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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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