Eagle Pharmaceuticals, Inc. v. Azar

Court: US Court of Appeals for the District of Columbia Circuit

Docket: 18-5207

Opinion Date: March 13, 2020

Judge: Henderson

Areas of Law: Drugs & Biotech, Government & Administrative Law

The DC Circuit affirmed the district court's grant of summary judgment in favor of Eagle, in an action brought by Eagle, alleging that the Orphan Drug Act's (ODA), 21 U.S.C. 360aa–360ee, plain language required the FDA to automatically grant Eagle marketing exclusivity upon designating its drug as an orphan drug and approving it for marketing. The court held that the district court correctly determined at Chevron step one that the FDA's post-approval clinical superiority requirement was forbidden and that Eagle was automatically entitled to a seven-year period of exclusive approval when it approved Bendeka for marketing.

Illumina, Inc. v. Ariosa Diagnostics, Inc.

Court: US Court of Appeals for the Federal Circuit

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.

Kaken Pharmaceutical Co., Ltd. v. Iancu

Court: US Court of Appeals for the Federal Circuit

Docket: 18-2232

Opinion Date: March 13, 2020

Judge: Richard Gary Taranto

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

Kaken’s patent, titled “Method For Treating Onychomycosis,” describes and claims methods for topically treating fungal infections in human nails. On inter partes review under 35 U.S.C. 311–319, the Patent Trial and Appeal Board determined that all claims of the patent are unpatentable for obviousness. The Federal Circuit vacated. The Board erred in its claim construction of one claim limitation--“treating a subject having onychomycosis.” Kaken’s unambiguous statement that onychomycosis affects the nail plate, and the examiner’s concomitant action based on this statement, make clear that “treating onychomycosis” requires penetrating the nail plate to treat an infection inside the nail plate or in the nail bed under it. The Board’s obviousness analysis materially relied on its erroneous claim construction.