On November 13, 2024, Amgen filed a BPCIA complaint in the District Court for the Eastern District of North Carolina against Accord Biopharma, Inc.; Accord Healthcare, Inc.; and Intas Pharmaceuticals, Ltd., related to Accord’s proposed biosimilar of Amgen’s PROLIA and XGEVA. This is the fifth BPCIA litigation regarding denosumab, following Amgen’s litigations against Sandoz, Celltrion, Samsung Bioepis/Samsung Biologics, and Fresenius. Amgen and Sandoz moved to dismiss litigation and entered into a settlement agreement in April 2024. Amgen filed its complaints against Celltrion in May 2024, Samsung Bioepis/Samsung Biologics in August 2024, and Fresenius in October 2024. In the prior cases, Amgen asserted 29, 34, and 33 patents against Celltrion, Samsung Bioepis/Samsung Biologics, and Fresenius, respectively.
Amgen has asserted 33 patents against Accord that, according to Amgen, cover “the denosumab antibody and pharmaceutical compositions comprising denosumab (the active ingredient in Prolia and XGEVA), innovative methods of manufacturing therapeutic proteins, like denosumab, and denosumab products.” Amgen alleges in its Complaint that “Defendants had not fully complied with the requirements set out in section 262(l)(2)(A) of the BPCIA, which requires disclosure of not only a copy of the BLA itself, but also ‘such other information that describes the process or processes used to manufacture the biological product that is the subject of such application.’” Although Defendants supplemented their document production after Amgen informed them of “gaps in Accord’s production regarding information that describes ‘the process or processes used to manufacture the biological product that is the subject of [Accord’s] application,’” Amgen maintained that the materials produced “remain deficient,” thereby frustrating Amgen’s “participat[ion] in the pre-litigation exchange contemplated under the BPCIA.”
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 case is exceptional and an award of attorneys’ fees.
Stay tuned to Big Molecule Watch for further developments in this case and check out the BPCIA Litigations Tracker for updates on additional BPCIA cases.
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