Fresh From the Bench: Latest Precedential Patent Case
Contributed by Schwabe Williamson & Wyatt. Originally published on Patexia; republished here as part of the LexDana archive.
CASE OF THE WEEK
In re Entresto (Sacubitril/Valsartan), Appeal Nos. 2023-2218, -2220, -2221 (Fed. Cir. Jan. 10, 2025)
In our Case of the Week, the Federal Circuit revived Novartis’s US Patent No. 8,101,659 by reversing the district court’s decision which found the patent invalid for lack of written description. The Federal Circuit also affirmed the district court’s holding that the patent was not invalid for obviousness or enablement. The patent protects Entresto®, a pharmaceutical drug for treating heart failure with reduced ejection fraction. Entresto is a combination drug composed of two others: valsartan and sacubitril. Valsartan is an angiotensin receptor blocker that reduces blood-vessel constriction, and sacubitril is a neutral endopeptidase inhibitor that also helps to reduce blood-vessel constriction, but by a different biological pathway. Together, the drugs provide superior treatment results than either drug alone. Representative claim 1 of the ’659 patent covers a pharmaceutical composition of the two drugs administered in combination in a ratio of about 1:1.
When MSN and other generic manufacturers filed an ANDA for a generic version of Entresto, Novartis sued for direct infringement of the ’659 patent claims.
Editors:
Nika Aldrich, IP Litigation Group Leader, Schwabe
Jason A. Wrubleski, Shareholder
Contributor:
Ann Bernert, Associate
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