Patenting and Licensing of
Genes for Diagnostic Purposes in Europe
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The least one could say about the BRCA1 case, it that
it has caused a stir in the field of genes and patenting.
In contrast to the colleagues in the US, the geneticists
in Europe had never worried about, nor considered, the
possibility that genes and genetic tests could become
the exclusive property of a laboratory or a company.
Under the existing legislation, based on the European
Patent Convention (EPC) and supported by the European
‘Biodirective’ 98/44/EC, genes and genetic
sequences are patentable. However, the debate has never
been closed, i.e. many people and organisations are
still questioning the patentability of genes and genetic
tests. Many professionals, mostly those who are familiar
with gene patenting, including the experts at the European
Patent Office (EPO), have commented that the problem
is in licensing, not in patenting. The only way out
is to define pragmatic solutions, that respect the rights
of the patent owners and the users, and at the same
time, warrant the patient’s right and access to
affordable health care provisions.
Patents are meant to reward the inventors who have
undertaken research as well as to encourage innovation.
Patent owners and the industry argue that this form
of protection of intellectual property is a prerequisite
for investment. But, for the identification of novel
genes, the patent owners have often heavily relied on
the data generated through other, mostly publicly funded,
research activities. In addition, it seems that the
market system does not always operate properly in the
case of patents on genes, probably because genes and
genetic sequences are different from classical chemical
compounds. At the same time, the compulsory licensing
system, which is the traditional safeguard against excesses
in licensing, is not effective, and may have to be replaced
by other systems.
During a special session on ‘Patenting and Licensing
of Genes for Diagnostic Purposes in Europe’ on
Monday, June 14 in Room 13a, the different topics will
be presented by speakers that represent the different
stakeholders. The session is organised in collaboration
with the German Technology Transfer Agency of National
Genome Research Network (TT-NGFN). From 10.30 am to
12.45 pm, the focus is on patenting. The legal context
will be situated by Dr. B. Stolz from the EPO, and the
related aspects will be highlighted by other patent
specialists. Legal specialists will present the different
aspects of licensing in the session from 1.15 pm to
3 pm. The keynote speaker will be Prof. J.F. Merz from
Philadelphia, who will present empirical insights into
the effect of patents in the field of genetic diagnostics.
The aim of these sessions is to inform and then commit
the European human genetics community to take part in
the discussions on the practical, ethical and societal
aspects on this matter.
Dr. Gert Matthijs, University
Dr. Gert-Jan van Ommen, University of Leiden
Dr. Dicky Halley, Erasmus University of Rotterdam
Dr. rer. biol. hum. Christine Scholz
Deutsche Gesellschaft für Humangenetik e.V.
Tel. (0)89/61 45 69 59
Fax (0)89/55 02 78 56