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23 Info. & Comm. Tech. L. 1 (2014)

handle is hein.journals/infctel23 and id is 1 raw text is: Information & Communications Technology Law, 2014 !Z Routledge Vol. 23, No. 1, 1-30, http://dx.doi.org/10.1080/13600834.2014.891310 U V 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, UK India'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; generics 1. Introduction India 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. *Email: jae.sundaramgbuckingham.ac.uk C 2014 Taylor & Francis

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