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Preface
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xi
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List of Tables
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xv
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List of Figures
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xvii
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Abbreviations
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xix
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Abstract
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xxiii
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1.
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Setting the Scene
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1
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1.1
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Background
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1
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1.2
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The Advent of TRIPS and Pharmaceutical Patents
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7
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1.3
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The Requirements of TRIPS
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14
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1.4
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TRIPS Flexibilities and the Doha Declaration
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15
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1.5
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The Experiences of Brazil, China, India and South Africa
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21
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1.6
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The Role of the WHO
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26
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1.7
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Research Questions and Methodology
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29
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1.8
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Chapter Summary
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34
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2.
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Case Study on Bangladesh’s Pharmaceutical Industry, Legislative and Institutional Framework and Pricing of Pharmaceuticals
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37
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2.1
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Introduction
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37
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2.2
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Legislative Framework: Pharmaceutical Patents and Pharmaceutical Regulation
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38
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2.2.1
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Patent Regime: Patent Law and the Patent Office
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38
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2.2.2
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Pharmaceutical Regulations: Relevant Laws and the Regulatory Body
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44
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2.2.3
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Changes Required in Patent Law and Pharmaceutical Regulation in Bangladesh
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56
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2.3
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The Pharmaceutical Industry in Bangladesh
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60
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2.3.1
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The Nature and Size of Firms
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60
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2.3.2
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Competitive Scenario
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61
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2.3.3
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Local Sales, Export and Import
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63
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2.3.4
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Production Capacity and Range
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67
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2.3.5
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Use of Technology
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69
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2.3.6
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Innovation Capacity and Research and Development
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70
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2.3.7
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Government Incentives for Supply of Raw Materials and Exports
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72
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2.3.8
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Human Resources
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73
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2.4
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(Potential) Effects of Pharmaceutical Patents on the Pricing of Drugs in Bangladesh
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74
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2.5
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Waiver for the Least Developed Countries and the Pharmaceutical Industry in Bangladesh: Opportunities and Challenges
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82
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2.6
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Which Way for Bangladesh?
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85
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3.
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The Experiences of TRIPS-compliant Patent Law Reform in Brazil, China, India and South Africa—Lessons for Bangladesh
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89
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3.1
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Background
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89
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3.2
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The Journey Towards TRIPS and Obligations for Patent Law Reforms
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92
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3.2.1
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Patentable Subject Matter
|
95
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3.2.2
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Rights and Obligations of Patentees
|
97
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3.2.3
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The Term of Patent Protection
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98
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3.2.4
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Enforcement Obligations
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100
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3.2.5
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Exceptions and Limitations of Exclusive Rights
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102
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3.2.6
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Provisions on August 30 Decision (Implementation of Para. 6 of the Doha Declaration)
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102
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3.3
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The Experience of Brazil
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106
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3.4
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The Experience of China
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114
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3.5
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The Experience of India
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120
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3.6
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The Experience of South Africa
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129
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3.7
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Comparative Review and Lessons for the LDCs, including Bangladesh
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143
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3.8
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Concluding Remarks
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148
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4.
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The Globalising Standard of Patent Protection in WTO Law and Policy Options for the LDCs: The Context of Bangladesh
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149
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4.1
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Introduction
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149
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4.2
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Legislative Options for Bangladesh
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153
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4.2.1
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A High Threshold and Exclusion Clause
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153
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4.2.2
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Best Mode Disclosure and Disclosure of the Source of Genetic Resources and Traditional Knowledge
|
158
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4.2.3
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Narrowing the Scope of Patent Claims
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163
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4.2.4
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Exceptions to Product Patent Rights
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164
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4.2.5
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Early Working (or Bolar Exceptions), Research and Experimental Use
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165
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4.2.6
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Parallel Imports
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169
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4.2.7
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Strong Compulsory Licensing Mechanisms
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175
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4.2.8
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Prior Use Exceptions
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186
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4.2.9
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Pre-grant and Post-grant Opposition
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187
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4.2.10
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Duration of Patent Protection
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190
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4.2.11
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Do Not Adopt Overprotective Enforcement Provisions
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192
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4.3
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Government Intervention Options
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195
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4.3.1
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Drug Price Control
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197
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4.3.2
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National Competition Law
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205
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4.3.3
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Patent Prize System
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211
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4.3.4
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Limit Data Protection
|
217
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4.3.5
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Patent Pool on Country-specific Diseases
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220
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4.3.6
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Avoiding Bilateral Investment Treaties or Free Trade Agreements that Erode TRIPS Flexibilities
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224
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4.3.7
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Utilisation of the Transitional Period for Pharmaceutical Patents
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228
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4.3.8
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Provision for Process Patent during the Transitional Period and Adoption of a Utility Model Law
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231
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4.3.9
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Special Investment Protection Regime, Open Drug Innovation Model and Promotion of Social Business Model in the Pharmaceutical Sector
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233
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4.4
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Conclusion
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236
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5.
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Has the TRIPS Waiver Helped the Least Developed Countries Progress Towards Innovation and Compliance?
|
239
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5.1
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Background: TRIPS Waivers for the LDCs and Designing a Plan of Action for Graduation and Progression Towards Innovation and Compliance
|
239
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5.2
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Extending the LDC Transition Period: Is it a Measure for Making a Viable Technological Base or Simply a Waste of Time?
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241
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5.3
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The Case of Bangladesh: Has the Country Gained from its LDC Status and the Transition Period?
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245
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5.4
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Progress Towards Graduation and Compliance
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248
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5.4.1
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When and How Might LDCs Graduate from this Category?
|
248
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5.4.2
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Competitiveness of the Local (Pharmaceutical) Industry and a Plan for Graduation from the LDC Category and Progress towards TRIPS Compliance: The Context of Bangladesh
|
250
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5.5
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Progress towards Graduation and Compliance: Institutional and Infrastructural Issues in Bangladesh
|
258
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5.5.1
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Capacity Building in the Department of Patents, Designs and Trademarks, and Intellectual Property-related Institutional and Infrastructural Issues
|
260
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5.5.2
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Capacity Building in the Directorate of Drug Administration and Public Health-related Institutional and Infrastructural Issues
|
264
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5.6
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Adopting a National Development-centred Intellectual Property Policy and a National Health Strategy Integrating Long-term Innovation and Access Objectives
|
270
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5.7
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Collaboration between Univeristies, Industry and Government and Public-private Partnerships
|
273
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5.8
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Limitations and Further Research
|
276
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5.9
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Concluding Remarks
|
277
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|
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Bibliography
|
281
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Appendices
|
311
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Appendix 1: Status of Patents in Bangladesh (1972–2012)
|
311
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Appendix 2: Relevant Provisions of the TRIPS Agreement
|
313
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Index
|
319
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