Efficacy Under Section 3(D): an Analysis Through the Lens of Indian Judiciary

Abstract

This chapter delves into the evolution of the "test of enhanced efficacy" within the framework of pharmaceutical patenting in Indian law, primarily shaped by judicial decisions. The culmination of this research aims to summarize key findings in the context of research objectives and questions concerning the interpretation of Section 3(d) of Indian patent law within the pharmaceutical context. Throughout the study, various international agreements and national laws were scrutinized to comprehend this evolution.

Notably, Indian patent law lacks a precise definition of "enhancement of efficacy," leading to its interpretation primarily through judicial pronouncements. The historical analysis of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) sheds light on the background that allowed member countries to incorporate flexibilities into their national legislations. Section 3(d) emerges as a distinctive feature of Indian patent law, introducing an additional requirement for demonstrating enhanced efficacy when dealing with pharmaceutical drugs in cases where a new form mirrors an existing known substance. This provision aligns with TRIPS requirements and has been widely recognized as an anti-evergreening measure.

Section 3(d) has garnered significant attention for its pivotal role in preventing the extension of patent exclusivity, making India a champion in combatting the practice of evergreening. Numerous countries have followed suit, integrating similar provisions into their patent laws, acknowledging the importance of Section 3(d) in fortifying the pharmaceutical patent regime in India. The Indian pharmaceutical industry's indispensable contribution to the global market is closely tied to Section 3(d), exemplifying its paramount role in shaping the sector's success.