Slimmed down breast cancer gene patent upheld

The latest challenge to a patent held by US firm Myriad Genetics on a test for hereditary breast cancer has failed. The European patent Office (EPO) ruled on 29 June that European patent EP 785216, which relates to the BRCA2 gene, is to be maintained in its amended form. The patent now covers just one particular BRCA2 gene mutation, which is commonly found in Ashkenazi Jewish women. The ruling followed a public hearing brought by a group of European scientists, who argued that the original patent had been wrongfully awarded.

Most breast and ovarian cancers are not inherited, but around 5-10 per cent are caused by inherited mutations - many of them in one of two genes, called BRCA1 and BRCA2. Myriad Genetics has faced criticism from scientists, governments and patient groups opposed to the patents it holds on tests that look for mutations in these two genes. There were concerns that the patents were too restrictive, and could give Myriad a worldwide monopoly on BRCA1 and BRCA2 genetic testing.

Myriad originally filed several patents relating to the BRCA1 gene, three of them in Europe. However, the EPO revoked one of these patents entirely in May 2004, and cut the scope of the remaining two in January 2005. Another EPO ruling granted a Europe-wide patent for a BRCA2 gene test to Cancer Research UK (CRUK) in February 2004. The BRCA2 gene was discovered in 1995, following CRUK-funded research at the Institute of Cancer Research in London. The charity grants free licences to European laboratories that want to carry out BRCA2 testing, unlike Myriad. However, in January 2005 the EPO approved an amended patent to Myriad for a BRCA2 test for 'diagnosing a predisposition to breast cancer in Ashkenazi-Jewish women'. This decision was unsuccessfully challenged last week, by scientists from the Institut Curie in Paris and the Belgian Society of Human Genetics.

Last week's ruling means that European doctors who want to offer a genetic test to Ashkenazi Jewish women will need a licence from Myriad to do so. Belgian geneticist Professor Gert Matthijs commented that 'there is something fundamentally wrong if one ethnic group can be singled out by patenting', adding 'women coming to be tested for breast cancer will have to be asked whether they are Ashkenazi Jewish or not'. Dominique Stoppa-Lyonnet, of the Institut Curie, told the journal Science that the Myriad patent amounts to 'discrimination', and is also impractical, since many people of Ashkenazi descent don't know their ancestry.

The EPO says it will publish the reasons behind the decision 'as soon as possible', both in print and online. The opposing scientists are now entitled to challenge the ruling in second-instance proceedings, before one of the EPO's technical boards of appeal. Despite the latest decision, Gert Matthijs described the opposition to Myriad's patents as 'a major achievement'. He told BioNews that 'we have come a long way - with the patents as they were granted in 2001 and 2003, breast cancer testing had become virtually impossible in Europe. Right now, everything is free again, except for BRCA2 in Ashkenazi Jewish women'.