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BRCA2 patent upheld

European geneticists disappointed by decision they say singles out Ashkenazi Jews

By | July 1, 2005

The European Patent Office (EPO) this week upheld a patent owned by Utah-based biotech firm Myriad Genetics for breast cancer susceptibility testing related to a particular BRCA2 mutation, despite opposition from geneticists who said the patent discriminated against Ashkenazi Jews.

Myriad's patent EP 785216 originally included much wider diagnostic applications, but in advance of the hearings this month had rewritten the original claims to focus on identification of one particular mutation–6974delT–"for diagnosing a predisposition to breast cancer in Ashkenazi Jewish women."

One in 100 Ashkenazi Jewish women carries the mutation which predisposes her to breast cancer and confers a 65% to 70% chance of developing the disease, according to the European Society of Human Genetics. A statement from the society said this was the first time that a racial or ethnic group has been specifically singled out as a diagnostic target in this way.

Geneticists from 18 national societies, including Gert Matthijs of the Belgian Society of Human Genetics, had opposed the patent ahead of the hearing on the grounds that it would prevent them from conducting genetic screening women they knew to be Ashkenazi Jews, unless they had a license with the US firm.

The European Society of Human Genetics also said it was strongly opposed to the selection of a particular group as a diagnostic target in a gene patent claim. "What it means in practice is that genetic centers that do not have licenses for this test–or where the healthcare systems cannot afford to pay for it–may be forced to deny it to Ashkenazi Jewish women," said Gert-Jan van Ommen, from Leiden University Medical Center, the Netherlands, in the statement.

On Thursday, the day after a panel of three experts at EPO upheld the patent, Matthijs told The Scientist, "I am disappointed." But the decision can still be challenged again, he added, and "we may still give this a try."

Matthijs, from the department of human genetics, Catholic University of Leuven, Belgium, said in a statement that the society still believes that "there is something fundamentally wrong if one ethnic group can be singled out by patenting."

According to Matthijs, "Women coming to be tested for breast cancer will have to be asked whether they are Ashkenazi Jewish or not. If they are, the healthcare providers will only be able to offer the test if they paid for a license, or they will have to send the women's samples abroad. Women who are not Ashkenazi Jewish–or who just don't know that they have Ashkenazi Jewish ancestors–will be entitled to a test which is free. This is the first time that this kind of situation has arisen in genetic testing, and we find it very worrying."

Jochen Decker, medical director at the German company Bioscientia, said that it does make sense to ask women for their ethnic origin in breast cancer testing. Bioscientia is one of Myriad's very few licensees. "It is very well known that certain genetic mutations are over-proportionally frequent in this population," Decker says, meaning that physicians should take care to test for them if a woman says she is Ashkenazi.

The fight between Myriad and the European geneticists is mostly about data. By creating a monopoly for performing breast cancer screening, the firm now has access to large data sets from thousands of woman, including their medical histories. This allows them to offer very good diagnosis indeed. "In my mind, Myriad has a performance monopoly," Decker said. He offers his patients a test that is partly undertaken by Myriad, for a fee of €3800.

Similar tests done by a consortium of a dozen universities in Germany cost around €1800. But as the data sets to compare with are much smaller, the tests occasionally display gene variants that cannot be assigned a disease risk. "We consider cooperation with Bioscientia in these cases," Norbert Arnold, director of the oncology laboratory in the Women's Hospital of the University of Kiel, told The Scientist.

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