Contents 1 Introduction 2 Patentability of Biotechnology: A Comparative Study with Regard to the USA, European Union, Canada and India

Transcription

1 Contents 1 Introduction Background Biotechnology and Intellectual Property Rights: A Conceptual Framework Biotechnology Intellectual Property Rights Nature, Purpose and Focus of the Book The Framework of the Book References Patentability of Biotechnology: A Comparative Study with Regard to the USA, European Union, Canada and India Biotechnology and Patent Law Transformation of Biotechnology: From a Noncommercial Science to a Commercial Industry Conjunction of Biotechnology and Patent Law: Challenges Posed by Biotechnology Before the Existing Patent Systems Human Genetic Patents: A Special and Controversial Case of Biotechnology Patents Divergence in Biotechnology Patent Practices Among Different Jurisdictions Patentability of Biotechnology in the USA Biotechnology as a Patentable Subject Matter Other Statutory Requirements Patentability of Biotechnology in European Union Traces of a Unified System of Patents for European Union Specific Legislative Response to Biotechnology Inventions Sources Governing Patent Grants in Europe Biotechnology as a Patentable Subject Matter in European Union Patentable Subject Matter Other Statutory Criteria for Patents ix

2 x Contents 2.4 Patentability of Biotechnology Inventions in Canada Statutory Framework for Patenting Patentable Subject Matter Other Statutory Requirements for Patenting Comparison of Canada with the USA and Europe Patentability of Biotechnology Inventions in India Dimminaco Case: Paving the Way for Biotechnology Patents in India Statutory Provisions Regarding Biotechnological Inventions Under the Current Patent Act 1970 (as Amended in 1999, 2002 and 2005) Biotechnological Inventions as Patentable Subject Matter Other Statutory Requirements Under Indian Patent Act for Patenting Status of Biotechnology Patent in India References Patentability of Biotechnology Under the International Patent Regime: Differentiation v. Harmonisation Territorial Nature of Patents Internationalisation of Patent System: From Territorial to Global Patent Regime Patentability of Biotechnology Under TRIPS: Interpreting TRIPS in the Light of Biotechnology Inventions Different Countries Interpret the Term Invention Differently Special Legislations for Different Technologies in Member Countries Violate Non-discrimination Provision Under TRIPS Exceptions Under the TRIPS Agreement Patenting of Life Forms Under the TRIPS Agreement: Internationalisation of Gene Patents Article 27.3(b) of the TRIPS Agreement: A Temporary Compromise GATT Negotiation Review of Art. 27.3(b) of the TRIPS Agreement Other Patent Eligibility Criteria Under TRIPS Feasibility of a Uniform Global Patent System: Differentiation v. Harmonisation Draft Substantive Patent Law Treaty Differentiation vis-a-vis Harmonisation Merits and Demerits of Uniform Patent Law Relevance of the Existing International Patent Regime in the Present Technological Age Tentative Harmonisation Efforts

3 Contents xi 3.5 Implications of Setting up a Uniform World Patent System References Legal, Social and Policy Implications of Genetic Patents: Issues of Accessibility, Quality of Research and Public Health Commercialisation of Genetic Research and Its Impact on Academics Importance of Patents in Genetic Research Impact of Patents with Broad Scope on Genetic Research Impact of Increasing Number of Gene Patents on Genetic Research: The Tragedy of Anticommons Patent Thickets Royalty Stacking Patenting of Genetic Research Tools and its Impact on Research and Innovation Patentability of Genetic Research Tools Implications of Patents Relating to Genetic Research Tools for Society Patenting of ESTs and Reach Through Claims Impact of Patenting of Genetic Research Tools on Innovation Common Practice Regarding Using Patented Research Tools in Public Sector and in Private Sector Viable Options Exclusive Licensing Practices May Retard Innovation Non-exclusive Licensing over Genetic Research Tools Should be Encouraged Research Exemptions and Their Scope Patenting of Genetic Tests for Diagnostic Purposes Myriad s Patents on BRCA1 and BRCA2 Genes: A Case Study Concerns Regarding Myriad s Patents on BRCA1 and BRCA2 Genes: Reactions Against Commercial Testing in the USA, European Union and Canada Arguments in Favour of Patents on Diagnostic Tests to Develop Diagnostic Tests Require Significant Efforts Policy Implications of Myriad s Patents on BRCA1 and BRCA The Possible Way Outs References Intellectual Property Protection to Bioinformatics and Genomic Databases and Open Source Analogy to Biotechnology Transition in Biotechnology: From Lab-based Technology to Computer-based Science Definition of Bioinformatics Objection to the Extension

4 xii Contents 5.2 Bioinformatics Databases Intellectual Property Protection to Bioinformatics Patentability of Bioinformatics Database Viability of Patent Protection with Respect to Bioinformatics Databases Copyright Protection to Bioinformatics Database EU Directive on Protection of Databases A Combination of Copyright Protection and Database Rights Bioinformatics Software Patent Protection to Software Copyright Protection to Software Trade Secret Intellectual Property Protection to Genomic Databases and Problem of Accessibility Goals of Genomic Databases Accessibility of Abstract Genomic Data: Current Standard Bermuda Principle Extension to Community Resource Projects Extension of Bermuda Principles to Phenotype Data Accessibility of Abstract (Post)Genomic Data: Developments The Limitations of a License Open Source Analogy to Biotechnology Nature and Scope of Open Biotechnology Difference Between Open Source Software and Open Source Bioinformatics Software Genomic Database Projects: The Human Genome Project as Open and Collaborative Genomic Database Importance of Open and Collaborative Databases Open Standards Free and Open Development Whether Open Development Is a Viable Business Model Is the Open Source Analogy Relevant to Biotechnology? Innovation and Open Development Is Open Bio Good for Developing Countries? References Implications of Genetic Patents on Human Genetic Resources: Issues of Ownership, Benefit Sharing and Informed Consent Ownership of Human Genetic Material Ownership Rights of Research Subjects over Their Genetic Material Used in Genetic Research

5 Contents xiii Moore versus Regents of the University of California Greenberg versus Miami Children s Hospital (Canavan Disease Case) Washington University Versus Catalona Havasupai Case Ownership of Human Genetic Resources from a Global Genetic Commons to National Property Genetic Resources: A Global Genetic Commons Global Genetic Commons Tradition Eroded with the Expansion of Intellectual Property Rights over Genetic Material The Reaction of Developing Countries Against the Extension of IPR over Genetic Material Andean Common System on Access to Genetic Resources (Common System) Indian Position on Non-human Genetic Resource: The Biodiversity Act Human Genetic Material International Law s Mishandling of Genetic Material and Its Implications Sovereign Control versus Open System Optimum Way Outs Position of International Agreements on the Access of Human Genetic Resources and Benefit Sharing: Convention on Biological Diversity and TRIPS Benefit Sharing Andean Pact TRIPS United States National Bioethics Advisory Commission The International Bioethics Committee of UNESCO Convention on Biological Diversity Human Genome Organisation (HUGO) Indian Position on Benefit Sharing Under Biological Diversity Act Possible Solutions Companies Incorporating Benefit-sharing Clauses in Their Strategies Certificates of Origin for (Non-human) Genetic Resources Whether an Amendment Required in Patent System or Outside of it Need for Modification in the Existing Patent Regime References

6 xiv Contents 7 Conclusion and Suggestions Suggestions Chapter Chapter Chapter Chapter Chapter References Index

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