During the last decade, the debate in Europe regarding the patentability of human gene inventions has been heavily influenced by “the Myriad case”, concerning patent applications by Myriad Genetics Inc (and others) that relate to the breast cancer susceptibility genes BRCA1 and BRCA2.
Through two decisions spaced less than a week apart, the European Patent Office has now finally settled the outcome of two European patent cases dealing with the BRCA1 gene.
On 13 November, an EPO Technical Board of Appeal decided T 666/05, concerning European patent EP 705 903, maintaining it in amended form. According to the EPO press release, the final scope of the claims is somewhat broader than what had previously been allowed by the first instance (Opposition Division), and relates to specific cancer mutations in the BRCA1 gene. The written decision in this case will not be available for some time, but we expect to have access to the granted claims as well as the minutes from the oral hearing within the coming weeks.
On 19 November, the same Board of Appeal decided T 80/05, concerning European patent EP 699 754. This patent had been completely revoked by the Opposition Division, but was re-instated by the Board of Appeal with amended claims that cover the detection of frameshift mutations in the BRCA1 gene. Again, the written decision will not be available for some time, but we will be able to comment in more detail shortly, once the minutes and claims are made public.
Opponents against granting patents on gene inventions have pointed to the Myriad case as illustrating the undesirable consequences of the existing European system, in which patents on genes are possible. Others have maintained that the patent system is working well, and that any problems arising from the Myriad case have more to do with unsound and aggressive licensing policies.
Whatever your standpoint on the issue of gene patents, it remains a fact that, among the thousands of patents on human and animal genes, the Myriad patents have attracted by far the most attention. For an interesting review of media and policy reactions to the Myriad case, see Caulfield et al, Nature Biotechnology 24(9):1091-1094 (2006).
Niklas Mattsson, European Patent Attorney