Ariosa Diagnostics, Inc. v. Sequenom, Inc., No. 2014-1139, -1144, 2015 U.S. App. LEXIS 9855 (Fed. Cir. Jun. 15, 2015) (Reyna, J.) (Linn, J., concurring). Click Here for a copy of the opinion.
Ariosa makes and sells the Harmony Test, a non-invasive test for prenatal diagnosis of certain fetal characteristics. Ariosa filed a declaratory judgment action alleging non-infringement of Sequenom's U.S. Patent No. 6,258,540, directed to methods of using cell-free fetal DNA ("cffDNA") in maternal plasma and serum. Claim 1 involves amplifying cffDNA from a pregnant female's plasma or serum and detecting paternally inherited cffDNA, which is used to determine fetal characteristics such as gender.
Sequenom counterclaimed for infringement and sought a preliminarily injunction. The district court denied the injunction and Sequenom appealed. The Federal Circuit vacated and remanded. The parties then filed cross motions for summary judgment regarding invalidity. The district court granted Ariosa's motion and found that the claims "were directed to the natural phenomenon of paternally inherited cffDNA and that the claims did not add enough to the natural phenomenon to make the claims patent eligible under §101." Sequenom appealed.
Using the two-part analysis in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012), the Federal Circuit first determined that the method claims at issue were directed to naturally occurring matter. The method started with a natural occurring cffDNA taken from maternal plasma, and it ended with paternally inherited cffDNA, also a natural phenomenon. The Court found support for its conclusion in the specification, which described the unexpected discovery and detection of cffDNA (especially paternal cffDNA) in maternal plasma. Thus, the Court concluded that the claims were directed to detecting the presence of cffDNA in maternal plasma, which is a naturally occurring thing, even if unexpected.
In the second step of the analysis, the Court examined the elements of the claim and concluded that "the practice of the method claims does not result in an inventive concept that transforms the natural phenomenon of cffDNA into a patentable invention." For process claims, the process steps must be new and useful in order to transform a natural phenomenon into a patent eligible application. Here, the method steps of preparation and DNA amplification were "well-understood, conventional and routine." Similarly, the detecting techniques were well understood in the art, as indicated by the Applicant during prosecution. "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." Thus, the Court concluded that the claims at issue were invalid.
Rejecting Sequenom's argument that the patent "does not preempt all uses of cffDNA" and therefore the claimed methods are patent eligible, the Court held that "[w]hile preemption may signal patent ineligibility subject matter, the absence of complete preemption does not demonstrate patent eligibility." Here, the claims only disclosed patent ineligible subject matter, so the issue of preemption was moot. The Court acknowledged that the "discovery regarding cffDNA may have been a significant contribution to the medical field." However, "groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry," as was the case here. The Court therefore affirmed.
In his concurrence, Judge Linn agreed that based on the broad language of Mayo, the claims were invalid. However, he believed that this broad language was unnecessary and caused unintended consequences in this case. According to him, the '540 patent claims a "new method that should be patent eligible" but for the broad language in Mayo.
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