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 Federal Circuit applied a two-part test from Mayo v. Prometheus (2011) and found a lack of patentable subject matter:
Thus, in this case, appending routine, conventional steps to a natural phenomenon, specified at a high level of generality, is not enough to supply an inventive concept. Where claims of a method patent are directed to an application that starts and ends with a naturally occurring phenomenon, the patent fails to disclose patent eligible subject matter if the methods themselves are conventional, routine and well understood applications in the art. The claims of the ’540 patent at issue in this appeal are not directed to patent eligible subject matter and are therefore, invalid.The petitioners argue that earlier Supreme Court case law does not mandate the result that the Federal Circuit arrived at. Citing the landmark case of Diamond v. Diehr (1981), concerning whether a patent claim to a rubber-curing method preempted the use of a mathematical formula, the petition notes that Diehr stated that “[i]n determining the eligibility of respondents’ claim[s]...under §101, their claims must be considered as a whole.” The petition further notes that the recent Mayo test is not rooted in the central imperative for excluding certain subject matter from patenting, which is a preemption of fundamental knowledge that becomes an obstacle to scientific progress. They characterize the Mayo test as a rote application of a two-step formula that avoids an actual analysis of whether a patent claim “preempts” further use of fundamental subject matter in the field. The petitioners argue that no preemption occurs here:
Demonstrated methods show that cffDNA may be used without practicing each of the patent’s core steps: One need not fractionate the sample; one may forego amplification; and one can use cffDNA without distinguishing paternally inherited sequences at all. These non-preempted innovations are conclusive evidence that petitioner’s patent does not claim the natural phenomenon itself —instead claiming merely one set of applications then known only to the inventors.The petition further develops the impact of the Ariosa (and Mayo) decisions on a wide swath of method patents in the life sciences:
[T]he decision below threatens to destroy the predictability and certainty the patent system needs to do its job. At a minimum, the biomedical community is now adrift in determining whether or not patents will ever be available in these or related fields. And that’s essentially the ballgame, because once you must seriously question the availability of patent protection, you cannot: (1) confidently invest in research; (2) confidently invest in clinical validation and commercialization of existing patents; or (3) confidently predict that it is better to disclose your discoveries through the patent system than it is to keep them a trade secret.In the denial for rehearing en banc, several judges of the Federal Circuit noted their disagreement with an outcome mandated by the Mayo test, but not commanded by the overall objectives of the patentable subject matter doctrine. This case is well-positioned to provide the Court with an opportunity to investigate the method (diagnostic, therapeutic, etc.) claims in biotechnology and consider whether the Mayo test has imposed a rigid formula that short-circuits case-by-case consideration of preemption. For that reason, the Court may respond to the appeal for clarification and review and accept the case; if so, this case would add to an unprecedented involvement by the Court in this patent law doctrine (5 cases in 6 years).