Ascendis Pharma and BioMarin Pharmaceutical are competing drug manufacturers developing treatments for achondroplasia, a genetic condition causing short-limbed dwarfism. BioMarin holds a patent covering a key treatment, Voxzogo, while Ascendis sought FDA approval for its competing drug, TransCon CNP. When BioMarin filed a complaint with the U.S. International Trade Commission (ITC) alleging patent infringement by Ascendis's imported drug, Ascendis filed a declaratory judgment action in the Northern District of California seeking a ruling of non-infringement. Ascendis initially filed this action on April 11, 2025, but failed to request a mandatory stay under 28 U.S.C. § 1659(a)(2) within the required 30-day window. Instead of amending the complaint or moving for a stay, Ascendis voluntarily dismissed the original action without prejudice and immediately filed a nearly identical 'refiled' complaint. Ascendis then moved for a mandatory stay under the statute, arguing that the 30-day clock should restart with the new filing. The district court denied the mandatory stay as moot, granting a discretionary stay instead. Ascendis appealed, arguing it was entitled to the mandatory stay under the refiled action.
The Federal Circuit, in an opinion by Judge Stoll, first addressed whether Ascendis had Article III standing and whether the court had jurisdiction under the collateral order doctrine. The court found that Ascendis had standing because BioMarin had threatened to lift the discretionary stay and seek a preliminary injunction upon FDA approval, creating a concrete and imminent injury. The court also held that the denial of a mandatory stay is effectively unreviewable on appeal from a final judgment, satisfying the collateral order doctrine requirements. On the merits, the court interpreted 28 U.S.C. § 1659(a)(2), which mandates a stay if requested within 30 days of the district court action being filed. The court reasoned that the statutory time limits are jurisdictional and mandatory. Applying common-law principles that prohibit using voluntary dismissal to indirectly circumvent explicit procedural rules, the court concluded that 'the district court action' refers to the original filing. Allowing Ascendis to restart the clock by refiling would undermine the statute's purpose of avoiding abuse and encouraging prompt adjudication. The court noted that the legislative history of the statute emphasized the need to prevent parties from delaying proceedings or engaging in parallel litigation indefinitely. Therefore, Ascendis's attempt to refile to reset the 30-day deadline was impermissible.
The decision clarifies that the 30-day deadline for requesting a mandatory stay of district court proceedings pending ITC investigations is strict and cannot be reset by voluntarily dismissing and refiling a complaint. Respondents must act promptly within 30 days of the initial filing or being named in the ITC proceeding. The ruling prevents parties from using procedural tactics to extend litigation timelines or avoid the mandatory stay requirements. The case was affirmed, meaning the district court's denial of the mandatory stay stands, and the parties must proceed under the discretionary stay or continue litigation subject to the ITC's final determination.
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