The 'Efficacy' of Indian Patent Law: Ironing out the Creases in Section 3(d)

Abstract:     
Indian patent law recently landed itself in the eye of a TRIPS storm on account of the rejection of a patent application covering Novartis' famed anticancer drug, Glivec. The rejection stemmed, inter alia, from a unique section in the Indian patent regime (section 3(d)) that seeks to prevent "ever-greening" by prohibiting 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 analyses this decision within the broader framework of section 3(d) and what it seeks to achieve. It argues that although the Madras High Court was correct in concluding that section 3(d) is constitutional, the court's reasoning leaves much to be desired. In particular, the court does not fully appreciate Novartis' alleged invention and the contours of section 3(d).

Though this lack of appreciation is not fatal to the constitutionality analysis by the court, it is reflective of some of the creases inherent in the wordings of section 3(d). The need of the hour is to iron out these creases in section 3(d) and to help brighten the line between pharmaceutical inventions that are patentable and those that are not. This paper not only offers suggestions on how these creases may be ironed out, but also goes on to suggest an amendment to section 3(d).

While some of the suggestions in the paper are immediately implementable, other issues will necessarily involve a more detailed empirical/policy investigation. This paper highlights some of the factors that one might consider whilst undertaking such empirical investigation, a task which is likely to go to the very heart of the age-old debate about what constitutes optimal intellectual property norms for developing countries.

Number of Pages in PDF File: 35

Keywords: Indian Patent Law, TRIPS Compliance, Constitution of India, Pharmaceutical Patents, Developing Countries

JEL Classification: O34, K10, K33

Accepted Paper Series