Concern over BRCA2 patent

European geneticists say changes would force them to ask whether women are Ashkenazi Jews

By | May 16, 2005

Some Jewish women in Europe could face discrimination in access to breast cancer diagnosis as a result of changes made to a patent for the gene BRCA2, owned by Utah-based firm Myriad Genetics, geneticists said at a meeting this week. They said that the changes could mean that women seeking testing would have to disclose whether they were Ashkenazi Jews, and might preclude testing in countries without testing licenses.

At the European Society for Human Genetics Meeting in Prague this week, researchers told The Scientist that, in advance of a challenge to the patent to be heard by the European Patent Office in Munich on June 29, Myriad has limited its claims for the patent and changed the phrasing of the related documentation.

The new wording covers the use of a certain DNA probe that comprises one single mutation "for diagnosing a predisposition to breast cancer in Ashkenazi Jewish women in vitro," congress members told The Scientist. The mutation described in the patent is somewhat more common among Ashkenazi Jews.

"This is definitely not the way to go," said Geert-Jan van Ommen, a human geneticist from the University of Leiden, in The Netherlands. "Because on the one hand, you would have to ask patients who come into your clinic and want to be tested if they are Ashkenazi Jews. And then if they are, it would block them from being diagnosed in countries that tend not to pay serious licenses for the diagnosis."

Myriad's patents for BRCA1 and BRCA2 gave it rights to develop commercial laboratory testing services, diagnostic tests, and therapies based on the gene sequences. They have since been challenged by scientists and as a consequence, one of the three patents on the BRCA1 gene was revoked in May 2004, the other two stand as product patents, according to a decision in January 2005.

"But we have been able to slim them down," said Gert Matthijs, from the Center for Human Genetics at the University in Leuven, Belgium, who is one of the organisers of the opposition against Myriad's European patents. The remaining BRCA1 patents, he said, "don't interfere any more with the practice in Europe. So we are now free to use our own methods to look for mutations in those genes."

This cannot be said about patent EP785216 on the BRCA2 gene. With its current wording, testing for this mutation in Ashkenazi Jewish women would be infringing with the patent, Matthijs said.

Another European patent on BRCA2, granted to Cancer Research UK last year, is not opposed by geneticists in Europe, because the charity is willing to grant free licenses for that patent. The existence of the two patents leaves the current legal situation unclear.

The geneticists emphasized that they are not against gene patents per se. "It is the licensing, that is the issue," said van Ommen. Currently, patent holders on genes can refuse to license the use of those genes even for diagnostic purposes. "The problem is that this patent is held by a company who wants to definitely exert a monopoly on its use."

In the upcoming hearing, the Belgian Society of Human Genetics and the French Institut Curie will argue that the BRCA2 patent was given to Myriad wrongfully. In front of several patent examiners, the opponents plan to argue that there is no way to define when a woman is Ashkenazi Jewish. They also want to make the ethical argument that a patent should not be granted on one population and not the other.

Myriad Genetics did not respond to repeated requests for comment by deadline.

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