On March 21, 2015, Sequenom filed a petition for writ of certiorari to the Supreme Court in Sequenom, Inc. v. Ariosa Diagnostics, et al. (No. 15-1182).  In its petition, Sequenom calls its case the “ideal vehicle” for the Supreme Court to address mounting concern – acknowledged by the Federal Circuit below – that Mayo Collaborative Servs. v. Prometheus Labs. Inc., 132 S. Ct. 1289 (2012), has been interpreted too broadly, rendering otherwise meritorious inventions patent ineligible.

The Mayo test – which Justice Breyer, Mayo’s author, described as only a “sketch” of “an outer shell” of patentability framework during oral argument inAlice v. CLS Bank Int’l – directs courts, in assessing patent eligibility under Section 101, to determine first whether the patent is directed at patent ineligible subject matter – laws of nature, natural phenomena, or abstract ideas – and, if so, whether the patent contains a sufficiently inventive concept to transform the claim into a patent-eligible application of the law or idea.

Sequenom’s patent is premised on the breakthrough discovery that paternally inherited cell-free fetal DNA (“cffDNA”) can be found in maternal plasma, material which prior to this discovery was discarded as waste.  The claimed invention uses known techniques to detect cffDNA in maternal plasma and determine, from the cffDNA, fetal characteristics such as chromosomal abnormalities and gender.  While these techniques – amplification and detection – were well known, they had never before been applied to cffDNA.

A panel of the Court of Appeals for the Federal Circuit affirmed a district court ruling invalidating Sequenom’s patent under Section 101, finding that the patent failed the two-part Mayo test.  The Federal Circuit held that the patent’s claims were directed at natural phenomena (the presence of cffDNA in maternal plasma or serum) and, because the amplification and detection techniques were already known, did not contain an inventive concept sufficient to transform the phenomenon into a patent-eligible application.  Although the panel invalidated the patent, it recognized the “valuable contributions” of Sequenom’s technology.   Judge Linn noted in concurrence that “[b]ut for the sweeping language in the Supreme Court’s Mayo opinion, I see no reason, in policy or statute, why this breakthrough invention should be deemed patent ineligible.”

On December 2, 2015, Sequenom petitioned the Federal Circuit for rehearingen banc, to no avail.  In denying the petition, two judges of the en banc court wrote concurring opinions, agreeing with the panel’s application of Mayo but expressing frustration at what they viewed as the expansive and potentially stifling nature of the test.  Judge Newman dissented.

Writing in concurrence, Judge Lourie, joined by Judge Moore, found that there was no principled basis on which to distinguish Sequenom’s case from Mayobecause under Mayo, the court was “obliged to divorce the additional steps from the asserted natural phenomenon to arrive at a conclusion that they add nothing innovative to the process.”  Judges Lourie and Moore noted, however, that the claims in Sequoenom’s patent did not “merely recite[] a law of nature, a natural phenomenon, or an abstract idea,” but rather were “directed to an actual use of the natural material of cffDNA” which was “not routine and conventional.”  The claims, therefore, should not have been taken out of the realm of patent eligibility on grounds that they claimed only natural a phenomenon plus conventional steps or an abstract concept.  Because Mayorequired a different result, however, the judges opined that there seemed to be “some truth” to the concern raised by Sequoenom and many amici that “a crisis of patent law and medical innovation may be upon us.”

Judge Dyk also wrote a concurring opinion, in which he praised Mayo as “an essential ingredient of a healthy patent system,” but proposed a doctrinal limitation that would incentivize “development and disclosure of new diagnostic and therapeutic methods in the life sciences, which are often driven by discovery of new natural laws and phenomena.”  Judge Dyk proposed that the discovery of new natural phenomena – which would fall under the first step in Mayo’s two-part test – should be able to provide the inventive concept necessary for eligibility, which under Mayo can only come from step two.  Where “the breadth of the claim is sufficiently limited to a specific application of the new law of nature discovered by the patent applicant and reduced to practice,” Judge Dyk urged that “the novelty of the discovery should be enough to supply the necessary inventive concept.”  This rule would provide patent protection for useful discoveries in “the life sciences, where development of useful new diagnostic and therapeutic methods is driven by investigation of complex biological systems.”  Judge Dyk concluded that application of such a rule would not change the result in Sequenom’s case, however, because “the major defect is not that the claims lack inventive concept but rather that they are overbroad.”

Judge Newman dissented, writing that Mayo did not require a finding of patent-ineligibility.  She reasoned that in Mayo, “both the medicinal product and its metabolites were previously known, leaving sparse room for innovative advance in using this information as a diagnostic dosage tool.”  Sequenom, in contrast, was “not claiming the scientific fact of the discovery of paternal DNA in the blood of a pregnant woman,” it was instead “claiming the discovery and development of a new diagnostic method of using this information.”  Judge Newman noted that not all discoveries of natural phenomena or their application in new ways are ineligible for patenting, and would have gone on to analyze Sequenom’s claims under the requirements of patentability.

In its cert petition, Sequenom argues that the Federal Circuit’s interpretation ofMayo is incorrect and would have sweeping and devastating effects on innovation in biotechnology.  Sequenom argues that Mayo does not prohibit claiming new methods that combine previously known techniques, even if the new method is motivated by or incorporates a newly discovered natural law.  Sequenom further contends that under the Federal Circuit’s interpretation ofMayo, many breakthrough medical innovations would be patent ineligible.  Vaccines, Sequemon argues by way of example, are merely the combination of “the natural fact of immune response with known methods of drug administration.”

Sequenom also argues that the Federal Circuit improperly discounted the concept of preemption in the Section 101 analysis.  Sequenom’s patent does not preempt all practical uses of cffDNA – a fact Sequenom argues weighs in favor of patentability.   However, the Federal Circuit held that while preempting all uses of a discovery tends to render subject matter ineligible, the lack of preemption does not establish eligibility.  Sequenom argues that preemption should play a more central role in Section 101 jurisprudence.

Finally, Sequenom urges the Court to take up its case due to its vital importance, citing the concern of biotech and pharmaceutical companies, associations, academics, and others over the consequences of the Federal Circuit’s interpretation of Mayo, the need for predictability and certainty in the patent system to facilitate confident investment, and the obligation of the United States to remain in step with international law (the European Patent Office upheld Sequenom’s patent).  Sequenom also stresses its case’s “vehicle strengths”:  it implicates the outer reaches of the Mayo test due to its “intuitive patent-eligibility”; the record is well-developed because claim construction,inter partes review, and extensive peer review have already taken place; and the patent contains broad independent claims and narrow dependent claims.

Ariosa’s opposition, if it chooses to file one, is due April 20.