Are developing countries going too far on TRIPS? A closer look at the new laws in India.

INTRODUCTION The goal of the Trade-Related Aspects of Intellectual Property Rights (TRIPS ) Agreement is to harmonize the intellectual property rights of World Trade Organization (WTO) member countries to a certain minimum standard.1 As a WTO member, the organization required India to enact legislation that enforces TRIPS by 2005.2 Part of India's motivation to pass its 2005 Patents Act stemmed from its obligations as a WTO member nation, as well as the government's desire to stimulate greater foreign investment, innovative research and economic growth.3 India's implementation of the TRIPS Agreement has generated a great deal of controversy.4 Disagreement exists about whether the Indian Patents Act overzealously protects intellectual property rights and whether the Patents Act goes beyond the spirit of the TRIPS Agreement.5 Many health officials and non-governmental organizations (NGOs) are seriously concerned about what the Patents Act implies for people suffering from diseases in less developed countries.6 Nonprofit and some World Health Organization officials argue that the new law prevents India from producing and supplying generic drugs within its borders and to other developing countries.7 A number of contentious issues surround the Patents Act, including the issue of compulsory licensing.8 In India, as companies are restructuring and adjusting to the new Patents Ordinance, the concern is that many companies will not embark on the process of obtaining permission to produce drugs within India or for the LDC market.9 Since the Patents Act of 2005 requires government permission for compulsory licenses, many NGOs and health officials fear that whatever marginal access to medicines poor patients once had is now gone.10 Indian companies' investment strategies have already changed in response to the 2005 Patents Act.11 However, as Indian companies' motivations for supplying essential medicines pre-TRIPS were not solely profit driven, these biotech companies would likely continue production of generics if the legal requirements for obtaining permission are not unduly burdensome.12 Currently, LDCs such as those in Sub-Saharan Africa have access to crucial ARV drugs because most of the ARVs produced in India and other developing countries are off-patent.13 Future innovation is the main concern in Sub-Saharan Africa. Since HIV/ AIDS constantly mutates, scientists must continuously develop new treatments.14 While barriers exist in the creation of effective ARVs for specific Sub-Saharan African strains of H I V/ AI DS, the concern about the Indian Patents Act and other TRIPS-related laws is that if and when a new technology is developed, countries like India will not be allowed to produce this new technology for patients in LDCs.15 This note examines the legal and ethical implications of the TRIPS Agreement with respect to compulsory licensing for public health crises. Specifically, it closely analyzes the TRIPS Agreement and India's Patents Act to see whether the new TRIPS-related legislation in India causes substantial interference for the provision of crucial drugs in the developing world. It looks at whether India has effectively taken advantage of the compulsory licensing provisions of TRIPS and the Paragraph 6 exception of the DOHA accords, and whether India is still able to aid itself and other smaller nations in their public health crises. Part I of the article explains the context of the relevant legal treatises: the TRIPS Agreement, the DOHA Accord, and the Indian Patents Act. This part addresses and summarizes the issues related to procuring essential medicines as well as the economic incentives for TRIPS compliance. Part II discusses the different international laws that pertain to intellectual property rights. It specifically focuses on those laws relevant to compulsory licensing, and laws regarding procurement of medicines for developing country diseases. Part III analyzes the language of the new laws, its possible interpretation, and judicial and administrative interpretations thus far. …