No Do-Overs: Federal Circuit Blocks Dismiss-and-Refile Tactic to Restart ITC Stay Deadline

"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."

"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."

Under Rule 41(a), plaintiffs can voluntarily dismiss lawsuits without permission before a defendant answers. This tactic is often used strategically to avoid unfavorable rulings or to refile in better forums. However, the Federal Circuit in Ascendis Pharma A/S v. BioMarin Pharmaceutical Inc. ruled that voluntary dismissal cannot be used to restart missed statutory deadlines. The case involved a patent dispute over treatments for achondroplasia, where Ascendis attempted to dismiss and refile to revive a 30-day window for a mandatory stay related to an ITC investigation.

Read at patentlyo.com