BioWorld International Correspondent

PARIS - A group of European clinical and medical research organizations led by the Curie Institute that is fighting to overturn three patents exploited by Myriad Genetics Inc. regarding the BCRA1 gene say they have won another round.

The European Patents Office announced on Jan. 21 that it was to modify the terms of the patents, Nos. EP 705902 and EP 705903. EP 705902 protected the composition of a specific portion of the BCRA1 gene, as well as the corresponding protein and the potential therapeutic applications (including gene therapy, drug screening and diagnostic kits), while EP 705903 covered 34 specific mutations of the gene associated with increased propensity to breast and/or ovarian cancer that could be used for diagnostic tests.

The EPO now has ruled that EP 705902 has no claims related to "therapeutic and diagnostic methods" and that EP 705903 has no claims "relating to diagnostic methods." The latter now relates to only one mutation of the BCRA1 gene - 185delAG, the deletion of two nucleotides. The EPO has not gone as far this time as it did in the case of an earlier patent, EP 699754, which it revoked outright in May.

While victory was proclaimed in Europe, Myriad, of Salt Lake City, issued a statement asserting that "two amended patents add to Myriad's existing intellectual property on BRACAnalysis test." It nevertheless acknowledged that EP 705903 now relates to a genetic probe for only one mutation of the gene, albeit describing it as the "single most common mutation that occurs in BRCA1 in the Ashkenazi Jewish population."

The modifications appear to break the monopoly that Myriad has enjoyed over diagnostic tests for predisposition to breast and ovarian cancer. That, at any rate, is the view of the head of the Curie Institute's genetics department, Dominique Stoppa-Lyonnet, who led the European campaign.

"We are going to be able to develop our screening tests and improve them without fear of being attacked for counterfeiting," she said.

Myriad could not be reached for comment.

The right to carry out genetics tests and the price charged for them were the main commercial issues at stake. The Curie Institute, of Paris, pointed out that Myriad charges €2,744 for its initial test of a genetic mutation of the BCRA1 gene in a family, whereas the cost in French laboratories is only €914. Myriad has not granted licenses for its test, so up to now European centers have theoretically had to send their samples to Myriad's testing center in the U.S.

In that regard, President of the Curie Institute Claude Huriet observed that the ruling was "not a victory against patentability," but instead "a victory against an abuse of monopoly."

The patent holder has two months in which to lodge an appeal against the decision. Myriad gave no indication of any plans to do so, but technically it no longer owns the patents. Although it was originally granted them, last November it handed over rights to both the BCRA1 and BCRA2 genes to the University of Utah Research Foundation, which already was the co-owner of the patents covering BCRA1.

Three French institutions - the Curie Institute, the Paris public hospital authority and the Institut Gustave Roussy, of Villejuif - jointly filed successive objections to the three patents covering the BRCA1 gene in October 2001, February 2002 and August 2002, respectively. They were supported by the French Hospital Federation, France's National Federation of Anti-Cancer Centers, the Dutch and Austrian health ministries, and human genetics companies and research organizations in 11 European countries.

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