Citations (1)



'Ducking' TRIPS in India: A Saga Involving Novartis and the Legality of Section 3(d)

Shamnad Basheer

National Law School of India University

Prashant Reddy


January 17, 2009

National Law School of India Review, Vol. 20, No. 2, pp. 131-155, 2008

Glivec, a path-breaking anticancer drug by Novartis propelled Indian patent law onto the world stage in an interesting theatre involving TRIPS and the yet unresolved issue of pharmaceutical patents and their impact on access to medicines.

In 2006, the Indian patent office rejected a patent application covering Glivec (or "Gleevec" as it is known in the United States). The rejection stemmed, inter alia, from a unique section in the Indian patent regime (section 3(d)) that prohibits the patenting of new forms of existing pharmaceutical substances that do not demonstrate significantly enhanced "efficacy."

Not only did Novartis appeal the patent office decision, but in a rather controversial move, it challenged the TRIPS compatibility and constitutionality of section 3(d). The Madras High Court ruled that section 3(d) was constitutional. It also held that it did not have jurisdiction to rule on the TRIPS issue. This paper will critically examine the constitutionality and TRIPS compatibility issues thrown up by section 3(d). It will argue that the court was right in defending the constitutionality of section 3(d). It will also go on to demonstrate that section 3(d) is compatible with TRIPS.

However, it will question the court's "ducking" of the TRIPS issue by claiming that it lacked "jurisdiction" on this count. In particular, it critiques the reasoning of the court on this count and argues that the court ignored a number of sound Indian precedents in favour of outdated case law from abroad.

Number of Pages in PDF File: 25

Open PDF in Browser Download This Paper

Date posted: January 18, 2009  

Suggested Citation

Basheer, Shamnad and Reddy, Prashant, 'Ducking' TRIPS in India: A Saga Involving Novartis and the Legality of Section 3(d) (January 17, 2009). National Law School of India Review, Vol. 20, No. 2, pp. 131-155, 2008. Available at SSRN: http://ssrn.com/abstract=1329201

Contact Information

Shamnad Basheer (Contact Author)
National Law School of India University ( email )
Gnana Bharathi Main Road
Bangalore, Karnataka 560242
9818825148 (Phone)
HOME PAGE: http://www.nls.ac.in
Prashant Reddy
Independent ( email )
No Address Available
United States
Feedback to SSRN

Paper statistics
Abstract Views: 4,766
Downloads: 1,080
Download Rank: 11,988
Citations:  1
Paper comments
No comments have been made on this paper

© 2015 Social Science Electronic Publishing, Inc. All Rights Reserved.  FAQ   Terms of Use   Privacy Policy   Copyright   Contact Us
This page was processed by apollo4 in 0.422 seconds