Unfair Competition Under the TRIPS Agreement: Protection of Data Submitted for the Registration of Pharmaceuticals

Before the entry into force of the TRIPS Agreement, countries had considerable latitude to determine rules for the protection of test data. The Agreement introduced the first international standard on the subject, as contained in its Article 39.3. But the Agreement is not a uniform law (it only establishes broad parameters for national rules). An important question is the extent to which the Agreement allows World Trade Organization ("WTO") members freedom to apply different approaches for test data protection and, in particular, the extent to which a competitive model- protection without exclusivity-is compatible with the minimum standards set forth by Article 39.3.

This paper first describes national legal practices with respect to protection of test data before the adoption of the TRIPS Agreement. It then examines the obligations established by Article 39.3 of the TRIPS Agreement and, finally, discusses the legal means that states may adopt to provide protection against commercial use of such data.