Hemant, Bipin, Gaurav, Saurabh and Abhinav, who have been sincerely
engaged with me during my work and extended their full support.
I sincerely acknowledge the support provided by the staff of Center for Cellular and Molecular Biology (CCMB), Hyderabad, India. I extend my thanks to the
Library Staff, Law School, BHU, particularly Mr. Brijpal and Mr. Shobhnath for
providing me valuable resources relating to my book. I must acknowledge the great
support extended by the Library Staff of Faculty of Law, University of Western Ontario, Canada, Indian Law Institute, New Delhi, and Indian Society of International
Law, New Delhi.
I am thankful to Sagarika Ghosh and Nupoor Singh at Springer India for their
continuous support and cooperation and anonymous reviewers for Springer for their
incisive and constructive comments.
Lastly, but most importantly, I acknowledge the contribution of my parents from
the bottom of my heart, who have always pushed me to follow my dream and encouraged me to strive for academic excellence even in adverse situations. I wish to
acknowledge and admire all kind of support and assistance provided by my siblings,
Renu, Alok, Pooja and Prabhakar during my work.
Dr. Kshitij Kumar Singh
Amity University U.P.
1 Introduction �����������������������������������������������������������������������������������������������    1
1.1 Background ����������������������������������������������������������������������������������������    1
1.2 Biotechnology and Intellectual Property Rights:
A Conceptual Framework ������������������������������������������������������������������ 10
1.2.1 Biotechnology ������������������������������������������������������������������������ 10
1.2.2 Intellectual Property Rights ���������������������������������������������������� 11
1.3 Nature, Purpose and Focus of the Book ��������������������������������������������� 12
1.4 The Framework of the Book �������������������������������������������������������������� 13
References ��������������������������������������������������������������������������������������������������� 15
2 Patentability of Biotechnology: A Comparative Study with
Regard to the USA, European Union, Canada and India ���������������������
2.1 Biotechnology and Patent Law ����������������������������������������������������������
2.1.1 Transformation of Biotechnology: From a Noncommercial Science to a Commercial Industry ����������������������
2.1.2 Conjunction of Biotechnology and Patent Law:
Challenges Posed by Biotechnology Before the
Existing Patent Systems ���������������������������������������������������������
2.1.3 Human Genetic Patents: A Special and Controversial Case of Biotechnology Patents ����������������������������������������
2.1.4 Divergence in Biotechnology Patent Practices
Among Different Jurisdictions �����������������������������������������������
2.2 Patentability of Biotechnology in the USA ����������������������������������������
2.2.1 Biotechnology as a Patentable Subject Matter �����������������������
2.2.2 Other Statutory Requirements ������������������������������������������������
2.3 Patentability of Biotechnology in European Union ���������������������������
2.3.1 Traces of a Unified System of Patents for European Union ��
2.3.2 Specific Legislative Response to Biotechnology Inventions ���
2.3.3 Sources Governing Patent Grants in Europe ��������������������������
2.3.4 Biotechnology as a Patentable Subject Matter in
European Union ���������������������������������������������������������������������
2.3.4.1 Patentable Subject Matter����������������������������������������
2.3.5 Other Statutory Criteria for Patents ����������������������������������������
2.4 Patentability of Biotechnology Inventions in Canada ����������������������    80
2.4.1 Statutory Framework for Patenting ��������������������������������������    81
2.4.1.1 Patentable Subject Matter��������������������������������������    81
2.4.1.2 Other Statutory Requirements for Patenting����������    97
2.4.2 Comparison of Canada with the USA and Europe ���������������    98
2.5 Patentability of Biotechnology Inventions in India �������������������������    99
2.5.1 Dimminaco Case: Paving the Way for Biotechnology Patents in India �������������������������������������������������������������� 100
2.5.2 Statutory Provisions Regarding Biotechnological
Inventions Under the Current Patent Act 1970 (as
Amended in 1999, 2002 and 2005) �������������������������������������� 102
2.5.2.1 Biotechnological Inventions as Patentable
Subject Matter�������������������������������������������������������� 102
2.5.2.2 Other Statutory Requirements Under
Indian Patent Act for Patenting������������������������������ 104
2.5.3 Status of Biotechnology Patent in India ������������������������������� 108
References ������������������������������������������������������������������������������������������������� 108
3 Patentability of Biotechnology Under the International
Patent Regime: Differentiation v. Harmonisation �������������������������������
3.1 Territorial Nature of Patents �������������������������������������������������������������
3.2 Internationalisation of Patent System: From Territorial to
Global Patent Regime ����������������������������������������������������������������������
3.3 Patentability of Biotechnology Under TRIPS: Interpreting
TRIPS in the Light of Biotechnology Inventions ����������������������������
3.3.1 Different Countries Interpret the Term ‘Invention’
Differently ����������������������������������������������������������������������������
3.3.2 Special Legislations for Different Technologies
in Member Countries Violate Non-discrimination
Provision Under TRIPS ��������������������������������������������������������
3.3.3 Exceptions Under the TRIPS Agreement �����������������������������
3.3.4 Patenting of Life Forms Under the TRIPS
Agreement: Internationalisation of Gene Patents ����������������
3.3.5 Article 27.3(b) of the TRIPS Agreement: A
Temporary Compromise �������������������������������������������������������
3.3.5.1 GATT Negotiation��������������������������������������������������
3.3.5.2 Review of Art. 27.3(b) of the TRIPS Agreement���
3.3.6 Other Patent Eligibility Criteria Under TRIPS ��������������������
3.4 Feasibility of a Uniform Global Patent System: Differentiation v. Harmonisation �������������������������������������������������������������������
3.4.1 Draft Substantive Patent Law Treaty �����������������������������������
3.4.2 Differentiation vis-a-vis Harmonisation �������������������������������
3.4.3 Merits and Demerits of Uniform Patent Law �����������������������
3.4.4 Relevance of the Existing International Patent
Regime in the Present Technological Age ����������������������������
3.4.5 Tentative Harmonisation Efforts ������������������������������������������
3.5 Implications of Setting up a Uniform World Patent System ������������
References �������������������������������������������������������������������������������������������������
4 Legal, Social and Policy Implications of Genetic Patents:
Issues of Accessibility, Quality of Research and Public Health ����������
4.1 Commercialisation of Genetic Research and Its Impact on
Academics ����������������������������������������������������������������������������������������
4.2 Importance of Patents in Genetic Research �������������������������������������
4.2.1 Impact of Patents with Broad Scope on Genetic Research ����
4.2.2 Impact of Increasing Number of Gene Patents on
Genetic Research: The Tragedy of Anticommons ����������������
4.2.3 Patent Thickets ���������������������������������������������������������������������
4.2.4 Royalty Stacking ������������������������������������������������������������������
4.3 Patenting of Genetic Research Tools and its Impact on
Research and Innovation ������������������������������������������������������������������
4.3.1 Patentability of Genetic Research Tools ������������������������������
4.3.2 Implications of Patents Relating to Genetic
Research Tools for Society ���������������������������������������������������
4.3.3 Patenting of ESTs and Reach Through Claims ��������������������
4.3.4 Impact of Patenting of Genetic Research Tools on
Innovation ����������������������������������������������������������������������������
4.4 Common Practice Regarding Using Patented Research
Tools in Public Sector and in Private Sector ������������������������������������
4.5 Viable Options ����������������������������������������������������������������������������������
4.5.1 Exclusive Licensing Practices May Retard Innovation �������
4.5.2 Non-exclusive Licensing over Genetic Research
Tools Should be Encouraged ������������������������������������������������
4.5.3 Research Exemptions and Their Scope ��������������������������������
4.6 Patenting of Genetic Tests for Diagnostic Purposes ������������������������
4.6.1 Myriad’s Patents on BRCA1 and BRCA2 Genes: A
Case Study ����������������������������������������������������������������������������
4.6.2 Concerns Regarding Myriad’s Patents on BRCA1
and BRCA2 Genes: Reactions Against Commercial
Testing in the USA, European Union and Canada ���������������
4.7 Arguments in Favour of Patents on Diagnostic Tests—to
Develop Diagnostic Tests Require Significant Efforts ���������������������
4.8 Policy Implications of Myriad’s Patents on BRCA1 and BRCA2 ���
4.9 The Possible Way Outs ���������������������������������������������������������������������
5 Intellectual Property Protection to Bioinformatics and
Genomic Databases and Open Source Analogy to Biotechnology ������
5.1 Transition in Biotechnology: From Lab-based Technology
to Computer-based Science ��������������������������������������������������������������
5.1.1 Definition of Bioinformatics ������������������������������������������������
5.1.2 Objection to the Extension ���������������������������������������������������
5.2 Bioinformatics Databases �����������������������������������������������������������������
