ABSTRACT

This chapter introduces the concept of test data exclusivity, differentiates it from patent and trade secret protection and presents empirical evidence of its impact on selected countries. It analyses the reason for the existence of test data exclusivity. The chapter examines the evolutionary picture of test data exclusivity from its birth up till now. It presents the Index of Data Exclusivity and Access, which enables comparison of test data exclusivity provisions in free trade agreements (FTA) and national laws. The chapter discusses the implications of these developments and offers some recommendations to countries that have already concluded FTAs providing for test data exclusivity or for countries that are or will negotiate this exclusivity in the context of an international trade agreement. In certain cases the protection conferred by test data exclusivity may overlap with other forms of protections such as trade secrets and patents.