United States Federal Circuit Judges Express Concerns for Current State of Patent Eligibility Law

There will be no en banc review of a Federal Circuit panel decision that an important medical diagnostic method is ineligible for patent protection under 35 U.S.C. 101. However, in opinions accompanying the order denying review, several Federal Circuit judges expressed concerns for medical diagnostics under the current state of patent eligibility law. Ariosa Diagnostics, Inc. v. Sequenom, Inc., Fed. Cir., No. 14-1139, 2 December 2015.

The patent at issue is directed at a process for detecting paternally-inherited fetal DNA in maternal blood samples and for performing a prenatal diagnosis based on that DNA. This method permits the diagnosis of possible birth defects without using highly intrusive measures.

The Federal Circuit panel decision acknowledged that the invention in this case revolutionized prenatal care. However, it ruled that the claimed method is patent-ineligible under Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S.Ct. 1289 (2012), because it acts on natural phenomenon with well-understood, routine, and conventional steps. In a concurring opinion, Judge Linn reluctantly agreed but only because of the Supreme Court’s sweeping and unnecessary statements about patent eligibility.

The Federal Circuit on December 2, 2015, denied the petition for en banc review.

To read the opinions accompanying the en banc order in this case, click here; to read the panel decision in this case, click here.