Transcending Differences: The Challenge for Pharmaceuticals in the Post-TRIPS Indian Patent Regime

Abstract

In the absence of a universal patent law with global jurisdiction , members of the World Trade Organisation (WTO), have adopted and legislated national laws in their respective countries though some what different interpretations of the TRIPS Agreement. While the Patent Cooperation Treaty (PCT) was the first attempt for a near harmonized system by accepting a common application, PCT has little use during the prosecution phase of patent applications. One of the important issues which have been differently interpreted is related to the patentability criteria and exceptions to patentability dealt with under Articles 27.2 and 27.3 of the TRIPS Agreement. Thus Section 3(d) of the Indian Patents Act has turned out to be a contentious issue, the resolution of which may have serious consequences on inventions related to pharmaceuticals. The Novartis case on the Gleevec patents is a case in point. While the Act provides for granting of patents even for known substances if substantial enhancement of activity vis-a-vis known activity is established, in practical terms several obstacles to a fair assessment of what is substantial has turned out to be difficult. The provision for pre-grant opposition in the Indian Patents Act has led to a large number of applications from patent groups, pharmaceutical companies and non-governmental organizations. These and related matters are discussed in detail in this paper.