The U.S. Supreme Court has denied certiorari in Sequenom, Inc. v. Ariosa Diagnostics, Inc. (No. 15-1182), declining to review the Federal Circuit’s June 12, 2015, decision that certain methods of detecting paternally inherited nucleic acids of fetal origin (cffDNA) in a maternal serum or plasma sample and related diagnostic methods did not meet the requirements for patent eligibility under 35 U.S.C. § 101. The Federal Circuit primarily relied on the 2012 Supreme Court decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. _, 132 S. Ct. 1289 (2012), and determined that the claimed methods did not amount to “significantly more” than the “natural phenomenon” of the existence of cffDNA in maternal blood samples.

In denying certiorari, the court ignored the suggestions in the concurring and dissenting opinions to the Federal Circuit’s December 2, 2015, order, denying rehearing en banc, where Judge Lourie, Judge Dyk, and Judge Newman provided alternative views on how best to apply the patent eligibility requirement to diagnostic methods. The court also ignored the urgings of the 22 individuals, companies, and organizations who filed amicus briefs asking the court to review the decision.

While denying certiorari usually maintains the status quo, the denial here may lead the U.S. Patent and Trademark Office (USPTO) to revisit the subject matter eligibility examples for diagnostic methods released May 4, 2016. It also may lead to renewed efforts towards congressional intervention and amendments to 35 U.S.C. § 101 to clarify the law of subject matter eligibility, especially as it relates to diagnostic methods swept into the “natural phenomenon” exception to patent eligibility.