Intellectual Property and Public Health in the Developing World

Intellectual Property and Public Health in the Developing World Monirul Azam
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The book is lucid in language, manageable in size and easy in navigation. Thus, legal scholars, researchers, policy makers and other stakeholders would find it as an excellent resource to successfully comprehend the dynamics of medicine patenting and public health concerns under TRIPS and post-TRIPS regimes for the developing word in general and Bangladesh in particular.

–Mohammad Ataul Karim, Journal of Intellectual Property Law & Practice, September 7, 2016

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. Azam's 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 Organization's 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.

Intellectual Property and Public Health in the Developing World

Monirul Azam | May 2016
348 | 3 colour illustrations | 6.14" x 9.21" (234 x 156 mm)
ISBN Paperback: 9781783742288
ISBN Hardback: 9781783742295
ISBN Digital (PDF): 9781783742301
ISBN Digital ebook (epub): 9781783742318
ISBN Digital ebook (mobi): 9781783742325
ISBN Digital (XML): 9781783746323
DOI: 10.11647/OBP.0093
BIC subject codes: LNR (Intellectual property law), LNRD (Patents law), LNTM2 (Regulation of medicines & medical devices), MBGR (Medical research); BISAC subject code: MED000000 (MEDICAL / General), MED022000 (MEDICAL / Diseases); OCLC Number: 1129851935.

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List of Tables
List of Figures

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

    Appendix 1: Status of Patents in Bangladesh (1972–2012)
    Appendix 2: Relevant Provisions of the TRIPS Agreement

Monirul Azam is the course director of intellectual property and sustainable development at Stockholm University as well as the course director in intellectual property law at the University of Chittagong. He has undertaken research on intellectual property and sustainable development under the auspices of the Institute of Advanced Studies at the United Nations (UNU/IAS), and has published extensively on intellectual property, access to medicines and pharmaceutical patents.

This study explored how to design national patent laws and undertake the required institutional and infrastructural reforms that are optimal in terms of enabling developing countries and Least Developed Countries (LDCs) to promote innovation in their domestic pharmaceutical sectors and ensure access to medicines. Individual countries were free to determine their own patent laws prior to the establishment of the World Trade Organization (WTO). However, the Agreement on Trade-Related Aspects of Intellectual Property Rights (the TRIPS Agreement), which is binding on all WTO members, aims at establishing strong minimum standards for intellectual property rights (IPRs). Such minimum standards include the implementation of patent protection for pharmaceuticals. Bangladesh is a member of the WTO and, as an LDC, has been granted transitional periods until 1 July 2021 to protect IPRs under the TRIPS Agreement. Further, being an LDC, Bangladesh can also exploit the waiver for pharmaceutical patents until 1 January 2033. This study analyses experiences of implementing TRIPS-compliant patent laws in Brazil, China, India and South Africa, and explores potential policy options for the LDCs with a case study on the pharmaceutical sector in Bangladesh.
Bangladesh has attained a degree of self-sufficiency with respect to the manufacture of pharmaceuticals: local industry now caters for 97% of local needs via the production of generic medicines that are free from the patent regime. However, this policy has both disadvantages and advantages. One advantage is the availability of lower-priced pharmaceuticals, and one disadvantage is that Bangladesh missed out on the opportunity to develop an innovative research and development (R&D)-based pharmaceutical industry. Further, the lack of a pharmaceutical patent regime over the years has created a vacuum in terms of the existence of relevant regulatory bodies (Patent Offices and the Directorate General of Drug Administration) and has also led to the local pharmaceutical industry being unprepared for the post-TRIPS situation. Brazil, China, India and South Africa were in a similar position prior to becoming TRIPS compliant, so those countries’ experiences are an important basis for the analysis of the transition to TRIPS compliance in pre-compliant countries. This study combines doctrinal analysis, comparative reviews and a case study, using a survey and interviews to answer specific research questions.
The study examines three underlying research questions:
  1. What are the policy options used by Brazil, China, India and South Africa for the implementation of the TRIPS Agreement and preservation of the local pharmaceutical sector?
  2. What are the (potential) policies for the LDCs (such as Bangladesh) to promote their local pharmaceutical industry and access to medicines?
  3. What are the infrastructural and institutional issues that need to be addressed by the LDCs to deal with a post-TRIPS patent regime?
To answer research question 1, the thesis used doctrinal analysis and comparative reviews, whereas to answer research question 2 it conducted a case study in selected LDCs (Bangladesh) using a survey instrument and interviews to examine the views of identified stakeholders such as the pharmaceutical industry, regulatory bodies in Bangladesh, public health groups and academics. Then, considering the findings in relation to research questions 1 and 2, and the perceptions of different stakeholders, this study further identified infrastructural and institutional issues that need to be addressed by the LDCs (such as Bangladesh) to deal with a post-TRIPS patent regime.
This research makes a contribution to the body of knowledge on TRIPS and intellectual property (IP) in four ways, as this study:
  • analyses the contemporary literature examining TRIPS and its effect on access to medicines in developing countries and the LDCs, particularly India, Brazil, China, South Africa and Bangladesh;
  • presents a case study using a survey and interviews to evaluate the status of the pharmaceutical industry and perceptions of other stakeholders regarding TRIPS and its implementation in Bangladesh;
  • produces recommendations that may facilitate the utilisation of TRIPS flexibilities in the LDCs, such as Bangladesh, and
  • identifies the infrastructural and institutional issues that need to be addressed by Bangladesh in a post-TRIPS patent regime, efforts which may also be replicated by other developing countries and the LDCs.