5.2.1 Intellectual Property Protection to Bioinformatics ��������������
5.2.1.1 Patentability of Bioinformatics Database��������������
5.2.1.2 Viability of Patent Protection with
Respect to Bioinformatics Databases���������������������
5.2.1.3 Copyright Protection to Bioinformatics Database���
5.2.1.4 EU Directive on Protection of Databases��������������
5.2.1.5 A Combination of Copyright Protection
and Database Rights�����������������������������������������������
5.3 Bioinformatics Software ������������������������������������������������������������������
5.3.1 Patent Protection to Software �����������������������������������������������
5.3.2 Copyright Protection to Software �����������������������������������������
5.3.3 Trade Secret ��������������������������������������������������������������������������
5.4 Intellectual Property Protection to Genomic Databases and
Problem of Accessibility ������������������������������������������������������������������
5.4.1 Goals of Genomic Databases �����������������������������������������������
5.4.2 Accessibility of Abstract Genomic Data: Current Standard �
5.4.2.1 Bermuda Principle��������������������������������������������������
5.4.2.2 Extension to Community Resource Projects����������
5.4.2.3 Extension of Bermuda Principles to Phenotype Data������������������������������������������������������������
5.4.2.4 Accessibility of Abstract (Post)Genomic
Data: Developments�����������������������������������������������
5.4.2.5 The Limitations of a License����������������������������������
5.5 Open Source Analogy to Biotechnology ������������������������������������������
5.5.1 Nature and Scope of Open Biotechnology ���������������������������
5.5.2 Difference Between Open Source Software and
Open Source Bioinformatics Software ���������������������������������
5.5.3 Genomic Database Projects: The Human Genome
Project as Open and Collaborative Genomic Database ��������
5.5.4 Importance of Open and Collaborative Databases ���������������
5.5.5 Open Standards ��������������������������������������������������������������������
5.5.6 Free and Open Development ������������������������������������������������
5.5.7 Whether Open Development Is a Viable Business Model ���
5.5.8 Is the Open Source Analogy Relevant to Biotechnology? ���
5.5.9 Innovation and Open Development �������������������������������������
5.6 Is Open Bio Good for Developing Countries? ���������������������������������
6 Implications of Genetic Patents on Human Genetic
Resources: Issues of Ownership, Benefit Sharing and
Informed Consent �����������������������������������������������������������������������������������
6.1 Ownership of Human Genetic Material �������������������������������������������
6.2 Ownership Rights of Research Subjects over Their Genetic
Material Used in Genetic Research ��������������������������������������������������
6.2.1 Moore versus Regents of the University of California ��������
6.2.2 Greenberg versus Miami Children’s Hospital
(Canavan Disease Case) �������������������������������������������������������
6.2.3 Washington University Versus Catalona ������������������������������
6.2.4 Havasupai Case ��������������������������������������������������������������������
6.3 Ownership of Human Genetic Resources—from a Global
Genetic Commons to National Property ������������������������������������������
6.3.1 Genetic Resources: A Global Genetic Commons �����������������
6.3.2 Global Genetic Commons Tradition Eroded with
the Expansion of Intellectual Property Rights over
Genetic Material �������������������������������������������������������������������
6.3.3 The Reaction of Developing Countries Against the
Extension of IPR over Genetic Material ������������������������������
6.3.4 Andean Common System on Access to Genetic
Resources (Common System) ����������������������������������������������
6.3.4.1 Indian Position on Non-human Genetic
Resource: The Biodiversity Act 2002��������������������
6.4 Human Genetic Material ������������������������������������������������������������������
6.4.1 International Law’s Mishandling of Genetic Material and Its Implications ��������������������������������������������������������
6.4.2 Sovereign Control versus Open System �������������������������������
6.4.3 Optimum Way Outs ��������������������������������������������������������������
6.5 Position of International Agreements on the Access of
Human Genetic Resources and Benefit Sharing: Convention on Biological Diversity and TRIPS ������������������������������������������
6.5.1 Benefit Sharing ���������������������������������������������������������������������
6.5.1.1 Andean Pact������������������������������������������������������������
6.5.1.2 TRIPS���������������������������������������������������������������������
6.5.1.3 United States National Bioethics Advisory
Commission�����������������������������������������������������������
6.5.1.4 The International Bioethics Committee of
UNESCO����������������������������������������������������������������
6.5.1.5 Convention on Biological Diversity����������������������
6.5.1.6 Human Genome Organisation (HUGO)�����������������
6.5.1.7 Indian Position on Benefit Sharing Under
Biological Diversity Act�����������������������������������������
6.6 Possible Solutions ����������������������������������������������������������������������������
6.6.1 Companies Incorporating Benefit-sharing Clauses
in Their Strategies ����������������������������������������������������������������
6.6.2 Certificates of Origin for (Non-human) Genetic
Resources �����������������������������������������������������������������������������
6.6.3 Whether an Amendment Required in Patent System
or Outside of it ����������������������������������������������������������������������
6.7 Need for Modification in the Existing Patent Regime ���������������������
7 Conclusion and Suggestions �������������������������������������������������������������������
7.1 Suggestions ��������������������������������������������������������������������������������������
7.1.1 Chapter 2 ������������������������������������������������������������������������������
7.1.2 Chapter 3 ������������������������������������������������������������������������������
7.1.3 Chapter 4 ������������������������������������������������������������������������������
7.1.4 Chapter 5 ������������������������������������������������������������������������������
7.1.5 Chapter 6 ������������������������������������������������������������������������������
Index ���������������������������������������������������������������������������������������������������������������
American Intellectual Property Law Association Quarterly
AIPLA Q.J.	
All England Law Reporter (European cases)
All ER (EC)
Court of Appeals, Federal Circuit., California
C.A. Fed. (Cal.)
Court of Appeals, Federal Circuit, New York
C.A. Fed. (N.Y.)
Court of Appeal for Federal Circuit
Cust. & Pat. App. Court of Customs and Patent Appeals Reports
DNA Database of Japan
E.P.O.R
ENCODE Encyclopedia of DNA elements
Federal Trial Reports
General Agreement on Tariffs and Trades
Hap Map
Haplotype Mapping Project
I.P.L.R.
Ibidem (in the reference immediately cited)
International Centre on Trade and Sustainable Development
IMTECH Institute of Microbial Technology
ITPGRFA	
NCHGR
NISCAIR 	National Institute of Science Communication and Information
Official Journal of the European Patent Office
Canadian Plant Breeders’ Rights Act
Above or on an earlier page
The tumor necrosis factor
U.S.P.Q.
UCLA L. REV University of California, Los Angeles Law Review
Convention on Protection of New Varieties of Plants
Kshitij Kumar Singh is an Assistant Professor at the Amity Law School, Noida,
India. He obtained his Ph.D. (Law) from the Banaras Hindu University, Varanasi,
India. During his doctoral study, he received the Canadian Commonwealth
Scholarship Asia-Pacific 2010. The field of gene patenting and biotech law has been
of special interest to him. Dr. Singh’s LL.M. dissertation is on the topic “Human
Genome and Cloning: Legal and Human Rights Issues”; he has also published many
articles on biotechnology law. He gained related experience as a research intern
(2009) and a visiting research fellow (2010) under the Canadian Commonwealth
Scholarship 2010 at the University of Western Ontario, London, Canada. During
this period he examined laws governing or needing biotechnology developments in
India and Canada. The term was instrumental in expanding his research interest to
the international aspect of the laws governing genetic patents and biotech research.
1.1 Background
Recent advances in biotechnology have brought dramatic transformations in the
society. These transformations have been remarkable in the field of molecular biology and genetics, where biotechnology has opened new vistas for medicine and
healthcare. The completion of the Human Genome Project has unravelled some
mysteries of human life, reshaping our understanding of human genetics. With the
increasing understanding of the genetic basis of human diseases through modern
techniques such as diagnostic genetic testing, biotechnology has shown its potential
to transform the basic framework of clinical medicine from one of ‘diagnosis and
treatment’ to one of ‘prediction and prevention’.1 Modern techniques in biotechnology promise the new era of ‘personalized medicines’ with more accurate results
as compared to traditional medicines. These scientific advances create commercial
possibilities for industries. It started in 1970s with the introduction of new biological techniques such as the recombinant DNA technology, genetic engineering and
cell culture which led to the emergence of the biotechnology industry. The enormous potential of biotechnological advances to produce commercial results has led
to the conjunction of biotechnology and intellectual property rights (IPR), where
industries and intellectual property developers seek to grab new biotechnological
inventions through intellectual property protection.
