On December 2, 2015, the Federal Circuit denied a petition for rehearing en banc to consider whether a three-judge panel had correctly affirmed a judgment of invalidity under 35 U.S.C. § 101. The court determined that although the nature of the claimed invention is such that it should be patentable, the Federal Circuit’s hands are tied by the Supreme Court’s two-part test in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012). The court also expressed concern about the implications of decisions like this on medical diagnostics patents: Judge Lourie stated, “[i]t is said that the whole category of diagnostic claims is at risk. It is also said that a crisis of patent law and medical innovation may be upon us, and there seems to be some truth in that concern.”
The claims-at-issue were “directed to methods for detecting paternally-inherited fetal DNA in maternal blood samples, and performing a prenatal diagnosis based on such DNA.” Applying the Supreme Court’s two-step framework to § 101, the court found that the claims were directed to a natural phenomenon and failed to include an “inventive concept sufficient to ‘transform’ the claimed naturally occurring phenomenon into a patent-eligible application.” Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1376 (Fed. Cir. 2015) (quoting Mayo).
Judges Lourie and Dyk each wrote concurring opinions that agreed with the court application of the Mayo framework but proposed alternative approaches to preserve the patentability of such valuable work–including possible further refinement of the standard by the Supreme Court. For example, Judge Lourie wrote, “[t]he claim to this invention…might have been better drafted as a…Jepson claim, which recites what is in the prior art and what is the improvement.” Judge Dyk expressed concern that “there is a problem with Mayo insofar as it concludes that inventive concept cannot come from discovering something new in nature.” He proposed “allowing narrow claims that have been actually reduced to practice when those claims embody an inventive, newly discovered law of nature…” and asserted that a “future case is likely to present a patent claim where the inventive concept resides in a newly discovered law of nature or natural phenomenon, but the claim is narrowly drawn and actually reduced to practice.” Such a claim, he suggested, may allow “the Supreme Court…an opportunity to revisit the Mayo/Alice framework in this one limited aspect.”
Ariosa Diagnostics, Inc. v. Sequenom, Inc., 2015 U.S. App. LEXIS 20842 (Fed. Cir. Dec. 2, 2015) (en banc).