Faculty Post: Supreme Court of India Rejects Pharmaceutical Patent Application

by Professor Brook K. Baker

This is an exciting day for me to be writing an admissions blog for the School of Law because the Supreme Court of India has just issued a landmark decision rejecting a patent application for a Novartis cancer medicine, Glivec.

Wait a minute, you might ask, how can it be important what a court in India does about something as esoteric as a patent on one drug.  Well, because India, like many countries previously, did not grant patents on medicines from 1972-2005, it developed a robust generic industry capable of producing medicines to global quality standards.  India became the “pharmacy of the developing world” thereafter, particularly with respect to AIDS medicines where its companies supply nearly 90% of the antiretrovirals used to treat 8 million HIV-infected people in low- and middle-income countries. Even when India was forced to become compliant with the WTO agreement addressing intellectual property rights, it adopted strict (high) standards of patentability designed to prevent so-called secondary patents on minor variations of existing medicines.

I have worked with an international coalition of AIDS activists for 13 years who have, among many other things, worked for the adoption of these strict standards of patentability in India and to preserve those protections.  Novartis, on the other hand, has filed successive court suits against India’s strict standards of patentability, first challenging them as unconstitutional and contrary to international law.  That case was thrown out in 2007 by the Madras High Court.  More recently, Novartis raised a more technical argument that attempted to eviscerate India’s strict patent standards on pharmaceuticals by arguing either that they don’t ordinarily apply or that the standard should be reinterpreted to cover such issues as solubility and shelf life rather than therapeutic efficacy.  In a decision, now celebrated around the world, the Supreme Court of India rejected that challenge, labeling it essentially frivolous.

The threat to Indian generics, which for AIDS medicines cost .5% of what they cost in United States, is not over.  Both the European Union and the United States are proposing terms in “free” trade agreements that would make high standards such as those in India unlawful.  The U.S. is putting intense diplomatic pressure on India both with respect to these standards and with respect to other lawful flexibilities that India has incorporated into its patent law.  I got up at 5:00 this morning to read the opinion, to contact journalists, and to write on activists listserves about the decision.  This is the kind of issue that brings passion to my scholarship, service, and teaching at Northeastern.