Biotechnology IPRs & Biodiversity

Description

Cover Contents Preface Introduction Chapter 1: Biotechnology Introduction Definition Transformation into New Products Agricultural Biotechnology Evolution of New Technologies Benefits Arising Out of Biotechnology Genetic Manipulation DNA New Food Products Genetic Engineering Recombinant DNA Technology (rDNA) Biotechnology and Medicine Research and Stem Cells Biotechnology and Vaccines Plant Biotechnology Commercialization of Biotechnology Patenting of New Inventions Safety Concerns About (GM) Products Ethical Concerns Biotechnology: Janus-Faced Developments in India GM Products in the USA Bio Products in EC Chapter 2: Biotechnology Laws and Practices in Some Countries The United States of America (USA) The Federal Food, Drug and Cosmetic Act (FFDCA) Consumer Concerns Labelling of GM Products Environmental Concerns Commercialization in the USA European Union (EU) Labelling Requirements in the EUA Japan China The United Kingdom (UK) Canada Australia India The Recombinant DNA Advisory Committee (RDAC) The Instutional Bio Safety Committee (IBSC) The Review Committee on Genetic Manipulation (RCGM) The Genetic Engineering Approval Committee (GEAC) Agricultural Research and Biotechnology Research in India GM Crops in India Safety Concerns and Release of GMOs Chapter 3: Biotechnology and Patent Law Patenting of Substances Found in Nature Patent Law Requirements Blurred by the Advent of Biotechnology Patent Law in the USA United States Supreme Court’s Decision in Chakraborty’s Case Patenting ‘the Harvard Mouse’ The Utility Requirement Obviousness Case Law Sufficient Disclosure/Written Description Case Law Conception of a DNA Molecule and Sufficiency of a Written Description Enablement On the Issue of Sufficiency of Written Description Conception and Joint Ownership Are Expressed Sequence Tags (ESTs) Patentable European Union (EU) Patents on Plants and Animals Case Law Patentability of New Use of Known Products The United Kingdom (UK) Indian Patent Law Developing Countries’ Experience in the Working of the Patent System Biopiracy in India Biopiracy in Other Countries Chapter 4: Biotechnology and TRIPS Agreement: Different Approaches Between TRIPS and CBD Difference in Approach Between Trips and CBD FAO Efforts With Respect to Plant Genetic Resources (PGRS) Chapter 5: Biodiversity and the Need to Preserve It Use Values of Biodiversity Human Benefits from Biodiversity Human Health from Plant Medicines Committee on Trade and Environment (CTE) Conflicts Between Trade Agreements and Environmental Agreements Case Law Are Environmental Standards Becoming Trade Barriers for Developing Countries Earlier International Agreements for Conserving Biodiversity Chapter 6: Earlier Agreements for the Conservation of Biodiversity International Agreements on Conserving Biodiversity Convention on The Conservation of Migratory Species of Wild Animals, 1979 (The Bonn Convention) (1980 ILM 15) Convention on Nature Protection and Wildlife Preservation in the Western Hemisphere, 1940 (The Western Hemisphere Convention) The African Convention on the Conservation of Nature and Natural Resources, 1968 (The African Convention) Convention on Conservation of Nature in the South Pacific, 1976 (Hereinafter the Apia Convention) ASEAN Agreement on the Conservation of Nature and Natural Resources, 1985 (The ASEAN Agreement) Protocol to the Convention, Management and Development of the Marine and Coastal Environment of East African Region Concerning Protected Areas and Wild Fauna and Flora in the East African Region, 1985 (The East African Protocol) Convention on the Conservation of European Wildlife and Natural Habitats, 1979 (The Berne Convention) Protocol to the Convention for the Protection Of The Mediterranean Sea Against Pollution Concerning Mediterranean Specially Protected Areas, 1982 (The Mediterranean Protocol) Protocol to the Convention ad Development of the Marine Environment of the Wider Carribean Region Concerning Specially Protected Areas and Wildlife, 1990 (Carribean Protocol) Weaknesses of the Earlier Agreements Other Sectoral Agreements Convention on Wetlands of International Importance Especially as Water Foul Habitat, 1971 (The Ramsar Convention) Convention for the Protection of World Cultural and Natural Heritage, 1972 (The World Heritage Convention) Chapter 7: Background to the Signing of the Convention on Biodiversity Advantages of and Need for Biodiversity Declaration of Brasila 1989 Langkawi Declaration Beijing Declaration Kuala Lumpur Declaration Different Points of View of the Participants Report of the Executive Director to Rationalize International Agreements United Nations Mandate Meetings of the Group of Experts Group of Experts Converted Into Inter-Governmental Negotiating Committee (INC) Differences Between Developed and Developing Countries on IPRs and the Like Final Compromises by Both Sides Leading to the Signing of CBD Chapter 8: Convention on Biodiversity Objectives Sustainable Use Article 3—Principles General Measures for Conservation and Sustainable Use Concept of Sustainable Use Identification and Monitoring In Situ – Ex Situ Conservation Incentive Measures Research Efforts and Monitoring Environmental Impact Assessment Access to Genetic Resources Article 15, 16 and 19—Access and Benefit Sharing (ABS) Provisions National Laws on Abs Provisions in Mega Biodiversity Rich (Developing) Countries Indian Law Bonn Guidelines Study by UN-IAS on ABS Provisions Reflection