Correa, Carlos M. --- "A Model Law for the Protection of Undisclosed Data" [2009] ELECD 593; in Meléndez-Ortiz, Ricardo; Roffe, Pedro (eds), "Intellectual Property and Sustainable Development" (Edward Elgar Publishing, 2009)

Book Title: Intellectual Property and Sustainable Development

Editor(s): Meléndez-Ortiz, Ricardo; Roffe, Pedro

Publisher: Edward Elgar Publishing

ISBN (hard cover): 9781848446458

Section: Chapter 15

Section Title: A Model Law for the Protection of Undisclosed Data

Author(s): Correa, Carlos M.

Number of pages: 20

Extract:

15. A model law for the protection of
undisclosed data
Carlos M. Correa1

INTRODUCTION

The free trade agreement signed by the Central American countries and the Dominican
Republic with the United States (CAFTA­DR) requires the introduction of a sui generis
regime for the protection of test data submitted for the registration of pharmaceutical
and agrochemical products. This modality of protection ­ which is not mandated by the
Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)2 ­ subjects
test data to standards of protection significantly higher than those required in TRIPS.3
The essential difference is that while the latter protects the test data under the framework
of unfair competition, CAFTA­DR requires the grant of exclusive rights for a period of
at least five years.
The `TRIPS-Plus' protection of test data has become a common element in the recent
free trade agreements (FTAs) signed by the United States with developed and develop-
ing countries,4 as well as in the protocols of accession subscribed by new Members of
the World Trade Organization (WTO). However, numerous developing countries keep a
standard of protection consistent with the TRIPS Agreement, without providing for an
exclusivity period.
Establishing an exclusive right over the test data implies that similar products cannot
be registered for its commercialization, within the period of exclusivity, by utilizing or
relying on the test data produced by the firm from which they were generated. Several
studies have pointed out and quantified5 the implications of such exclusivity for public
...