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Recent PTAB Developments for Regeneron’s Aflibercept Formulation Patent

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

DOJ Files False Claims Act Complaint Against Regeneron, Alleging Fraudulent Eylea Drug Pricing

​​​​​​​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...more

Federal Circuit Dismisses Appeals in Regeneron v. Mylan (Aflibercept) BPCIA Litigation

​​​​​​​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’...more

Post-Trial Updates on Regeneron v. Mylan (Aflibercept) BPCIA Litigation

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

Updates on Aflibercept BPCIA Litigation - February 2024

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

Celltrion and Samsung File IPR Petitions on Aflibercept Patents

​​​​​​​Celltrion and Samsung recently filed IPR petitions challenging claims of Regeneron patents directed to treating angiogenic eye disorders with aflibercept. Specifically, Celltrion and Samsung have each filed petitions...more

Celltrion Files IPR Petition on Aflibercept Patent

Last week, Celltrion filed an IPR petition, PTAB IPR2023-00462, seeking cancellation of claims 1-18 of U.S. Patent No. 10,464,992 (“the ’992 patent”), assigned to Regeneron Pharmaceuticals, Inc. According to the Petition, the...more

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