On August 3, 2020, the Court of Appeals for the Federal Circuit issued a modified opinion in Illumina, Inc. v. Ariosa Diagnostics, Inc.,[1] reiterating its earlier opinion[2] finding claims directed to method of preparing cell-free fetal DNA in maternal blood as patent-eligible subject matter under 35 U.S.C. §101. This modified opinion reflected Ariosa’s recent petition for rehearing en banc, which was denied by the Fed Circuit, with the modified opinion taking its place.
This was a split opinion, with the majority formed by Judges Lourie and Moore, both generally §101 proponents, and the dissent by Judge Reyna, a §101 skeptic. This is the exact make-up as the earlier opinion.
The patents at-issue were U.S. Patent 9,580,751 (‘751) and 9,738,931 (‘931). The earlier case between the two parties found another patent, U.S. Patent No. 6,258,540, as directed to patent-ineligible subject matter because the claims were directed to natural phenomenon that cell-free fetal DNA exists in maternal blood, i.e., naturally occurring matter.[3]
Judge Lourie, writing for the majority, noted:
This is not a diagnostic case. And it is not a method of treatment case. It is a method of preparation case. Under Mayo, we have consistently held diagnostic claims unpatentable as directed to ineligible subject matter. See Athena Diagnostics, Inc. v. Mayo Coll. Servs., LLC, 927 F.3d 1333, 1352 (Fed. Cir. 2019). The claims in this cse do not fall into either category . . . The focus of the dispute in this case is whether the claims of the ‘751 and ‘931 patents are “directed to” the natural phenomenon, i.e., whether they claim the discovered natural phenomenon itself versus eligible subject matter that exploits the discovery of the natural phenomenon.
Judge Lourie, as he explained in the earlier opinion:
The [Supreme] Court stated[] [i]t is important to note what is not implicated by this decision. First, there are no method claims before this Court. Had Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent. But the processes used by Myriad to isolate DNA … are not at issue in this case . . . . Thus, in Myriad, the claims were ineligible because they covered a gene rather than a process for isolating it. Here, we encounter the opposite situation, i.e., the claims do not cover cell-free fetal DNA itself but rather a process for selective removal of non-fetal DNA to enrich a mixture in fetal DNA. Thus, the Supreme Court’s decision in Myriad is not on point.
Further, and to note the modification from the earlier opinion, he emphasized:
Here, we encounter the opposite situation, i.e., the claims do not cover separated cell-free fetal DNA itself but rather a process for selective removal of non-fetal DNA to enrich a mixture in fetal DNA. That process includes size parameters that the inventors engineered to balance the practicalities of the specific problem that they were facing, namely, removing enough cell-free maternal DNA to enrich the mxiture while leaving enough cell-free fetal DNA to allow for testing. Thus, the Supreme Court’s decision in Myriad is not on point in this case where the inventors claimed to have conceived and reduced to practice, not the separated DNA, but a method that uses unconventional size parameters to perform the separation.
Judge Reyna, in his dissent, criticized the majority’s opinion:
The Majority sidesteps well-established precedent by reasoning that the claims in this case belong in a unique “bucket” reserved for patents that claim “a method of preparation.” By placing this case in that bucket and not in a “diagnostic case” bucket, the Majority summarily dismisses precedent like Athena, Roche Molecular, Cleveland Clinic, Genetic Techs., Ariosa, and others. Id. Our precedent, however, does not support the Majority’s per se grouping of claims. A “method of preparation case” is treated no differently than any other process claim under our law.
To wit, while Judge Reyna is technically correct, Judge Lourie focuses his analysis on the very specific inventive aspects of the ‘751 and ‘931 patents, distinguishing these two patents’ claims from the diagnostics claims in Ariosa, and of which are consistent with Supreme Court precedents in Mayo and Myriad.
This ruling is not over, as Ariosa will no doubt seek petition for writ of certiorari before the U.S. Supreme Court on this very issue.
[1] ___F.3d___ (Fed. Cir. 2020) (mod. op.), rev’g 356 F. Supp. 3d 925 (N.D. Cal. 2018).
[2] 952 F.3d 1367 (Fed. Cir. 2020).
[3] See Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1373 (Fed. Cir. 2015).