Illumina, Inc. v. Ariosa Diagnostics, Inc., No. 19-1419 (Fed. Cir. 2020)Annotate this Case
In 1996, two doctors discovered cell-free fetal DNA in maternal plasma and serum, previously discarded as medical waste. In 2001, they obtained a patent, claiming a method for detecting the small fraction of paternally inherited cell-free fetal DNA in the plasma and serum of a pregnant woman. In 2015, the Federal Circuit (Ariosa) held that the patent's claims were invalid under 35 U.S.C. 101, as directed to “matter that is naturally occurring.” The patents at issue are unrelated to the Ariosa patent and begin by acknowledging the "Ariosa" natural phenomenon, then identify a problem that was the subject of further research: there was no known way to distinguish and separate the tiny amount of fetal DNA from the vast amount of maternal DNA. The patents use an additional discovery to claim methods of preparing a fraction of cell-free DNA that is enriched in fetal DNA.
The Federal Circuit concluded that the claims are patent-eligible. These inventors patented methods of preparing a DNA fraction. The claimed methods utilize the natural phenomenon that the inventors discovered by employing physical process steps to selectively remove larger fragments of cell-free DNA to enrich a mixture in cell-free fetal DNA. Those steps change the composition of the mixture, resulting in a DNA fraction that is different from the naturally-occurring fraction in the mother’s blood.