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23 Berkeley Tech. L.J. 281 (2008)
Trials and TRIPS-ulations: Indian Patent Law and Novartis AG v. Union of India

handle is hein.journals/berktech23 and id is 285 raw text is: TRIALS AND TRIPS-ULATIONS: INDIAN PATENT
LAW AND No VAR TIS A G v. UNION OF INDIA
By Linda L Lee
I.     INTRODUCTION
When pharmaceutical company Novartis challenged the rejection of its
patent application for the leukemia drug Gleevec in Novartis A G v. Union
of India,' it became the first major legal challenge to India's newly
amended patent law. In 2005, India purportedly made the final changes
required to bring its intellectual property laws in compliance with the
Trade-Related Aspects of Intellectual Property Rights (TRIPS), the World
Trade Organization's (WTO) minimum standards for intellectual property
protection,2 but its patent law is still fraught with a number of controver-
sial provisions. The ability of pharmaceutical companies such as Novartis
to secure patent protection in India not only is important in creating incen-
tives for pharmaceutical research, but also greatly affects the Indian ge-
neric drug industry, and therefore the price of medicine available to pa-
tients. India is the world's second most populous country3 and the second-
fastest growing major economy,4 but has 70% of its population living on
less than $2 per day,5 making Novartis A G of paramount importance.
© 2008 Linda L. Lee.
1. Novartis AG v. Union of India, (2007) 4 MADRAS L.J. 1153, available at
http://www.scribd.com/doc/456550/High-Court-order-Novartis-Union-of-India.
2. Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15,
1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, Le-
gal Instruments-Results of the Uruguay Round, 33 I.L.M. 81 (1994) [hereinafter
TRIPS], arts. 27-38 (setting forth obligations for patent protection). The WTO granted
developing countries and least developed countries (LDC) transitional periods to comply
with all the provisions of TRIPS. See TRIPS, art. 65.4 (To the extent that a developing
country Member is obliged by this Agreement to extend product patent protection to ar-
eas of technology not so protectable in its territory on the general date of application of
this Agreement for that Member, ... it may delay the application of the provisions on
product patents of Section 5 of Part II to such areas of technology for an additional period
of five years.). Under this provision, India had a January 1, 2005 deadline to fully com-
ply with TRIPS. See infra Part II.D.3.
3. Central Intelligence Agency, Rank Order-Population, https://www.cia.gov/
librarypublications/the-world-factbook/rankorder/2119rank.html (last visited Apr. 5,
2008). See also CENTRAL INTELLIGENCE AGENCY, THE 2007 WORLD FACTBOOK 261
(2006).
4. U.S. Dept. of Agriculture, Economic Research Service, Briefing Room-India,
http://www.ers.usda.gov/Briefing/India/ (last visited Oct. 28, 2007).
5. Fareed Zakaria, India Rising, NEWSWEEK, Mar. 6, 2006, at 38.

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