Fetal DNA Test Cannot Give Birth To A Patent

Ariosa Diagnostics, Inc., et al. v. Sequenom Inc., et al.

Addressing the issue of patent eligibility of a pre-natal testing invention, the U.S. Court of Appeals for the Federal Circuit unanimously affirmed the district court's judgement of invalidity under 35 U.S.C. § 101 with respect to a test for determining fetal characteristics using only maternal serum. Ariosa Diagnostics, Inc., et al. v. Sequenom Inc., et al., No. 14-1139 and -1144 (Fed. Cir., June 12, 2015) (Reyna, J.) (Linn J., concurring).

The claims in issue are directed toward the discovery of cell-free fetal DNA (cffDNA) in maternal serum or plasma, which can be used to determine fetal characteristics such as gender and genetic defects. Previously, the serum had been discarded as medical waste. Importantly, this claimed method had replaced the more dangerous technique of taking samples from the placenta during pregnancy.