Arguing that the current state of the law weakens the patent system and poses a danger to life science innovators, biotechnology company, Sequenom, Inc., has filed a writ of certiorari with the U.S. Supreme Court, asking the Court to provide clarification regarding the limits of 35 U.S.C. § 101 as it relates to patent eligibility of diagnostic tests. The Sequenom petition offers an opportunity for the Supreme Court to loosen the seemingly universal prohibition against diagnostic method claims set forth in Mayo Collaborative Services v. Prometheus Labs. The Mayo decision, together with the Court’s holding in Association for Molecular Pathology v. Myriad Genetics, has significantly reduced the ability to obtain patentable subject matter in the life science arena.

Sequenom’s U.S. Patent No. 6,258,540 derives from the discovery that cell-free fetal DNA (cffDNA) may be found in maternal plasma and serum. Applying a combination of known laboratory techniques to their discovery, the inventors implemented a method for detecting and amplifying paternally inherited cffDNA in maternal plasma or serum to determine certain fetal characteristics, such as gender and/or the presence or absence of various genetic defects. In Ariosa Diagnostic, Inc. v. Sequenom, Inc., 788 F.3d 1380 (Fed. Cir. 2015), the Court of Appeals for the Federal Circuit affirmed the Northern District of California’s broad interpretation of Mayo that claims directed to the mere application of naturally occurring products and phenomena constitute unpatentable subject matter. Please see our July 8, 2015 and December 8, 2015 blog posts for additional background.

Sequenom’s petition, which was filed on March 21, 2016, asks the Court to provide clarification regarding the limits of 35 U.S.C § 101 as it relates to patent eligibility of diagnostic tests. Sequenom’s petition asks whether a novel method is patent-eligible where:

  1. A researcher is the first to discover a natural phenomenon;
  2. That unique knowledge motivates such researcher to apply a new combination of known techniques to that discovery; and
  3. The researcher thereby achieves a previously impossible result without preempting other uses of the discovery.

Sequenom is requesting that the Court grant the petition because “[r]ight now, Section 101 doctrine lacks any discernable limits, and so no company can trust in the patent system when deciding whether to invest in bringing an invention to market.”

Ariosa has until April 20, 2016 (extendable with permission from the Court) to file a brief in opposition. As indicated by the number of amici briefs filed in the Federal Circuit, this case is sure to be closely monitored by biotech and pharmaceutical companies, academic medical centers, medical schools, practitioners, professors, universities, associations, international interests, the USPTO, and more.