July 8, 2015
On June 12, 2015, the Federal Circuit issued its decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc., finding that Sequenom’s patent claiming methods of using cell-free fetal DNA (“cffDNA”) for prenatal diagnosis test is patent ineligible under 35 U.S.C. § 101. The Sequenom’s patent is directed to a revolutionary finding that there is cffDNA in the blood stream of a pregnant woman. The presence of cffDNA in maternal blood samples provides a safer, cheaper, and faster alternative to the conventional invasive methods to determine fetal genetic abnormalities, such as Down Syndrome. Several popular prenatal diagnosis tests, including Sequenom’s MaterniT21 and Ariosa’s Harmony, embody Sequenom’s discovery.
The Sequenom’s patent claims methods of using cffDNA, including the steps of amplifying cffDNA, detecting genetic information of the fetus, and/or analyzing the fetal genetic information. Applying the two-step framework set forth by the Supreme Court in Mayo Collaborative Services v. Prometheus Laborites, Inc., the Federal Circuit held that Sequenom’s patent claims patent ineligible subject matter and thus is invalid. In step one of the Mayo framework, the court found that all Sequenom’s method claims are directed to a natural phenomenon – the presence of cffDNA in maternal blood. In the second step of the Mayo framework, the court found that the methods of amplifying, detecting, and analyzing cffDNA “were well-understood, conventional and routine” at the time of invention. Thus, the practice of these methods “does not result in an inventive concept that transforms the natural phenomenon of cffDNA into a patentable invention.” The court also addressed the applicability of the preemption principle in Section 101 analysis. The court noted that “[w]hile preemption may signal patent ineligible subject matter, the absence of complete preemption does not demonstrate patent eligibility.”
The Ariosa decision makes clear that the operative test for patent eligibility of method or process claims encompassing a natural phenomenon is whether the claims embody an “inventive concept.” The Supreme Court in Mayo did not address what additional steps or elements could meet the “inventive concept” requirement. According to the Ariosa court, to be patent eligible, such claims must include individual steps that are “new and useful.” This view is certainly more restrictive than a view that new applications of a natural phenomenon may be patent eligible, a position not rejected by the Supreme Court in Association for Molecular Pathology v. Myriad Genetics, Inc.. Under Ariosa, biotech method or process patents, even those that embody major breakthroughs, are likely to be invalid unless they claim innovative methods or applications of the underlying breakthroughs.
This concern is highlighted by Judge Linn in his concurring opinion, where he concluded 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.” Judge Linn believed that “Sequenom’s invention is nothing like the invention at issue in Mayo” because it is directed to “a new method that should be patent eligible.” Yet, he found that “[t]he Supreme Court’s blanket dismissal of conventional post-solution steps leaves no room to distinguish Mayo from this case[.]”
Absent a further review by the Supreme Court or a legislative involvement, many biotech method or process patents are likely to be found patent ineligible under the Ariosa decision because they usually embody applications of natural phenomena with convention steps and/or routine techniques.
 __ F.3d__, 2015 WL 3634649, at *1 (Fed. Cir. June 12, 2015).
 566 U.S. __, 132 (2012).
 Ariosa, __ F.3d__, 2015 WL 3634649, at *3.
 Id. at 4.
 Under the preemption principle, a method applying a natural phenomenon in a manner that precludes other applications of the phenomenon are not patent eligible.
 Ariosa, __ F.3d__, 2015 WL 3634649, at *5.
 Id. at *5.
 569 U.S. __, 133 S. Ct. 2107, 2120 (2013) (the Supreme Court noted that
Similarly, this case does not involve patents on new applications of knowledge about the BRCA1 and BRCA2 genes. Judge Bryson aptly noted that, “[a]s the first party with knowledge of the [BRCA1 and BRCA2] sequences, Myriad was in an excellent position to claim applications of that knowledge. Many of its unchallenged claims are limited to such applications.
 Ariosa, __ F.3d__, 2015 WL 3634649, at *10.
 Id. at * 9.
Edited by Mieke Malmberg, Partner Glaser Weil LLP