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India’s trade-related aspects of Intellectual Property Rights compliant pharmaceutical patent laws: what lessons for India and other developing countries?Jae Sundaram*Law School, University of Buckingham, Buckingham, UKIndia’s trade-related aspects of Intellectual Property Rights (TRIPS) compliant Patent (Amendment) Act 2005 saw the transformation of its laws from a process patent regime to a product patent regime. The amendments have had a direct impact on India’s generic drugs manufacturing sector, which was developed through the process patent regime introduced under the 1970 Act. The knock-on effect will soon be felt both domestically and globally, as a number of developing countries have come to rely strongly on Indian generics. This article seeks to study the effectiveness of the Act of 2005, and if it can be seen as an instance of success of the TRIPS provisions in Articles 7 and 8 read along with the Doha Declaration. It will be queried if developing countries in the World Trade Organization can possibly benefit from the model set-up by India for the issuance of compulsory licenses, and to check the practice of ‘evergreening’ by pharmaceutical patent holders. Recent decisions from the Indian judiciary and the quasi-judicial authorities, along with the procedures and policies put in place will be used to carry out the study.Keywords: TRIPS; India; patents; compulsory-licensing; evergreening; generics1. IntroductionIndia passed the Patent (Amendment) Act of 2005 to bring its patent laws in line with the trade-related aspects of Intellectual Property Rights (TRIPS) Agreement’s agenda of extending international intellectual property protection to patent right holders, who were mostly from developed countries. India through the implementation of the TRIPS Agree- ment was constrained to give up on its process patent regime, which was originally intro- duced in 1970 to develop its generic drug manufacturing market and to create better access to medicines. The introduction of the new patent laws witnesses a radical shift in Indian policies on pharmaceutical and chemical patenting. Taking the TRIPS compliance exercise as an opportunity, India has firmed up on its compulsory licensing laws, introduced direct provisions on ‘exhaustion of patent rights,’ ‘pre-grant’ and ‘post-grant’ opposition, and has most importantly introduced provisions to check the practice of evergreening. It can be argued that the patent law regime introduced in India demonstrates how developing countries can utilize the TRIPS flexibilities to introduce laws to suit the requirements of its own health care policies.© 2014 Taylor & Francis*Email: & Communications Technology Law, 2014 Vol. 23, No. 1, 1–30, decision to change the patent laws gains in importance, as India is one of the fastest growing pharmaceutical markets, with some writers referring to it as the ‘pharmacy of the developing world.’ The jurisprudence from the courts on the Amended Act of 2005 is still nascent; but one can still infer, from the decisions of Indian courts and quasi-judicial auth- orities, the strong stance taken by India on patent evergreening, the use of pre-grant and post-grant opposition, and compulsory licensing. Although there is clear judicial precedent, emerging from developed countries like the USA and UK where evergreening is scorned upon, it is India that has taken the first step in introducing legislative measures to check the practice of evergreening. A combined reading of the amended laws, the provisions of the TRIPS Agreement and the recent judicial and quasi-judicial renderings from India present an interesting area for study. They seem to suggest that developing countries can operate the TRIPS flexibility to deal with national emergencies, as access to patented medi- cines become unaffordable and reliance is more on generic medicines.2. Indian patent lawsIndian patent laws are steeped in its colonial past, as it was under British rule for close to 200 years, between 1757 and 1947.1 This period saw the introduction of the common law in India, and importantly the first legislation on patent rights in 1856, which was primarily designed to serve the interest of British patent holders. It is safe to assume that any legis- lative attempts to codify a practice of granting patents began in India only during the British rule and in particular from the nineteenth century.2 The Indian patent laws can be broadly categorized under two heads, namely ‘pre-independent India’ and ‘post-independent India.’3 The legislative history of pre-independent India’s patent laws is well chronicled,4and the current study will focus on patent laws passed in India from the post-independent period, leading up to its amendment in 2005.2.1. Post-independenceAt the time of independence from British rule, India was predominantly an agrarian society, with over two-thirds of its population living in rural areas. Access to medicines was scarce, and much limited to the affluent, due to a lack of indigenous production of drugs,5 and for1India was under the British East India Company Rule from 1757 until the transfer of power to the British Crown in 1858, and later Queen Victoria was proclaimed Empress of India in 1876. The British rule, referred to as ‘British Raj’ came to an end in August 1947. The region referred to as ‘British India’ also included the modern day states of India, Pakistan, Nepal, Bangladesh and other countries. 2Legislative attempts began with the first legislation under British rule on the subject, and the Indian Patent Act was passed in 1856. Roundabout the same time, power was completely transferred to the Crown from the British East India Company. 3The modern history of Indian patent laws can be brought within three categories, namely pre-legis- lation period, the period of exclusive privileges and the period of patents. DN Choudhary, Evolution of Patent Laws: Developing Countries Perspective (Capital Law House, 2006) 13. 4TV Garde, ‘India’ in P Goldstein and J Strauss (eds), Intellectual Property in Asia: Law, Economics, History and Politics (Springer, 2009). For a detailed legislative history of the Indian Patent Act, see generally, JM Mueller, ‘The Tiger Awakens: The Tumultuous Transformation of India’s Patent System and the Rise of Indian Pharmaceutical Innovation’ (2007) 68 U Pitt L Rev 491. 5Choudhary (n 3) 9–10. See also ‘First Five Year Plan’ promulgated by India, where one of the objec- tives sought to be achieved was identified as improvement of ‘ … standard of living of the people by


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