Published September 24, 2024 | Version v2
Journal article Open

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

  • 1. University of Trento

Description

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.

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Additional details

Funding

European Union
European Union—Next Generation EU, under the Call for tender PRIN 2022, Project “Clinical trial data between privatization of knowledge and Open Science (acronym: CLIPKOS)”—(2022K4HBFA), Mission 4, Component 2 CUP E53D23006760006 CUP E53D23006760006