On May 28, Amgen filed a BPCIA complaint in the District Court for the District of New Jersey against Celltrion related to its denosumab biosimilar of Amgen’s PROLIA and XGEVA.  This is the second BPCIA litigation regarding denosumab, following Amgen’s earlier litigation against Sandoz. Amgen and Sandoz stipulated to dismiss the litigation and entered into a settlement agreement in April 2024.

Amgen has asserted 29 patents against Celltrion, that according to Amgen “cover denosumab (the active ingredient in PROLIA and XGEVA) and methods of manufacturing denosumab and denosumab products.”  Amgen alleges in its Complaint that, during the patent dance, Celltrion provided a copy of its BLA, but failed to provide other information regarding its manufacturing processes pursuant to 42 U.S.C § 262(l)(2)(A).  According to the Complaint, Amgen provided a list of patents that it believed could be reasonably asserted against Celltrion, including patents purported to cover denosumab and methods of manufacturing denosumab and denosumab products.

Amgen seeks a judgment that Celltrion has infringed, and will infringe, one or more claims of the asserted patents, and a permanent injunction against the commercial manufacture, use, offer to sell, and sale within the United States, and importation into the United States, of Celltrion’s proposed denosumab biosimilar product.  According to Amgen, Celltron’s “failure to comply with § 262(l)(2)(A) authorized Amgen Inc. to file a suit for declaration of infringement.”

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