The European Patent Office, after conducting opposition hearings, said that it will amend a BRCA1 gene patent (EP 705903) held by Myriad Genetics.  See announcement here.  The original patent related to 34 mutations in the BRCA1 gene sequenced from the human genome and diagnostic methods for detecting these mutations to show predisposition to breast cancer.  According to the EPO, the amended patent now relates to a gene probe of a defined composition for the detection of a specific mutation in the breast- and ovarian cancer susceptibility gene and no longer includes claims for diagnostic methods. Full details of the decision will be published shortly on the EPO website.  The patent, “17q-linked breast and ovarian cancer susceptibility gene” was originally granted May 23rd, 2001.

Opponents believe that the breadth of these patents meant that Myriad could block further research on the gene. Opposition to the patents in Europe has been led by French medical organizations since 2001: the Institut Curie and Institut Gustave Roussy, with support from the Dutch and Austrian health ministries and research organizations from across Europe, including the UK. Their concern was that the Myriad BRCA1 and BRCA2 patents gave Myriad a virtual monopoly on genetic testing. But, to state the obvious, isn’t that why we have patents? To give inventors a monopoly for limited times in exchange for disclosing their inventions? There is a lot of sentiment in Europe against gene patenting although no one seems to know how research will be funded.  Without patent protection, no one is going to invest the money in the first place.

Apparently, Myriad was requiring that all samples be sent to their laboratories in the US for analysis at a fee of over $2600 (approximately ?1380). European laboratories had developed their own methods of BRCA1 testing and did not want to have to pay Myriad for analysis. There are a lot of things I don’t want to pay for either. Making Myriad out to be the bad guy for doing exactly what the patent system is designed to do just doesn’t make sense.

After a public hearing with the parties to the opposition proceedings against the patent, the opposition division panel, consisting of three technical members and one legal member, concluded that the patent can be maintained but in in amended form.  The patent now relates to a gene probe of a defined composition for the detection of a specific mutation in the breast- and ovarian cancer susceptibility gene and no longer includes claims for diagnostic methods.

Last year, the EPO revoked Myriad?s first patent (EP 699754) for methods to diagnose a predisposition to breast or ovarian cancer using the normal BRCA1 sequence. The parties to the proceedings are entitled to challenge the opposition division’s decision.

Opposition hearings on another Myriad patent, EP 705902, were also held earlier this month and a decision is expected soon and details of these decisions will be posted at www.epoline.org as part of the EPO’s public file inspection service.

See key dates in the time-line for the Myriad patents here.

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