Health Law Daily Wrap Up, DRUGS AND BIOLOGICS—S.D.N.Y.: Novartis wins dismissal of Entresto generic-delay suit, (Sep 30, 2026)

By Sara Cracau, J.D.

The court’s ruling clarifies that Orange Book listing is proper when a patent claims a drug’s active ingredients and dosage form, even if it does not specifically claim the drug’s noncovalently bound complex form.

A federal district court in New York dismissed an employee health fund’s antitrust, unfair competition, and unjust enrichment claims against Novartis, concluding that the company properly listed its Entresto patent in the FDA’s Orange Book. The court held that the patent claimed Entresto’s active ingredients and dosage form, making the listing permissible under the Hatch-Waxman Act. Because the Orange Book listing was proper, the fund failed to allege any unlawful conduct supporting its claims that Novartis delayed generic competition. The court therefore granted Novartis’s motion to dismiss and dismissed the action with prejudice (The Iron Workers Local 580 Insurance Fund v. Novartis Pharmaceuticals Corporation, No. 25-cv-7230 (LJL) (S.D.N.Y. Sept 23, 2026)).

The FDA approved the New Drug Application No. 207620 for the manufacture and sale of the drug Entresto (sacubitril/valsartan), which is used to treat heart failure, on July 7, 2015 and Novartis began selling it in the United States soon thereafter. Entresto was the first and only ARNI drug on the market until the generic version of the drug was launched in July 2025 and it was Novartis’s top-grossing drug in 2024, resulting in more than $4 million in sales.

Novartis held eleven patents related to Entresto including four entitled “Methods of treatment and pharmaceutical composition” which were issued between December 23, 2008 and August 5, 2014, and extended due to pediatric exclusivity. The patent at issue in this action, U.S. Patent Number 8,101,659 (the ‘659 patent), issued in January, 2012, had an expiration date of January 15, 2025. Novartis requested that the FDA list the ‘659 patent in the Orange Book under the Entresto patent on or about August 16, 2015 which formed the basis of a claim for patent infringement if a person not licensed by Novartis would engage in the manufacture, use, or sale of the drug. Novartis initiated patent infringement actions against certain generic manufacturers that submitted paragraph IV certifications, which assert that such patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted, but the district court dismissed the actions finding that the ‘659 patent was not valid because it lacked a written description of the valsartan/sacubitril complex. The federal circuit court reversed the district court’s decision finding that the ‘659 patent was valid as the issue on appeal was whether the ‘659 patent described what was claimed, the composition comprising valsartan-sacubitril was administered in combination.

The Iron Workers Local 580 Insurance fund, an employee welfare plan, brought an action against Novartis Pharmaceuticals Corporation alleging that it paid and reimbursed for Entresto more than it would have if Novartis had not engaged in anticompetitive conduct to delay generic versions of Entresto from launching. During the relevant period (January 16, 2025 until the effects of Novartis’s allegedly anticompetitive conduct ceased), the fund purchased and provided reimbursement for some or all of the purchase price for brand-name Entresto in at least Arizona, Florida, Georgia, Nevada, New Jersey, and New York. The fund brought claims of monopolization, attempted monopolization, unfair or deceptive trade practices, and unjust enrichment under the laws of various states, including the District of Columbia and Puerto Rico. Novartis filed a motion to dismiss.

Failure to state a claim. After reviewing the relevant statutory and regulatory scheme, the court found that the complaint failed to state a claim. The court evaluated the meaning of “claims” and the meaning of “the drug for which the applicant submitted the application.” It concluded that the ‘659 patent could simultaneously not specifically claim the complex of valsartan and sacubitril but be infringed by a drug that reads on all claims of the patent and contains a complex. The federal circuit court has held that a patent must claim at least the drug’s active ingredient in order to be listed in the Orange Book. However, that alone, was not sufficient to claim the drug. It must claim the drug’s combination of active ingredients and its dosage form to claim “the drug for which the applicant submitted the application.” To claim Entresto, the patent had to claim the composition of active ingredients- valsartan and sacubitril in an about 1:1 ratio. According to the FDA regulations, that composition was in a final dosage form (a tablet) which the ‘659 patent did so. In addition, the court’s conclusion aligned with the overall balancing scheme of the Hatch-Waxman Act which was designed to promote innovation while reducing the price of pharmaceuticals by allowing generic manufacturers to “piggy-back” off of brand manufacturers’ drug approvals and clinical trials.

Claims of the amended complaint. The court found that the employee fund failed to allege any unlawful activity in support of its claims of monopolization, attempted monopolization, unfair trade practices, and unjust enrichment. By submitting the information on the ‘659 patent to the FDA, Novartis complied with the FDCA requirements. Novartis requested the opportunity to replead with the benefit of discovery and obtain the confidential NDA that was submitted, the court found Novartis’s argument without merit. The NDA language is immaterial to the question of whether the '659 patent was properly listed in the Orange Book. The “drug” in question was the drug that was approved by the FDA not the drug characterized by Novartis. The court’s conclusion was based on its statutory interpretation, the text of the ‘659 patent, and the FDA-approved label for the drug at issue which described the active ingredients as the same as those clamed in the ‘659 patent in the same proportions. An Orange Book listing that claims the FDA-approved drug cannot be considered improper by the description in the NDA. Neither can an NDA make an Orange Book listing proper if the listing fails to claim the FDA-approved drug.

The case is No. 25-cv-7230 (LJL).

Judge: Liman, L.

Attorneys: Dena C. Sharp (Girard Sharp LLP) for The Iron Workers Local 580 Insurance Fund. Arlene Lee Chow (Latham & Watkins LLP) for Novartis Pharmaceuticals Corp.

Companies: Novartis Pharmaceuticals Corp.

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