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Myriad Wins BRCA1 Patent Appeal in Europe; Scope Limited

NEW YORK (GenomeWeb News) – A technical board of appeal of the European Patent Office this week decided that Myriad Genetics’ patent covering the BRCA1 gene be maintained but in an amended and more limited form.
 
The patent, EP 699754, was granted in May 2001 and covers methods for using the BRCA1 and BRCA2 genes for diagnosing predisposition to breast and ovarian cancer. Later that year, a number of parties, including several French research institutes and various national centers for human genetics, filed an opposition to the patent. That opposition led the Opposition Division of the EPO to revoke the patent.
 
Myriad then filed an appeal, requesting that its patent be maintained in a form that restricts the original patent claims. The board of appeal has now decided to maintain the patent in an amended form.
 
“The patent now relates to diagnostic methods for the detection of a predisposition for breast and ovarian cancer caused by a specific group of mutations of the gene, so-called shift mutations,” the EPO said in a statement. “It does not contain claims directed to the BRCA1 gene itself or to mutated forms thereof.”
 
The EPO said that the patent cannot be further contested at the European level.
 
The EPO’s decision may interfere with genetic testing for breast and ovarian cancer in many European countries, according to a statement issued by geneticists from the Center for Human Genetics at the University of Leuven in Belgium and the Institut Curie in Paris. However, they said the anticipated impact will be small.
 
“For a molecular geneticist, the latest decisions hardly make sense,” they said. “Also, after seven years of discussing the content of these patents, the latest decisions do not appear to make it any clearer at all how the claimed inventions, which are limited to certain mutations and exclude other mutations, will have to be interpreted in practice.”
 
Myriad uses the BRCA1 and BRCA2 genes in its BRACAnalysis testing service for assessing a woman’s risk of developing breast or ovarian cancer.

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