Case Comment - Novartis AG v. Union of India: A Landmark Judgment Against Patent Evergreening

The landmark Supreme Court of India judgment in Novartis AG v. Union of India serves as a critical precedent in pharmaceutical patent law, establishing robust legal safeguards against patent evergreening. The dispute arose from Novartis AG's patent application for the beta crystalline form of Imatinib Mesylate—an anti-cancer medication—which was rejected by the Indian Patent Office under Section 3(d) of the Patents Act, 1970, on the grounds that it constituted a new form of a known substance without demonstrating enhanced therapeutic efficacy. Upon appeal, the Supreme Court dismissed Novartis's petition, reinforcing that Section 3(d) acts as an additional tier of qualifying standards for chemical and pharmaceutical substances beyond the standard requirements of novelty and inventive steps. The Court clarified that for medicinal products, "efficacy" is strictly construed as therapeutic efficacy, explicitly excluding general physico-chemical properties such as improved thermodynamic stability, flow properties, or lower hygroscopicity. Furthermore, the ruling established that an increase in bioavailability does not automatically equate to enhanced therapeutic efficacy unless robust comparative research data correlates the two. By strictly defining these parameters, the judgment successfully balances the promotion of genuine pharmaceutical innovation with the protection of public health and access to affordable medicines in India