The Battle for the Patent

As the years have passed, India has established itself as one of the major producers of affordable generic drugs and it is also a leader in research and development of new drugs.

Criticism and concern about the effect of pharmaceutical patents on domestic drug prices compelled the Indian Government to retain legitimate means for balancing innovation incentives against social costs of pharmaceutical product patents. An efficient way to limit the reach of product patent protection can be found in Section 3(d) of the Patents (Amendment) Act, 2005 which states that just the mere discovery of a new substance or new use of an existing process without enhancing the already existing substance/process cannot be patented.

This article is in relevance to the Novartis, a large multinational company filed a patent application of an existing substance and it was rejected in India. Glivec, a product of the synthesis of Imatinib Mesylate was patented in 40 countries. Novartis filed a patent application for Glivec in India after the formation of the WTO and passage of TRIPs in 1995 in accordance with the mailbox requirement.

In 2006, the Madras Patent Office rejected the Glivec patent on the ground that it was “an unpatentable modification of an existing substance, Imatinib.” Glivec failed to show “novelty and inventiveness” as per Section 3(d), stated the Patent Office. As a rebuttal, Novartis petitioned that Section 3(d) was not in consonance with TRIPs and therefore could not be a ground for rejection of the Patent application. They stated that section 3(d) was vague, confusing and in violation of Article 14 of the Indian Constitution because it was discriminatory against Novartis.

Madras High Court heard the contentions made by Novartis while at the same time the Intellectual Property Appellate Board, Chennai reviewed the Patent Controller’s rejection. Both arrived at decisions against Novartis. With regard to the TRIPS compliance question, however, the Madras High Court simply concluded that it was beyond the Court’s jurisdiction and that the proper venue for such an issue would be the WTO. Novartis subsequently appealed to the Indian Supreme Court.

The Indian Supreme Court followed suit, handing down a decision on April 1, 2013, in which it echoed the previous court rulings that Novartis failed to demonstrate Glivec’s enhanced or superior efficacy in accordance with section 3(d). The Court, however, did not deem it necessary to articulate a single, definitive definition of “enhanced (therapeutic) efficacy” in order to render a decision. The Court also noted that it’s ruling in the Novartis case should not be read as a general prohibition of all patents for “incremental inventions of chemical and pharmaceutical substances.”

Article 27 of the TRIPs Agreement, which gives member states a fair amount of flexibility when enacting patent laws that conform to their national interests states that patents can be granted only if there is a new and inventive step capable of industrial application.

Fortunately for member states of WTO, many terms have been left undefined. This has given India the opportunity to devise its own standards for patentability as exemplified by Section 3(d). The Indian Supreme Court in Novartis AG v. Union of India in its discussion concerning the legitimacy of Indian patent laws under TRIPS, despite lacking ultimate jurisdiction to rule conclusively in such matters and did not grant a patent to Novartis.