USA Trends and Developments Contributed by: Steven Lieberman and Nicole (Nikki) DeAbrantes, Rothwell, Figg, Ernst & Manbeck PC
manufacturing its biosimilars of Amgen’s Neu- lasta (Pegfilgrastim) and Neupogen (Filgrastim) products did not infringe the asserted claims of Amgen’s patent and that Apotex had not estab- lished that Amgen’s patent was invalid. Preliminary Injunctions BPCIA litigations have also seen a recent uptick in preliminary injunction proceedings. Prior to mid-2022, motions for preliminary injunctions in BPCIA cases were not particularly common. In fact, prior to mid-2022, preliminary injunction motions had only been filed in six cases with only one motion having been granted. That motion related more towards regulatory com- pliance than typical patent-based injunctive relief. The court in Amgen Inc. v Apotex Inc ., No. 15-cv-61631, Dkt. 71 (S.D. Fla. 9 December 2015), granted Amgen’s motion for a preliminary injunction, preventing Apotex from marketing its biosimilar until 180 days after Apotex had noti- fied Amgen that the FDA approved its biosimilar and that Apotex intends to begin commercially marketing its product. Further, parties can no longer be granted injunctive relief in that type of situation because FDA approval is no longer required to trigger the 180-day notice of com- mercial marketing. The U.S. Supreme Court in Sandoz Inc. v Amgen Inc ., 582 U.S. 1, 19-21 (2017) held that a biosimilar applicant must pro- vide notice at least 180 days prior to marketing its biosimilar but such notice may be provided either before or after receiving FDA approval. Since mid-2022, patent professionals saw a slew of preliminary injunction decisions handed down in litigations involving aflibercept, natalizumab and eculizumab. See Biogen Inc. v Sandoz Inc ., No. 22-cv-1190, Dkt. 270 (D. Del. 29 June 2023)
(denying motion for a preliminary injunction seek- ing to prohibit defendant from releasing its natal- izumab biosimilar). In May 2024, the U.S. District Court for the District of Delaware denied Alexion Pharmaceuticals, Inc.’s motion for a preliminary injunction against Samsung Bioepis Co., Ltd. in connection with Samsung’s biosimilar of Alex- ion’s Soliris (eculizumab) product. See Alexion Pharms., Inc. v Samsung Bioepis Co. Ltd ., No. 24-cv-5, Dkt. 57 (D. Del. 6 May 2024). The Court held that there was a substantial question as to the validity of the asserted patent because the PTAB had instituted inter partes review against the patent. In June 2024, the U.S. District Court for the Northern District of West Virginia granted Regen- eron Pharmaceuticals, Inc.’s preliminary injunc- tion motions against Celltrion, Inc., Formycon AG and Samsung Bioepis Co., Ltd., prevent- ing those companies from marketing or selling their biosimilar versions of Regeneron’s Eylea (aflibercept) product. See In Re: Aflibercept Patent Litig., No. 24-md-3101, Dkts. 171, 193, 215 (N.D. W. Va.). The Court granted preliminary injunctive relief based on those companies’ alleged infringement of Regeneron’s U.S. Patent No. 11,084,865, a formulation patent. That court also granted Regeneron’s motion for a perma- nent injunction against Mylan Pharmaceuticals Inc. in connection with its aflibercept biosimilar after the court held a bench trial and concluded that Mylan infringed Regeneron’s formulation patent. See Dkt. 162. By contrast, in Septem- ber 2024, the district court denied Regeneron’s preliminary injunction motion against Amgen, finding that Amgen’s aflibercept biosimilar was unlikely to infringe Regeneron’s formulation pat- ent. See Dkt. 343.
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