On June 27, 2016, the US Supreme Court denied certiorari in Ariosa Diagnostics, Inc. v. Sequenom, Inc. Thus, the Federal Circuit’s decision stands; namely that Sequenom’s methods for detecting foetal DNA in plasma samples are not patent eligible.
This news comes as something of an unpleasant surprise. It was widely felt (as supported by a large number of amicus briefs) that this case represented a prime opportunity to revisit the Supreme Court’s earlier decisions in relation to patent eligibility, which have led to such difficulty in pursuing and enforcing method claims in the US.
Our previous bulletin (see here) discussed recent guidance from the USPTO on this topic and that guidance should not be affected by this decision. Nevertheless, it seems there will be significant difficulties with patent eligibility in the US for innovative life science companies for the foreseeable future. Unless Congress intervenes of course.