Pharmacy of the developing world: reconciling intellectual property rights in India with the right to health: TRIPs, India's patent system and essential medicines.

Author:Bazzle, Timothy
Position:Agreement on Trade-Related Aspects of Intellectual Property Rights

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. (11)

This Note will explore how India has reconciled the emergence of global IPR with its role as the pharmacy of the developing world, all the while interpreting these competing obligations in terms of the right to health. The Note will first consider the contours of the right to health in India, examining both the substantive right to health under India's Constitution and the interlacing international agreements to which India is a party that reinforce the right to health. Next, the Note will turn to the newly emergent international intellectual property rights (IPR) regime formalized in TRIPS and how India has mapped its domestic patent system to align with TRIPS. Finally, the Note will analyze three separate patent cases recently decided by Indian courts and the Indian patent law provisions on which they are based. The resolution of these cases reveals the intricate inter-balancing Indian courts and advocates have advanced in reconciling patent law requirements with the right to health. Much scholarly attention has focused on the relationship between emergent IPR norms, India's incorporation of these norms into its domestic patent system and the production of Indian generics. (12) Rather than belabor these arguments, this Note examines the extent to which Indian courts have adapted right to health principles into their interpretation of Indian patent law provisions. By explicitly invoking the right to health in their disposition of several recent challenges to the production of generic drugs, Indian courts have signaled that the growing hegemony of IPR will not subvert the right to health, at least within India's domestic patent law framework. This jurisprudence could provide a propitious set of legal arguments to health rights' advocates seeking to protect and expand Indian generic drug production within the landscape of international IPR.


    Adopted in 1950, the Indian Constitution presciently anticipated many of the ideals enshrined in the watershed international human rights agreements that followed it. (13) While not explicitly delineating a right to health, the Indian Constitution enshrines the right to life as a fundamental right in Article 21, (14) and the Indian Supreme Court has expansively construed the right to life to encompass a right to health. (15) For example, the Indian Supreme Court has interpreted the constitutional right to life as requiring the State to provide timely medical treatment to preserve human life (16) and as including a right to the protection of health at work and freedom from sexual harassment. (17) This right to life jurisprudence has gone hand-in-hand with a longstanding tradition in Indian constitutional law to relax standing requirements for cases that implicate the public interest. (18) By broadening the substantive dimensions of the right to life and liberalizing standing requirements so that "any member of the public" may seek redress for a legal wrong in the public interest, the Indian judiciary has created a uniquely hospitable litigation culture for pursuing legal claims to the right to health. (19)

    The right to health also has an important place within international law. Article 25.1 of the Universal Declaration of Human Rights (UDHR) affirms that "everyone has the right to a standard of living adequate for the health and well-being of himself and his family, including ... medical care and necessary social services." (20) The right to health has also been elaborated on in a number of binding treaty instruments, including the International Convention on the Elimination of All Forms of Racial Discrimination, (21) the Convention on the Elimination of All Forms of Discrimination against Women, (22) and the Convention on the Rights of the Child (23)--all of which have been either ratified or acceded to by India. Reinforcing its constitutional obligations to promote the right to health, India also ratified the International Covenant on Economic, Social and Cultural Rights (ICESCR) in 1979, which is the foundational treaty agreement recognizing and individual right to health. (24) Aspirational in tone but legally binding nevertheless, Article 12 of the ICESCR obligates States Parties to "take steps" to realize the universal "right of everyone to the enjoyment of the highest attainable standard of physical and mental health." (25) In May 2000, the Committee on Economic, Social and Cultural Rights adopted General Comment 14, which gave content to the lofty principles set forth in Article 12. (26) General Comment 14 is a thoughtful and pragmatic consideration of the multi-dimensional nature of the right to health in a global landscape where disparate economic, cultural and political conditions preclude a one-size-fits-all approach to realizing each person's individual right to health. While a detailed exploration of General Comment 14 is beyond the scope of this Note, a brief discussion of what the Committee identified as the "essential elements" to the right to health is useful because it will orient the analysis that follows on how India's implementation of TRIPS's intellectual property requirements in its domestic patent system implicates its domestic and international obligations to promote the right to health.

    General Comment 14 states that the right to health contains the "essential elements" of availability, accessibility, acceptability and quality. (27) Within these four essential elements are various sub-components, and the Committee devotes particular attention to elaborating the multiple dimensions of the "accessibility" prong, explaining that "accessibility" entails "nondiscrimination," "physical accessibility," "affordability" and "information accessibility." (28) How a State goes about fulfilling its ICESCR obligations to promote the right to health depends on its "prevailing" domestic conditions, (29) but the Comment makes clear that a State will not meet its ICESCR duties unless it ensures the availability, accessibility, acceptability and quality of all of the "underlying determinants of...

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