on ABS Provisions Legislation to Give Effect to Abs Provisions in the Patent Applications in Some Countries Trips Provisions and the Requirement of Disclosure of Origin The Indigenous People and the Natural Habitats What is Left to the Indigenous People? Advance Informed Agreement Under a New Biosafety Protocol Financial Resources and Fiscal Managment Dispute Settlement Establishment of Sbstta Meetings of SBSTTA Other Provisions General Observations on the Working of the Convention Chapter 9: The Cartagena Protocol on Biosafety Meetings of the Conference of Parties (COP) Under the Convention AD Hoc Biosafety Working Group (BSWG) Meetings Meetings of the ICCP An Analysis of the Articles of the Cartagena Protocol Precautionary Principle Preamble Objectives General Provisions Definitions Scope of the Protocol Transit and Contained Use Advance Informed Agreement and ransboundary Movement of LMOs Notification of the Party of Import Risk Assessment Risk Management Unintentional Transboundary Movement of LMOs Documents to Accompany LMOs Designation of Local Focal Points and Competent Authorities Biosafety Clearing House Confidential Information Capacity Building Liabilities and Redress Exchange of Information Socio-Economic Considerations Financial Mechanism and Resourcesa General Observations Chapter 10: International Treaty on Plant Genetic Resources for Food and Agriculture: Further Developments Meeting of LMMCs at New Delhi The New Delhi Declaration Annexures I: Convention on Biological Diversity (1992) Part 1: Arbitration Article 1 Article 2 Article 3 Article 4 Article 5 Article 6 Article 7 Article 8 Article 9 Article 10 Article 11 Article 12 Article 13 Article 14 Article 15 Article 16 Article 17 Part 2: Conciliation Article 1 Article 2 Article 3 Article 4 Article 5 Article 6 Preamble Article 1. Objectives Article 2. Use of Terms Article 3. Principle Article 4. Jurisdictional Scope Article 5. Cooperation Article 6. General Measures for Conservation and Sustainable Use Article 7. Identification and Monitoring Article 8. In-situ Conservation Article 9. Ex-situ Conservation Article 10. Sustainable Use of Components of Biological Diversity Article 11. Incentive Measures Article 12. Research and Training Article 13. Public Education and Awareness Article 14. Impact Assessment and Minimizing Adverse Impacts Article 15. Access to Genetic Resources Article 16. Access to and Transfer of Technology Article 17. Exchange of Information Article 18. Technical and Scientific Cooperation Article 19. Handling of Biotechnology and Distribution of its Benefits Article 20. Financial Resources Article 21. Financial Mechanism Article 22. Relationship with Other International Conventions Article 23. Conference of the Parties Article 24. Secretariat Article 25. Subsidiary Body on Scientific, Technical and Technological Advice Article 26. Reports Article 27. Settlement of Disputes Article 28. Adoption of Protocols Article 29. Amendment of the Convention or Protocols Article 30. Adoption and Amendment of Annexes Article 31. Right to Vote Article 32. Relationship Between this Convention and its Protocols Article 33. Signature Article 34. Ratification, Acceptance or Approval Article 35. Accession Article 36. Entry Into Force Article 37. Reservations Article 38. Withdrawals Article 39. Financial Interim Arrangements Article 40. Secretariat Interim Arrangements Article 41. Depositary Article 42. Authentic Texts Identification and Monitoring Annexures II: Cartagena Protocol on Biosafety Preamble Article 1. Objective Article 2. General Provisions Article 3. Use of Terms Article 4. Scope Article 5. Pharmaceuticals Article 6. Transit and Contained Use Article 7. Application of the Advance Informed Agreement Procedure Article 8. Notification Article 9. Acknowledgement of Receipt of Notification Article 10. Decision Procedure Article 11. Procedure for Living Modified Organisms Intended for Direct Use as Food or Feed, or for Processing Article 12. Review of Decisions Article 13. Simplified Procedure Article 14. Bilateral and Multilateral Agreements and Arrangements Article 15. Risk Assessment Article 16. Risk Management Article 17. Unintentional Transboundary Movements and Emergency Measures Article 18. Handling, Transport, Packaging and Identification Article 19. Competent National Authorities and National Focal Points Article 20. Information Sharing and the Biosafety Clearing-house Article 21. Confidential Information Article 22. Capacity-building Article 23. Public Awareness and Participation Article 24. Non-parties Article 25. Illegal Transboundary Movement Article 26. Socio-economic Considerations Article 27. Liability and Redress Article 28. Financial Mechanism and Resources Article 29. Conference of the Parties Serving as the Meeting of the Parties to this Protocol Article 30. Subsidiary Bodies Article 31. Secretariat Article 32. Relationship With the Convention Article 33. Monitoring and Reporting Article 34. Compliance Article 35. Assessment and Review Article 36. Signature Article 37. Entry Into Force Article 38. Reservations Article 39. Withdrawal Article 40. Authentic Texts Annex 1. Information Required in Notifications Under Article 8, 10 and 13 Annex II. Information Required Concerning Living Modified Organisms Intended for Direct Use as Food or Feed, or for Processing Under Article 11 Annex III. Risk Assessment Objective Use of Risk Assessment General Principles Methodology Points to Consider Bibliography Websites Index