[Ip-health] WIPO Symposium on the Evolution of the Regulatory Framework of Test Data

[Thiru Balasubramaniam]

Source URL: http://keionline.org/node/777

WIPO Symposium on the Evolution of the Regulatory Framework of Test Data
By thiru
Created 2 Feb 2010 - 10:25am

As mentioned, before [1] 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 [2] of the symposium can be found here: http://www.wipo.int/edo=
cs/mdocs/mdocs/en/wipo_ip_lss1_ge_10/wipo_ip_lss1
... [2]

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 =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 audience. The event is free of charge."

Source URL: http://keionline.org/node/777

Links:
[1] http://keionline.org/node/744
[2] http://www.wipo.int/edocs/mdocs/mdocs/en/wipo_ip_lss1_ge_10/wipo_ip_lss=
1_ge_10_inf_1_prov.pdf


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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