Compulsory licensing: Procedural requirements under the TRIPS agreement

Abstract

Compulsory licenses of patents under the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) are often mistakenly viewed as a solution to problems relating to access to medicines in developing countries. Access requires a strong political commitment, a health system that contains multi-disciplined health professionals, and an adequate infrastructure to enable transportation of patients and equipment. The use of compulsory licenses should be a rare event considered only under extremely limited circumstances and not an instrument of industrial policy. If a government decides to issue a compulsory license, there are several technical and procedural requirements that must be satisfied under TRIPS. This paper explores those requirements and examines instances where courts have issued decisions relating to compulsory license requests or grants. It analyses the key provisions of TRIPS that are relevant to a government grant of a compulsory license without the authorization of the right holder. It also provides examples and analyses of previous grants of compulsory licenses that have been deficient in meeting on more more procedural requirements under TRIPS.