Diagnostics & Imaging Week Correspondent

A group of European clinical and medical research organizations that is fighting to overturn three patents used by Myriad Genetics (Salt Lake) covering the therapeutic and diagnostic applications of the BRCA1 gene says they have won another round.

The European Patents Office reported last month that it would modify the terms of the second pair of patents, nos. EP 705902 and EP 705903. EP 705902 protected the composition of a specific portion of the BRCA1 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 BRCA1 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 the group of institutions led by the Curie Institute (Paris) proclaimed victory, Myriad issued a statement asserting that "two amended patents add to Myriad's existing intellectual property on BRACAnalysis test." It did acknowledge 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."

Dominique Stoppa-Lyonnet, the head of the Curie Institute's genetics department, who led the European campaign, said she believes the EPO's modifications break the monopoly that Myriad has enjoyed over diagnostic tests for predisposition to breast and ovarian cancer. "We are going to be able to develop our screening tests and improve them without fear of being attacked for counterfeiting," she said.

The right to carry out genetics tests and the price charged for them have been the main commercial issues at stake in this long-running case. The Curie Institute said that Myriad charges EUR 2,744 for its initial test of a genetic mutation of the BRCA1 gene in a family, whereas the cost in French laboratories is only EUR 914.

The patent-holder has two months in which to lodge an appeal against the decision. While Myriad gave no indication of any plans to do so, it technically no longer owns the patents. Although it was originally granted them, last November the company handed over its rights to both the BRCA1 and BRCA2 genes to the University of Utah Research Foundation (also Salt Lake City, which already was the co-owner of the patents covering BRCA1.

Three French institutions the Curie Institute, the Paris public hospital authority and the Institut Gustave Roussy (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.