Biotech and IPR- Kshitij - Biotechnology and...

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Unformatted text preview: Biotechnology and Intellectual Property Rights Kshitij Kumar Singh Biotechnology and Intellectual Property Rights Legal and Social Implications 1  3 Kshitij Kumar Singh Amity Law School Noida Uttar Pradesh India 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 © Springer India 2015 This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. Exempted from this legal reservation are brief excerpts in connection with reviews or scholarly analysis or material supplied specifically for the purpose of 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 Springer. Permissions for use may be obtained through RightsLink at the Copyright Clearance Center. Violations are liable to prosecution under the respective Copyright Law. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. While the advice and information in this book are believed to be true and accurate at the date of publication, neither the authors nor the editors nor the publisher can accept any legal responsibility for any errors or omissions that may be made. The publisher makes no warranty, express or implied, with respect to the material contained herein. Printed on acid-free paper Springer is part of Springer Science+Business Media ( ) Author’s Preface 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 v vi Author’s Preface 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 intellectual property rights. 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 vii 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 problems. 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. viii Author’s Preface 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. NOIDA May 2014 Dr. Kshitij Kumar Singh Asst. Professor Amity Law School NOIDA Amity University U.P. Contents 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 ���������������������   17 2.1 Biotechnology and Patent Law ����������������������������������������������������������  17 2.1.1 Transformation of Biotechnology: From a Noncommercial Science to a Commercial Industry ����������������������  18 2.1.2 Conjunction of Biotechnology and Patent Law: Challenges Posed by Biotechnology Before the Existing Patent Systems ���������������������������������������������������������  19 2.1.3 Human Genetic Patents: A Special and Controversial Case of Biotechnology Patents ����������������������������������������  20 2.1.4 Divergence in Biotechnology Patent Practices Among Different Jurisdictions �����������������������������������������������  22 2.2 Patentability of Biotechnology in the USA ����������������������������������������  23 2.2.1 Biotechnology as a Patentable Subject Matter �����������������������  23 2.2.2 Other Statutory Requirements ������������������������������������������������  50 2.3 Patentability of Biotechnology in European Union ���������������������������  64 2.3.1 Traces of a Unified System of Patents for European Union ��  64 2.3.2 Specific Legislative Response to Biotechnology Inventions ��� 65 2.3.3 Sources Governing Patent Grants in Europe ��������������������������  66 2.3.4 Biotechnology as a Patentable Subject Matter in European Union ���������������������������������������������������������������������  66 2.3.4.1 Patentable Subject Matter����������������������������������������  66 2.3.5 Other Statutory Criteria for Patents ����������������������������������������  70 ix x Contents 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 �������������������������������   111 3.1 Territorial Nature of Patents �������������������������������������������������������������  111 3.2 Internationalisation of Patent System: From Territorial to Global Patent Regime ���������������������������������������������������������������������  112 3.3 Patentability of Biotechnology Under TRIPS: Interpreting TRIPS in the Light of Biotechnology Inventions ����������������������������  113 3.3.1 Different Countries Interpret the Term ‘Invention’ Differently ����������������������������������������������������������������������������  114 3.3.2 Special Legislations for Different Technologies in Member Countries Violate Non-discrimination Provision Under TRIPS ��������������������������������������������������������  115 3.3.3 Exceptions Under the TRIPS Agreement �����������������������������  116 3.3.4 Patenting of Life Forms Under the TRIPS Agreement: Internationalisation of Gene Patents ����������������  118 3.3.5 Article 27.3(b) of the TRIPS Agreement: A Temporary Compromise �������������������������������������������������������  121 3.3.5.1 GATT Negotiation��������������������������������������������������  123 3.3.5.2 Review of Art. 27.3(b) of the TRIPS Agreement���  124 3.3.6 Other Patent Eligibility Criteria Under TRIPS ��������������������  125 3.4 Feasibility of a Uniform Global Patent System: Differentiation v. Harmonisation �������������������������������������������������������������������  127 3.4.1 Draft Substantive Patent Law Treaty �����������������������������������  129 3.4.2 Differentiation vis-a-vis Harmonisation �������������������������������  129 3.4.3 Merits and Demerits of Uniform Patent Law �����������������������  130 3.4.4 Relevance of the Existing International Patent Regime in the Present Technological Age ����������������������������  131 3.4.5 Tentative Harmonisation Efforts ������������������������������������������  132 Contents xi 3.5 Implications of Setting up a Uniform World Patent System ������������  134 References �������������������������������������������������������������������������������������������������  135 4 Legal, Social and Policy Implications of Genetic Patents: Issues of Accessibility, Quality of Research and Public Health ����������   137 4.1 Commercialisation of Genetic Research and Its Impact on Academics ����������������������������������������������������������������������������������������  137 4.2 Importance of Patents in Genetic Research �������������������������������������  139 4.2.1 Impact of Patents with Broad Scope on Genetic Research ���� 140 4.2.2 Impact of Increasing Number of Gene Patents on Genetic Research: The Tragedy of Anticommons ����������������  140 4.2.3 Patent Thickets ���������������������������������������������������������������������  141 4.2.4 Royalty Stacking ������������������������������������������������������������������  141 4.3 Patenting of Genetic Research Tools and its Impact on Research and Innovation ������������������������������������������������������������������  142 4.3.1 Patentability of Genetic Research Tools ������������������������������  143 4.3.2 Implications of Patents Relating to Genetic Research Tools for Society ���������������������������������������������������  143 4.3.3 Patenting of ESTs and Reach Through Claims ��������������������  144 4.3.4 Impact of Patenting of Genetic Research Tools on Innovation �����������������������...
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