December 21, 2015

Federal Circuit Denial of Rehearing for Prenatal DNA Testing Patent: Supreme Court Review?

The Federal Circuit denied a petition for an en banc rehearing of Ariosa v. Sequenom (Fed. Cir 2015). This case tests the patent eligibility of a method to detect fetal DNA in maternal blood in order to perform prenatal testing. This case is set against a lingering unrest over the recent Supreme Court decision in Mayo v. Prometheus (2012), invalidating a method of drug dosaging as the improper patenting of a natural phenomenon. Claim 1 of the Sequenom patent is as follows: 
A method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises amplifying a paternally inherited nucleic acid from the serum or plasma sample and detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample. 
The denial was accompanied by two concurring opinions (Judges Lourie and Moore, Judge Dyk) and one dissent (Judge Newman). The concurrences both thought that Ariosa was wrongly decided as a policy matter, but that their court was bound by the Mayo decision. In Mayo, a 2-part test which required the identification of any "patent-ineligible concept" and if found, a patent claim would then need an "inventive concept" to make the claim patentable.

Application of the Mayo test in the panel decision of the Federal Circuit identified a natural phenomenon (the presence of the fetal DNA in maternal serum) in Claim 1 that was appended to conventional laboratory techniques (not to an inventive concept) and that result did not present a patentable invention. The recent petition for a rehearing and the accompanying amici involvement indicate continued discomfort with Mayo’s demand for the addition of an inventive concept to any discovered natural phenomeon before patenting is permitted. An “inventive concept” is not identified, nor is that requirement demanded by the statute or even explicitly required by the earlier 35 U.S.C. 101 landmark cases of the high Court (while also suggesting a consideration of prior art as well). It should be noted that the current debate is particularly centered on method claims, especially those with either diagnostic or therapeutic application. Will the Mayo test not only invalidate many diagnostic patent claims but challenge the eligibility of standard pharmaceutical treatment claims, for example, if the underlying metabolic processes are simply natural phenomena? Judge Dyk suggested that the Mayo framework may overlook a form of creativity that can emerge from discovery-based effort: 

But, as I see it, there is a problem with Mayo insofar as it concludes  that  inventive concept cannot come from  discovering something new in nature — e.g. , identification  of a previously  unknown natural relationship or property. In my view, Mayo did not fully take into account the fact that an inventive concept can come not just from creative and unconventional application of a natural law, but also from the creativity and novelty of the discovery of the law itself. This is especially true in the life sciences, where development of useful new diagnostic and therapeutic methods is driven by investigation of complex biological systems.
Thus, until the Supreme Court returns to consider whether Mayo has imposed a rigid, inflexible test with inapposite and/or ambiguous requirements, many argue that diagnostic and therapeutic innovation is at risk. Alternatively, however, more attention to embedding unambiguously detailed and physical manipulation into patent claims may overcome some of the concerns with breadth and scope underlying the preemption rationale for exclusion of the type of claim seen in the Sequenom patent. A petition for certiorari to the Supreme Court can be expected; 2016 could see the Court return to the issue of life science patent eligibility.

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