The conjunction of biotechnology and IPR has posed unprecedented challenges
before intellectual property laws. The existing intellectual property laws struggle
to cope up with the challenges posed by biotechnological advances as they were
framed in an age when these advances were not foreseen by the framers. The traditional doctrines of intellectual property laws have been extended to new subject
matters such as genes, proteins and other unicellular and multi-cellular living organisms, which previously remained outside the grab of intellectual property law.
Moreover, rapid advances in genomics and bioinformatics have raised the intellectual property protection debate for scientific information. IPR developers and
holders claim that new technologies such as biotechnology fall within the existing
Zimmern (1999).
K. K. Singh, Biotechnology and Intellectual Property Rights,
DOI 10.1007/978-81-322-2059-6_1
bundle of the IPR, while end users assert that the technological change is so significant that contemporary intellectual property laws do not apply.
One of the most contentious issues in biotechnology-IPR discourse is the patentability of biotechnology. The traditional patent doctrines: patentable subject matter,
novelty, non-obviousness (inventive step), utility (industrial applicability) and written description struggle while dealing with biotechnology inventions, especially genetic inventions. Human genes have become one of the most controversial subject
matters of patent law because of its diverse nature. Since a gene comprises a number
of elements, therefore, it is possible that a number of patents could be granted in
relation to one gene. For instance, in relation to a particular gene, patents could be
sought for the full sequence of a gene, an expressed sequence tag (EST), a single
nucleotide polymorphism (SNP) or other variations of the gene. A gene has numerous uses as it can be a medically valuable product; an upstream research tool and
vital information about the molecular basis of a disease.
One of the common objections against the gene patents is that genes are naturally
occurring entities that are there to be discovered but not invented. In the context of
gene patents, the line between discovery and invention is very thin and sometimes
even discoveries are patentable through a broad interpretation of patent laws. With
the development of human genomics and success of the Human Genome Project,
a gene becomes more important because of its informational content rather than its
material qualities. Here, the question arises, whether a gene as information is a patent eligible subject matter. Some critics see it as departure from the traditional patent doctrine, ‘which is based on an agreement to disclose information in exchange
of giving the inventor rights over material invention’.2 They also argue that gene,
being a patentable subject matter as information, would not only challenge the traditional patent system but also pose a great challenge to those who need access to
information.3
The relevant novelty issue in gene patenting is whether the inventor has transformed the starting (pre-existing) natural materials into something new or simply
removed imperfections from the original. Gene sequencing and gene isolation, once
considered as laborious manual tasks have now become highly automated and routine parts of the laboratory exercise. This presents a great challenge to the inventive
step/non-obviousness criterion as patent claims regarding these techniques seldom
satisfy this criterion. In the case of gene patents, the utility criterion is also problematic as patents are being granted on gene fragments of unknown functions and
gene sequences of limited or questionable utility. Since great uncertainty is involved
in genetic technology, sometimes the description of an invention remains inconclusive. Sometimes patent claims are drafted in such a way that discloses only a
correlation between a gene and a disease and the patent holders do not describe how
the correlation was used to predict the disease.
The evolving jurisprudence of gene patents stems from the biotech patent practices of different countries. The scope and coverage of biotechnology patents vary
World Health Organization (2005).
1.1 Background
from country to country. Even in countries having similar patent laws such as the
USA and Canada, judicial interpretations by courts differ significantly. Judicial decisions rather than legislative efforts have shaped the fate of biotechnology patents
in the USA and Canada. On the contrary, in Europe and India, significant legislative efforts have provided elaborated legislative provisions regarding biotechnology patents. Both the European Union and India have a list of patentable and nonpatentable subject matter in their respective legislations. Further, Europe and India
contain the ordre public and morality clause to check the patentability of biotechnological inventions; however, the USA and Canada lack such provision in their patent laws. Patenting of a genetically engineered mouse called Harvard Oncomouse
received different responses in the USA, Canada and Europe, which demonstrates
diverse patent approaches towards higher life forms.
At the international level, the international patent regime struggles to cope up
with the new challenges posed by biotechnology. It is due to certain ambiguities and
potential gaps in the text of the Agreement on Trade-Related Aspects of Intellectual
Property Rights (hereinafter TRIPS Agreement). The specific terms of the TRIPS
Agreement set broad boundaries for the protection of biotechnological inventions.
Article 27.1 of the TRIPS Agreement clearly states that patents should be granted
for inventions in any field of technology without discrimination, subject to certain
clauses. This provision gives legal mandate to biotechnology patents and eventually gene patents and obligates member states to accommodate biotechnological
inventions. It is contended that the principle of equal treatment for all technologies
as embodied in Art. 27.1 of the TRIPS Agreement undermines the unique nature
of a gene and its distinct requirements. The term ‘invention’ under Art. 27.1 of the
TRIPS Agreement is not defined and left open to the individual nation’s interpretation. Further, Article 27.2 of the TRIPS Agreement allows member nations to exclude inventions from patentability for enforcing ordre public or morality; however,
it does not stipulate the essence of such provision.
Article. 27.3(b) of the TRIPS Agreement specifically deals with biotechnological inventions, which excludes animals and plants from patentability but mandates
patent protection for microorganisms and microbiological processes. However, the
TRIPS Agreement neither defines the terms microorganisms and microbiological
processes nor sets any parameter for determining the scope of these terms. This
leaves great uncertainty as to the extent of patent protection for biotechnological
inventions. Under the TRIPS, compelling signatory nations to provide patent protection to ‘microorganisms’ and ‘microbiological processes’, without defining the
scope of the said terms, affects the interests of developing nations where the biotechnology field is not developed, when as signatory nations they are bound to provide patent protection to an all illusive term microorganism. Moreover, Art. 27.3(b)
of the TRIPS Agreement provides that states can exclude from patentability ‘essentially biological processes for the production of plants or animals’; however, it
does not provide any parameter to ascertain which biological processes fall under
the category of essentially biological processes.
The question also arises regarding the flexibility of the TRIPS Agreement. The
TRIPS Agreement sets minimum standards before the member signatory nations to
follow and generally requires that signatory countries provide broadly similar patent systems.4 ‘It does not delve much into the details of systems in part because the
precise effects of those details are not known with certainty.’5 To what extent the
flexibilities under the TRIPS are helpful in dealing with biotechnological inventions
remains a debatable issue.
Arguments are being made to harmonize patent laws of member nations by setting uniform standards beyond the TRIPS Agreement. The issue of harmonization
of patent laws has generated much heated debates as establishing a single set of
patent law is not only problematic but against the territorial nature of patents. Both
uniformity and diversity has potentials and pitfalls. Uniformity simplifies the law,
makes it easier to learn and describe, and reduces administrative costs. But, at the
same time, uniformity brings certain disadvantages too as it makes the law unresponsive to local variations, eliminates inter-jurisdictional competition and decreases the possibilities for legal experimentation.6 Diversity in patent laws is significant
as it ‘permits competition and breeds innovation’.7 However, it does not check the
free riding problem and cost burden. Therefore, ‘the relevant policy question is to
what extent inter-jurisdictional diversity and competition should be sacrificed to
achieve global uniformity?’8 There has been a political divide between developed
and developing countries over this issue. Developed countries push for expanding
the subject matter boundary by effectively eliminating exceptions. They advocate
for the inclusion of a broader definition of patent eligible subject matter than the
minimum set out under the TRIPS Agreement. Developing countries protest against
this approach. The International Bureau of the World Intellectual Property Organization (WIPO) composed a draft Substantive Patent Law Treaty (SPLT) in 2001.
However, disagreement between member states has put further discussion about
the SPLT on indefinite hold. In the biotechnological context, creating a single set of
patenting guidelines for the entire world has been proved to be very difficult given
the controversy over issues such as patenting plants and animals.
