BioWorld International Correspondent

PARIS The Paris-based cancer center Institut Curie is contesting another patent issued by the European Patents Office to the U.S. company Myriad Genetics Inc. for the BRCA1 cancer susceptibility gene, after filing a formal complaint in October against an earlier patent for the same gene.

This new complaint, which was lodged jointly by the Institut Curie, the Paris public hospital authority and the Institut Gustave Roussy, of Villejuif, Europe’s leading cancer center, concerns EP Patent No. 705903 B1 titled “Mutations in the 17q-linked breast and ovarian cancer susceptibility gene,” which was issued to Myriad, of Salt Lake City, on May 23, 2001.

Like the earlier Myriad patent challenged by the French, which was for a “diagnostic method for predisposition to breast and ovarian cancer associated with the BRCA1 gene,” this patent also protects a method for diagnosing predisposition to these two cancers and relates to 34 specific mutations of the gene.

The main arguments being advanced by the three plaintiffs, which have the backing of the French health minister, France’s National Federation of Anti-Cancer Centers and the French Hospital Federation, are that it lacks inventive activity and that it does not have any industrial application. On the first point, they argue that any geneticist had the knowledge needed to isolate the BRCA1 gene and that once the gene’s sequence had been discovered, the use of basic methods to look for mutations in the sequence among patients does not represent inventive activity.

As regards the second argument, in maintaining that the mutated sequences of the BRCA1 gene have no clearly defined industrial application, the opponents are again disputing the excessively large scope of this patent which, like the first one, covers all diagnostic methods and thus effectively gives Myriad a monopoly in North America and Europe over genetic testing for these cancers.

The Institut Curie and its co-plaintiffs maintain that they are taking this step in order to “guarantee the quality of genetic tests” for these cancers and to ensure freedom of access to them, claiming that Myriad’s methods do not detect 10 percent to 20 percent of mutations and that its tests cost three times more than those carried out in France. They also stress that their move is aimed at encouraging further research and the development of new diagnostic methods, pointing out that under the agreements Myriad has concluded to date in Germany, DNA samples taken from high-risk people being tested for family predisposition to cancer for the first time have to be sent to Myriad’s research center in the U.S. This, they say “would enable the company to create a unique genetic database” and “give it complete control over research into predisposition to breast and ovarian cancer.”

As the Institut Curie’s communications manager, Catherine Goupillon, pointed out, every case is unique, since mutations vary from family to family. “There are as many mutations as there are families with a predisposition to these cancers,” she told BioWorld International. “More than 900 mutations have been discovered so far.”

The objection to this patent was submitted to the Munich-based European Patents Office on Feb. 22, almost the last day on which it was admissible, since the EPO’s regulations require objections to new patents to be filed within nine months of their being granted. The same day the Belgian and Dutch Centers for Human Genetics, the Belgian ministers of Health, Social Affairs and Scientific Research, and the Dutch minister of Health all filed separate but coordinated oppositions.

It can take up to two years for the EPO to rule on this kind of objection, after which Myriad might lodge an appeal that could last another two years or more. Goupillon pointed out that consideration of the first objection had been delayed by several months because other complaints submitted by the Belgians and Italians were first examined for their form and deemed inadmissible.

Although the objections lodged by the French to the two Myriad patents are founded on identical arguments, Goupillon said they would be examined separately by different EPO commissions and could result in different decisions. Meanwhile, the Institut Curie continues to use its own genetic tests for predisposition to cancer in defiance of Myriad’s patents and, as Goupillon readily conceded, could pay a heavy price if those patents are upheld by the EPO.