June 30, 2016
Supreme Court Denies Certiorari in Sequenom v. Ariosa
The Supreme Court has denied certiorari for the appeal in Sequenom v. Ariosa (Fed. Cir. 2015). There has been widespread interest in this case, which invalidated patent claims to a method of performing prenatal diagnosis using cell-free fetal DNA (cffDNA) collected from a maternal blood sample (see earlier post here). The method has been critical to the development of non-invasive prenatal testing (NIPT). NIPT testing can be used to identify chromosomal abnormalities or other genetic aberrations, and it offers an alternative to the invasive techniques of amniocentesis or chorionic villi sampling, both of which carry some risk to the fetus. Sequenom would have followed a sequence of recent Supreme Court decisions, AMP v. Myriad (2013) and Mayo v. Prometheus (2012) (Mayo) that each invalidated patent claims in the life sciences for a lack of patentable subject matter. The most controversy has followed the Mayo decision, which was then followed by a software-related patent case, Alice v. CLS (2014). The Mayo/Alice pair has distilled an analytic framework for determining when method patent claims impermissibly read on a law of nature or a natural phenomenon. The framework has been criticized for being overly broad, and for having a deleterious impact on the viability of method patent claims in the life sciences, particularly in the diagnostic testing sector. In the Federal Circuit decision in Sequenom last year, the concurrence by Judge Linn also took direct issue with the Court’s recent dictates in these method patent cases. But the Court did not take the invitation to focus on its own recently developed test. So in deciding not to take the case, the Court will not - for now - review its Mayo/Alice roadmap. One example of continuing influence of the Court's current paradigm is Cleveland Clinic v. True Health Diagnostics (N.D. Ohio 2016), invalidating the method patent claims on a method of detecting cardiovascular disease by detecting the elevation of specific enzyme levels (see earlier post here).