A division bench of the Madras High Court today dismissed a challenge to section 3(d) of the Indian Patents Act, 1970 filed by Swiss pharmaceutical multinational Novartis AG and its Indian subsidiary, Novartis India . These petitions challenged the validity of a key provision in the Indian law, which seeks to prevent ever greening and which provided one of several grounds on which the Patent Controller rejected Novartis AG’s patent application for the beta-crystalline of Imatinib Mesylate, brand name Glivec (Gleevec).

In March 2005, with retrospective effect from 1 January 2005, the Indian Parliament amended its patent law to protect product patent protection. A significant and important provision was introduced to prevent every greening and granting of frivolous patents, section 3(d).In May 2006, Novartis filed writ petitions before the Madras High Court, claiming that the Patent Controller erred in rejecting its patent application, and further claiming that section 3(d) was, among other things, vague, ambiguous, and contrary to the requirements of the TRIPS Agreement.In the challenge to section 3(d), Novartis argued that this provision is not in compliance with the TRIPS Agreement and that it is in violation with the government’s (non-enforceable) constitutional duty to harmonise its domestic laws with its international obligations.

Recognising the fact that the TRIPS agreement is non-self executing and provides no private right of enforcement (unlike the rights created under Chapter 11 of NAFTA and many subsequent FTAs), Novartis advanced a somewhat novel claim that while it is open for the Indian Parliament to repudiate its international obligations altogether, it is somehow invalid and unconstitutional for Parliament to otherwise comply with TRIPS except for one particular provision.

The Government of India, CPAA and the generic companies argued that neither could private companies such as Novartis challenge a law as being TRIPS non-compliant nor could an Indian court decide whether the Indian patent law is TRIPS compliant or not. The appropriate forum, they argued, is the WTO Disputes Settlement Body. Upholding this argument, the Madras High Court held that it was not the proper forum to decide whether the Indian patent law was TRIPS compliant or not.The other ground of challenge raised by Novartis was that the use of the term “efficacy” in section 3(d) is vague and ambiguous, and therefore violates the equality provision (Article 14) of the Indian Constitution. During the arguments, while conceding that the meaning of the term “efficacy” is known, Novartis contended that because there was no clarity as to what constituted “enhancement of efficacy” and “significant enhancement of efficacy” as required by section 3(d), the law was vague and lent itself to arbitrary decisions by the Patent Controller.

The Government of India, CPAA and generic companies argued that section 3(d) is not in violation the equality provision of the Indian Constitution as the concept of efficacy is well-known to persons in the pharmaceutical industry and it is impossible to lay down a “one size fits all” standard to determine what constitutes a significant enhancement of efficacy. Dismissing the petition, the Madras High Court held that section 3(d) was not vague or arbitrary and therefore did not violate the Indian Constitution.Novartis’ challenge to the Patent Controller’s decision, which was filed before the Madras High Court, has been subsequently transferred to and is pending before the Intellectual Property Appellate Board.

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