“This is not a diagnostic case. And it is not a method of treatment case. It is a method of preparation case,” wrote the CAFC. “The claims in this case do not fall into either bucket.”
The U.S. Court of Appeals for the Federal Circuit (CAFC) has reversed a district court decision finding certain claims of two patents covering prenatal DNA testing patent ineligible. The CAFC held that “the claimed methods utilize the natural phenomenon that the inventors discovered by employing physical process steps” and thus were patent-eligible. The patents at issue in the case acknowledge but are not related to the patented invention held invalid in Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1373 (Fed. Cir. 2015). The opinion was authored by Judge Lourie, with Judge Reyna dissenting.
U.S. Patent 9,738,931 (the ’931 patent) and U.S. Patent 9,580,751 (the ’751 patent) are owned by Sequenom and licensed by Illumina. The two companies brought suit against Ariosa Diagnostics, Inc., Roche Sequencing Solutions, Inc., and Roche Molecular Systems, Inc. (Roche) for infringement in the United States District Court for the Northern District of California in 2018, three years after the decision in Ariosa v. Sequenom. The district court found the asserted claims invalid under 35 U.S.C. § 101 as directed to an ineligible natural phenomenon and granted summary judgment to Roche.
According to the Federal Circuit, the inventors in the present case were attempting to solve the following problem: “Although it was known that cell-free fetal DNA existed in the mother’s bloodstream, there was no known way to distinguish and separate the tiny amount of fetal DNA from the vast amount of maternal DNA.”
To find a solution, the inventors first made the discovery that “the majority of the circulatory extracellular fetal DNA has a relatively small size of approximately 500 base pairs or less, whereas the majority of circulatory extracellular maternal DNA in maternal plasma has a size greater than approximately 500 base pairs.”
Next, they developed a solution, articulating an invention in which “separation of circulatory extracellular DNA fragments which are smaller than approximately 500 base pairs provides a possibility to enrich for fetal DNA sequences from the vast bulk of circulatory extracellular maternal DNA.”
The claims of the ’931 and ’751 patents are directed to “methods of preparing a fraction of cell-free DNA that is enriched in fetal DNA.”
“Laws of nature and natural phenomena are not patentable, but applications and uses of such laws and phenomena may be patentable,” explained the CAFC. Turning to the two-step Alice test, the Court distinguished the case from the many diagnostics cases in which it has held patents in this field ineligible, such as Athena Diagnostics and Cleveland Clinic, as well as from method-of-treatment cases in which it has held patents eligible, such as Endo Pharmaceuticals, Natural Alternatives Int’l, Inc. and Vanda.
“This is not a diagnostic case. And it is not a method of treatment case. It is a method of preparation case,” wrote the Court. “The claims in this case do not fall into either bucket, and we consider the claims under the Alice/Mayo test.”
Ultimately, the CAFC said that the claims at issue were not directed to a natural phenomenon, but “include specific process steps—size discriminating and selectively removing DNA fragments that are above a specified size threshold—to increase the relative amount of fetal DNA as compared to maternal DNA in the sample.”
These steps result in a DNA fraction that is distinct from the naturally occurring fraction in the mother’s blood, said the court. “Thus, the process achieves more than simply observing that fetal DNA is shorter than maternal DNA or detecting the presence of that phenomenon.”
The Court dismissed Roche’s arguments that the claims are no more eligible than the claims at issue in Ariosa:
In essence, the inventors in Ariosa discovered that cell-free fetal DNA exists, and then obtained patent claims that covered only the knowledge that it exists and a method to see that it exists. Here, in contrast, the claims are directed to more than just the correlation between a DNA fragment’s size and its tendency to be either fetal or maternal.
The CAFC likewise dismissed the argument that the claims were invalid under Myriad, which held that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.” 569 U.S. 576, 580 (2013). Judge Lourie wrote: “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.”
The Court added that Rapid Litig. Mgmt. Ltd. v. CellzDirect, Inc. is instructive on this and other points made by the majority. The opinion concluded:
The invention in this case is the product of further research on cell-free fetal DNA. This time, the inventors discovered that, not only does the fetal DNA exist in the bloodstream of a pregnant mother, but it has characteristics that make it distinguishable, and therefore separable, from the maternal DNA.
The district court’s decision was thus reversed and remanded for further proceedings.
Judge Reyna was not moved by the majority’s distinction between this case and the Court’s previous precedent in diagnostics cases. He said in his dissent that “the claims are directed to a natural phenomenon. The patents’ only claimed advance is the discovery of that natural phenomenon.” He continued:
The Majority sidesteps well-established precedent by reasoning that the claims in this case belongin 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.
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