SpicyIP Scholarship: Paper on the Novartis Patent Case and Section 3(d)


We’re happy to inform our readers that two of our blog members (Prashant Reddy and me) have just completed a draft of an article analysing the Madras High Court judgment in the Novartis case. We focus in particular on the TRIPS compatibility and “constitutionality” of section 3(d) in this paper. I’m copying the abstract below. If you need to access a copy of the article, please click here. Once the page opens, scroll down and click the “download the document from SSRN” button. This is still a draft–so we would love your comments. Any inputs will be gratefully acknowledged in the paper.

I also wanted to share some good news with you. Another paper of mine dealing with section 3(d) and the Novartis patent case (where the focus is more on the policy level implications of section 3(d) for Indian pharmaceutical innovation) was submitted to a competition held by ATRIP (Intellectual Association for the Advancement of Teaching and Research in Intellectual Property), a global association of intellectual property teachers and researchers. It won the first place.

I am very grateful to my colleagues on the blog and many of our readers who vociferously participated in the debates on the Novartis patent case and section 3(d). I’m in the process of revising this paper and will post it soon here for those of you interested in a more indepth analysis of this case.

Anyway, here is the abstract of the paper dealing with section 3(d) and TRIPS/international law/constitutionality:

Title: Section 3(d) of India’s Patent Act: Crude, Yet Constitutional

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 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. More importantly, it also stated that it did not have jurisdiction to rule on the TRIPS issue. As one can appreciate, this does not conclusively settle the TRIPS issue, but only shifts the jurisdictional venue. It is therefore an opportune moment to examine section 3(d), the Madras High Court decision and TRIPS compliance issues.

The paper will argue that section 3(d) is compatible with TRIPS. It will also argue that although the Madras High Court got its conclusions right, it’s reasoning leaves much to be desired. It relied on an antiquated and wrong notion of contract law to rule that it had no jurisdiction to rule on a WTO-TRIPS issue. In order to defend the constitutionality of section 3(d), it relies on propositions that are mutually contradictory and sometimes wrong. This is deplorable, given the fine repertoire of constitutional law jurisprudence that India is home to and which the court might have dipped into. The court also reveals a fascination for citing foreign case law, even when some of these judgments issued more than a century back and are sometimes at loggerheads with what the Supremes have ruled in this country.

On a broader note, this paper will demonstrate that constitutionality notwithstanding, section 3(d) remains a poorly drafted section. Therefore, the government needs to take urgent steps to iron out the creases in section 3(d).”

We would greatly appreciate your feedback and comments.

Shamnad Basheer

Shamnad Basheer

Prof (Dr) Shamnad Basheer founded SpicyIP in 2005. He is currently the Honorary Research Chair of IP Law at Nirma University and a visiting professor of law at the National Law School (NLS), Bangalore. He is also the Founder of IDIA, a project to train underprivileged students for admissions to the leading law schools. He served for two years as an expert on the IP global advisory council (GAC) of the World Economic Forum (WEF). In 2015, he received the Infosys Prize in Humanities in 2015 for his work on legal education and on democratising the discourse around intellectual property law and policy. The jury was headed by Nobel laureate, Prof Amartya Sen. Professional History: After graduating from the NLS, Bangalore Professor Basheer joinedAnand and Anand, one of India’s leading IP firms. He went on to head their telecommunication and technology practice and was rated by the IFLR as a leading technology lawyer. He left for the University of Oxford to pursue post-graduate studies, completing the BCL, MPhil and DPhil as a Wellcome Trust scholar. His first academic appointment was at the George Washington University Law School, where he served as the Frank H Marks Visiting Associate Professor of IP Law. He then relocated to India in 2008 to take up the MHRD Chaired Professorship in IP Law at WB NUJS, a leading Indian law school. Prof Basheer has published widely and his articles have won awards, including those instituted by ATRIP and the Stanford Technology Law Review. He is consulted widely by the government, industry, international organisations and civil society on a variety of IP issues. He also serves on several government committees.

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