On August 12, 2024, Amgen filed a BPCIA complaint in the District Court for the District of New Jersey against Samsung Bioepis and Samsung Biologics related to Samsung Bioepis’s proposed biosimilar of Amgen’s PROLIA and XGEVA. This is the third BPCIA litigation regarding denosumab, following Amgen’s litigations against Sandoz and Celltrion, also 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 complaint against Celltrion in June 2024. In that case, Amgen asserts 29 patents against Celltrion.
Here, Amgen has asserted 34 patents against Samsung Bioepis and Samsung Biologics, which according to Amgen “cover denosumab (the active ingredient in PROLIA and XGEVA), 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 “the purported BLA produced to Amgen contained numerous and substantial redactions.” Amgen alleges that Bioepis “refused to provide an unredacted copy of the BLA as submitted to the FDA.” According to the Complaint, Amgen “has participated in the pre-litigation exchange contemplated under the BPCIA to the best of its ability…[but] those efforts have been frustrated by Defendants’ initial and ongoing refusal to comply with subsection (l)(2)(A) of 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” as well as 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.