Pharmacy of the Developing World: Reconciling Intellectual Property Rights in India with the Right to Health: TRIPS, India's Patent System and Essential Medicines

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TABLE OF CONTENTS

INTRODUCTION

  I. THE RIGHT TO HEALTH IN INDIA

 II. INTELLECTUAL PROPERTY RIGHTS: TRIPS, INDIA'S PATENT
     SYSTEM AND ESSENTIAL MEDICINES
     A. The Trade-Related Aspects of Intellectual Property Rights
        Agreement
     B. Indian Patent Law: A Brief History, Before and After
        TRIPS

III. THE RIGHT TO HEALTH IN INDIAN PATENT LAW: THREE RECENT
     CASES
     A. Novartis AG v. Union of India: Patents for
        Pharmaceutical Products and the Right to Health
     B. Tenofovir: Pre-Grant Oppositions to Pharmaceutical
        Patents and the Right to Health
     C. Bayer Corporation v. Union of India: Patent Linkage
        and the Right to Health

CONCLUSION

INTRODUCTION

India's importance to the developing world as a generic drug producer cannot be overstated. Dubbed the "pharmacy of the developing world," India exports nearly 67% of its considerable output of generic medicines to developing countries, making it the main supplier of essential medicines to the developing world. (1) UNICEF, the International Dispensary Association, the Global Fund, and the Clinton Foundation have collectively provided anti-retroviral (ARV) treatments to more than 900,000 individuals affected with HIV/AIDS in eighty-seven developing countries since 2005, a prodigious effort facilitated in no small part by India's thriving generics industry--70% of the treatments these organizations dispensed were provided by Indian suppliers. (2) Data shows that the prices for first-line ARV regimens decreased by 30-68% from 2004 to 2008 and by 10-40% from 2006 to 2008, and these sharply reduced prices are largely attributable to the development and distribution of generic drugs. (3) The proliferation of these low-cost alternatives to name-brand, patented drugs has had a profound impact on global health, particularly in the developing world, significantly reducing the HIV-attributable mortality rate in many countries. (4) It does not exaggerate matters to credit Indian generics for their role in realizing these impressive gains in global health outcomes.

However, looming just on the horizon and threatening to unravel these remarkable gains is the prospect of diminished generic medicine production as a result of expanding international intellectual property rights (IPR). (5) In 1995, the Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPS) was opened for signature with the stated goal of "reduc[ing] distortions and impediments to international trade." (6) All Members of the World Trade Organization (WTO)--the international body charged with overseeing TRIPS--were given a prescribed period of years to bring their domestic patent systems in line with TRIPS requirements, and India ultimately modernized its patent law in 2005 to reflect the purposes and goals articulated in TRIPS. (7) Before migrating to TRIPS, India had maintained a deliberately weak, protectionist patent regime in order to allow its government to invest in industrial development and nuture a strong domestic pharmaceutical industry. (8) It was in this pro-technology transfer environment that India's generic medicine infrastructure flourished and that India raced to the forefront in providing essential medicines to combat the world's most grievous infectious diseases. (9) Given India's pre-TRIPS, genetic-friendly patent law system, there was a great deal of anxiety within India and across the developing world that India's adoption of a TRIPS-modeled intellectual property regime would thwart its robust generic drug industry and thereby deprive the world's most destitute populations of ready access to affordable and high quality essential medicines. (10) This anxiety has grown even more pronounced since 2005, as the grasp of global IPR has grown stronger, and the need for new generic copies of second and third-generation ARV treatments has increased as more individuals have developed drug resistance to existing ARV therapies. …