In addition to legal implications, patents on gene and gene fragments have significant social and policy implications. These implications are related to the accessibility of genetic research tools, genetic innovation, health policies, patients’
rights, clinical practice and the society at large. The potential of genetic research to
produce commercial results prompted industries to collaborate with academic institutions in order to ensure commercial benefits through commercial agreements and
patents. Governments have supported this trend because they believed that research
carried by universities can contribute significantly in national economy. The trend
of university-industry relationship began with the passage of the Bayh-Dole Act
in the USA in 1980. The act gave universities the right to obtain IPR in inventions
resulting from publicly funded research. It allowed industries to invest and col4
Duffy (2002).
laborate in the university research and reap exclusive benefits through licensing and
commercialization agreements. In other places such as Canada and Europe, where
there was no law similar to the Bayh-Dole Act, universities committed themselves
to enhance their commercialization outcomes.9
The commercialization of basic genetic research has threatened the free flow
and open sharing of academic knowledge. Sceptics argue that patenting of upstream
discoveries like DNA and genetic sequences would potentially block downstream
research, which in turn blocks the development and access of new treatments. They
maintain that the current commercialization process in the field of human genetics
have made it more difficult for academic researchers to access and build upon scientific discoveries, and to openly disseminate their research results. The increased
commercialization of upstream or basic genetic research has led to the patenting
of gene fragments such as expressed sequence tags (ESTs) and single nucleotide
polymers (SNPs), which are basically research tools. These research tools have no
immediate therapeutic or diagnostic value but have a great value in conducting research. Patenting of these genetic research tools may stifle the genetic innovation.
In the field of human genetics, the breadth of patent claims and multiple numbers
of patents on a single genetic innovation are the most problematic issues. Broad
patents potentially limit opportunities for researchers to carry out further investigations on patented genes, to find out how they interact with other parts of the genome
and any relationship they may have to particular diseases.10 Multiple numbers of
patents on a single gene create problems of anticommons, patent thickets and royalty stacking.
In the USA, Heller and Eisenberg described the problem of anticommons in the
biomedical field as ‘the tragedy of anticommons’, where multiple patents on genes
and gene fragments, which can be used as a tool for further research, discourage
genetic innovation.11 Access to these tools demands negotiation with all the patent holders, which can raise the transaction costs. This may result in underuse of
resources. Patent thickets create a dense web of overlapping patents, where every
patent holder has to find its way through the web in order to exercise his rights effectively. This again requires negotiation of multiple licenses, which may increase
the transaction costs and retard the pace of innovation. A considerably large number
of patents on genes and gene fragments may lead to royalty stacking problem. Royalty stacking arises when, in order to take a product to the market, the developer of
the product takes licenses from all of the owners of the patents which affect the final
product. These problems make the accessibility of research tools and platform genetic technologies more difficult for a researcher as he has to negotiate for a license
from the patent holder.
Patenting of genetic testing, especially in the field of diagnostics has become a
very controversial issue. Overbroad patent claims and aggressive licensing strategies impede the innovation process. Diagnostic gene patents also have serious imSilverstein et al. (2009).
Dutfield (2006).
Heller and Eisenberg (1998).
plications for patients, researchers, physicians and the society at large. Patents in
the diagnostic field inhibit the use of genetic diagnosis and the development of new
drugs, giving rise to a conflict between patient’s rights and patent rights.12
Myriad’s patents on breast and ovarian cancer genes BRCA1 and BRCA2 reflect various social and policy implications involved in patenting of genetic testing.
By using BRCA1 and BRCA2 genes, Myriad developed a method of diagnosing a
predisposition for breast cancer and obtained patents in the USA, European Union,
Japan and Canada. Myriad got the monopoly over the genetic diagnosis by maintaining arbitrary licensing policy, curtailing the access to the diagnostic technology.
‘The U.S. BRCA patents are quite broad, covering a host of deleterious mutations
in the BRCA1 and BRCA2 genes, the use of these mutations for diagnosis and
prognosis for breast and ovarian cancer, screening for cancer pre-disposition, and
the development of therapeutics to treat cancers with mutations in either gene.’13
The company insists that all testing be performed by Myriad’s own laboratories,
charging exorbitant fee per test in spite of the fact that the same tests are available
at a low cost. The company made it compulsory to send all DNA samples obtained
from high-risk individuals for testing to its own laboratories in the USA. This allows Myriad to build up the only BRCA databank in the world, giving Myriad total
control over the key research materials relating to genes coding for breast cancer
Myriad’s BRCA tests have low predictive power for women without a family
history of breast cancer. Moreover, the test offered by Myriad reportedly fails to
detect 10–20 % of all expected mutations. ‘The failure to detect such a large percentage of mutations in effect seriously jeopardizes the test quality and also significantly falls short of appropriate patient care when alternative more effective tests,
could be readily available to the patient.’14 Myriad does not allow any follow-up
individualized genetic counselling regarding BRCA test results, preventing patients
from obtaining a second opinion or alternative testing. This really undermines the
appropriate quality of patient care. Further, since Myriad bars physicians and researchers to use the test without license, there remains little or almost no scope for
improvement of the test. This impedes the training of the next generation of medical
and laboratory geneticists, physicians and scientists in the area covered by the patent or license. Myriad patents have more deleterious impact on innovation as new
scientific findings have shown that the one gene one disease concept is over and it
is proved that one gene may be responsible for more than one disease; for instance,
BRCA genes are no longer just associated with breast and ovarian cancer, but with
prostate and pancreatic cancer too.15
Myriad faced strong opposition to the patenting of BRCA genes in Canada
and Europe when it obtained the patent and began licensing of the patent to local
Bryn (2002).
Paradise (2004).
Allison (2009).
companies.16 Myriad’s patents have been very controversial in Canada because of
its impact on access to healthcare services and the potential cost of providing useful healthcare services within a publicly funded system. Recently, there has been
strong reaction against Myriad’s patent practice in the USA. In order to contend
the social and policy implications of Myriad’s gene patent practice, a lawsuit was
filed on behalf of researchers, cancer survivors, breast cancer and women’s health
groups, and scientific associations representing geneticists, pathologists and laboratory professionals against the Myriad Genetics Inc. in the New York District Court.
The plaintiffs were universities, professional organizations and cancer patients who
could not afford to pay Myriad’s monopoly price on diagnostics. The complaint
charged that the patents-in-suit stifle diagnostic testing and research.
The US District Court for the Southern District of New York invalidated Myriad’s patents covering mutations in BRCA1 and BRCA2, recognizing the growing
concern about the impact of gene testing on the clinical practice and eventually on
the rights of patients, researchers and other stake-holders.17 The case reached to
the Court of Appeal for Federal Circuit (CAFC) and eventually to the US Supreme
Court, and it has been established by the Apex Court that ‘naturally occurring DNA
segment is a product of nature and not patent eligible merely because it has been isolated but cDNA is patent eligible because it is not naturally occurring.’18 The court
upheld the verdict of the CAFC that finding a link between a gene and a disease is
not an invention denying the long-term patent practice. The case is significant from
a policy perspective as many women are at risk for breast and ovarian cancer and
they see genetic testing as one of the few preventative measures available.
In recent years, there has been enormous growth in the amount of genomic information due to significant genomic advances including the success of the Human
Genome Project. Sometimes, the actual utility of most information is unknown, but
needs to be preserved for future use. This necessitates devising methods to manage
all the information gleaned so far and to arrange and catalogue them in a manner
that may facilitate their use. Here, a fairly new discipline, bioinformatics,19 comes
into play which aims at the interpretation, integration and analysis of biological
information including genetic information. The technology in bioinformatics comprises mostly programs and software which would aid in the compilation and updating of extensive databases of information, databases themselves, and also includes
software which aid in the retrieval, analysis and comparison of relevant data.20
Jones, supra note 13 at 138.
Association for Molecular Pathology v. United States Patent and Trademark Office, Civil Action No. 09-4515 RWS (S.D.N.Y. 2009).
Association of Molecular Pathology et al. v. Myriad Genetics, Inc. et al. 569 U.S. 12-1398 (Slip
opinion) available at http://www.supremecourt.gov/opinions/12pdf/12-398_1b7d.pdf (last visited
on 14 January 2014).
The National Centre for Biotechnology Information defines it as ‘field of study in which biology, information technology and computer science merge together to form a single discipline.’
available at http://www.ncbi.nlm.nih.gov/About/primer/bioinformatics.html (last visited on December 16, 2011).
Gopalan (2009).
Since a great amount of money and intellectual effort is involved in the study of
bioinformatics (especially in genetic databases), intellectual property protection for
bioinformatics becomes pertinent.
