PARIS--When a research team identified a new mutation in BRCA1, a human gene linked to elevated risk for breast and ovarian cancer, the announcement included a broadside against a biotech firm that holds patents on the gene. The attack is the opening volley in a battle over who controls patents to certain cancer tests in Europe, and the fight is likely to get even uglier.
Mutations in BRCA1 and a related gene, BRCA2, are thought to be responsible for up to 10% of all breast cancers. Myriad Genetics, a Salt Lake City, Utah-based biotech firm, holds at least 17 patents worldwide on the use of these genes and has developed an automated test for mutations. But because the test doesn't pick up defects like the newly identified mutation, it represents "a potential danger" to French cancer patients, claim representatives of the Institut Curie in Paris.
The Curie and 16 other labs are considering a challenge to a European patent awarded to Myriad last January for BRCA1 and BRCA2 applications. The reason is that a team led by Curie geneticist Dominique Stoppa-Lyonnet has found a new mutation--a deletion of three exons, or coding regions, in BRCA1. The mutation, described in this month's issue of the Journal of Medical Genetics, was caught with a technique developed by researchers at the Institut Pasteur in Paris, and the Curie-led team argues that the technique should be used as an alternative or supplement to Myriad's test.
Myriad's European patent, and several it has pending, may make that impossible, the French researchers say. Myriad officials counter that the criticisms are off base. "If there is a technique that can detect a mutation not detected by our test, we are not stopping anyone from getting that test done," says Greg Critchfield, president of Myriad Genetic Laboratories. However, if Myriad were to develop techniques to detect mutations similar to the newfound one, the company would have the exclusive right to use them, Critchfield claims: "A company has to protect its intellectual property rights."
France's Genetics and Cancer Group--a network of 17 labs, including the Curie, that conduct BRCA1 and BRCA2 testing using a variety of methods--is discussing a legal challenge to the patent Myriad received in January. This "opposition" procedure must be filed no later than October.