Context: In August 2025, The Iron Workers Local 580 Insurance Fund, a New York health and welfare fund, sued Novartis in the United States District Court for the Southern District of New York (SDNY) as a payor of Entresto costs. It alleged that Novartis wrongly listed its U.S. Patent No. 8,101,659 (“Methods of treatment and pharmaceutical composition”) in the FDA’s Orange Book, which let a six-month pediatric extension push generic Entresto entry from January 16, 2025 to July 2025. The ’659 patent covers valsartan and sacubitril administered in about a 1:1 ratio, and the Federal Circuit had already upheld its validity in In re Entresto. ip fray covered the generic-side fight over the drug: Novartis and MSN settled their dispute over the ’659 patent in Delaware in June 2025 (June 17, 2025 ip fray article), and MSN’s generic reached the market after the Federal Circuit lifted a short-term injunction against it (July 23, 2025 ip fray article).
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Court and counsel
Court: Judge Lewis J. Liman, United States District Court for the Southern District of New York.
Novartis is being represented by Latham & Watkins’ David J. Marriott and Jason R. Burt.
The Iron Workers Local 580 Insurance Fund and the drug purchasers is being represented by Kessler Topaz Meltzer & Check’s Joseph H. Meltzer, Carella Byrne’s James E. Cecchi, Hagens Berman’s Thomas M. Sobol, and Girard Sharp’s Dena C. Sharp.