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http://www.biomedcentral.com/news/20040213/02

February 13, 2004

Charity wins BRCA2 patent: Genetics researchers welcome a decision that
will make the gene freely available in Europe
By Susan Mayor

Researchers have welcomed the announcement this week (February 11) that
the charity Cancer Research UK had obtained a Europe-wide patent on the
cancer susceptibility gene BRCA2 and will allow publicly owned
laboratories to use the gene free of charge.

The patent awarded by the European Patent Office covers all attempts to
sequence the BRCA2 gene or to test for damaged or inactive variants. It
will extend the access currently available to researchers in the UK,
where the commercial subsidiary of Cancer Research UK (Cancer Research
Technology Limited) already holds a patent on the gene. The charity
suggested that it will significantly boost cancer research throughout
the continent. Any laboratory wanting to investigate the gene would
usually have to pay a license fee to the patent holder, but Cancer
Research Technology has agreed in principle to waive the fees for all
public laboratories that apply to it.

Peter Rigby, chief executive of the Institute of Cancer Research in
London, said: “This patent means that the discovery of the BRCA2 gene,
which was made here at the Institute, will be freely available to our
colleagues throughout Europe to research.”

The situation in Europe was previously complicated by the fact that a US
biotechnology company, Myriad Genetics, had been awarded patents on the
BRCA1 and BRCA2 genes that gave it rights to develop commercial
laboratory testing services, diagnostic tests, and therapies based on
the gene sequences. However, a UK patent was also held by Cancer
Research Technology because much of the BRCA2 gene was first published
by Mike Stratton's group at the Institute of Cancer Research, London,
based on work funded by Cancer Research UK.

Gert Matthijs, head of molecular diagnostics, University Hospital
Leuven, Belgium, and a representative of the European Society of Human
Genetics, said: “On behalf of the many European genetic diagnostic
laboratories involved in the opposition procedures against the patents
on the BRCA1 and BRCA2 genes owned by Myriad Genetics, we wish to
express our strong appreciation to Cancer Research UK because they have
chosen to offer royalty-free licenses on its patent on the BRCA2 gene to
public health services in European countries.”

“This decision may contribute to the resolution of the precarious
situation that had arisen after Myriad Genetics had effectively denied
other laboratories [the chance] to perform complete testing of the BRCA1
and BRCA2 genes by retaining its monopoly and requesting all samples to
be sent to [its headquarters in] Utah,” Matthijs said.

The BRCA2 patent issue illustrates why Europe needs new legislation on
the licensing of genes and genetic tests, argued Mattijs. “Genes are not
inventions in the same way as other products covered by patent law. If
someone holds a patent on a gene, it creates a monopoly because no one
can invent a competing product as they could with other items, such as a
drug.” He suggested a system rather like royalties for use of music
might be one way forward to reimburse researchers for the costs of
discovering genes and then make them available to others at an
affordable price.

Helen Wallace, deputy director of GeneWatch, a not-for-profit public
interest group, suggested that the only solution was a total ban on
patents for genes: “Defensive patents are limited in what they can
achieve because they do not address the underlying problems with gene
patenting. The granting of this patent should mean better public access
to this piece of the genetics jigsaw, but it will not stop gene
patenting from stifling research.

“Only a ban on patenting gene sequences will allow scientists to put the
pieces of the genetic jigsaw together freely—leading to possible new
treatments,” she said.
Links for this article
“Charities to make breast cancer gene (BRCA2) freely available across
Europe,” Cancer Research UK press release, February 11, 2004.
http://www.cancerresearchuk.org/news/pressreleases/

European Patent Office
http://www.european-patent-office.org/index.en.php

Peter Rigby
http://enjoy.underwired.com/portfolio/sites/icr/seniorstaff.htm l#rigby

Myriad Genetics
http://www.myriad.com

R. Wooster et al., “Identification of the breast-cancer susceptibility
gene BRCA2,” Nature, 378:789-791, December 21–28, 1995.
[PubMed Abstract]

Gert Matthijs
http://cwisdb.cc.kuleuven.ac.be/research/E/expertX3962.htm

European Society of Human Genetics
http://www.eshg.org


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