Table des matières
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 Mechanism
- 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
