Entresto® (sacubitril/valsartan)
Case Name: Novartis Pharms. Corp. v. Becerra, No. 24-CV-02234 (DLF), 2024 WL 3823270 (D.D.C. Aug. 13, 2024) (Friedrich, J.)
Drug Product and Patent(s)-in-Suit: Entresto® (sacubitril/valsartan); U.S. Patents Nos. 9,517,226 (“the ’226 patent”), 9,937,143 (“the ’143 patent”), 11,058,667 (“the ’667 patent), and 11,135,192 (“the ’192 patent”)
Nature of the Case and Issue(s) Presented: Novartis brought suit against HHS and FDA for injunctive relief. Specifically, Novartis alleged that FDA unlawfully approved MSN’s application to market a generic version of Novartis’s heart failure medication Entresto. MSN intervened.
Novartis moved for a temporary restraining order and a preliminary injunction, asserting four patents (three covering a method of treating a particular patient population (“preserved ejection fraction”), one covering a specific dosing regimen). Novartis argued that the generic’s label carve-outs violated the FDCA and FDA’s safety and efficacy regulations. FDA had rejected these same arguments in a detailed response to a citizen petition before Novartis filed suit. The court denied Novartis’s motion.
Why FDA Prevailed: “The Court’s analysis begins and ends with irreparable harm.” The court relied on D.C. Circuit precedent providing that economic loss, alone, does not constitute irreparable harm. The court was not persuaded that market share loss would be as significant as Novartis suggested, citing past instances of generic entry affecting Novartis. And any effect on Novartis’s U.S. market share would not be significant compared to the company’s worldwide revenue figures. Novartis’s price erosion arguments were speculative. The court did, however, commit to resolve the merits of Novartis’s claims within 60 days.
