Intellectual Property > IP Newsflash > Sequenom Seeks Supreme Court Review of Diagnostic Claims Held Invalid Under § 101
25 Mar '16

On Monday, March 21, 2016, Sequenom, Inc. filed a petition for writ of certiorari in Sequenom, Inc. v. Ariosa Diagnostics, Inc., et al., No. 14-1139 (Fed. Cir. June 12, 2015). The question posed to the Supreme Court centers around the patentability of diagnostic claims applied to newly-discovered natural phenomena.

The claimed work dates back to 1996, when two doctors discovered paternal cell-free fetal DNA (cffDNA) in maternal blood serum and plasma. With that discovery, the doctors developed a method of testing fetal DNA to determine, among other things, the risk of certain birth defects in a manner far less invasive than conventional techniques, which required DNA samples to be taken directly from the fetus or placenta. The doctors obtained U.S. Patent No. 6,258,540 covering the methods.

Sequenom filed an infringement suit against Ariosa. The district court granted Ariosa’s motion for summary judgment that asserted claims were invalid for failure to claim patentable subject matter under 35 U.S.C. § 101. A panel of the Federal Circuit affirmed. The Federal Circuit applied the two-part test set forth in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012), and held that (1) the asserted claims were directed to naturally occurring phenomena, and (2) the practice of the claimed method did not transform that natural phenomenon into patent-eligible subject matter. Judge Linn concurred, explaining that Mayo compelled such an outcome, even though the patent at issue claimed a meritorious invention. The Federal Circuit denied rehearing en banc with several judges authoring opinions.

In its petition, Sequenom presents a single issue to the Supreme Court:

Whether a novel method is patent-eligible where: (1) a researcher is the first to discover a natural phenomenon; (2) that unique knowledge motivates him to apply a new combination of known techniques to that discovery; and (3) he thereby achieves a previously impossible result without preempting other uses of the discovery.

Sequenom explains that the doctors did not try to patent cffDNA itself or preempt all uses of it by others. Instead, the doctors claimed an application of their discovery and taught others new combinations and techniques that are now available. According to Sequenom, the Federal Circuit reads Mayo so broadly that the only solution is Supreme Court intervention. Sequenom argues that multiple judges and amici agree that the result in this case is untenable and that, in light of Mayo, only the Supreme Court can fix the problem.

Petition for Writ of Certiorari, Sequenom, Inc. v. Ariosa Diagnostics, Inc., et al., No. 15-__ (Mar. 21, 2016).