There are four pending BPCIA litigations brought by Amgen against biosimilar companies seeking to market denosumab biosimilars. Two of the four cases are pending in the District Court for the District of New Jersey before Judge O’Hearn: Amgen Inc. et al. v. Celltrion, Inc., No. 1:24-cv-06497-CPO-EAP (D.N.J.), filed on May 28, 2024, and Amgen Inc. et al. v. Samsung Bioepis Co., Ltd. et al., No. 1:24-cv-08417-CPO-EAP (D.N.J.), filed on August 12, 2024. On October 4, 2024, Amgen filed a BPCIA litigation against Fresenius Kabi in the District Court for the District of Illinois. Amgen Inc. et al. v. Fresenius Kabi USA, LLC, et al., No. 1:24-cv-09555 (N.D. Ill.). Most recently, on Nov. 13, 2024, Amgen filed a BPCIA litigation against Accord Biopharma in the Eastern District for the District of North Carolina. Amgen Inc. et al. v. Accord BioPharma, Inc., et al., No. 5:24-cv-00642 (E.D.N.C.).
On November 15, 2024, Amgen filed a motion to transfer with the U.S. Judicial Panel on Multidistrict Litigation, seeking to consolidate the currently pending BPCIA litigations for coordinated or consolidated pretrial proceedings before Judge O’Hearn in the New Jersey federal court. Amgen asserts that “[t]he four pending actions arise out of similar underlying fact,” and that “[a]bsent consolidation, three different district courts may have to address identical factual and legal issues, including issues relating to infringement, claim construction, and validity of the overlapping asserted patents.”
On November 18, 2024, the MDL Panel issued a briefing schedule on Amgen’s motion to transfer, with responses due on December 9 and reply briefing due on December 16. The MDL Panel further requested that the parties “address what steps they have taken to pursue alternatives to centralization (including, but not limited to, engaging in informal coordination of discovery and scheduling, and seeking Section 1404 transfer of one or more of the subject cases).”
Additionally, on November 25, Judge O’Hearn entered a scheduling order in Amgen’s case against Celltrion, setting a trial to begin on April 7, 2025. The schedule was entered following a status conference on November 13, whereafter the parties proposed contested case schedules on November 15. Fact discovery is to be completed by February 21, 2025, and expert discovery to be completed by March 7, 2025.
Stay tuned to Big Molecule Watch for further updates on the denosumab BPCIA litigations.