By Timo Minssen
With a potential petition for writ of certiorari in the Sequenom v. Ariosa case approaching, it appears as if the US Supreme Court will once again have to consider crucial patent eligibility questions with a great significance for biomedical innovation and diagnostic methods.
The claims at issue (see U.S. Patent No. 6,258,540 ) are directed to methods of genetic testing by detecting and amplifying paternally inherited fetal cell-free DNA (cffDNA) from maternal blood and plasma. Before the development of this non-invasive prenatal diagnostic test, patients were placed at much higher risk and maternal plasma was routinely discarded as waste.
In an earlier decision the district court ruled that the method claims were patent ineligible and an – apparently reluctant – Federal Circuit agreed in Ariosa Diagnostics, Inc. v. Sequenom, Inc. 788 F.3d 1377 (Fed Cir. 2015). Judge Linn, for example, wrote that the innovation deserves patent protection, but also that the “sweeping language of the test” established in Mayo v. Prometheus requires a determination that the claims are patent ineligible. Read More