However, intellectual property protection varies according to the technology
used in the bioinformatics field such as biological databases, algorithms, complex
software etc. While some of these technologies may fit into the existing framework
of intellectual property law, others may fall outside the scope of current legal protections. Databases per se, existing simply as collections or arrangements of raw
data, are generally not patentable. It can be protected through copyright and sui generis database rights, where the former protects the compilation of database and latter the content of the same. However, providing an effective protection to genomic
databases remains a challenge for copyright as well as database rights as they have
certain inherent limitations.
Bioinformatics and genomic databases require significant collaborative efforts,
therefore, need a continuously open and collaborative process for data collection
and analysis. In such a situation, strict proprietary protection to genomic databases
may conflict with public access to genetic information. Moreover, in the case of
software and other bioinformatics research tools, it can be argued that free and open
access to such tools might lead to the development of more efficient and streamlined methods of use, and to the discovery of new technologies or applications.
These important aspects of bioinformatics are in direct conflict with the proprietary
protection given to it. To remedy this situation, the most viable solution is seen in
the open source biotechnology, inspired by the success of open source movement in
the field of information technology.
However, unlike in information technology, where software is largely protected
through copyright, products of biotech are usually protected through the patent system. Here, it remains doubtful whether the patent system can be used in the same
successful manner as copyrights are used in the IT field to ensure open access.
Moreover, the high cost and legal uncertainty associated with the genetic patents
makes the biotech developers to choose alternative options in the form of copyrights, sui generis database rights, contractual agreements and commercial secrecy.
Since biotech industries and even public research grant agencies are making huge
investment in the development of an invention, so sometimes they see open biotechnology as antagonistic to IPR. Here, the relevant issue is whether it is possible
that open-source software could be a viable option for commercial entities seeking
profit in the bioinformatics field. Further, what would be the licensing strategies to
ensure the open access to genomic databases?
The ownership of human genetic material remains another contentious issue as
variety of proprietary rights are claimed over human genetic material. Although the
fact that human genome is shared by the entire human race has prompted the United
Nations to proclaim that human DNA is the Heritage of Humanity,21 potential uses
Art. 1 of UNESCO’s Universal Declaration on Human Genome and Human Rights 1997 proclaims that “[t]he human genome underlies the fundamental unity of all members of the human
family, as well as the recognition of their inherent dignity and diversity. In a symbolic sense, it is
the heritage of humanity.”
of human DNA in development of diagnostics and therapeutics have led to patenting of human DNA, giving rise to patent claims over human genetic material. Since
human genetic material promises future possible use, therefore, DNA is collected
from human populations and contained in national bio-banks, where individual nations claim it as a national property. Human genetic material is also collected during medical treatment and research studies, where individual patients and research
subjects stand up for their personal property rights in their blood, genes and data.
Academic researchers, on the other hand, claim the human genetic material and data
they have collected in the course of their research as their academic property.
Among these different claims for the ownership of human genetic material, the
claims of patients and research subjects over their genetic material in medical treatment and genetic research have generated much heated debates. In genetic research,
researchers and sponsors of clinical research are well placed to exploit the research
carried on human genetic material of research subjects. The legal question of what
ownership rights patients and research subjects have in their biological materials
and their medical data is itself exceedingly ambiguous. Researchers contend that
conferring ownership rights to research subjects and patients over their excised cells
would impede the research and innovation processes. They also add that such materials become valuable due to their contribution as a scientist or researcher. Here,
the question arises: Do research subjects or patients who have given their genetic
material have no contribution at all? Further, whether may researchers obtain IPR
through observation, isolation and manipulation of the human genetic material,
without recognizing the contribution of the research subject, who contributed the
genetic material in the first place?
The discussion relating to the ownership of human genetic material and benefit
sharing is not confined to an individual and to a particular nation but it has gained
utmost importance at the international level with the rapid increase in bio-prospecting. The human genome holds greater potential for drug development than genes of
plants and animals. The main purpose of bio-prospecting is to find genetic materials
that can be used to develop pharmaceutical, and other useful products that could be
patented and marketed for profit. For the said purpose, researchers from academic and governmental institutions and private companies are paying much heed to
population genetics and disease mechanisms. Here, ‘the concern is that developing
countries as a supplier of genetic material may end up having to pay high prices to
the products that eventually developed from their own genetic material’.22 The increased exploitation of human genetic resources through IPR has great implications
for society. It is argued that potential exploitation of the DNA on all cell lines of
indigenous people through patenting may give rise to increasing opposition to some
vital population genetic studies and other works, beneficial to many countries.23
TRIPS does not contain any explicit reference to genetic material, and the laws
that restrict access to genetic material to obtain remuneration for the member nation
such as Convention on Biological Diversity (CBD) exclude human genetic material
World Health Organization (2002).
Id, at 143.
from their ambit. This has led to a growing exploitation of human genetic resources for scientific or commercial purposes. Objections are raised against permitting
companies to profit from patented genes or goods utilizing such genetic material
without compensating the donors of the underlying genetic material. Here, if the
genetic material comes from a developing country, concerns regarding equitable
sharing of benefits between developed and developing countries arise as well. Due
to increased exploitation of human genetic resources of developing countries by
developed countries, a trend towards viewing human genetic material as a natural
or national resource is apparent.
1.2.1 Biotechnology
Biotechnology is an evolving concept as its edifice is continuously expanding with
the advancement of biotechnological advances. Over the period, the definition of
biotechnology acquired a confusing status due to variety of interpretations. The
Organization for Economic Cooperation and Development (OECD) has developed
both a single definition of biotechnology and a list-based definition of different
types of biotechnology. The single definition defines biotechnology as ‘the application of science and technology to living organisms, as well as parts, products and
models thereof to alter living or non living materials for the production of knowledge goods and services’.24 The list-based definition contains a range of biotechnology techniques related to DNA/RNA, proteins and other molecules, cell and tissue
culturing, process biotechnology techniques, gene and RNA receptors, bioinformatics and nano-biotechnology.25 Scholars suggest that the single definition should always be accompanied by the list-based definition.
One important international definition is contained in the multinational environmental agreement, the CBD, which defines ‘biotechnology’ as: ‘any technological
application that uses biological systems, living organisms, or derivatives thereof, to
make or modify products or processes for specific use’.26 The Biosafety Protocol
(The Cartegena Protocol on Bio safety to the CBD) defines ‘modern biotechnology’
as the application of:
in vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and
direct injection of nucleic acid into cells or organelles, or fusion of cells beyond the taxonomic family, that overcome natural physiological reproductive or recombination barriers
and that are not techniques used in traditional breeding and selection.27
Statistical Definition of Biotechnology (updated in 2005).
Art. 2 of the Convention on Biological Diversity, 1992.
Art. 3(i) of the Cartegena Protocol on Biosafety, 2000.
1.2 Biotechnology and Intellectual Property Rights: A Conceptual Framework
In essence ‘biotechnology is the application of biological system (animals, plants
and microbial) to industries, agriculture and environment to produce better goods
and services and enhance the wellbeing of mankind.’28 It is the synergistic union
of the biological sciences and technology based industrial art; the utilisation of the
biological processes for the exploitation and manipulation of living organisms and
biological systems in the development or the manufacture of a product or in the
technological solution to a real world problem.29 Finally, it can be concluded that
‘biotechnology’ is a term for a group of technologies that use biological matter
or processes to generate new and useful products and processes.30 Many suggest
that the term should be used in a much broader sense to describe the whole range
of methods, both ancient and modern, used to manipulate organic to reach the demands of human.31
1.2.2 Intellectual Property Rights
The term IPR is also a dynamic term with a continuously expanding scope. To put
it simple, ‘intellectual property rights are first of all property rights; secondly, they
are property rights in something intangible and finally, they protect innovations and
creations and reward innovative and creative activity.’32 Intangible things or products which are derived from human intellectual activity constitute the subject matter
of IPR. The human intellectual activities that commonly result in most intellectual
properties are innovation and creativity.33 Since exclusivity or exclusionary right is
the hallmark of property, intellectual property is seen as an intangible subject matter
emanating from the human intellect in respect of which a legal right of exclusivity
may be granted.34 This exclusionary right is termed as IPR, which is an artificial
creation of law to secure exclusive possession of intellectual property. There are
two underlying policies of intellectual property law: first to secure for the public the
benefits of intellectual property, and second to regulate and manage competition.
It is always difficult to give a precise and uniform definition of IPR as the subject
matter of these rights is continuously expanding. ‘The definitional dimensions of
intellectual property are further complicated by the fact that intellectual property
regimes are the products of different philosophical and legal traditions.’35 Intellectual property is used as a generic term, which came into regular use in the twentieth
Noorzad (2000).
