Test Data Protection: Different Approaches and Implementation in Pharmaceuticals

By Armouti, Wael; Nsour, Mohammad F. A. | Marquette Intellectual Property Law Review, Summer 2016 | Go to article overview

Test Data Protection: Different Approaches and Implementation in Pharmaceuticals


Armouti, Wael, Nsour, Mohammad F. A., Marquette Intellectual Property Law Review


  I. Introduction  II. Different Protection Approaches      A. Bans on Misappropriation      B. Compensatory regime or cost-sharing approach         to registration data         1. Overview of Cost-Sharing Approach         2. Compliance with Article 39.3         3. Advantages of Cost-Sharing Approach         4. Problems with Cost-Sharing Approach         5. Issues with Calculating Costs Under this Approach            a. The Simple Division Royalties Model            b. The Readjustable Royalties Model         6. How U.S. Utilizes Cost-Sharing Approach         7. Cost-Sharing approach & Developing Countries      C. Data Exclusivity Approach         1. Data Exclusivity versus Patent         2. Effect of Data Exclusivity on Compulsory License      D. Public Health Variants of the Data-Exclusivity Approach III. Test Data Protection Implementation in      Different Countries      A. United States      B. Canada      C. The European Union      D. India      E. Egypt  IV. Conclusion 

I. Introduction

Binding on all members of the World Trade Organization ("WTO"), the Agreement on Trade-Related Aspects of Intellectual Property Rights ('TRIPS") (1) aimed to create a standard of international property protection. (2) In particular, Article 39.3 of TRIPS requires WTO members to protect the secret test data that originator pharmaceutical companies submit for regulatory approval of New Chemical Entities (NCE) against "disclosure" and "unfair commercial use." (3) Notably, however, Article 39.3 goes no further in defining these constitutive terms, a deliberate maneuver designed to give WTO members the freedom to interpret the parameters of the Article's prohibition against disclosure and unfair commercial use. In effect, this latitude allows members to set their own rules and to implement the Article by adopting an approach that takes account of national individuality.

The importance of the interpretive freedom that Article 39.3 allows WTO members is reflected in the varied approaches to test data protection adopted by member countries: test data protection approaches differ along the lines of how the "unfair commercial use" obligation found in Article 39.3 is construed. Some of these approaches are considered public health-friendly more than data exclusivity. (4) In practice, the permissive language of Article 39.3 permits a government to authorize a generic product based on an earlier grant of regulatory approval for the original product without running afoul of the Article's prohibition on disclosing test data submitted by the original company. (5)

This article discusses different protection approaches. The first approach bans any policy that ultimately allows direct entry of generic products (i.e. misappropriation). The second approach is a cost-sharing mechanism that ensures higher political acceptance and still meets the obligations of Article 39.3 of the TRIPS agreement to prevent unfair commercial use. The third approach is protecting clinical pharmaceutical test data submitted to regulatory agencies from generic drug manufacturing application (i.e. data exclusivity). Under the data exclusivity approach, a comparison to patents and their relation to compulsory license are discussed. The fourth approach allows releasing the data exclusively protected in certain public health variants, which mitigate the effect of data exclusivity.

After discussing these distinct approaches to test data protection, I will then consider the implementation of test data protection in the United States, Canada, and the European Union. I will conclude by comparing these approaches with the demonstrably less restrictive approaches to test data protection employed by both India and Egypt.

II. Different Protection Approaches

A. Bans on Misappropriation

Taking maximum advantage of the flexibilities afforded by the broad language of the TRIPS Agreement, this first approach is considered to facilitate the early entry of a generic product directly after the original product is approved. …

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