The Munich-based European Patent Office (EPO), at the end of January,dealt fresh blows to Myriad Genetics’ controversial monopoly on diagnostic testing for mutations in human breast and ovarian cancer gene BRCA1, by limiting the scope of two remaining patents. A coalition of European research institutes, clinicians and governments disputed three of Myriad’s patents.
Last year, the EPO revoked the first and broadest patent (EP 699 754) because back in 1995, when Myriad filed corrections to its originally submitted sequence, that same sequence had already been published in GenBank, rendering it ‘non-inventive’ in Europe (Nat. Biotechnol. 22, 797, 2004). For the same reason, the EPO has now limited patents EP 705 902 and EP 705 903 to probes based only on parts of the sequence that had been correct at the first filing.
During proceedings, the patent holders themselves had already reduced the last claim to testing on just 1 instead of 34 mutations. “If upheld, the amendments virtually open up diagnostic testing on BRCA1 [in Europe],” says Bart Swinkels, patent attorney at law firm Nederlandsch Octrooibureau in The Hague, which represented the Dutch government in the dispute.
But Gert Matthijs, a geneticist at the University of Leuven, in Belgium, who coordinated the opposition, says he is disappointed the EPO rejected more fundamental objections against granting patents for identifying common mutations in known genes. That leaves him pessimistic about overturning patents for other disease genes.
The University of Utah, currently the main patent holder, says it “has not yet made a final decision”whether to appeal.