Organon and Shanghai Henlius resolve 26-patent BPCIA litigation with Amgen over denosumab biosimilars
Client(s) Organon LLC; Shanghai Henlius Biologics Co., Ltd.; Shanghai Henlius Biotech, Inc.
Jones Day represented Organon LLC, Organon & Co. (collectively "Organon"), Shanghai Henlius Biotech, Inc., and Shanghai Henlius Biologics Co., Ltd. (collectively "Shanghai Henlius") in patent litigation under the Biologics Price Competition and Innovation Act (BPCIA) filed in June 2025 by Amgen Inc. and Amgen Manufacturing Limited LLC (collectively "Amgen") in the U.S. District Court for the District of New Jersey. Amgen alleged that Shanghai Henlius's denosumab biosimilar, HLX14 --developed by Shanghai Henlius and licensed to Organon for U.S. commercialization as BILPREVDA® and BILDYOS® (denosumab-nxxp) --infringed 26 Amgen patents covering the denosumab antibody, pharmaceutical compositions containing denosumab, and methods of manufacturing therapeutic proteins. Denosumab is the active ingredient in Amgen's PROLIA® and XGEVA®. The case was part of a coordinated multidistrict litigation involving multiple waves of complaints against groups of biosimilar applicants. During the course of litigation, Jones Day succeeded in obtaining key protections on behalf of its clients, including a favorable confidentiality order --entered over Amgen's opposition and preserved on Amgen's motion for reconsideration --that established significant and novel safeguards for Shanghai Henlius's trade secret information. The court entered a Consent Order and Judgment amicably resolving the dispute.
Amgen Inc. et al v. Shanghai Henlius Biotech, Inc. et al., No. 1-25-cv-12160 (D.N.J.); In re Denosumab Patent Litigation, MDL No. 3138 (D.N.J.)
