As we previously reported, the U.S. Department of Justice (“DOJ”) filed a lawsuit under the Anti-Kickback Statute against Regeneron Pharmaceuticals in the District of Massachusetts regarding Regeneron’s sales of Eylea in 2020. The DOJ recently announced that it has filed another False Claims Act complaint against Regeneron Pharmaceuticals, alleging that…
As we previously reported, trial in Regeneron Pharmaceutical, Inc.’s BPCIA case against Mylan Pharmaceuticals Inc. and Biocon Biologics, Inc. (collectively, “the Biocon Defendants”) regarding the Biocon Defendants’ proposed aflibercept biosimilar concluded on June 15, 2023 in the Northern District of West Virginia. On December 27, 2023, the court entered judgment in the…
As we previously reported, on January 11, 2024, Regeneron Pharmaceuticals, Inc. (“Regeneron”) moved to establish a multi-district litigation (“MDL”) for its aflibercept BPCIA litigation, and to transfer its case against Amgen, Inc. (“Amgen”) to the Northern District of West Virginia under 28 U.S.C. § 1407. The litigation consists of six…
Regeneron’s request for multi-district litigation As we previously reported, on January 11, 2024, Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed a motion seeking to establish a multi-district litigation (“MDL”) encompassing the aflibercept BPCIA cases it has filed in the U.S. District Court for the Northern District of West Virginia and transfer its case against…
On March 4, Biocon Biologics Ltd. announced it has signed a settlement agreement with Bayer Inc. and Regeneron Pharmaceuticals, Inc. regarding YESAFILI, Biocon’s proposed biosimilar to EYLEA (aflibercept). The settlement resolves multiple patent infringement proceedings in the Federal Court of Canada. Under the agreement, Biocon can launch YESAFILI in Canada…
Appeals from and redacted memorandum and opinion in support of judgment in Regeneron v. Mylan (aflibercept) BPCIA case filed As we previously reported, trial in Regeneron Pharmaceutical, Inc.’s BPCIA case against Mylan Pharmaceuticals Inc. and Biocon Biologics, Inc. (collectively, “the Biocon Defendants”) regarding the Biocon Defendants’ proposed aflibercept biosimilar concluded…
Late last month, a Patent Trial and Appeal Board (“PTAB”) panel instituted two petitions that were filed separately by Celltrion and Biocon for inter partes review (“IPR”) of Regeneron’s U.S. Patent 11,253,572 (“the ’572 patent”) and joined the two IPR proceedings with a pending IPR proceeding filed by Samsung Bioepis…
Regeneron files ex parte application for a preliminary injunction schedule in case against Amgen On Friday, January 20, 2024, Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed an ex parte application for a scheduling order setting the schedule for preliminary injunction proceedings or, in the alternative, an emergency status conference. Regeneron requested that…
Celltrion Submits BLA for Tocilizumab Biosimilar On January 28, 2024, Celltrion USA announced that it has completed submission of its application to the FDA for CT-P47, its proposed tocilizumab biosimilar. CT-P47 references Genentech’s ACTEMRA, an interleukin 6 receptor antagonist indicated for adult rheumatoid arthritis, juvenile idiopathic polyarthritis, and systemic juvenile…
Regeneron Filed Complaint Against Amgen in C.D. Cal. Over ABP 938 Biosimilar to EYLEA On January 10, 2024, Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed a Complaint in the U.S. District Court for the Central District of California against Amgen Inc. (“Amgen”) alleging infringement of 32 patents under the BPCIA based on Amgen’s…