WIPO Symposium on the Evolution of the Regulatory Framework of Test Data

Posted on by Thiru

As mentioned, before WIPO is holding a symposium on February 8, 2010 on the “Evolution of the Regulatory Framework of Test Data – From the Property of the Intellect to the Intellect of Property”. The symposium will be held from 9:30 AM to 5 PM in Room B of WIPO headquarters.

The program of the symposium can be found here: http://www.wipo.int/edocs/mdocs/mdocs/en/wipo_ip_lss1_ge_10/wipo_ip_lss1_ge_10_inf_1_prov.pdf

The agenda of this one-day symposium is broken up into three tranches. The first tranche deals with the “International Perspective”. According to the draft agenda, the following agencies will provide their perspective on the evolution of the regulatory framework of test data: 1) WIPO, 2) WTO, 3) WHO and 4) UNCTAD. Nuno Pires de Carvalho, Deputy Director, Patent Division, Global Challenges Division will provide the WIPO perspective. Mr. Roger Kampf, Counsellor, Intellectual Property Division will provide the WTO perspective. Peter Beyer, Technical Officer, and Maria Auxiliadora Oliveira, Consultant, WHO Secretariat on Public Health, Innovation and Intellectual Property will provide the WHO perspective. Mr. Christoph Spennemann, Legal Expert, Intellectual Property Unit, Division on Investment and Enterprise will provide the UNCTAD perspective.

The two speakers providing the ‘Regulatory Authority’ perspective include Mr. Vincenzo Salvatore, Head of the Legal Sector, European Medicines Agency (EMEA) and Dr. Batool Jaffer Suleiman, Director, Rational Drug Use, Ministry of Health, Muscat, Oman.

There are two speakers providing the “Industry Perspective”. The speaker from the Biotechnology Industry Organization (BIO) is Jeffrey Kushan, Sidley Austin, LLP. The speaker from the European Generic Medicines Association (EGA) is Mrs. Beata Stepniewska, Director of Regulatory Affairs,

For those interested in registering for this event, please contact: lifesciences [at] wipo.int

Here is WIPO’s description of the event.

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.

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