Data Exclusivities and the Limits to TRIPS Harmonization

69 Pages Posted: 5 Dec 2018 Last revised: 13 Nov 2023

See all articles by Peter K. Yu

Peter K. Yu

Texas A&M University School of Law

Date Written: December 5, 2018


2019 marks the silver anniversary of the WTO TRIPS Agreement. Policymakers and commentators remain deeply divided about the agreement's strengths and limitations. On the one hand, they marvel at its success in establishing international minimum standards for the protection and enforcement of intellectual property rights. On the other hand, they widely criticize the TRIPS Agreement for imposing on developing countries "one size fits all" standards.

Regardless of one's perspective, the harmonization project advanced by the TRIPS Agreement, and continued through TRIPS-plus bilateral, regional and plurilateral agreements, has been at the forefront of the international intellectual property debate. While this article is interested in exploring this continuous, and continuously controversial, project, the discussion will focus on a topic that international intellectual property scholars have underexplored: the limits to TRIPS harmonization.

To help examine these limits, this article focuses on the protections for undisclosed test or other data for pharmaceutical and agrochemical products. It begins by discussing issues on which the TRIPS negotiating parties had achieved consensus or had failed to do so. The article then examines the negotiation of new international minimum standards under the TPP Agreement, the proposed RCEP Agreement and the recently signed United States–Mexico–Canada Agreement.

The article continues to identify three sets of additional complications that have affected developments at both the multilateral and nonmultilateral levels: (1) the arrival of new technologies; (2) the arrival of new politics; and (3) the arrival of new spillovers of regulatory standards from international regimes lying outside the intellectual property area. It concludes by drawing six distinct lessons regarding the TRIPS harmonization project.

Suggested Citation

Yu, Peter K., Data Exclusivities and the Limits to TRIPS Harmonization (December 5, 2018). Florida State University Law Review, Vol. 46, pp. 641-708, 2019, Texas A&M University School of Law Legal Studies Research Paper No. 18-68, Available at SSRN:

Peter K. Yu (Contact Author)

Texas A&M University School of Law ( email )

1515 Commerce St.
Fort Worth, TX Tarrant County 76102
United States


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