Incremental pharmaceutical innovation in India: the Supreme Court's judgment in the Novartis Gleevec case

Abstract

Stefano Barazza is a lawyer at Studio Legale Barazza in Italy. The recent decision of the Indian Supreme Court in the highly controversial case concerning the patentability of Gleevec offers an occasion to examine the issues surrounding the patentability of incremental pharmaceutical innovation in India. The court, reviewing the development of the country's patent law, provided some long-awaited guidance on the interpretation of Section 3(d) of the Patents Act, and examined the interplay between the tests of ‘inventive step’ and ‘enhanced efficacy’, the related burdens of proof, and the distinction between coverage and disclosure. Although the rejection of Novartis's claims attracted significant criticism by the pharmaceutical industry, and appeared to shift the balance in favor of the protection of public health, the Supreme Court expressly recognized that the decision does not represent a repeal of India's commitment to the respect of international standards of patent protection. A review of the court's approach to incremental pharmaceutical innovation, in light of the peculiarities of the Gleevec case, demonstrates that India is still struggling to make sense of the many changes introduced in its patent law in the last twenty years.