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22 December 2008

European Patent Office maintains, in amended form, a patent relating to mutations in BRCA1

Following a public hearing, a technical board of appeal of the European Patent Office (EPO) decided that European Patent No 699754 (EP 699754) is to be maintained, although in amended form. This decision overrules the EPO's first-instance decision of May 2004 to revoke the patent.

EP 699754 was granted in January 2001 to joint proprietors Myriad Genetics, the United States of America, and the University of Utah Research Foundation. The grant was opposed by a number of parties in October 2001 on the grounds that its subject matter did not meet the requirements of the European Patent Convention (EPC), including the requirements for novelty, inventive step, and not being contrary to morality (under EPC 1973, European patents could not be granted for inventions, the publication or exploitation of which would be contrary to "ordre public" or morality). The first-instance Opposition Division decided in favour of the opponents, and revoked the patent in May 2004.

The patent proprietors appealed the revocation decision, requesting that the decision be reversed, and that the patent be maintained in a limited form. The appeal was assigned to the Technical Board of Appeal, a second-instance judiciary body of the EPO, who subsequently repealed the first-instance decision and maintained the patent in an amended form.

The patent is now directed to methods for diagnosing a predisposition for breast and ovarian cancer caused by frameshift mutations within the BRCA1 gene. It no longer contains claims directed to the BRCA1 gene itself, or to mutated forms thereof.

The Board of Appeal of the EPO is not referring the case to the Enlarged Board of Appeal, and so this patent will not be further contested at a European level.

Further information on this decision is available from the European Patent Office.

Donal M Kelly, Ph.D., FRKelly