[Ip-health] OECD Working Party on Biotechnology's Project on Best Practices Guidelines for the Licensing of Genetic Inventions

[James Love]

http://www.oecd.org/dataoecd/2/39/9230380.PDF

Brief Explanation of the Working Party on Biotechnology's Project on
Best Practices Guidelines for the Licensing of Genetic Inventions

Contact: Benedicte.Callan@oecd.org

As a follow on to the publication of the report "Genetic Inventions,
IPRS, and Licensing Practices," the Working Party on Biotechnology gave
the OECD Secretariat a mandate to develop guidelines for good licensing
practices in order to facilitate access to, and the diffusion of,
technologies for the public good. The report concluded that the problems
that exist with access to genetic inventions often have more to do with
licensing than with the patent system /per se/.

Licensing practices are rapidly changing as companies, public
institutions, governments and civil society grapple with the complexity
of intellectual property protection for genetic inventions. For this
reason, the report suggested that:

=93governments [should] consider the development of good practice
guidelines or codes of conduct. Good licensing practices are already
being developed by [some] public sector organisations for internal use
[=85]. Guidelines [should] be developed in consultation with industry to
determine the limits of acceptable licensing practices=94.1

These Guidelines would be voluntary, non binding recommendations, and
would serve as examples of good practices. They would be a
self-regulatory solution to some of the problems associated with the
patenting of genetic inventions.

The OECD=92s Working Party on Biotechnology has thus set up a Steering
Group of experts to develop Best Practice Guidelines for the Licensing
of Genetic Inventions. The Steering Group met in May 2003 to discuss how
the WPB could take forward a dialogue between governments and with
industry, the research community, and other interested parties, on the
scope and nature of =93good licensing practices=94 as well as on the proces=
s
for developing these guidelines.

The Steering Group decided to hold a working meeting in November 2003 in
order to draft Best Practice Guidelines for the Licensing of Genetic
Inventions. The proposed expert meeting would involve approximately 30
participants. Participants could include public sector research groups
and technology transfer officers, health ministries, clinicians,
biotechnology companies and pharmaceutical firms, and patient advocacy
groups. A number of speakers would be asked to comment or make
presentations on common licensing practices and how these might be
improved.

The Secretariat, with the help of external consultants, is drafting a
background document as a starting point for discussions of the
Guidelines. The background document will present cases of genetic
invention licensing, illustrating both good and problematic practices.
It will identify the characteristics or clauses within licenses that are
deemed by some as problematic. If feasible, the paper will propose some
topics and initial wording for the draft Guidelines.

At the November Expert meeting, participants will be asked to discuss
the cases raised in the background paper, giving a sense of how common
such licensing practices are and what working solutions are being
adopted. Some participants will be asked to comment on particular
aspects of genetic invention licensing. The objective of the expert
meeting would be to agree topics and draft wording for the Guidelines.

It is anticipated that some further iteration would be required with
experts and/or Steering Group members once a draft set of Guidelines is
generated. Once there was a general level of agreement the draft
Guidelines would be brought back to the OECD=92s Working Party on
Biotechnology for agreement on any next steps (for example, whether and
how to proceed with a stakeholder consultation meeting).

1. OECD (2002). Genetic Inventions, Intellectual Property Rights and
Licensing Practices: Evidence and Policies. OECD: Paris.
(http://www.oecd.org/pdf/M00038000/M00038462.pdf).

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