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.

Acknowledging that the claimed discovery made a significant contribution to prenatal care, the Federal Circuit nevertheless invalidated the claims citing the Supreme Court decision in Mayo Collaborative Serv. v. Prometheus Labs. (IP Update, Vol. 15, No. 3). Applying the first step of the Mayo analysis, the Court concluded that the claimed invention was directed to a patent-ineligible concept because it began and ended with the naturally occurring cffDNA, without any transformation of the naturally produced product. Applying the second step, the Court found that the claims lacked the required inventive concept. That is, under Mayo, a process based on a natural phenomenon may be patentable, but only if the method adds new and useful steps. Here, the Court explained the claimed collection, amplification and assessment of DNA in plasma or serum to be “well-understood, routine, conventional activities performed by doctors in 1997,” i.e., at the time of the invention. Thus, these steps failed to rescue the invention from lack of eligibility.

In an unusual concurrence, Judge Linn explained that he only joined the decision because he was “bound by the sweeping language” of Mayo. Judge Linn opined that the broad language of the second step in the Mayo test is unnecessary and lamented that it leaves “truly meritorious invention[s],” like the one here, unprotected. Judge Linn also distinguished the unpatentable procedures in Mayo, which doctors already performed in combination with the claimed steps, from those in the present case, which for the first time made use of serum and plasma that had previously been discarded. Nevertheless, because the Supreme Court’s “blanket dismissal of conventional post-solution steps” left no room for these factors to bear any weight, Judge Linn reluctantly joined in the decision.