by Dennis Crouch
Voluntary dismissal: Under Rule 41(a), a plaintiff can walk away from a lawsuit before the defendant answers or moves for summary judgment, no questions asked, no permission required. The tactic gets used strategically all the time: to avoid an unfavorable ruling, to refile in a better forum, etc. Courts have generally tolerated this practice, recognizing that voluntary dismissals serve important functions in managing litigation. But, there has always been some concern about strategic over-use. In Ascendis Pharma A/S v. BioMarin Pharmaceutical Inc., No. 26-1026 (Fed. Cir. Mar. 26, 2026), the Federal Circuit drew a line, holding that a party cannot use voluntary dismissal to restart a statutory deadline it already missed. The court affirmed the district court’s denial of a mandatory stay under 28 U.S.C. § 1659(a)(2), holding that Ascendis’s dismiss-and-refile maneuver could not revive the 30-day window for requesting that the district court halt proceedings pending a parallel ITC investigation.
The case arises from a pharmaceutical patent dispute between two drug manufacturers developing treatments for achondroplasia (ACH), a genetic condition that causes short-limbed dwarfism. BioMarin sells Voxzogo, an FDA-approved ACH treatment covered by U.S. Patent No. RE48,267. Ascendis filed a New Drug Application for its competing product, TransCon CNP, on March 31, 2025. The very next day, BioMarin filed a complaint with the U.S. International Trade Commission alleging that Ascendis’s importation of TransCon CNP infringed the ‘267 patent. Ten days later, on April 11, 2025, Ascendis filed a declaratory judgment action in the Northern District of California seeking a declaration of non-infringement with the argument that its imports were within the 35 U.S.C. § 271(e)(1) safe harbor – i.e., for reasons directly related to obtaining FDA approval.
This setup with parallel ITC and district court proceedings sets up a discussion of the mandatory stay provision of 28 U.S.C. § 1659(a). That section provides that the district court shall stay proceedings with respect to any claim involving the same issues, at the request of a party that is also a respondent in the ITC proceeding. But, the stay mandate is only required if requested within 30 days after the district court action is filed.
In our case, Ascendis had waited more than 30 days to request a stay – it then voluntarily dismissed its DJ action without prejudice and immediately refiled a nearly identical complaint the same day for the express purposes of resetting the clock. Apparently Ascendis realized the DJ action created a problem: once the FDA approved the drug, BioMarin could use the pending district court case as a vehicle to seek a preliminary injunction. A mandatory stay under § 1659 would protect against that occurrence. (more…)

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