TRIPS in the Field of Test Data Protection

THE FIRST 25 YEARS AND THE FUTURE OF THE TRIPS AGREEMENT, Christopher Heath and Anselm Kamperman Sanders, eds., Kluwer Law International, 2021, Forthcoming

Texas A&M University School of Law Legal Studies Research Paper No. 20-28

19 Pages Posted: 21 Oct 2020 Last revised: 27 Oct 2020

See all articles by Peter K. Yu

Peter K. Yu

Texas A&M University School of Law

Date Written: October 21, 2020

Abstract

On April 15, 1994, the TRIPS Agreement was adopted in Marrakesh. For the past twenty-five years, this Agreement has established for both developed and developing countries the international minimum standards for the protection and enforcement of intellectual property rights. One area in which such standards were deficient before the founding of the WTO concerns the protections for undisclosed test or other data for pharmaceutical and agrochemical products. Article 39.3 of the TRIPS Agreement became the first multilateral provision in the field of test data protection.

This chapter takes stock of the evolution of international standards for protecting undisclosed test or other data for pharmaceutical, agrochemical and, more recently, biological products. Focusing on Article 39.3 of the TRIPS Agreement, the chapter begins by recapturing the origins and normative contents of this provision. It then identifies several unresolved issues surrounding the provision, which have continued to raise concerns for developing countries. The chapter concludes by outlining three distinct sets of challenges that will have serious ramifications for the future development of international standards in the field of test data protection.

Suggested Citation

Yu, Peter K., TRIPS in the Field of Test Data Protection (October 21, 2020). THE FIRST 25 YEARS AND THE FUTURE OF THE TRIPS AGREEMENT, Christopher Heath and Anselm Kamperman Sanders, eds., Kluwer Law International, 2021, Forthcoming, Texas A&M University School of Law Legal Studies Research Paper No. 20-28, Available at SSRN: https://ssrn.com/abstract=3716105

Peter K. Yu (Contact Author)

Texas A&M University School of Law ( email )

1515 Commerce St.
Fort Worth, TX 76102
United States

HOME PAGE: http://www.peteryu.com/

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