Data Exclusivities in the Age of Big Data, Biologics, and Plurilaterals

Abstract

The past decade has seen many new developments impacting the intellectual property system. The introduction of big data analytics has transformed the fields of biotechnology and bioinformatics while ushering in major advances in drug development, clinical practices and medical financing. The arrival of biologics and personalized medicines has also revolutionized the healthcare and pharmaceutical industries. In addition, the emergence of bilateral, regional and plurilateral trade agreements have raised serious, and at times difficult, questions concerning the evolution of domestic and international intellectual property standards.

One topic linking all three developments together concerns the establishment of international standards to protect clinical trial data that have been submitted to regulatory authorities for the marketing approval of pharmaceutical products. During the TPP negotiations, for example, the protection of clinical trial data submitted for the marketing approval of biologics was highly contentious. Although the United States' withdrawal in January 2017 has placed the TPP Agreement and its data exclusivity provisions for pharmaceuticals and biologics on life support, the debate on the protection of clinical trial data will continue and will emerge in future bilateral, regional and plurilateral trade negotiations, including the NAFTA renegotiations.

This article begins by reviewing the protection of clinical trial data under Article 39.3 of the WTO TRIPS Agreement. The discussion focuses only on pharmaceutical products, even though the provision also covers agricultural chemical products. The article then examines the additional protection clinical trial data have received through TRIPS-plus bilateral, regional and plurilateral trade agreements. It concludes by outlining five specific recommendations to help advance the debate on such protection in the age of big data, biologics and plurilateral trade agreements.