The European Patent Office, after conducting opposition hearings earlier this month, has announced that it will amend a BRCA1 gene patent (EP 705903) held by Myriad Genetics. 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. The amended patent, according to the EPO, “…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 on 23 May 2001. Oppositions to the patent were filed by six different groups: the Institut Curie; Assistance publique – Hopitaux de Paris; the Institut Gustave Roussy; the Vereninging van Stichtingen Klinische Genetica, Leiden, the Netherlands; the Netherlands represented by the Ministry of Health; and Greenpeace Germany. Their concern was that the patent, with the others that had been granted to Myriad for the BRCA1 and BRCA2 genes), were too restrictive, giving a virtual monopoly on genetic testing to Myriad. Myriad were 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. In addition some argued that Myriad’s test was not completely effective in finding large DNA deletions or rearrangements [Benowitz S (2002) JNCI 94(2):80-81].
Whether in response to these arguments or other factors, the EPO has been backing off from its original decisions. 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 (as opposed to any mutated sequences) (see newsletter article May 2004). In February 2004, EPO granted a patent to Cancer Research UK for the BRCA2 gene, although Myriad also has a BRCA2 patent (see newsletter article February 2004). Now it appears that the broader community will be able to provide genetic tests for BRCA1 mutations without challenge, although Myriad is entitled to contest the opposition division's decision in this case. Opposition hearings on another Myriad patent, EP 705902, were also held earlier this month and a decision is expected soon. Details on that decision will be posted on their website and at www.epoline.org as part of their public file inspection service.