On April 15, 1994, the TRIPS Agreement was adopted in Marrakesh. For the past twenty-five years, this Agreement has established for both developed and developing countries the international minimum standards for the protection and enforcement of intellectual property rights. One area in which such standards were deficient, if not non-existent, before the founding of the WTO concerns the protections for undisclosed test or other data for pharmaceutical and agrochemical products. Article 39.3 of the TRIPS Agreement became the first multilateral provision in the field of test data protection.

This chapter takes stock of the evolution of international standards for protecting undisclosed test or other data for pharmaceutical, agrochemical and, more recently, biological products. Focusing on Article 39.3 of the TRIPS Agreement, the chapter begins by recapturing the origins and normative contents of this provision. It then identifies several unresolved issues surrounding the provision as well as the related concerns for developing countries. The chapter concludes by outlining three distinct sets of challenges that will have serious ramifications for the future development of international standards in the field of test data protection.