Regeneron Pharmaceuticals, Inc. v. Formycon AG, decided 29 Jan 25

This non-precedential opinion from the United States Court of Appeals for the Federal Circuit affirms a preliminary injunction against Formycon AG, preventing it from marketing a biosimilar to Regeneron's EYLEA® without a license. The court upheld the lower court's finding of personal jurisdiction over Formycon, despite its arguments regarding its business operations outside of West Virginia. The appeals court also rejected Formycon's challenges to the injunction based on alleged patent invalidity due to obviousness-type double patenting and insufficient written description. Finally, the court affirmed the lower court's conclusion that Regeneron demonstrated a causal link between potential infringement and irreparable harm. The decision largely relies on a nearly simultaneous, very similar case involving Samsung Bioepis.