In the last week, Amgen, Inc and Amgen Manufacturing Ltd, LLC ("Amgen") filed three more BPCIA complaints against companies seeking approval for a denosumab biosimilar.
On June 25, 2025, Amgen filed a complaint in the U.S. District Court for the District of New Jersey against Hikma Pharmaceuticals USA Inc. ("Hikma"), Gedeon Richter Plc., and Gedeon Richter USA, Inc. (collectively, "Gedeon"), alleging that their denosumab biosimilars, RGB-14-P and RGB-14-X, will infringe 32 patents. According to the complaint, Gedeon is responsible for manufacturing and global clinical development of the proposed products, while Hikma handles regulatory approval and commercialization in the U.S. market. Amgen alleges that Hikma and Gedeon Richter failed to comply with the BPCIA's "patent dance" by withholding key manufacturing information.
On the same day, Amgen also filed complaint against Shanghai Henlius Biotech, Inc., Shanghai Henlius Biologics Co., Ltd. (collectively, "Shanghai Henlius"), Organon LLC, and Organon & Co. ("Organon") under the BPCIA, 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. Amgen also alleges that Shanghai Henlius and Organon failed to comply with the BPCIA's "patent dance" by withholding key manufacturing information.
On June 30, 2025, Amgen filed a complaint in the District Court for the District of Massachusetts, Eastern Division against Biocon Biologics, Inc., Biocon Biologics UK Limited, and Biocon Biologics Limited (collectively, "Biocon"). Amgen alleges that Biocon will infringe 34 patents related to denosumab, including patents directed to pharmaceutical compositions and manufacturing methods, including methods for modulating glycosylation and filtration processes. Amgen further contends that Biocon 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."
In each of the three cases, Amgen seeks a "judgment that Defendants have infringed, either literally or under the doctrine of equivalents, one or more claims of each of the Patents-In-Suit under 35 U.S.C. § 271(e)(2)(C); . . . a permanent injunction against the commercial manufacture, use, offer to sell, and sale within the United States, and importation into the United States, of Defendants' denosumab biosimilar products before the expiration of each of the Patents-In-Suit that are found infringed; . . . a judgment that Defendants have infringed or will infringe one or more claims of each of the Patents-In-Suit by making, using, offering for sale, or selling within the United States, or importing into the United States, one or more of Defendants' denosumab biosimilar products during the term of the Patents-In-Suit; . . . a permanent injunction against future infringement by Defendants, as well as by its officers, employees, agents, representatives, affiliates, assignees, successors, and all persons acting on behalf of, at the direction of, or in active concert with Defendants, until each of the Patents-In-Suit that are found infringed has expired" in addition to damages and a declaration that the cases are exceptional and an award of attorneys' fees.
These three new cases brought by Amgen are the sixth, seventh and eighth BPCIA litigations regarding denosumab, following Amgen's litigations against Sandoz, Celltrion, Samsung Bioepis/Samsung Biologics, Fresenius, and Accord Biopharma.
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