The “Efficacy” of Indian Patent Law: Ironing out the Creases in Section 3(d)
Authors
Shamnad Basheer and T. Prashant Reddy
Shamnad Basheer (Research Associate, Oxford IP Research Centre) and T. Prashant Reddy (Vth Year B.A.LLB (Hons.) Student, National Law School of India University). A previous and somewhat distinct version of this article, authored by Shamnad Basheer, won the first place in a competition held by ATRIP, an international association of IP law teachers and researchers. The authors wish to sincerely thank Feroz Ali (Advocate), Tahir Amin (IMAK), Pravin Anand (Anand and Anand), Nihas Basheer (Wadia Gandhy), Caleb Gabriel (K&S), Mrinalini Kochupillai (Consultant), Janice Mueller (Univ of Pittsburgh), Dr Gopakumar Nair (Patent Gurukul), Promod Nair (Herbert Smith, UK), Chris Ohly (Schiff Hardin), Vivek Reddy (Advocate, Hyderabad), Bhaven Sampat (Columbia Univ), Swathi Sukumar (Anand and Anand), Steven Smith (NuPharm, UK), H Subramaniam (S&N Associates) Arun Kumar Thiruvengadam (NUS, Singapore), CH Unnikrishnan (Mint) and Vijayaraghavan (Ranbaxy) for their inputs and/or comments on earlier drafts. We also thank Shawn Harmon, Wiebke Abel and other editors of SCRIPTed for giving us ample time to build on our initial draft and for helping better the paper through their fine editing. Our gratitude comes with the usual caveat that they are in no way responsible for our mistakes. A separate paper focussing only on the constitutionality and TRIPS compatibility aspects of section 3(d) is being published in the National Law School of India Review. See Shamnad Basheer and T. Prashant Reddy “Ducking TRIPS in India: A Saga involving Novartis and the legality of Section 3(d)” (2008) 20(2) National Law School of India Review.
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.
