Political and scientific groups last week succeeded in reducing the
scope of a human gene patent used to facilitate the diagnosis of
breast and ovarian cancer in women.
Following a two-day hearing, the European Patent Office (EPO) on
January 21 ruled in favour of reducing the scope of a European
patent to the human BRCA1 gene from around 30 to just three
claims.
The patent is the second in a series of three disputed patents
covering different aspects of the BRCA1 gene which Myriad Genetics
was granted by the EPO in 2001. In January the University of Utah
and the US Department of Health, the co-owners with Myriad from the
beginning, became sole patent owners.
In May 2004, the EPO revoked the first patent, which covered
methods used to facilitate early prediction of a woman's
predisposition to cancer by looking at certain mutations in the
gene. The EPO ruled that the sequence in the gene covered by a 1994
US patent and claimed as prior art by Myriad was faulty and that
any prior art claimed before 1995, when Myriad submitted the
corrected gene sequence, was erroneous.
Last week's patent, granted in November 2001 and described as
"17Q – Linked breast and ovarian cancer susceptibility gene",
originally covered claims to the entire gene. Because it claims the
same priority date as the first (now invalid) patent, the hearing
in this case had been limited to the usages of the gene itself, an
EPO spokesperson explained.
Though it did not cancel the entire patent, the EPO opposition
division decided that the patent should be reduced to three claims
related to specific gene usages – the nucleic probe, the cloning
vector and host cells transformed with the vector – dashing
ownership of the gene itself.
The spokesperson added that the decision can be appealed in the
two months following the written ruling, which is due to be
published in the next two to six months. The appeal in last year's
patent case was only submitted by the owners on January 14.
Opponents of the three patents argue that they should be revoked
because they do not comply with the requirements of the European
Patent Convention and they provide the owners with a monopoly
preventing the research and development of similar diagnostic tests
in Europe, a point with which the EPO agreed in last year's
case.
Greenpeace, which took part in last week's hearing alongside
eight other opposing groups including the Social Democratic Party
of Switzerland, the French Institut Curie, the Belgian Society of
Human Genetics and the Netherlands, welcomed the ruling.
"The unbelievably broad patents covering entire genes, plant
families and animal breads cause considerable damage for society as
a whole. Even if such patents are revoked at a later stage, it
usually takes years, and all the while access is blocked to a lot
of things," said Christoph Then, patent specialist at
Greenpeace.
The EPO's opposition division, an independent panel made up of
three technical and one legal adviser, will this week rule on the
final patent concerning the BRCA1 gene, claiming ownership to
certain mutations in the gene. The hearing on January 24 will
consider oppositions from six bodies, including again the Institut
Curie, the Netherlands and Greenpeace, as well as the Institut
Gustave Roussy, the Belgian Verenigung van Stichtingen Klinische
Genetica, and the Assistance Publique of the Parisian hospitals.
The third patent is owned by the University of Utah Research
Foundation, the Canadian Centre de Recherche du Chul and the
Japanese Cancer Institute.
The patent owners are represented by German firm Vossius &
Partner.
-Find out
here about the disputed patent
(EP0705902).
-Find out
here about the first patent, decided on last
year (EP0699754).
-Read the written decision (published November 11 2004) on the
first patent and the appeal
here (enter publication number
EP0699754).
-Find out
here about next week's patent
(EP0705903).
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