Protecting Clinical Trial Data with Data Exclusivity: A Comparative Legal Analysis

This paper provides a comparative analysis of data exclusivity, form of protection for test data obtained from clinical trials of a new medicine. The purpose of this paper is to analyse the nature of this sui generis IP right by examining art.39(3) of the Agreement on the Trade-Related Aspects of Intellectual Property Rights and comparing the local regulatory frameworks of the United States and the European Union, which are the pioneers of data exclusivity protection and play a significant role in the pharmaceutical market. Attention will be also given to the new policies aimed at increasing the transparency and openness of clinical trial data, thereby offering potential alternatives to existing frameworks from a de iure condendo perspective.