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Intellectual Property and Sustainable Development

Development Agendas in a Changing World

Edited by Ricardo Meléndez-Ortiz and Pedro Roffe

This comprehensive book considers new and emerging IP issues from a development perspective, examining recent trends and developments in this area. Presenting an overview of the IP landscape in general, the contributing authors subsequently narrow their focus, providing wide-ranging case studies from countries across Africa, Asia and Latin America on topical issues in the current IP discourse. These include the impact of IP on the pharmaceutical sector, the protection of life forms and traditional knowledge, geographical indications, access to knowledge and public research institutes, and the role of competition policy. The challenges developing countries face in the TRIPS-Plus world are also explored in detail.
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Chapter 15: A Model Law for the Protection of Undisclosed Data

Carlos M. Correa


Carlos M. Correa1 INTRODUCTION The free trade agreement signed by the Central American countries and the Dominican Republic with the United States (CAFTA–DR) 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, CAFTA–DR 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 developing 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 health. Since it delays the market entry of generic products, it can be expected...

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