On January 29, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the grant of a preliminary injunction by the Northern District of West Virginia in favor of Regeneron Pharmaceuticals, Inc. against Samsung Bioepis Co., Ltd. (“SB”) and other biosimilar applicants. Regeneron had sued defendants for infringing its U.S. Patent No. 11,084,865, which covers formulations of aflibercept, a fusion protein that binds to vascular endothelial growth factor (VEGF) and is used to treat angiogenic eye diseases. Regeneron markets aflibercept under the brand name EYLEA®.
Defendants had filed abbreviated Biologics License Applications (aBLAs) with the FDA, seeking approval to market EYLEA® biosimilars under the Biologics Price Competition and Innovation Act (BPCIA). Regeneron moved for a preliminary injunction to prevent defendants from launching their biosimilars upon FDA approval, alleging that they would infringe the ’865 patent. The district court granted the motion, finding that it had personal jurisdiction over defendants, that Regeneron had shown a likelihood of success on the merits of its infringement claims, and that the other preliminary injunction factors favored Regeneron.
The Federal Circuit reviewed the personal jurisdiction decision without deference under Federal Circuit law and reviewed the grant of injunctive relief under the law of the regional circuit for abuse of discretion. The Federal Circuit affirmed the district court’s ruling, rejecting defendants’ challenges to the district court’s exercise of personal jurisdiction and award of preliminary injunctive relief.
SB argued that the district court could not exercise personal jurisdiction because SB had no contacts with West Virginia, and there was no evidence that SB planned to commercialize SB15 (the subject of SB’s aBLA) in West Virginia in particular. Rejecting those arguments, the court held that the district court had personal jurisdiction over SB (and the other foreign defendants), noting, “SB’s filing of its aBLA, serving of its Notice of Commercial Marketing, failure to deny the allegation that it would commercialize SB15 in West Virginia through Biogen, and establishment of a robust distribution channel that includes West Virginia suffice to satisfy the minimum-contacts standard for personal jurisdiction over SB when it is sued for infringement under 35 U.S.C. § 271(e).” The court applied the precedent of Acorda Therapeutics Inc. v. Mylan Pharms. Inc., 817 F.3d 755 (Fed. Cir. 2016), which held that an ANDA filer’s plans to market its generic drug in a forum state established minimum contacts for personal jurisdiction. The court elaborated, “A court may constitutionally exercise specific personal jurisdiction when the defendant has certain minimum contacts with the forum such that the maintenance of the suit does not offend traditional notions of fair play and substantial justice.” (quotations and citations omitted)
The court held that the district court did not abuse its discretion in granting the preliminary injunction, finding that Regeneron had made out its affirmative case, including that defendants had not raised a substantial question of invalidity of the ’865 patent. The court rejected defendants’ arguments that the ’865 patent was invalid for obviousness-type double patenting over an earlier patent in the same family and for lack of written description. It found that the ’865 patent claimed patentably distinct features, such as a higher level of stability and glycosylation of the VEGF trap, and that the specification adequately disclosed those features. The court also found that Regeneron had demonstrated it was likely to suffer irreparable harm without injunctive relief, that the balance of hardships favored Regeneron, and that the public interest favored the grant of a preliminary injunction. Last, the court rejected SB’s arguments that there was no causal nexus between SB’s infringement and irreparable harm that Regeneron would incur absent injunctive relief, noting that “when the infringing product contains no feature relevant to consumers’ purchasing decisions other than what the patent claims,” “the causal-nexus inquiry may have little work to do in an injunction analysis.” In finding the causal nexus requirement met, the court also favorably noted that the district court had found that limitations in the ’865 patent drive demand.
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