Novartis Patent Case: Paper dealing with Constitutional Law Issues

Along with Prashant Reddy (who blogs me with me at SpicyIP), I just finished a paper 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 very rough draft –so we would love your comments. Any inputs will be gratefully acknowledged in the paper.

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


“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).”

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