IPR, Biosafety and Bioethics

Description

Contents Preface Acknowledgements About the Authors Chapter 1: Meaning and Justifi cation of Patenting an Invention Introduction to Intellectual Property Rights Concept of IPR Forms of Intellectual Property Rights Designs Trademarks™ Trade Secret (TS) Domain Names Geographical Indications Copyright© Author’s Right Performer’s Right Broadcasting Rights Exclusions of Copyright Copyright Societies Copyright Infringement Chapter Summary Multiple Choice Questions Review Questions Chapter 2: History and Evolution of Patent Law Evolution of Patent Laws History of Indian Patent System Indian Patent Act 1970 International Conventions and Treaties World Intellectual Property Organization World Trade Organization The TRIPs Agreement Patent Cooperation Treaty Patent Laws in Other Countries Patent Laws in Unites States Patent Laws in European Countries Patent Laws in China Patent Laws in Japan Chapter Summary Multiple Choice Questions Review Questions Chapter 3: Classification of Patents Classification of Patents in India Classification of Patents by WIPO Utility Patent Design Patent Plant Patent Categories of Patent Industrial or Non-Industrial Patents Product and Process Patent Utility Patent Special Patents Evolution of Patents in Microorganisms Patent Laws Before and After Amendments Preparation of the Application The Impact of Plant Variety Protection Patenting Biological Products Scope of Patent in Biotechnology Industry Problems in Biotechnology Patenting Pre-Requisites to Render a Biotechnology Invention Patentable Additional Requirement to Obtain a Valid Patent in Case of Biotechnology Patentable Ingredients of Biotechnology Chapter Summary Multiple Choice Questions Review Questions Chapter 4: Grant of Patent and Patenting Authorities Invention Eligibility Criteria Patentable Inventions in India and Abroad In Other Countries Non-Patentable Inventions in India and Abroad In Other Countries Patentability in Microorganism-Related Inventions Patent Office Patent Authorities The General and Specific Powers of the Controller andthe Central Government Powers of the Central Government Application for the Grant of Patents Procedure for the Grant of Patent Patent Specification Documents Required for Filing the Patent Chapter Summary Multiple Choice Questions Review Questions Chapter 5: Patent Owner: Rights and Duties Ownership of Patent Rights of Patent Holder and Co-owners Duties of Patent Holder and Co-owners Transfer of Patent Rights Limitations of Patent Rights Restoration of Patents Infringement of Patent Rights and Offences Types of Infringements Actions Against Infringement: Remedies/Relief Injunction Damages Accounts of Profit Order for Delivery or Destruction Certificate of Validity Limitations on IPR Remedies Defender’s Defence Infringement of Copyright Infringement of Trademark Rights Infringement of Design Patent Agent Chapter Summary Multiple Choice Questions Review Questions Chapter 6: Protection of Plant Varieties and Farmers' Rights Act, 2001 Methods of Protection of Plant and Plant Products Patent on Plants Plant Breeder’s Right Trade Secrets Genetic Mechanism Contracts A sui generis System (India) Essentialities of Plant Protection Plant Variety Protection and Farmer's Right Act Need for Protection Objectives of Protection Benefit Sharing Registration of Plant Variety Procedure of Registration Authority Functions of Authority (Section 8) Compulsory License Infringement and Remedies Farmers’ Rights UPOV Convention (Plant Varieties) 1961 Functions of UPOV Chapter Summary Multiple Choice Questions Review Questions Chapter 7: Patent Law: Present Scenario Patent and Economy Patent Management Patent Growth Patenting in Life Forms Biodiversity and IPR The Effect of IPR on Biodiversity Bioinformatics Patenting Gene Patenting New Patent Regime Chapter Summary Multiple Choice Questions Review Questions Chapter 8: Introduction to Biosafety Overview of Biosafety Risk Assessment Risk Groups and Biosafety Levels The Process of Risk Assessment Risk Assessment for Planned Introduction of GMO Risk Assessment for the Release of Transgenic Crops Risk Assessment of Food and Additives Obtained from GMOs Cartagena Protocol on Biosafety Capacity Building Components of Capacity Building Advance Informed Agreement (AIA) for Intentional Use of GMO A Simplified System for Agricultural Commodities for Direct use of GMOsas Food or Feed The Biosafety Clearing-House (BCH) Documentation of the Export An Approach to Public Awareness and Participation Different Organizations and Database Information on Biosafety Indian Biosafety Framework Chapter Summary Multiple Choice Questions Review Questions Chapter 9: GMOs: Concerns and Challenges Introduction Transgenic Technology Potential of Transgenic Technology Concerns and Challenges of GMO Animal Biotechnology Plant Biotechnology Gene Flow Major Consequences of Gene Flow Other Concerns Related to