Novartis AG v. Union of India: Why the Court’s Narrow Interpretation of Enhanced Efficacy Threatens Domestic and Foreign Drug Development

Abstract

Through the Patents (Amendment) Act of 2005, the Indian Parliament revised the Patents Act of 1970 to permit the grant of patents for pharmaceutical products. A core provision in the 2005 Amendment was Section 3(d), which prohibited granting patents to a new form of a known substance that did not enhance the efficacy of that substance. In Novartis AG v. Union of India, the Supreme Court of India applied this new provision to Novartis’s patent application for the final form of its drug Gleevec. The court engaged in an unreasonably narrow analysis of enhanced efficacy, potentially stifling secondary patents on important drugs and creating significant uncertainty for pharmaceutical companies going forward. Novartis AG evinces the ongoing tension between maintaining India’s status as the “pharmacy of the world” and promoting scientific innovation in South Asia.