The Judgment in Novartis v. India: What the Supreme Court of India Said

Abstract

As part of a series of amendments to the India Patents Act that took effect on January 1, 2005, the Parliament of India adopted Section 3(d). This statutory provision has been in force for more than seven years. A challenge brought by Novartis to the constitutionality of the provision and to its compatibility with the WTO TRIPS Agreement (World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights) was rejected by the High Court at Madras in 2007. That judgment was not appealed. On 1 April 2013, the Supreme Court of India rendered judgment on an appeal by Novartis against rejection by the India Patent Office of a product patent application for a specific compound, the beta crystalline form of imatinib mesylate. Imatinib mesylate is used to treat chronic myeloid leukemia and is marketed by Novartis as “Glivec” or “Gleevec”. Affirming the rejection, the Supreme Court confirmed that the beta crystalline form of imatinib mesylate failed the test of Section 3(d). The Court clarified that efficacy as contemplated under Section 3(d) is therapeutic efficacy.

This judgment has attracted worldwide press coverage. It has received severe criticism from a number of originator pharmaceutical companies, including Novartis, and from the US Chamber of Commerce, to the effect the judgment of the Indian Supreme Court has dealt a harsh blow against the future of innovation, particularly in India. It is somewhat difficult to know why this decision interpreting Section 3(d) should come as a major surprise to anyone. Perhaps more important, it is difficult to understand what it is about the Supreme Court judgment that might so offend the sensibility of patent lawyers or government policymakers. The judgment is well-crafted, with close attention to the facts presented, and appears to take a balanced view of the matters brought before the Court. This essay discusses what the Supreme Court of India said, with concluding reference to some policy considerations.

Keywords: India, patent, Supreme Court, pharmaceutical, therapeutic efficacy

JEL Classification: K33, O34