Intellectual property and public health in the developing world Across the world developing countries are attempting to balance the international standards of intellectual property concerning pharmaceutical patents against the urgent need for accessible and affordable medicines. In this timely and necessary book Monirul Azam examines the attempts of several developing countries to walk this fine line. He evaluates the experiences of Brazil China India and South Africa for lessons to guide Bangladesh and developing nations everywhere. Azams legal expertise concern for public welfare and compelling grasp of principal case studies make Intellectual Property and Public Health in the Developing World a definitive work. The developing world is striving to meet the requirements of the World Trade Organizations TRIPS Agreement on intellectual property. This book sets out with lucidity and insight the background of the TRIPS Agreement and its implications for pharmaceutical patents the consequences for developing countries and the efforts of certain representative nations to comply with international stipulations while still maintaining local industry and public health. Azam then brings the weight of this research to bear on the particular case of Bangladesh offering a number of specific policy recommendations for the Bangladeshi government—and for governments the world over. Intellectual Property and Public Health in the Developing World is a must read for public policy makers academics and students non governmental organizations and readers everywhere who are interested in making sure that developing nations meet the health care needs of their people. Publishers website Preface List of Tables List of Figures Abbreviations Abstract 1. Setting the Scene. 1.1 Background.1.2 The Advent of TRIPS and Pharmaceutical Patents. 1.3 The Requirements of TRIPS. 1.4 TRIPS Flexibilities and the Doha Declaration. 1.5 The Experiences of Brazil China India and South Africa.1.6 The Role of the WHO. 1.7 Research Questions and Methodology. 1.8 Chapter Summary 2. Case Study on Bangladesh’s Pharmaceutical Industry Legislative and Institutional Framework and Pricing of Pharmaceuticals. 2.1 Introduction. 2.2 Legislative Framework: Pharmaceutical Patents and Pharmaceutical Regulation. 2.2.1 Patent Regime: Patent Law and the Patent Office. 2.2.2 Pharmaceutical Regulations: Relevant Laws and the Regulatory Body. 2.2.3 Changes Required in Patent Law and Pharmaceutical Regulation in Bangladesh. 2.3 The Pharmaceutical Industry in Bangladesh. 2.3.1 The Nature and Size of Firms. 2.3.2 Competitive Scenario. 2.3.3 Local Sales Export and Import. 2.3.4 Production Capacity and Range. 2.3.5 Use of Technology. 2.3.6 Innovation Capacity and Research and Development. 2.3.7 Government Incentives for Supply of Raw Materials and Exports. 2.3.8 Human Resources. 2.4 (Potential) Effects of Pharmaceutical Patents on the Pricing of Drugs in Bangladesh. 2.5 Waiver for the Least Developed Countries and the Pharmaceutical Industry in Bangladesh: Opportunities and Challenges. 2.6 Which Way for Bangladesh 3. The Experiences of TRIPS compliant Patent Law Reform in Brazil China India and South Africa—Lessons for Bangladesh. 3.1 Background. 3.2 The Journey Towards TRIPS and Obligations for Patent Law Reforms. 3.2.1 Patentable Subject Matter. 3.2.2 Rights and Obligations of Patentees. 3.2.3 The Term of Patent Protection. 3.2.4 Enforcement Obligations. 3.2.5 Exceptions and Limitations of Exclusive Rights. 3.2.6 Provisions on August 30 Decision (Implementation of Para. 6 of the Doha Declaration). 3.3 The Experience of Brazil. 3.4 The Experience of China. 3.5 The Experience of India. 3.6 The Experience of South Africa. 3.7 Comparative Review and Lessons for the LDCs including Bangladesh. 3.8 Concluding Remarks 4. The Globalising Standard of Patent Protection in WTO Law and Policy Options for the LDCs: The Context of Bangladesh. 4.1 Introduction. 4.2 Legislative Options for Bangladesh. 4.2.1 A High Threshold and Exclusion Clause. 4.2.2 Best Mode Disclosure and Disclosure of the Source of Genetic Resources and Traditional Knowledge. 4.2.3 Narrowing the Scope of Patent Claims. 4.2.4 Exceptions to Product Patent Rights. 4.2.5 Early Working (or Bolar Exceptions) Research and Experimental Use. 4.2.6 Parallel Imports. 4.2.7 Strong Compulsory Licensing Mechanisms. 4.2.8 Prior Use Exceptions. 4.2.9 Pre grant and Post grant Opposition. 4.2.10 Duration of Patent Protection. 4.2.11 Do Not Adopt Overprotective Enforcement Provisions. 4.3 Government Intervention Options. 4.3.1 Drug Price Control. 4.3.2 National Competition Law. 4.3.3 Patent Prize System. 4.3.4 Limit Data Protection. 4.3.5 Patent Pool on Country specific Diseases. 4.3.6 Avoiding Bilateral Investment Treaties or Free Trade Agreements that Erode TRIPS Flexibilities. 4.3.7 Utilisation of the Transitional Period for Pharmaceutical Patents. 4.3.8 Provision for Process Patent during the Transitional Period and Adoption of a Utility Model Law. 4.3.9 Special Investment Protection Regime Open Drug Innovation Model and Promotion of Social Business Model in the Pharmaceutical Sector. 4.4 Conclusion 5. Has the TRIPS Waiver Helped the Least Developed Countries Progress Towards Innovation and Compliance 5.1 Background: TRIPS Waivers for the LDCs and Designing a Plan of Action for Graduation and Progression Towards Innovation and Compliance. 5.2 Extending the LDC Transition Period: Is it a Measure for Making a Viable Technological Base or Simply a Waste of Time 5.3 The Case of Bangladesh: Has the Country Gained from its LDC Status and the Transition Period 5.4 Progress Towards Graduation and Compliance. 5.4.1 When and How Might LDCs Graduate from this Category 5.4.2 Competitiveness of the Local (Pharmaceutical) Industry and a Plan for Graduation from the LDC Category and Progress towards TRIPS Compliance: The Context of Bangladesh. 5.5 Progress towards Graduation and Compliance: Institutional and Infrastructural Issues in Bangladesh. 5.5.1 Capacity Building in the Department of Patents Designs and Trademarks and Intellectual Property related Institutional and Infrastructural Issues. 5.5.2 Capacity Building in the Directorate of Drug Administration and Public Health related Institutional and Infrastructural Issues. 5.6 Adopting a National Development centred Intellectual Property Policy and a National Health Strategy Integrating Long term Innovation and Access Objectives. 5.7 Collaboration between Univeristies Industry and Government and Public Private Partnerships. 5.8 Limitations and Further Research. 5.9 Concluding Remarks Bibliography Appendices. Appendix 1: Status of Patents in Bangladesh (1972–2012) . Appendix 2: Relevant Provisions of the TRIPS Agreement Index