The Supreme Court today denied Sequenom Inc.’s petition for writ of certiorari, in which Sequenom asked the Court to review a decision of the Federal Circuit invalidating its patent on a breakthrough prenatal diagnostic procedure. In denying the petition, the Court has declined to revisit the patent eligibility framework it set out in Mayo Collaborative Servs. v. Prometheus Labs. Inc., 132 S. Ct. 1289 (2012) and reaffirmed in Alice Corp. Pty. Ltd. v. CLS Bank International, 134 S. Ct. 2347 (2014).
Sequenom’s patent is premised on the discovery that cell-free fetal DNA (“cffDNA”) can be found in maternal plasma, material which prior to this discovery was discarded as waste, and that by amplifying and detecting paternally inherited genetic sequences using known techniques the inventors could reliably identify fetal DNA in a sample otherwise dominated by maternal DNA. This made it possible to diagnose certain fetal genetic conditions by obtaining blood from the pregnant mother rather than putting the mother and fetus through invasive and risky amniocentesis. The invention revolutionized prenatal care.
In the lawsuit, Ariosa, a competitor, argued that Sequenom’s patent claims were directed to patent ineligible subject matter under the Supreme Court’s Mayo framework and invalid on that basis. The district court and the Federal Circuit agreed. The Federal Circuit also denied rehearing en banc, with Judge Newman dissenting, and Judges Lourie (joined by Judge Moore) and Dyk writing concurring opinions agreeing with the panel’s application of Mayo but calling for the Supreme Court to revisit the issue.
Sequenom seized on that sentiment in its cert petition and received strong support from twenty-two amici in the biotech and life sciences communities. Ariosa argued in opposition that the lower courts faithfully applied Mayo and its progeny. The Supreme Court’s denial leaves Sequenom’s claimed process for prenatal diagnosis unprotectable in the United States and signals that, at least for now, patents on diagnostic technology remain vulnerable to section 101 challenges whenever they apply known techniques to novel discoveries.
Meanwhile, Sequenom and Ariosa’s dispute over this technology roils on elsewhere. On June 7, Sequenom filed suit in the Federal Court of Australia against Ariosa and two Australian companies who Sequenom alleges use Ariosa’s infringing cffDNA test. Sequenom announced that it is seeking “all available remedies” in its bid to enforce its Australian patent. The Australian suit adds to those already filed in the U.K. and Europe over the diagnostic procedure.