genetic patent singles out jewish women

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NEWS NATURE|Vol 436|7 July 2005 12 Genetic patent singles out Jewish women MUNICH Europe’s rules for gene patenting are under attack for allowing racial discrimination. On 29 June, the European Patent Office (EPO) upheld a patent that will mean Ashkenazi Jews have to pay for screening for a particular breast-cancer gene. The patent, on the BRCA2 gene, was filed by Myriad Genetics of Salt Lake City in Utah, although the company has since transferred ownership to a consortium that includes the University of Utah Research Foundation. It was submitted in 1996, granted in 2003, and originally covered all possible research and diagnostic tools involving the gene. After chal- lenges, the consortium narrowed the patent’s scope to cover the diagnosis of a particular mutation in Ashkenazi Jews. In January, a European patent that Myriad filed on the related BRCA1 gene was revoked, because critics revealed errors in the DNA sequence as first registered (see Nature 433, 344; 2005). The BRCA2 sequence seems to be correct, but the consortium has refocused its BRCA2 patent on the point where its claims of intellectual ownership are strongest — a muta- tion that seems to be found exclusively in Ashkenazi Jews. The EPO decision means that European patients will be asked whether they are Ashkenazi. If they are, they will have to pay the same high royalties for BRCA2 testing that US doctors have to demand from all patients — the US patent office has granted broad ver- sions of both the BRCA1 and BRCA2 patents. The Munich-based EPO has granted patents on hundreds of individual genes. But very few patent holders demand licence fees from public health clinics. When Myriad bucked that trend, many European clinics decided to ignore its royalty requests. And var- ious geneticists challenged Myriad’s patents. Those challengers are unhappy with last week’s result. “We are thinking about whether to appeal again, but given the general rules of the EPO, the basis on which we might be suc- cessful is not obvious,” says Gert Matthijs of the Centre for Human Genetics at Belgium’s Catholic University of Leuven. Dorit Lev, head of the Israel Association of Medical Geneticists, says that the situation is unacceptable. Ashkenazi Jewish women with this mutation frequently develop breast cancer. A simple genetic test identifies those at risk and screening is routine. “It’s not right that they should be discriminated against,” says Lev. The only option for opponents is to press for changes to the grounds on which the EPO grants patents. “This is a moral not a legal issue and we are now thinking about challenging the political basis of the European rules,” says Mary Rice, spokeswoman for the Vienna-based European Society of Human Genetics. Alison Abbott “This is a moral not a legal issue.” Nature Publishing Group ©2005

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Page 1: Genetic patent singles out Jewish women

NEWS NATURE|Vol 436|7 July 2005

12

Genetic patent singles out Jewish womenMUNICHEurope’s rules for gene patenting are underattack for allowing racial discrimination. On29 June, the European Patent Office (EPO)upheld a patent that will mean Ashkenazi Jewshave to pay for screening for a particularbreast-cancer gene.

The patent, on the BRCA2 gene, was filed byMyriad Genetics of Salt Lake Cityin Utah, although the companyhas since transferred ownership toa consortium that includes theUniversity of Utah Research Foundation. Itwas submitted in 1996, granted in 2003, andoriginally covered all possible research anddiagnostic tools involving the gene. After chal-lenges, the consortium narrowed the patent’sscope to cover the diagnosis of a particularmutation in Ashkenazi Jews.

In January, a European patent that Myriadfiled on the related BRCA1 gene was revoked,because critics revealed errors in the DNA

sequence as first registered (see Nature 433,344; 2005). The BRCA2 sequence seems to becorrect, but the consortium has refocused itsBRCA2 patent on the point where its claims ofintellectual ownership are strongest — a muta-tion that seems to be found exclusively inAshkenazi Jews.

The EPO decision means that Europeanpatients will be asked whetherthey are Ashkenazi. If they are,they will have to pay the same highroyalties for BRCA2 testing that

US doctors have to demand from all patients— the US patent office has granted broad ver-sions of both the BRCA1 and BRCA2 patents.

The Munich-based EPO has grantedpatents on hundreds of individual genes. Butvery few patent holders demand licence feesfrom public health clinics. When Myriadbucked that trend, many European clinicsdecided to ignore its royalty requests. And var-ious geneticists challenged Myriad’s patents.

Those challengers are unhappy with lastweek’s result. “We are thinking about whetherto appeal again, but given the general rules ofthe EPO, the basis on which we might be suc-cessful is not obvious,” says Gert Matthijs ofthe Centre for Human Genetics at Belgium’sCatholic University of Leuven.

Dorit Lev, head of the Israel Association ofMedical Geneticists, says that the situation isunacceptable. Ashkenazi Jewish women withthis mutation frequently develop breast cancer.A simple genetic test identifies those at risk andscreening is routine. “It’s not right that theyshould be discriminated against,” says Lev.

The only option for opponents is to press forchanges to the grounds on which the EPOgrants patents. “This is a moral not a legal issueand we are now thinking about challenging thepolitical basis of the European rules,” says MaryRice, spokeswoman for the Vienna-basedEuropean Society of Human Genetics. ■

Alison Abbott

“This is a moralnot a legal issue.”

7.7 News 12 MH 5/7/05 10:03 AM Page 12

Nature Publishing Group© 2005