Chawala (2005).
“Key Issues in Biotechnology”, United Nations Conference on Trade and Development 2002,
available at www.unctad.org/en/docs/poitetebd10.en.pdf. (last visited on May 12, 2011).
Bud (1991).
Holyoak and Torremans (2005).
Derek Bosworth & Elizabath Webster, The Management of Intellectual Property 25 (Edward
Elgar Publishing Inc., Massachusetts, 2006).
Holyoak and Torremans, supra note 32 at 27.
Drahos (1999).
century. Initially there were two distinct terms in use: ‘industrial property’ and ‘intellectual property’; the former was used to refer technology-based subject areas
like patents, designs and trademarks while the latter used to refer copyright.36 But,
in the due course of time, this distinction has diminished and the modern convention
is to use ‘intellectual property’ to refer to both industrial and intellectual property.37
Most definitions, in fact, simply list examples of IPR or the subject matter of those
rights (often in inclusive form) rather than attempt to identify the essential attributes
of intellectual property. An example of this approach is found in Article 2(vii) of the
Convention Establishing the WIPO, signed at Stockholm on 14 July 1967.
The Convention Establishing the WIPO concluded in Stockholm on 14 July 1967
(Article 2(viii)) provides that ‘intellectual property shall include rights relating to:
performances of performing artists, phonograms and broadcasts;
trademarks, service marks and commercial names and designations;
and all other rights resulting from intellectual activity in the industrial, scientific,
literary or artistic fields.38
For the purposes of the TRIPS Agreement, ‘intellectual property’ refers to:
‘… all categories of intellectual property that are the subject of Sections 1
through 7 of Part II of the agreement.’39 This includes copyright and related rights,
trademarks, geographical indications, industrial designs, patents, integrated circuit
layout-designs and protection of undisclosed information.
Despite this categorisation, the canvas of IPR is expanding on an almost daily
basis as new rights are created or existing rights are applied to fairly new subject
matters such as genetic databases, semiconductor chips, human genes etc. Such
expansion implicates the most basic tenets of society such as information, scientific
data, entertainment and technology.
1.3 Nature, Purpose and Focus of the Book
In the line of the foregoing discussion, the book analyses the legal and social implications arising from the conjunction of biotechnology (specifically, genetic technology) and IPR. The study concentrates on a particular aspect of biotechnology i.e.
the human gene. Since the traces of human gene patents are deeply rooted in the
Art. 2(vii) of the Convention Establishing the World Intellectual Property Organization, 1967.
Art. 1, para. 2 of TRIPS Agreement.
1.4 The Framework of the Book
development of biotechnology patents as a whole, the present study carries discussion on biotechnology patents. For the purpose of the book, legal implications mean
the challenges posed by biotechnology (especially genetic technology) before the
existing IP laws. Social implications mean the wider implications of the genetic
patents on the society, comprising various stake holders as patients, researchers,
scientists, indigenous people and other social groups. The nature of the study is
interdisciplinary, which focuses upon the interface of law and technology. In the
discussion of the law-human genetic interface, ethical concerns are bound to come.
These ethical concerns sometimes guide law to promote social good and reach legal
excellence. Therefore, though the present study is primarily concerned with the
legal and social implications, it also includes concerns relating to bioethics.
The topic of IPR is traditionally and to a large extent essentially concerned with
questions inside a jurisdiction. Although the adoption and ratification of TRIPS has
brought a unified character to intellectual property laws of member countries of
World Trade Organization (WTO) to some extent yet these countries have adopted
different approaches regarding gene patents, largely governed by their national policies. Keeping in view the divergence in intellectual property laws and their practice
among various countries, the book analyses the intellectual property laws and trends
relating to genetic technology of the USA, European Union, Canada and India. A
detailed study of the USA is pertinent because being a pioneer in biotechnology
research; it exerts great influence upon other countries. The European Union reflects
the unified approach of different member states in a politically diversified system.
The study of Canada becomes important because of its distinct approach regarding
patenting of higher life forms despite having almost similar patent law to the USA.
Canada reflects a nice blend of US and European approaches and is quite relevant in
the context of India as a commonwealth country. Since India is in dearth of cases on
gene patents and gene patent practices, it is always relevant to look into the case law
and patent practices of other countries to develop a better understanding of the intricacies involved in the IPR debate relating to human gene. Since international agreements exert great influence on the intellectual property laws of member countries, the
book also concentrates on international IPR regime dealing with genetic technology.
The book adds to the existing knowledge, giving fresh insights regarding the patent approaches of various countries to human gene patents. It analyses the potential
gaps and ambiguities in international patent laws in the light of harmonisation and
differentiation of patent laws. The book would be useful for India to develop better
understanding of biotechnology patents by looking into the IP approaches of different countries and international practices and select the best, most appropriately
suited to its own conditions.
1.4 The Framework of the Book
The book is divided into seven chapters. Chapter 1 introduces the topic in a lucid
way, giving a proper legal and scientific background and connecting various aspects of the study. It contains the background of the book, conceptual framework
of biotechnology and IPR, nature, purpose and focus of the book and the theme of
Chapter 2 analyses the different patent approaches adopted by the USA, Canada,
European Union and India regarding biotechnological inventions (especially genetic inventions) to bring about common issues and differences among these jurisdictions.
In Chap. 2, the author analyses the patent approaches of the USA, European
Union, Canada and India on the basis of patent laws, administrative decisions and
case laws, bringing common points and differences among and between them. The
author comes up with the conclusion that the selected countries for the study vary
significantly in their approach to biotechnology in the degree of patent protection
and patent exclusions; however, the common point among them is that they all
recognize patenting of biotechnology invention, given its economic value. He concludes that patent laws in the entire four jurisdictions struggle to cope up with new
biotechnology inventions. In the light of such struggle, the author insists upon a
comprehensive review of existing patent laws to address the genetic inventions in
tune with the information age. He maintains that lack of such approach may prevent some useful inventions from society. As regards to the divergence in patent
approaches of countries opted for the study, the author emphasises that the patent
approach should always follow the socio-economic conditions of a particular country. He adds further that while making a distinction between patentable and nonpatentable subject matter, the degree of human intervention should be considered.
In Chap. 3, the author analyses the international patent regime dealing with
biotechnology, highlighting the potential gaps and uncertainties as to the scope of
numerous terms such as invention, microorganisms, microbiological processes, essentially biological processes under TRIPS. He also discusses the impact of such
uncertainties on developing countries given their relatively slow pace of scientific
and technological development. The author explains the intricacies involved in providing an effective patent protection to new biotechnology inventions (that differ
markedly from traditional subject matters of patents) at the international level in the
light of technology neutral character of TRIPS.
Chapter 4 includes the study regarding the implications of patenting of genetic
research tools and basic genetic research on the accessibility of genetic innovation.
It discusses the viability of research exemption clauses under patent laws, and other
relevant statutes regarding the accessibility of genetic research tools. The emphasis
is on the patenting of genetic tests for diagnostic purposes and their impact on the
rights of patients, researchers and other stakeholders. In this chapter, the author
undertakes a detailed study of Myriad Genetics’ patents on BRCA1 and BRCA2
genes, which prevents patients from taking a second opinion and verification testing. The author maintains that the social and policy implications of patents on genetic research tools and genetic testing cannot be adequately addressed only by
making changes in the patent systems as patent law is not expected to provide solution to broad social and policy issues. He insists upon formulating policies and making legislations specific to genetic patents to regulate the patent practices such as
patent licensing in order to provide viable solutions to such issues. The author adds
that exclusivity provided by aggressive patent licensing strategies may not be in the
public interest, and there is a continuing need for active defence of open science.
In Chap. 5, the author examines the intricacies involved in providing effective intellectual property protection to bioinformatics and genomic databases and suggests
a comprehensive review of existing intellectual property laws in the light of the
present information age. Keeping in view the collaborative nature of bioinformatics
and genomic databases, the author evaluates the pros and cons of open biotechnology. He suggests that a variety of licensing schemes with or without intellectual
property should be used to support the open nature of bioinformatics and genomic
databases. The author adds that the intellectual property approach to bioinformatics
should be balanced in such a way that it should not only incentivise the inventor or
creator but also ensure the open and collaborative nature of bioinformatics.
