This session will start out by discussing the Indian Supreme Court decision in the Novartis case concerning the Constitutional validity and scope of the recently added Sec. 3(d) of the Indian Patents Act, 1970. An analysis of this dispute is very important since one of the issues brought forth is India's compliance with TRIPS. Further, this case raises crucial issues with regard to the patentability of formulation inventions, which is linked to the so-called “evergreening” debate.
Next, this session will discuss the recent Indian Natco decision by the Intellectual Property Appellate Board (IPAB, which has laid down the foundations of the Indian jurisprudence of compulsory licensing with respect to pharmaceutical products. The decision has clarified the legislative intent behind various key provisions governing compulsory licensing under the Indian Patents Act, 1970 and contains interesting interpretations of the TRIPs Agreement.
The objective of this session is to describe these decisions and to discuss their compliance with Indian law and the TRIPs agreement.