ABSTRACT

This chapter discusses the threat, use and trends of compulsory licensing. It examines the meaning and functions of compulsory licensing. The chapter reviews the requirements under the Trade-Related Aspects of Intellectual Property Rights Agreement. It proposes factors that should be considered when adopting compulsory licensing in order to maintain the balance between the accessible and affordable drugs for developing countries and the legitimate interest of pharmaceutical patent holders. Compulsory licensing allows third parties to use patented subject matter without the authorization of the patent holder. Among fields of technology and industrial sectors where compulsory licensing can be applied, the most controversial and frequently applied is the pharmaceutical sector. There were only a modest number of pharmaceutical compulsory licences issued that mostly related to drugs for HIV/AIDS and occurred between 2003 and 2005. Looking at the cases of compulsory licensing, the reliance on such mechanisms has been decreasing.