In Chap. 6, the author analyses the extension of IPR to human genetic resources
in the light of benefit sharing and informed consent. He explains the ownership
puzzle of human genetic material used in genetic research and suggests that ownership rights of research subjects in their extracted genetic material must be recognized. Further, if researcher or sponsor conducting the research gains any benefit,
the equitable sharing of that benefit must also be recognized. The author insists
upon a careful application of IPR to human genetic resources. He also suggests
that a clear distinction should be made between human genetic resources and nonhuman genetic resources and demands a specific legal approach to the former at the
The concluding observations and possible submissions surfaced out of the study
covered by the book are dealt in Chap. 7.
Allison Malorye (2009) Diagnostic firms face new patent claim worries. Nature Biotechnology
27: 586
Andrew F. Christie (2006) A Legal Perspective. In: Bosworth Derek & Webster Elizabeth (2006)
The Management of Intellectual Property. Edward Elgar Publishing Inc., Massachusetts
Bud Robert (1991) Biotechnology in twentieth century. Social Studies of Science 21: 444–445
Chawala H. S. (2005) Patenting of biological Material and Biotechnology. Journal of Intellectual
Property Rights 10: 44
Duffy John F. (2002) Harmony and Diversity in Global Patent Law. Berkeley Technology Law
Journal 7: 685–726 http://www.btlj.org/data/articles/17_02_02.pdf. Accesses 9 May 2012
Dutfield Graham (2006) DNA patenting: implications for public health research. Bulletin of World
Health Organisation 84: 389
Gopalan Raghuvaran (2009) Bioinformatics: Scope of Intellectual Property Protection. Journal of
Intellectual Property Rights 14: 48
Heller Michael A. and Eisenberg Rebecca S. (1998) Can Patents Deter Innovation? The Anticommons in Biomedical Research. Science 280: 698
Holyoak Jon & Torremans Paul (2005) Intellectual Property Rights. Oxford University Press, New
York p. 11
Jones Bryn Williams (2002) History of Gene Patents: Tracing the Development and Application of
Commercial BRCA Testing. Health Law Journal 10: 133
National Centre for Biotechnology Information (2011) Definition of Bioinformatics. http://www.
ncbi.nlm.nih.gov/About/primer/bioinformatics.html. Accessed 16 December 2011
Noorzad Hazarat (2000) Biotechnology: its evolution, application, and environmental implications. www.mass.gov/envir/ota/pubs/biotech.pdf. Accessed 12 May 2011
Paradise Jordan (2004) European opposition to exclusive control over predictive breast cancer
testing and the inherent implications for U.S. patent law and public policy: a case study of the
Myriad genetics BRCA Patent Controversy. Food and drug law journal 59: 147
Peter Drahos (1999) The universality of intellectual property rights: origin and development http://
www.wipo.int/edocs/mdocs/tk/en/wipo_unhchr_ip_pnl_98/wipo_unhchr_ip_pnl_98_1.pdf.
Accessed 30 May 2011
Silverstein Tina, Joly Yann, Harmsen E. et al (2009) The commercialisation of genomic academic
research: conflicting trend In: E. Richard Gold & Bartha Maria Knoppers (eds.) Biotechnology
IP & Ethics LexisNexis Canada Inc., Markham, Ontario, p. 133
Smith Carrie P. (2000) Patenting Life: The potential and the pitfalls of using the WTO to globalize intellectual property rights. North Carolina Journal of International Law and Commercial
Regulation 26: 143. www.international.westlaw.com. Accessed 18 May 2008
Statistical definition of biotechnology (2005). http://www.oecd.org/sti/biotech/statisticaldefinitionofbiotechnology.htm. Accessed 16 June 2011
United Nations Conference on Trade and Development (2002) Key issues in biotechnology. www.
unctad.org/en/docs/poitetebd10.en.pdf. Accessed 12 May 2011
World Health Organization (2002) Genomics and World Health, Report of the Advisory Committee on Health Research 142 http://whqlibdoc.who.int/hq/2002/a74580.pdf. Accessed 15 June
World Health Organization (2005) Genetics, genomics and the patenting of DNA-Review of potential implications for health in developing countries. http://www.who.int/genomics/FullReport.pdf. Accessed 20 May 2011
Zimmern R.L. (1999) The human genome project: a false dawn? British Medical Journal 319:1282
Patentability of Biotechnology: A Comparative
Study with Regard to the USA, European
Union, Canada and India
Modern biotechnological advances have posed new challenges before the existing
patent laws of countries as biotechnological inventions differ markedly from chemical and mechanical inventions that have been the traditional subject matter of patents. With the development of human genomics and success of the Human Genome
Project, the gene becomes more important because of its informational content
rather than its material qualities (physical attributes). Patent is a subject primarily
concerned with questions inside a jurisdiction. Although the adoption and ratification of trade-related aspects of intellectual property rights (TRIPS) has brought a
unified character to patent laws of member countries of the World Trade Organization (WTO) to a certain extent, these countries have adopted different approaches
regarding biotechnology patents in tune with their national policies. As a result, the
scope and coverage of biotechnology patents vary from country to country. Even in
countries having similar patent laws such as the USA and Canada, interpretations
of such laws by courts vary significantly. These variations among countries are important for the proper understanding of the trends in biotech patents. Therefore, the
present chapter makes a comparative study of patent laws and practices relating to
biotechnology patents in the USA, Canada, European Union and India in order to
collate the common issues and the differences among and between them. The USA
being a pioneer in biotechnology research exerts great influence upon other countries; the European Union reflects the unified approach of different member states
in a politically diversified system; Canada makes a distinction between patenting of
higher life forms and lower life forms and India represents the concerns of developing countries.
2.1 Biotechnology and Patent Law
Biotechnology and patent laws are not of recent origin; they have been present in
our society for a long time. However, they became associated in recent years. This
association became possible when biotechnology started creating commercial possibilities. Biotechnology, once primarily concerned with the academic field, has
DOI 10.1007/978-81-322-2059-6_2
Patentability of Biotechnology
been transformed into a commercial industry with an immense commercial potential. Recent bio-technological advances have presented unprecedented challenges
before the existing patent laws, which have been slow to respond to technological
challenges thus far.
2.1.1 Transformation of Biotechnology: From a Non-commercial
Science to a Commercial Industry
Although the term ‘biotechnology’ gives an impression of modern, cutting-edge
technology, its traces have remained present in early human settlements in the form
of selective plant and animal breeding. Microorganisms have been employed for
brewing and baking purposes for thousands of years. However, it was in early twentieth century, when the term biotechnology came into use. Karl Ereky, a Hungarian
engineer, is said to have coined the term ‘to refer to science and methods that permits products to be produced from raw materials with the aid of the living organisms’.1 He first used the term Biotechnologie in a 1917 article (written in German)
describing his pig fattening plant.2 Taking the analogy of chemical technology, he
suggested the word Biotechnologie to cover the area of technology associated with
the living beings.3
Technology was generally associated more with chemistry and physics and less
with biology, however, with the great advancements in biological sciences, this
trend has anomalously changed.4 Although from the 1880s analogies between physiological and technological structures did suggest a link between technological and
biological evolution, however, biotechnology acquired a professional engineering
dimension when the Americans took the biotechnics and biotechnology in the 1930s
and 1940s.5 Swedes emphasised on microbiology and Germans gave it institutional
strength. America became a pioneer in the integration of molecular biology and
engineering.6
The major breakthrough in the field of molecular biology and genetics was the
discovery of deoxyribonucleic acid (DNA) in 1953 by Francis Crick and James
Watson. It was considered as the discovery of secret of life. The discovery had been
a grand success as the modern biotechnological advances in DNA technology have
demonstrated that ‘the DNA not only explains the very essence of every living cell
but it promises great possibilities for future’.7
Organisation for Economic Co-operation and Development (1999).
Id at 444.
Id at 444–45.
Yelpaala (2000).
