4/3/2025 9:34:23 PM The Landscape of Regeneron’s Eylea® Litigation—Update 1: the Federal Circuit Affirmed the District Court’s Decisions in Celltrion and Amgen By Dan Liu After the Federal Circuit’s January decisions1 affirming the preliminary injunction orders that bar Samsung Bioepis (SB) and Formycon...
2/19/2025 6:32:40 PM The Landscape of Regeneron’s Eylea® Litigation After the Federal Circuit Affirmed Two Preliminary Injunction Orders Blocking Biosimilar Market Entry By Dan Liu A biosimilar is a biologic drug that is highly similar, but not identical, to an already approved biologic drug, i.e. the reference...
5/14/2024 10:10:17 PM GSK Joins COVID-19 mRNA Vaccine Patent War By Dan Liu mRNA-Based Vaccine and Other Therapeutics mRNA-based vaccines have become one of the most discussed technologies both inside and outside...
4/25/2024 9:24:10 PM Amending ANDA by Purportedly Carving Out Infringing Use—After Trial—Does Not Rescue the Amended ANDA from the Negative PIV Judgment By Dan Liu The district court in Salix Pharmaceuticals, Ltd. et al v. Norwich Pharmaceuticals, Inc., Civil Action No. 20-430-RGA (D. Del.) was asked...
3/9/2024 1:20:28 AM FDA Denied Boehringer’s Citizen Petition Concerning Humira®, Reaffirming Its Interpretation of “Strength” to Include “Concentration” for Biologics By Dan Liu The Biologics Price Competition and Innovation Act (“BPCIA”) created an abbreviated pathway for the licensure of biosimilar and...