Regeneron Pharmaceuticals holds Food and Drug Administration (FDA)-approved Biologics License Application (BLA) for EYLEA (R), containing aflibercept, a vascular endothelial growth factor (VEGF) antagonist treating angiogenic eye diseases. Regeneron owns U.S. Patent No. 11,084,865, covering VEGF-trap formulations suitable for intravitreal injection. Mylan and several biosimilar applicants, including Samsung Bioepis (SB), filed abbreviated BLAs seeking FDA approval of EYLEA (R) biosimilars. Regeneron sued SB for patent infringement and sought a preliminary injunction to block SB from selling its biosimilar. SB challenged personal jurisdiction and patent validity on grounds of obviousness-type double patenting (ODP) and inadequate written description. The Federal Circuit affirmed the district court's decision granting the preliminary injunction. It held the district court correctly exercised personal jurisdiction because SB intended nationwide distribution, including West Virginia, by contracting with Biogen, without explicitly excluding any state. Applying Acorda Therapeutics Inc. v. Mylan Pharmaceuticals Inc., 817 F.3d 755 (Fed. Cir. 2016), the court held that SB's national distribution channels provided sufficient minimum contacts. On patent validity, the Federal Circuit rejected SB's ODP arguments. The Court held the '865 patent's limitations-including requiring "at least 98%" stability and glycosylation-were patentably distinct from Regeneron's earlier patent (the '594 patent), which was more broadly defined. SB failed to show a motivation or reasonable expectation of success for achieving the claimed stability and glycosylation levels, which the district court properly found significant. The Federal Circuit also rejected SB's written description challenge, concluding the specification adequately described glycosylation and the stability range, even though it disclosed stability slightly above the lower bound. Finally, the Court upheld the finding of irreparable harm, rejecting SB's argument that it could sell non-infringing alternatives. Thus, the Federal Circuit affirmed the preliminary injunction, finding SB had not raised substantial questions on personal jurisdiction, invalidity, or irreparable harm.
