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WEEKLY NEWS - JANUARY 23, 2005

This article is part of MIP Week, a weekly email newsletter written by the editors of Managing IP magazine. Take a one week trial to Managing IP and find many more related articles.

EPO limits cancer gene patent

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

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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