Comment: It is apparently possible to split legal hairs endlessly over whether DNA is or is not patentable, and these patent claims will certainly be fought to the bitter end, as they are a crucial test case for future decisions. However, lawyer Dan Vorhaus also notes that this case does not even begin to address issues such as the impact of whole genome sequencing on patents for isolated DNA sequences. Unfortunately, the snail-like legal process makes it in many ways wholly unsuited to handling the lightning pace of the biomedical sector.
The US Federal Court of Appeals has ruled that the company Myriad Genetics is, after all, entitled to US patents held for the BRCA1 and BRCA2 genes (see previous news), mutations in which are associated with hereditary breast-ovarian cancer syndrome.
This epic legal saga has hinged on whether it is possible to patent human DNA sequences; last year, the US government Justice Department said such patents should not be granted because all DNA sequences are a product of nature (see previous news). Conversely, the new ruling from a panel of three judges supports the current policy of the US Patent and Trademark Office by stating that isolated DNA is patentable because it is markedly different from the DNA that exists within the body and is therefore not merely a product of nature, after all.
A third patent claim over the analytic process for examining genes to identify cancer-associated mutations was ruled invalid on the basis that it involved ‘patent-ineligible abstract mental steps’. Myriad was nevertheless buoyant after the decision, but – unsurprisingly - the plaintiffs were said to be considering appealing to the full Court of Appeals or the Supreme Court.