Latest Case: Illumina, Inc. v. Ariosa Diagnostics, Inc. (Drugs & Biotech)

The Perils of Relying on the Wrong Clause—Grounding the Ministerial Exception at the Supreme Court

IRA C. LUPU, ROBERT TUTTLE

GW Law professors Ira C. Lupu and Robert W. Tuttle explain why the path the U.S. Supreme Court is taking in ministerial exception cases—relying on the Free Exercise Clause of the First Amendment—is dangerously misguided. Lupu and Tuttle argue that the ministerial exception rests primarily on the Establishment Clause and is strictly limited to employment decisions about who leads or controls a faith community, or who transmits a faith.

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Illumina, Inc. v. Ariosa Diagnostics, Inc.

Docket: 19-1419

Opinion Date: March 17, 2020

Judge: Alan David Lourie

Areas of Law: Drugs & Biotech, Intellectual Property, Patents

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.