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WIPO Symposium on the Evolution of the Regulatory Framework of Test Data - From the Property of the Intellect to the Intellect of Property

February 8, 2010 – WIPO, 34, chemin des Colombettes, Geneva, Room B

The protection of test data is a new frontier of Intellectual Property (IP). It provides a certain sort of protection – which sort, actually, is yet to be defined – to factual information, the origination of which requires efforts, but not necessarily invention or creation. It has some roots in trade secret law, because only undisclosed test data are to be protected, and yet they are originated in the course of relations between governments (sanitary agencies) and private citizens and companies. Therefore, where a government agency relies on data provided by an originator to approve a bioequivalent molecule, there is no unfair competition in the traditional meaning of the term. Protection could arise from the need to protect privacy, but test data in general are of a commercial nature.

These are only a few of the many perplexities to which protection of test data gives rise to. In the context of its work on the contribution of IP to meet certain global challenges, WIPO is convening a Symposium which will focus on the legal practice and experience of test data protection in the pharmaceutical industry. Its main objective is to offer a forum for an exchange of views with a number of stakeholders, including intergovernmental organizations, regulatory agencies and the industry.

The Symposium will involve WIPO staff and external speakers as well as discussion with the audience.  The event is free of charge.