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About
MIHR
PIPRA
Fiocruz, Brazil
bioDevelopments- Institute
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COOK, Trevor
Trevor Cook joined Bird & Bird in 1974 with a degree in chemistry from Southampton University. He was admitted as a Solicitor in 1977 and then joined the Intellectual Property Department of Bird & Bird, where since 1981 he has been a partner. He specializes in intellectual property and regulatory law. He is Treasurer of the U.K. Group of The International Association for the Protection of Industrial Property (AIPPI), Secretary to the British Copyright Council Standing Committee on Copyright and Technology, and a member of the Council of the Intellectual Property Institute. In recent years, he has acted in many of the leading patent infringement cases that have come before the English courts, most of which have concerned pharmaceuticals and biotechnology, and also in many of the leading cases regarding the protection of regulatory data that have come before the European Court of Justice.
Abstract
Regulatory Data Protection in Pharmaceuticals and Other Sectors
Abstract:
Generating data to secure regulatory approval in sectors, such as pharmaceuticals and agricultural chemicals in which product safety and efficacy is paramount, has become ever more extensive and expensive. There is thus a need to provide an incentive to undertake such data-generation efforts by protecting the investment in them against free riding. Article 39.3 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) recognizes as an intellectual property right the need for such protection in those sectors. This chapter discusses how certain jurisdictions, and in particular the European Community, have implemented the TRIPS requirement involving regulatory data protection regimes. Such protection is not provided by the patent system, which instead protects invention.
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