RE48267

ITC Section 337 investigation titled Certain Drug Products Containing C-Type Natriuretic Peptide Variants, and Components Thereof, brought by BioMarin against Ascendis entities and suppliers regarding TransCon CNP / navepegritide. The asserted patent was U.S. Reissue Patent No. RE48,267; US 8,377,884 was relied on by Ascendis as prior-art Exhibit 32, not asserted. Resolved by a global settlement announced August 30–31, 2026, with the investigation to be dismissed.

Ascendis entities filed a declaratory judgment action of non-infringement against BioMarin, also invoking the 35 U.S.C. § 271(e)(1) safe harbor. Ascendis voluntarily dismissed without prejudice on July 7, 2025, stating it would refile to seek a mandatory stay under 28 U.S.C. § 1659(a)(2).

Ascendis Pharma A/S filed a declaratory judgment action against BioMarin; the docket listed U.S. Patents 8,198,242, 8,906,847, and RE48,267. The district court granted BioMarin's motion for a discretionary stay on September 19, 2025, and denied Ascendis's mandatory stay motion as moot; the case was later resolved by the August 2026 global settlement.