Fresh From the Bench: Latest Precedential Patent Case

ALMOST THIS WEEK

Ascendis Pharma A/S v. BioMarin Pharmaceutical Inc., Appeal No. 2026-1026 (Fed. Cir. Mar. 26, 2026)

The Federal Circuit’s only precedential opinion last week was not quite a “patent case,” but instead concerned when a stay of district court proceedings is available to a respondent in a Section 337 proceeding before the U.S. International Trade Commission.  While 28 U.S.C. § 1659(a) provides that such a stay is mandatory if requested within 30 days of the respondent being named in the ITC action or of the district court action being filed (whichever is later), the Court held that appellant Ascendis was not permitted to game the deadline by voluntarily dismissing its own declaratory judgment action without prejudice and then re-filing it.  En route to that determination, the reviewing panel also upheld Ascendis’s standing to appeal an interlocutory order entering a discretionary stay, as opposed to the mandatory stay Ascendis had sought under the statute.

The underlying dispute concerned pediatric treatments for achondroplasia (a form of genetic dwarfism) using C-type natriuretic peptide (CNP) variants.  Appellant Ascendis sought FDA approval for a new CNP treatment, and BioMarin filed an ITC complaint seeking to  enjoin Ascendis’s importation of the drug on grounds that it infringed BioMarin’s patent.  Ascendis contended that it was exempt from infringement liability under the safe-harbor provisions of 35 U.S.C. 271(e)(1)—which immunizes otherwise infringing acts undertaken solely for regulatory approval purposes—and filed a district court action seeking declaratory judgment to that effect.  When it became apparent FDA approval for the new drug would soon be granted, however, and that BioMarin would seek preliminary injunctive relief when it was, Ascendis reversed course and sought to stay the district court litigation pending completion of the ITC proceedings.

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Editors:

Nika Aldrich, IP Litigation Group Leader, Schwabe

Jason A. Wrubleski, Shareholder