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

Abstract:     
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reasoning of the court on this count and argues that the court ignored a number of sound Indian precedents in favour of outdated case law from abroad.

Accepted Paper Series