IPR, Biosafety and Bioethics This page is intentionally left blank. IPR, Biosafety and Bioethics Deepa Goel Assistant Professor IMS Engineering College Ghaziabad Shomini Parashar Assistant Professor IMS Engineering College Ghaziabad Copyright © 2013 Dorling Kindersley (India) Pvt. Ltd. Licensees of Pearson Education in South Asia No part of this eBook may be used or reproduced in any manner whatsoever without the publisher’s prior written consent. This eBook may or may not include all assets that were part of the print version. The publisher reserves the right to remove any material in this eBook at any time. ISBN 9788131774700 eISBN 9789332514249 Head Office: A-8(A), Sector 62, Knowledge Boulevard, 7th Floor, NOIDA 201 309, India Registered Office: 11 Local Shopping Centre, Panchsheel Park, New Delhi 110 017, India AA0011__SSHHEETTHH33882244__0011__SSEE__PPRREELL..iinndddd iiii 11//88//22001133 33::0044::5599 PPMM Contents Preface xi Acknowledgements xiii About the Authors xiv Chapter 1 Meaning and Justifi cation of Patenting an Invention 1 Introduction to Intellectual Property Rights 1 Concept of IPR 2 Designs 10 Trademarks™ 11 Trade Secret (TS) 12 Domain Names 13 Geographical Indications 13 Copyright© 14 Chapter Summary 19 Multiple Choice Questions 20 Review Questions 20 Chapter 2 History and Evolution of Patent Law 21 Evolution of Patent Laws 21 History of Indian Patent System 22 International Conventions and Treaties 27 Patent Laws in Other Countries 39 Chapter Summary 45 Multiple Choice Questions 46 Review Questions 46 Chapter 3 Classifi cation of Patents 47 Classifi cation of Patents in India 47 Classifi cation of Patents by WIPO 48 Categories of Patent 50 Special Patents 50 Patenting Biological Products 57 Chapter Summary 60 Multiple Choice Questions 61 Review Questions 61 vi Contents Chapter 4 Grant of Patent and Patenting Authorities 62 Invention 62 Eligibility Criteria 62 Patentable Inventions in India and Abroad 63 Non-Patentable Inventions in India and Abroad 66 Patent Offi ce 70 Patent Authorities 72 Chapter Summary 81 Multiple Choice Questions 82 Review Questions 83 Chapter 5 Patent Owner: Rights and Duties 84 Ownership of Patent 84 Rights of Patent Holder and Co-owners 85 Duties of Patent Holder and Co-owners 86 Transfer of Patent Rights 87 Limitations of Patent Rights 90 Restoration of Patents 92 Infringement of Patent Rights and Off ences 92 Actions Against Infringement: Remedies/Relief 94 Patent Agent 99 Chapter Summary 100 Multiple Choice Questions 101 Review Questions 101 Chapter 6 Protection of Plant Varieties and Farmers’ Rights Act, 2001 102 Methods of Protection of Plant and Plant Products 102 Essentialities of Plant Protection 106 Plant Variety Protection and Farmer’s Right Act 106 UPOV Convention (Plant Varieties) 1961 113 Chapter Summary 114 Multiple Choice Questions 115 Review Questions 115 Chapter 7 Patent Law: Present Scenario 116 Patent and Economy 116 Patent Management 118 Patent Growth 119 Patenting in Life Forms 119 Biodiversity and IPR 121 Contents vii Bioinformatics Patenting 122 Gene Patenting 124 New Patent Regime 126 Chapter Summary 127 Multiple Choice Questions 128 Review Questions 128 Chapter 8 Introduction to Biosafety 129 Overview of Biosafety 129 Risk Assessment 130 Cartagena Protocol on Biosafety 132 Capacity Building 133 Chapter Summary 137 Multiple Choice Questions 137 Review Questions 137 Chapter 9 GMOs: Concerns and Challenges 138 Introduction 138 Transgenic Technology 138 Gene Flow 143 Future Opportunities and Challenges 148 Chapter Summary 149 Multiple Choice Questions 149 Review Questions 149 Chapter 10 National and International Regulatory Mechanism for GMO 150 Introduction 150 International Regulatory Bodies 151 National Regulatory Bodies 153 Regulatory Measures for Biosafety 159 Biosafety Guidelines in India Evolved by DBT 160 Prevention Food Adulteration Act, Food and Safety Standard Bill and Seed Policy 161 Rules for the Manufacture and Storage of Hazardous Microorganism and GMO 163 Biosafety Management 164 Chapter Summary 165 Multiple Choice Questions 166 Review Questions 166 viii Contents Chapter 11 Biosafety of Genetically Engineered Products 167 Genetically Engineered Products and Recombinant DNA Technology 167 Risk Assessment of RDT Products 168 Regulating Recombinant DNA Technology 168 Permit for Movement and Import of GMOs 169 Some of the Products Developed from RDT and Their Biosafety Issues 169 Biosafety in Gene Therapy 171 Ecological Safety Assessment of Recombinant Organisms 172 Chapter Summary 173 Multiple Choice Questions 174 Review Questions 174 Chapter 12 Allergenicity: Assessment of Genetically Modifi ed Food 175 Introduction 175 Food Allergy 175 Allergens and GMOs 177 Chapter Summary 180 Multiple Choice Questions 180 Review Questions 181 Chapter 13 Introduction to Bioethics 182 Bioethics and Its Scope 182 Diff erent Approaches to Ethics 183 Biological Weapons and Their Social and Ethical Implications 194 Chapter Summary 195 Multiple Choice Questions 195 Review Questions 196 Chapter 14 NGOs for Biosafety and Bioethics 197 Introduction to NGOs 197 Public Sector Organizations 198 Private Sector Organizations 198 National NGOs 199 Media 200 Important Roles that NGOs Play 200 Chapter Summary 201 Multiple Choice Questions 201 Review Questions 201 Contents ix Chapter 15 Web-based Information of Biosafety on GMO 202 Introduction 202 Biosafety Database 203 Chapter Summary 205 Review Questions 205 Chapter 16 Good Laboratory Biosafety Practices 206 Importance of Good Laboratory Practices 206 General Good Laboratory Practices 212 Multiple Choice Questions 212 Review Questions 212 Chapter 17 Case Studies in IPR and Biosafety 214 Diamond vs Chakraborty Case (1980) 214 Dimminaco A.G. Case (2002) 215 Neem Patent Case 215 Turmeric Patent Case 215 Asgrow Seed Co. vs Winterboer Case 216 Harward College vs Canada Case 216 Delta Pineland Co. vs the Sinker’s Corporation Case 217 Myriad’s Case on Gene Patenting 217 Bt Brinjal 218 Bt Cotton 220 Golden Rice 221 Glossary 225 Related Websites 229 References 230 Index 231