Correa, Carlos M. --- "Test Data Protection: Rights Conferred Under the TRIPS Agreement and Some Effects of TRIPS-plus Standards" [2011] ELECD 562; in Dreyfuss, C. Rochelle; Strandburg, J. Katherine (eds), "The Law and Theory of Trade Secrecy" (Edward Elgar Publishing, 2011)

Book Title: The Law and Theory of Trade Secrecy

Editor(s): Dreyfuss, C. Rochelle; Strandburg, J. Katherine

Publisher: Edward Elgar Publishing

ISBN (hard cover): 9781847208996

Section: Chapter 21

Section Title: Test Data Protection: Rights Conferred Under the TRIPS Agreement and Some Effects of TRIPS-plus Standards

Author(s): Correa, Carlos M.

Number of pages: 23

Extract:

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 interna-
tional set of binding rules on the protection of `undisclosed information'.1
This provision covers two different categories of information: what is gen-
erally known as `trade secrets', that is, information (including of a techni-
cal 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 agrochemi-
cal 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 ade-
quacy 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 ...