A Handbook of Contemporary Research
- Research Handbooks in Intellectual Property series
Edited by Rochelle C. Dreyfuss and Katherine J. Strandburg
Chapter 21: Test Data Protection: Rights Conferred Under the TRIPS Agreement and Some Effects of TRIPS-plus Standards
21 Test data protection: rights conferred under the TRIPS Agreement and some effects of TRIPS-plus standards Carlos M. Correa* INTRODUCTION Article 39(3) of the TRIPS Agreement introduced the first-ever international set of binding rules on the protection of ‘undisclosed information’.1 This provision covers two different categories of information: what is generally known as ‘trade secrets’, that is, information (including of a technical nature) valuable for a commercial activity; and the information that is the focus of this chapter, test data, that is, the results of clinical trials made to demonstrate the efficacy and safety of pharmaceutical and agrochemical products. The introduction of specific rules on test data reflects the influence of the powerful lobbying of the pharmaceutical industry during the TRIPS negotiations.2 The protection of test data was one of the issues that divided the North and the South during the negotiations of the Uruguay Round. It also raised controversies among the developed countries themselves. At the time of the negotiations, many developed countries, including Australia and Canada, did not grant specific protection to test data equivalent to the sui generis regimes of ‘data exclusivity’, which the United States and the European Communities (EC) instituted in 1984 and 1986, respectively. Divergences included operational as well as basic issues, such as the adequacy of the concept of ‘proprietary’ confidential information, suggested by the U.S. delegation.3 * Director of the Centre for Interdisciplinary Studies on Industrial Property and Economics (CEIDIE), University of Buenos Aires. 1 Agreement on Trade-Related Aspects of Intellectual Property...
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