On October 4, 2024, Amgen filed a BPCIA complaint in the District Court for the Northern District of Illinois Eastern Division against Fresenius Kabi related to Fresenius Kabi’s proposed biosimilar of Amgen’s PROLIA and XGEVA. This is the fourth BPCIA litigation regarding denosumab, following Amgen’s litigations against Sandoz, Celltrion, and Samsung Bioepis/Samsung Biologics, all filed in the District Court for the District of New Jersey. Amgen and Sandoz moved to dismiss litigation and entered into a settlement agreement in April 2024. Amgen filed its complaints against Celltrion in June 2024 and Samsung Bioepis/Samsung Biologics in August 2024. In the prior cases, Amgen asserted 29 and 34 patents against Celltrion and Samsung Bioepis/Samsung Biologics, respectively.
In the present litigation, Amgen has asserted 33 patents against Fresenius Kabi that cover “denosumab (the active ingredient in Prolia and XGEVA) and methods of manufacturing denosumab and denosumab products, and technologies necessary to produce, deliver, and use these denosumab-containing medicines in patients.” Amgen alleges in its Complaint that Fresenius provided an “Incomplete BLA” containing “numerous and substantial redactions . . . of manufacturer, supplier, and vendor identities, manufacturing locations, lot numbers, document titles, signatures on batch records, portions of testing printouts, and blanket redactions to entire portions of the BLA.” Amgen argues that Fresenius Kabi has “fail[ed] to comply with subsection (l)(2)(A) of the BPCIA” by “fail[ing] to provide ‘a copy’ of the BLA . . . as required by the statute and [by] rebuff[ing] Amgen’s multiple letters identifying specific missing information and urging [Fresenius Kabi] to produce the BLA without redactions,” 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.