Amgen has intensified its patent protection strategy for denosumab by filing three new Biologics Price Competition and Innovation Act (BPCIA) lawsuits in late June 2025, targeting multiple companies developing biosimilar versions of its blockbuster osteoporosis and cancer bone disease treatments.
Multiple Patent Infringement Claims Filed
On June 25, 2025, Amgen filed complaints in the U.S. District Court for the District of New Jersey against two separate partnerships. The first lawsuit targets Hikma Pharmaceuticals USA Inc. and Gedeon Richter companies, alleging that their denosumab biosimilars RGB-14-P and RGB-14-X will infringe 32 patents. According to the complaint, Gedeon Richter is responsible for manufacturing and global clinical development of the proposed products, while Hikma handles regulatory approval and commercialization in the U.S. market.
The second June 25 lawsuit was filed against Shanghai Henlius Biotech companies and Organon, alleging that their denosumab biosimilar HLX14 will infringe 26 patents. Amgen alleges that Shanghai Henlius is responsible for development of the denosumab biosimilar, designated as HLX14, and that Organon is responsible for commercialization of the products in the United States.
Biocon Faces Largest Patent Challenge
On June 30, 2025, Amgen filed its third complaint in the District Court for the District of Massachusetts against Biocon Biologics entities. This lawsuit alleges infringement of 34 patents related to denosumab, including patents directed to pharmaceutical compositions and manufacturing methods, including methods for modulating glycosylation and filtration processes.
BPCIA Compliance Disputes
In all three cases, Amgen contends that the defendants failed to comply with the BPCIA's "patent dance" provisions. Amgen alleges that Hikma and Gedeon Richter failed to comply with the BPCIA's "patent dance" by withholding key manufacturing information. Similarly, Amgen alleges that Shanghai Henlius and Organon failed to comply with the BPCIA's "patent dance" by withholding key manufacturing information.
Regarding Biocon, Amgen argues the company failed to comply with the disclosure requirements mandated by the patent-dance provisions of the BPCIA. Specifically, Amgen alleges that Biocon did not provide sufficient information about its manufacturing process, despite multiple requests, and as a result, Amgen argues it was unable to fully engage in the "patent dance."
FDA Approval Timeline Context
The litigation follows significant regulatory milestones for the targeted biosimilars. The FDA accepted Richter/Hikma's BLA for RGB-14-P and RGB-14-X in December 2024, with these products serving as biosimilars to Amgen's Prolia and Xgeva (denosumab). Under an exclusive license agreement entered in December 2021, Gedeon Richter is responsible for the development of RGB-14, while Hikma is responsible for FDA registration and has exclusive rights to commercialize it in the U.S. following approval.
Organon and Shanghai Henlius' BLA for HLX14 (denosumab) was accepted for review by the FDA in October 2024. In June 2022, Shanghai Henlius entered into a license agreement with Organon regarding HLX14 under which Organon has exclusive global commercialization rights for all countries except China, Hong Kong, Macau and Taiwan.
Comprehensive Legal Relief Sought
In each of the three cases, Amgen seeks extensive legal remedies including judgment that defendants have infringed one or more claims of each patent under 35 U.S.C. § 271(e)(2)(C), permanent injunctions against commercial manufacture, use, offer to sell, and sale within the United States, and importation into the United States of defendants' denosumab biosimilar products before patent expiration.
Amgen also seeks permanent injunctions against future infringement by defendants and their associated entities until each infringed patent expires, in addition to damages and a declaration that the cases are exceptional with an award of attorneys' fees.
Expanding Denosumab Patent Litigation Landscape
These three new cases brought by Amgen represent the sixth, seventh and eighth BPCIA litigations regarding denosumab, following Amgen's previous litigations against Sandoz, Celltrion, Samsung Bioepis/Samsung Biologics, Fresenius, and Accord Biopharma. This pattern demonstrates Amgen's systematic approach to defending its denosumab patent portfolio against the growing number of biosimilar competitors seeking market entry.
