BioWorld International Correspondent

PARIS - Three French medical establishments are challenging a third patent issued by the European Patents Office to U.S. company Myriad Genetics Inc. for the BRCA1 cancer susceptibility gene, after filing earlier complaints in October 2001 and February 2002 against other patents granted to Myriad for the same gene.

The new complaint again was lodged jointly by the Paris-based cancer center Institut Curie, the Paris public hospital authority and the Institut Gustave Roussy, of Villejuif, Europe's leading cancer clinic. It also has the support of 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, among others.

The French-led bid to prevent Myriad Genetics, of Salt Lake City, from establishing an international monopoly over genetic testing for predisposition to breast and ovarian cancer is thus gaining wide European support, and the condemnation of Myriad's strategy has become noticeably harsher. The president of the Institut Curie, Claude Huriet, was particularly vehement in his condemnation of Myriad Genetics' strategy. "It is the first time a company has displayed such monopolistic designs," he said. While he was "not hostile to the principle of patents . . . excessively broad patents can hamper whole swathes of genetics research."

This time the patent concerned is No. EP 705 902, which was issued on Nov. 28, 2001, and protects the isolated gene as such, as well as the corresponding protein and the potential therapeutic applications of the BRCA1 gene (including gene therapy, drug screening and diagnostic kits).

The plaintiffs claim the patent is defective on three counts. First, the gene and protein sequences contained in the original patent application filed by Myriad in the U.S. in September 1994 were incorrect. The gene was not isolated and completely sequenced until March 1995, and was immediately available in scientific databases, thus invalidating Myriad's patent. Hence, they say, there is a "complete absence of novelty" in that patent.

In addition, they denounce a lack of inventive activity in Myriad's patent application, insofar as it was possible to isolate the gene with the elements already known at the time the patent application was filed. Finally, they say, the potential therapeutic applications, especially in the area of gene therapy, are not described in sufficient detail for a predisposition test to be conducted.

The plaintiffs maintain that "apart from the patent's scope in the diagnostics area, this is a broad and dominant patent, since the fact of being the first to file a patent for an application of the BRCA1 gene grants Myriad Genetics rights over BRCA1 itself. This implies that any other patent filed for a different application of the BRCA1 gene will depend on the patent held by Myriad Genetics."

Myriad thus is accused of seeking to monopolize all potential applications of the BRCA1 gene, even though its own activities are focused essentially on diagnostics. That "industrial logic" led Myriad to "file complementary patent applications [covering both diagnostics and therapeutics], while taking care to introduce into each of its applications diagnostics-related elements in order to obtain patents that can be substituted for each other in the event that one or other were revoked," the Institut Curie maintains. "Confronted with this strategy, it was logical on the part of the French opponents to lodge an appeal with the European Patents Office against these three patents, each of which has a blocking effect on the conduct of genetic tests."

The effective monopoly granted to Myriad means that any European center carrying out its own test, whatever the detection method used, faces a lawsuit for counterfeiting. The U.S. company does not intend to grant licenses for the initial test of a genetic mutation in a family, so European centers theoretically have to send samples to Myriad's testing center in the U.S. Moreover, according to the Institut Curie, Myriad Genetics charges €2,744 for the test, three times as much as the same test in one of France's 17 cancer genetics laboratories.

Myriad also is accused of promoting its genetic tests among doctors in the U.S. despite the fact that only 5 percent to 10 percent of breast and ovarian cancer cases have a genetic origin.

Pending a ruling from the EPO, which can take up to two years (while an appeal by Myriad could extend the process for a further two years or more), the Institut Curie intends to continue using its own genetic tests for predisposition to cancer, which could expose it to costly legal action if Myriad's patents are upheld by the EPO.