The Sound of Silence: International Treaties and Data Exclusivity as a Limit to Compulsory Licensing

Abstract

Among various grounds, data exclusivity is often criticised for impeding the correct functioning of the flexibilities guaranteed by the TRIPS Agreement in relation to compulsory licensing. Several commentators have noted that, in cases where a generic competitor obtains a non-voluntary license on a patented pharmaceutical compound, the impossibility of relying on the regulatory data submitted by a previous applicant prevents access to the market and therefore neutralises the effectiveness of the license. By thoroughly looking at the relevant international provisions and state practices, this article brings into question the soundness of these claims. International legal sources, once rightly interpreted, rarely limit the possibility to waive data exclusivity in a more stringent manner than in patent regimes, so that the real threat to compulsory licensing lies in the political disparities between developed and developing countries rather than in the substantive law of data exclusivity.

Keywords: Access to medicines; Compulsory licensing; Data protection; Developing countries; Pharmaceuticals; Preferential trade agreements; Regulatory bodies; TRIPS

JEL Classification: K19, K33