An Attempt at Quantification of ‘Efficacy’ Factors under Section 3(d) of the Indian Patents Act

Abstract

This policy paper attempts to develop a very simplistic theoretical model for helping patent authorities determine the patentability / patent-eligibility of a pharmaceutical invention. Though yet to be empirically tested, the proposed model (based on the wider interpretation of ‘efficacy’) may serve a very useful guideline, thereby lessening the arbitrariness and uncertainty in the application of the ‘efficacy’ standard under Section 3(d). This model has been proposed as part of a comprehensive reform in the extant patents regime in India. However, this domestic level reform has to be matched by a concomitant reform at the international level.