PARIS ¿ The Institut Curie, one of France¿s leading cancer research and treatment centers, will file a formal complaint against the patent issued by the European Patents Office to Myriad Genetics for its test for predisposition to breast and ovarian cancer. The initiative has the backing of the French Ministries of Research and Health, as well as hospitals and medical centers around the country.

The patent granted in January to Myriad Genetics, of Salt Lake City, to which the University of Utah and the National Institutes of Health (representing the U.S. government) are parties, covers its ¿diagnostic method for predisposition to breast and ovarian cancer associated with the BRCA1 gene.¿ It effectively gives the company a monopoly in North America and Europe over genetic testing for these cancers.

The Paris-based Curie Institute disputes the validity of Myriad¿s patent on a number of grounds. First, it maintains that it is too broad and inclusive, since it covers any testing method based on a comparison between the sequence of a person at risk and the reference sequence described in the patent, whatever the method used (sequencing, combing or screening).

Secondly, Curie claims that the test developed by Myriad is defective. Its cancer genetics department, headed by Dominique Stoppa-Lyonnet, published a paper in June showing that Myriad¿s industrial testing method, which is based on the direct comparison of DNA sequences, does not detect all mutations of the BRCA1 gene. Stoppa-Lyonnet said the ¿test compares sequences on a steamroller, high-throughput basis and fails to detect 10 [percent] to 20 percent of mutations.¿

The institute¿s challenge to Myriad¿s patent is based on what it views as three fundamental shortcomings: absence of novelty, on the grounds that predisposition tests based on indirect methods already existed before Myriad Genetics filed its original patent application in 1994; absence of invention, because the company benefited from knowledge acquired by the international Breast Cancer Linkage Consortium set up in 1990; and insufficiently precise description, since the protein sequence that was the basis for Myriad¿s first patent for a diagnostic method proved insufficient in itself for carrying out a predisposition test.

As the industrial property expert advising the Curie Institute, Jacques Warcoin of the Cabinet Regimbeau in Paris, pointed out, Myriad¿s original patent application in the U.S. was based on the wrong sequence, as were its next three submissions; it was only with its fifth application in March 1995 that it got the sequence right. Since then, he said, many other research establishments besides the Curie Institute have developed alternative tests for detecting mutations in the BRCA1 gene on a non-commercial basis and have made them freely available.

As the Curie Institute sees it, not only is Myriad Genetics refusing to license out rights to its test, but it is imposing ¿unacceptable financial conditions¿ for carrying out initial screening at its research facilities. Stoppa-Lyonnet said that genetic testing for breast cancer was carried out in 17 hospitals and medical centers around France and that it was vital for the well being of patients that they be able to continue doing so. Myriad Genetics was charging $2,400 for its test and required the samples to be sent to its research center in Salt Lake City, while the cost in French hospitals was only one-third of that. For her, the patent was ¿intolerable¿ because it made the world dependent on the U.S. company and its particular choice of screening test, and would block the development of alternative genetic tests.

Research Minister Roger-Girard Schwartzenberg echoed her sentiments in voicing his support for the Curie Institute¿s initiative: ¿Because of its excessively broad scope, the patent issued by the European Patents Office to Myriad Genetics gives it an abusive monopoly for conducting tests for predisposition to breast cancer. On any assumption, this patent does not appear to correspond to the conditions of novelty, since predisposition tests based on indirect methods already existed, or inventiveness, in view of the work already carried out by the international public consortium.¿

Under the regulations of the Munich, Germany-based European Patents Office, objections to new patents have to be filed within nine months of their being granted. Since Myriad received its patent on Jan. 10, the deadline expires Oct. 9. Other organizations are likely to challenge Myriad¿s patent besides the Curie Institute, according to Warcoin, who said the EPO probably would take two years to rule on the objections submitted, after which there would be an appeal that would extend the procedure for a further two years or more.

In the meantime, he added, Myriad¿s patent was valid and could be enforced by legal action on charges of counterfeiting against medical and research establishments that performed their own genetic tests. He stressed that the patent being challenged was only the one covering Myriad¿s diagnostic method, not its other patents covering the BRCA1 gene (altogether, it holds a dozen patents in the U.S. covering the BRCA1 and 2 genes).

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