Biotechnology and Patent Law
Before the 1970s, biotechnology was primarily concerned with the academic
development, intellectual curiosity, and expansion of scientific knowledge and the
propagation of ideas for the benefit of humanity. Since the 1970s, with the advent
of modern biotechnological techniques such as recombinant DNA technology, and
tissue culture, researchers, venture capitalists and business community in general
realised that DNA technology held the promise of significant financial rewards if
the science could be converted into products or services. This realisation, in part,
led to the emergence of the modern biotechnology industry of today.8 Universities
and research scientists once committed to the total openness were now interested
in scientific discoveries that could be appropriated, protected within an intellectual property regime and eventually transformed into products and services in the
market place.9 This commercial trend led to a paradigm shift in biotechnological
research from openness and sharing of knowledge and ideas to acquisitiveness and
exclusivity.10
2.1.2 Conjunction of Biotechnology and Patent Law: Challenges
Posed by Biotechnology Before the Existing Patent Systems
The Biotechnology industry is primarily made up of small, single product start-up
companies. There is a close relationship between basic and applied science in the
biotechnology field, and the biotechnology industry has a highly educated workforce.11 Due to the close association between academic laboratories and industrial
laboratories, biotechnology companies developed a culture that borrows several
features of university setting.12 The highly skilled work force required for the biotechnology industry can only be made available when the industry continues to
attract academic scientists to the industry. Here, it becomes pertinent for the biotechnology industry to maintain a university like atmosphere and provide good economic incentives to the researchers, encouraging them to maintain a high level of
innovation.13 Further, due to the influence of academic research on biotechnology
industry, the research ethos is encouraged with the encouragement of publication
and sharing of results.14
Patents offer a viable option in this regard. Some form of economic incentive is
sine qua non for the development of any start-up technological industry and patent
offers such an incentive. Patents also encourage public disclosure of the invention
so that society can be benefitted from that. Whether biotech patents fulfil the overall
Boyd (1997).
social goal for which patents are intended is still a debatable issue but there is no
doubt that patents are critical for the protection of biotechnology industry.15 Due to
the high level of uncertainty involved in biotechnology, investors are reluctant to
invest into biotechnology ventures where the patent protection is lacking, or where
the rights of patent holders are not clear.16 This necessitates the conjunction of biotechnology and patent law.
Though patents are seen as an effective protection for biotechnology inventions,
however, concerns have been made in recent years that current patent laws do not
adequately encourage continued growth and research in biotechnology industry.
Arguments have been made that a patent system designed to accommodate older
technologies produces undesirable results when applied to a new and radically different technology such as biotechnology.
The commercial potential of biotechnology has led to the existing patent systems
to accommodate fairly new subject matters such as DNA sequences, microorganisms, plants and animals which were not intended at the time of the framing of
patent laws. Since a very high economic incentive has been involved with these
subject matters, biotechnology industries and patent community have persuaded
courts and legislatures that these subject matters should be treated no differently
from mechanical and chemical invention.17 In recent years, it has been realised that
this analogy has failed to ensure a clear and adequate protection for modern biotechnology. Modern biotechnology differs significantly from chemical inventions
with regard to structure and function and the manner and circumstances in which
modern biotechnology and chemical inventions being created have been shown to
differ markedly.18 Apart from subject matter, modern biotechnological advances
have posed new challenges before the existing patentability criteria such as novelty,
non-obviousness, utility etc.
2.1.3 Human Genetic Patents: A Special and Controversial Case
of Biotechnology Patents
There are groups which see the patenting of life forms such as human gene plainly
wrong; there are some others who do not consider it necessarily wrong but in terms
of its consequences. Sometimes the problem does not lie in the availability of patents but the way that granted patents are being asserted by the ruthless corporations
on to the detriment of the public and especially vulnerable people like patients.19
The opposition was driven by a variety of concerns including effects of such patenting on the environment, animal welfare, sustainable development, public health and
Burk (1991).
Dutfield (2009).
Pila (2003).
Dutfield, supra note 17, at 192.
patient’s rights. One of the most fundamental objections regarding gene patents is
based on religious conviction—the notion that humans are ‘Playing God’.20
As regards to patenting of gene, it is always contended that gene occurs naturally, hence is product of nature and not new. With rapid advancement in the field
of molecular biology and genetics, gene sequencing once considered as a laborious
manual task has become a highly automated and routine part of laboratory practice. This presents a great challenge to the inventive step/non-obviousness criterion.
There is a significant challenge to the utility criterion as patents are being granted
on gene fragments of unknown functions and gene sequences of limited or questionable utility. Since great uncertainty is involved in genetic technology, sometimes the description of an invention is not full. Many patents claimed far more
than what the inventor actually discovered (e.g. claiming the sequence of a protein
within the patent and then also asserting rights over all of the DNA sequences that
encode that protein without describing those DNA sequences). The unique nature of
science of genetics is the main reason for this failure.
Since a gene comprises a number of elements, therefore, it is possible that a number of patents could be granted in relation to one gene. For instance, in relation to a
particular gene, patents could be sought for the full sequence of gene, an expressed
sequence tag (EST), a single nucleotide polymorphism (SNP) or other variation of
the gene, its promoter or enhancer, its individual exons or some other combination
of the sequence.21 Furthermore, a gene may be the subject of a product patent, process patent and use patents. For example, a product patent would cover the sequence
itself which may be a product sold as a diagnostic tool to determine whether a particular gene is present. There could also be a product patent asserting rights over a
gene and its product protein. The scope of the product patent is relatively wide as it
asserts rights over all the uses of that product.22
A process patent may apply to some method of isolation and purification of a
gene. As compared to product patents, process patent is unlikely to assert rights
over the sequence of gene itself. However, if the gene or protein (which it encodes)
is an element of a process or method that is used to produce some other product, the
process patent may assert rights over the sequence of the gene.23
The use patent relates to a specific use of a gene. It could take the form of the use
of a gene or part of its sequence in the manufacture of a medicine. It could also be
framed in terms of the use of a gene for the diagnosis of a disease. The use patents
in relation to gene and genetic components are very controversial due to their broad
scope.24 Commenting on the ‘use patent’ practice of Myriad over BRCA 1 the Nuffield Council of Bioethics observed:
A broad use patent for a diagnostic test for BRCA1 that referred specifically to breast
cancer would give the owner rights over all testing for that genetic susceptibility to breast
Cain (2003a).
cancer but not for other diseases. However, the effect of the patent owner having broad
property rights over the diagnostic use of the gene for just one disease, would be that the
patent owner has the monopoly over all ways of testing for that disease. This is because,
even though the use patent does not include the sequence itself in the patent claims, in
practice any other diagnostic test for the disease specified in a use patent would infringe
that patent.25
So, the actual scope of gene patents depends upon the extent of the analysis carried out by the examiner at the relevant patent office. In addition to this with recent
advancement in the field of genomics, gene has become more important as information rather than as a tangible entity. This transformation raises issue of patent eligibility of information, which has been excluded from patenting as ‘scientific truths’
and ‘abstract ideas’.26 Patenting gene as information has been viewed as departure
from the long established patent practice.
2.1.4 Divergence in Biotechnology Patent Practices Among
Although the minimum standards set out in international agreements brought some
sort of uniformity in patent laws among member countries, however, the patent
practices of these countries vary significantly. This is because the agreements provide considerable discretion to member countries in deciding how they choose to
implement and operate their respective patent systems in tune with their respective
needs.27 The USA considers a much wider range of subject matter e.g. software,
business methods and methods of medical treatment to be patentable as compared
to Europe and Canada.28 European patent law includes, for example, an ‘ordre public and morality clause’29 in its legislation that allows the European Patent Office
(EPO) to exclude biotechnology patents for inventions, the commercialisation of
which violates fundamental moral norms in Europe.30 This clause has been interpreted to prevent the patenting of human embryonic stem cells by the EPO.31 Indian
patent law also contains a similar public order and morality clause.32 However,
Canadian and US law do not contain such clause, which provides them similar discretion to exclude patents on the basis of public order and morality.33
Patenting of whole animals and plants is another classic example of the discrepancies that exist between otherwise similar jurisdictions. These differences are
Nuffield Council of Bioethics (2002).
Merrill and Mazza (2006a).
Gold (2009a).
Sec. 53(a) European Patent Convention, 1973.
Gold and Knoppers, supra note 27, at 22.
Sec. 3(b), Patents Act, 1970.
Patentability of Biotechnology in the USA
explicit in the patenting of the Harvard College’s genetically modified oncomouse,
which received different treatments in the USA, Canada and Europe.34 Further,
three main patentability criteria—novelty, non-obviousness and utility—are applied more or less rigidly by different patent offices.35 In order to understand the
commonalities and differences in patent approaches of different countries regarding
biotechnology inventions, a comparative study is pertinent. In this regard, the present study focuses on the patent approaches of the USA, European Union, Canada
2.2 Patentability of Biotechnology in the USA
The USA has been a pioneer in the field of biotechnology and patent law. Initially,
it has adopted relatively liberal approach while dealing with biotechnology patents
but in due