Earlier this month, a Patent Trial and Appeal Board (“PTAB”) panel denied institution of two petitions that were filed separately by Samsung Bioepis (IPR2025-00176) and Formycon (IPR2025-00233) for inter partes review (“IPR”)...more
6/20/2025
/ Appeals ,
Biosimilars ,
Inter Partes Review (IPR) Proceeding ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Preliminary Injunctions ,
Regeneron ,
Samsung Bioepis
Regeneron’s regulatory exclusivity for EYLEA expired on May 18, 2024. Two days later, on May 20, 2024, the FDA announced that it has approved Mylan Pharmaceuticals, Inc. and Biocon Biologics, Inc.’s YESAFILI...more
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...more
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...more
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...more
On August 23, 2022, Amgen announced positive top-line results from a phase 3 study of ABP 959, Amgen’s proposed biosimilar to SOLIRIS (eculizumab). Amgen noted that the study was “a randomized, double-blind,...more
On May 16, 2022, Alvotech Holdings S.A. (“Alvotech”) announced positive top-line results from a pharmacokinetic (PK) study for AVT04, Alvotech’s proposed biosimilar to STELARA® (ustekinumab). Alvotech notes that the study...more
The New Jersey district court in the Immunex v. Samsung Bioepis BPCIA litigation entered a Final Judgment and Order of Permanent Injunction on November 3, 2021. As we previously reported, the litigation pertains to ETICOVO...more