Patenting diagnostic methods post-Myriad


Antoinette Konski

Patenting diagnostic methods post-Myriad

The first US court decision applying the Myriad decision has landed, and it makes for interesting reading, as Antoinette Konski reports.

Patents claiming diagnostic methods that use natural phenomena must recite more than conventional and existing detection steps to satisfy the US Supreme Court’s patent-eligibility standard set forth in Association for Molecular Pathology v Myriad Genetics, the Northern District of California held in Ariosa Diagnostics, Inc v Sequenom, Inc on October 30.

The decision, the first by a US trial court applying the Myriad decision, provides guidance to those seeking to patent diagnostic methods that correlate a natural phenomenon, such as a biomarker or chemical analyte, to the presence or absence of disease or to a treatment decision.

The court’s decision arose from a declaratory judgment action brought by plaintiff Ariosa. Ariosa asked the court to declare that its non-invasive prenatal test (the Harmony test) using cell-free foetal DNA circulating in the blood of pregnant women does not directly infringe or contribute to infringe US patent no. 6,258,540 (the ‘540 patent) exclusively licensed by defendant Sequenom.

Diagnostic methods, patentability, Myriad, Prometheus, Ariosa