[Ip-health] WIPO Symposium (February 8, 2010): Evolution of the Regulatory Framework of Test Data

[Thiru Balasubramaniam]

http://keionline.org/node/744

WIPO Symposium (February 8, 2010): Evolution of the Regulatory
Framework of Test Data
By thiru
Created 12 Jan 2010 - 10:07am

On February 8, 2010, the World Intellectual Property Organization
(WIPO) will hold a " Symposium on the Evolution of the Regulatory
Framework of Test Data =96 From the Property of the Intellect to the
Intellect of Property [1]".

The description of the event below is taken directly from the WIPO
website. 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. Antony Taubman,
Director, Mrs. Jayashree Watal, Counsellor and Mr. Roger Kampf,
Counsellor, Intellectual Property Division will provide the WTO
perspective. Mr. Christoph Spennemann, Legal Expert, Intellectual
Property Unit, Division on Investment and Enterprise will provide the
UNCTAD perspective. At this juncture, the speaker from WHO has not
been named.

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 name
of the speaker from the Biotechnology Industry Organization (BIO) will
be announced soon. Mrs. Beata Stepniewska, Director of Regulatory
Affairs, will provide the European Generic Medicines Association (EGA)
perspective.
February 8, 2010 =96 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 =96 which sort, actually,
is yet to be defined =96 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 invited public. For information on the program,
please click on the below link."


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Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)
thiru@keionline.org


Tel: +41 22 791 6727
Mobile: +41 76 508 0997