The dispute stems from competing treatments for achondroplasia, a genetic condition causing short-limbed dwarfism. After Ascendis filed a new drug application with the FDA for its TransCon CNP treatment, BioMarin filed an ITC complaint alleging patent infringement by Ascendis's imports. Ascendis then filed a declaratory judgment action seeking non-infringement, but waited over 30 days before requesting a mandatory stay under 28 U.S.C. § 1659(a)(2), which requires such requests within 30 days of filing or being named an ITC respondent.
Judge Stoll, writing for the three-judge panel, applied common law principles prohibiting the misuse of voluntary dismissals to circumvent procedural deadlines. "Ascendis voluntarily dismissed the Original Complaint and filed a virtually identical Refiled Complaint in an attempt to restart the 30-day deadline under § 1659(a)(2)," the court found. The panel distinguished this case from removal statute provisions that explicitly reference "initial" versus "amended" pleadings, finding no such congressional intent in the ITC stay provision.
The case arose after Ascendis initially opposed BioMarin's motion to dismiss or stay the declaratory judgment action, then abruptly reversed course by voluntarily dismissing without prejudice "for purposes of refiling its declaratory judgment action to seek a mandatory stay." The district court ultimately granted a discretionary stay under Landis v. North American Co. while denying the mandatory stay motion as moot, prompting Ascendis's appeal.
The Federal Circuit's decision prevents parties from gaming ITC stay deadlines through strategic refiling, reinforcing Congress's intent to "avoid abuse and encourage prompt adjudication" in parallel patent proceedings. With the FDA having approved Ascendis's drug during the appeal, BioMarin has already indicated plans to seek a preliminary injunction, setting up continued litigation under the discretionary stay framework the district court established.