Transgenics Various Aspects of Assessment and Evaluation on GMO toAscertain Biosafety Future Opportunities and Challenges Chapter Summary Multiple Choice Questions Review Questions Chapter 10: National and International Regulatory Mechanism for GMO Introduction International Regulatory Bodies World Trade Organization Organization for Economic Cooperation and Development (OECD) Food and Agriculture Organization (FAO) Codex Alimentarious Commission (CAC) Convention on Biological Diversity National Regulatory Bodies Institutional Biosafety Committee (IBSC) Review Committee on Genetic Manipulation (RCGM) Genetic Engineering Approval Committee State Biotechnology Coordination Committee (SBCC) District Level Committee (DLC) Monitoring cum Evaluation Committee Regulatory Measures for Biosafety General Procedure for the Approval of Environmental Releaseof Transgenic Crop Biosafety Guidelines in India Evolved by DBT Prevention Food Adulteration Act, Food and Safety Standard Bill and Seed Policy Prevention of Food Adulteration Act, 1954 Food and Safety Standard Bill Seed Policy Rules for the Manufacture and Storage of Hazardous Microorganism and GMO Biosafety Management Scientific and Well Framed Biosafety Guidelines for theBiosafety Management People Involved in Decision Making Review Process Feedback Mechanism Chapter Summary Multiple Choice Questions Review Questions Chapter 11: Biosafety of Genetically Engineered Products Genetically Engineered Products and Recombinant DNA Technology Risk Assessment of RDT Products Regulating Recombinant DNA Technology Permit for Movement and Import of GMOs Some of the Products Developed from RDT and Their Biosafety Issues Recombinant Insulin Human Growth Hormone Bovine Growth Hormone Recombinant Tryptophan Biosafety in Gene Therapy Different Issues Related to Gene Therapy Ecological Safety Assessment of Recombinant Organisms Transfer of Genes to Ecologically Competent Relative Risk with Plants that are Altered for Bioactive Moleculesrather than for Food Ecological Pleiotropic Effect of Genetically Engineered Organism Chapter Summary Multiple Choice Questions Review Questions Chapter 12: Allergenicity: Assessment of Genetically Modified Food Introduction Food Allergy Animal-Derived Food Allergens Food Allergens Derived from Plant Origin General Traits of Food as Allergens Allergens and GMOs Assessing Allergenicity in GMO Food Allergenicity Assessment Methods Animal Models for Testing Potential Allergenicity Chapter Summary Multiple Choice Questions Review Questions Chapter 13: Introduction to Bioethics Bioethics and Its Scope Origin of Bioethics Branches or Theories of Bioethics Different Approaches to Ethics Bioethical Issues and Conflicts in the Development of GMOs Bioethical Issues in Transgenic, Gene Therapy and Human Cloning andIts Bioethical Implications andsConflicts Bioethical Issues in Genetically Modified Organisms(Plants, Animals, Microbes) GMOs Contain Altered Gene from Other Varied Sources Transgenics have Traits that are Conventionally Not Present in the Species Bioethical Issues in Gene Therapy Ethical Issues in Human Cloning Transgenic Animals and Bioethical Issues Other Major Issues Related to Bioethics Bioethics and Consumer Acceptance Bioethics Advisory Committees EuropaBio Convention on Human Rights and Biomedicine Bioethics Guidelines from European Nutrigenomics Organization (NuGO) Biological Weapons and Their Social and Ethical Implications Potential Biological Weapons Chapter Summary Multiple Choice Questions Review Questions Chapter 14: NGOs for Biosafety and Bioethics Introduction to NGOs Public Sector Organizations Private Sector Organizations National NGOs Gene Campaign Research Foundation for Science, Technology and Ecology (RFSTE) Farmers Movement and its NGO Media Important Roles that NGOs Play Chapter Summary Multiple Choice Questions Review Questions Chapter 15: Web-based Information of Biosafety on GMO Introduction Biosafety Database Databases from National and International Organizations Other Databases Role of Bioinformatics in Creating Databases Chapter Summary Review Questions Chapter 16: Good Laboratory Biosafety Practices Importance of Good Laboratory Practices Containment Methods Certain Guidelines to be Followed Using This Containment Equipment Facility Design Different Containment Levels and Their Safety Practices Biological Spillage Precaution When the Use of Human Blood or Other Infectious Material Managing Biological Waste Treatment of the Biological Waste General Good Laboratory Practices Multiple Choice Questions Review Questions Chapter 17: Case Studies in IPR and Biosafety Diamond vs Chakraborty Case (1980) Dimminaco A.G. Case Neem Patent Case Turmeric Patent Case Asgrow Seed Co. vs Winterboer Case Harward College vs Canada Case Delta Pineland Co. vs the Sinker's Corporation Case Myriad's Case on Gene Patenting Bt Brinjal Bt Cotton Golden Rice Glossary Related Web Sites References Index