United States: Federal Circuit Affirms Ariosa, But Not Without Concerns

Ariosa Diagnostics, Inc. et al. v. Sequenom Inc. et al.

Denying a petition for en banc rehearing, the U.S. Court of Appeals for the Federal Circuit confirmed the panel's decision that Sequenom's patent claiming "a method of detecting paternally inherited nucleic acid" is an unpatentable law of nature. The order was accompanied by two concurrences by Justices Alan Lourie and Timothy Dyk addressing the patentability concerns of medical diagnostics and therapeutic methods, and a dissent by Justice Sandra Schultz Newman drawing distinctions between the facts here and those in Mayo. Ariosa Diagnostics, Inc. et al. v. Sequenom Inc. et al. 2014-1139, 2014-1144 (Fed. Cir. December 2, 2015).

At issue is Sequenom's U.S. Patent No. 6,258,540, directed to diagnosing birth defects of an unborn child without the use of highly intrusive means by detecting the presence of cell-free fetal DNA (cffDNA) in maternal plasma. It was believed that fetal DNA present in maternal blood could be amplified based on the portions inherited paternally, as opposed to maternally, and then screened for birth defects. Specifically, the claims are directed to two steps: 1) amplifying paternally inherited DNA from a plasma sample taken from a pregnant female; and 2) detecting the presence of cffDNA. The court relied on the Supreme Court of the United States' decision in Mayo v. Prometheus, as controlling precedent, in holding that the amplification and detection steps add nothing innovative to the natural phenomenon of cffDNA in maternal serum to make the subject matter patent-eligible. Under the framework of Mayo, detecting the presence of a naturally occurring thing or phenomenon, coupled with general instructions applying known routines and/or conventional techniques, does not transform the unpatentable law of nature into patentable subject matter. The same is true in Ariosa. In Ariosa, Sequenom's testing and determination steps were well known in the art and therefore those additional conventional steps were not enough to make the claims patent-eligible.

In two separate concurrences, Justices Lourie and Dyk shared concerns that the patent-eligibility test set forth in Mayo may be too restrictive, particularly as it applies to medical diagnostics and therapeutic methods where the discoveries are often driven by natural laws of life science. Specifically, there is concern that "method claims that apply newly discovered natural laws and phenomenon in somewhat conventional ways are screened out by the Mayo test." This is true particularly in cases where a claim is narrowly tailored to what an applicant has actually invented and reduced to practice, thus limiting any risk of undue preemption of the underlying idea. Notwithstanding, the court agreed that the panel's decision was correct in view of the Supreme Court's precedent, and rehearing was denied.

Judge Newman's dissent criticized the original panel's reliance on Mayo stating the facts here and in Mayo are clearly distinguishable. In Mayo, the claimed medicinal product and its metabolite were previously known, "leaving sparse room for innovative advance in using this information as a diagnostic tool." Whereas here, the inventors are claiming the discovery of a new diagnostic method using breakthrough information, namely, that birth defects can be identified earlier in the gestation period and without the risks of an invasive procedure.

The Federal Circuit's denial for a rehearing paves the way for a writ of certiorari to the Supreme Court, particularly with so many members of the Federal Circuit requesting that the breath of Mayo should be revisited.

Federal Circuit Affirms Ariosa, But Not Without Concerns

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