Patentability of Pharmaceutical Inventions Under TRIPS: Domestic Court Practice as a Test for International Policy Space

Abstract

This article examines the leeway the TRIPS Agreement grants to WTO Members to define their own standard of patentability in the field of pharmaceutical inventions. To this end, the contribution adopts an anecdotal approach: instead of abstractly analyzing the boundaries set by Article 27 TRIPS, it takes up specific questions related to patentability raised before national judges where the TRIPS consistency of a domestic practice or interpretation has been an issue. In this context, this article answers the questions whether or not Article 27 TRIPS allows for (i) denying composition claims for naturally occurring substances; (ii) ruling out absolute product protection in all or specific technical fields, and excluding from patent protection (iii) new forms of known substances when they do not show an improvement in known efficacy and (iv) new uses of known substances. The conclusions drawn on the above-mentioned issues are relevant for several reasons. De lege lata, they will outline the interpretative leeway national judges enjoy when applying their domestic patent laws. De lege ferenda, they will serve as examples for the flexibility WTO members have in reforming internal legislation to pursue specific national policy in the field of public health and pharmaceutical innovation. One might add that just because the TRIPS Agreement grants a specific flexibility to WTO members does not mean that in all instances it is sound policy to make use of it, or use it in a particular way. Whether and when this is the case depends on the aims and the context of a possible reform of the domestic legislation. A last section hence explores possible purposes and effects of some of the measures addressed.

Keywords: TRIPS, pharmaceutical patents, naturally occurring substances, absolute and purpose bound product protection, Section 3(d) Indian Patent Act, first and second medical indication