Entresto® (sacubitril/valsartan)
Case Name: Novartis Pharms. Corp. v. MSN Pharms. Inc., Civ. No. 20-MD-2930-RGA, 2024 WL 3756787 (D. Del. Aug. 12, 2024)
Drug Product and Patent(s)-in-Suit: Entresto® (sacubitril/valsartan); U.S. Patent No. 11,096,918 (“the ’918 patent”)
Nature of the Case and Issue(s) Presented: Novartis filed suit against MSN and several other defendants alleging infringement of the ’918 patent. After Novartis filed suit, FDA approved MSN’s ANDA product. After MSN received final approval, Novartis moved for a preliminary injunction to prevent MSN’s launch. The court denied the motion.
Why MSN Prevailed: The court determined that Novartis did not show (i) a likelihood of success on the merits, specifically, did not prove infringement of the amorphous-solid-form patent; or (ii) irreparable harm, specifically, because Novartis tried to argue that MSN’s launch would trigger others and that those launches would cause harm, and because Novartis did not show that money could not remedy the alleged harm. The court also noted that “[b]ased on the billions in annual net revenues that Novartis has earned, and continues to earn, from Entresto® sales . . . I doubt that maintaining its current level of investment for these services would cause Novartis to face financial hardship.”
Though included almost as an afterthought, of note, the court also mentioned that it would not grant the PI based on § 271(e)(4)(A) infringement because “[n]o finding of infringement has yet to be made.” Novartis indicated that it would appeal.
