Context: In October 2022, Novartis sued MSN over two of its patents related to its chronic heart failure drug Entresto in the District of Delaware. The companies settled their dispute over one patent earlier this year (U.S. Patent No. 8,101,659 (“Methods of treatment and pharmaceutical composition”): June 17, 2025 ip fray article). Meanwhile, in the other case, Novartis filed a letter requesting the Delaware court to issue a final decision and verdict on the case before July 15, to further reset the effective approval date of MSN’s generic drug until after November 9, 2026 the expiration date of the other patent-in-suit: U.S. Patent No. 11,096,918 (“Amorphous solid form of compounds containing S—N-valeryl-N-{[2′-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl}-valine and (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and sodium cations”). Earlier this month, the court denied Novartis an injunction (July 14, 2025 ip fray article), so the company brought an emergency motion, which was granted last week (July 16, 2025 ip fray article). We noted last week that following the emergency injunction, the hurdle for a temporary injunction pending the entire appellate proceedings remained high.
What’s new: The Federal Circuit has denied Novartis’s motion and lifted the temporary injunction on MSN. This means MSN can now launch its Entresto drug into the market, and that the door is open for other generics to do so, too.
Direct impact: While Novartis could still win this patent infringement fight, the Federal Circuit recently had a median time from filing to disposition of 19.5 months (January 8, 2025 Law360 article), and as the patent expiration date gets closer, the less likely the Federal Circuit will enter an injunction even if it agreed that an infringement was proven.
Wider ramifications: If Novartis pursues and wins a potential appeal, it could seek damages from MSN, which MSN needs to factor into decisions such as its pricing. While the outcome in the district court and the Federal Circuit’s denial of a temporary injunction make it more likely than not that the final ruling will clear MSN of infringement, an appeal and damages are still a possibility.
In its decision yesterday, the Federal Circuit noted that the outcome on appeal could still be different, but that the hurdle for entering a temporary injunction pending appeal was not met. There is no clear indication as to where the concern was. The court merely recited the general legal standard for a preliminary patent injunction.
The patent infringement fight between Novartis and MSN comes down to time-to-market. While Novartis managed to gain some time, after its patent expired six months ago, the company can no longer stop rivals from launching their drugs into the market.
Court and Counsel
The order was entered by Circuit Judges Alan David Lourie, Sharon Prost, and Richard G. Taranto.
Novartis is being represented by McCarter & English LLP’s Daniel M. Silver and Alexandra M. Joyce, as well as Venable LLP’s Christina A. L. Schwarz, Nicolas Kalla, Shannon K. Clark, Susanne L. Flanders, Melinda R. Roberts, and Erin Belfield.
Meanwhile, MSN is being represented by Stamoulis & Weinblatt’s Richard Charles Weinblatt and Stamatios Stamoulis, as well as Ronald M. Daignault, Richard Juang, and Elizabeth Bernard at Daignault Iyer LLP, and RMMS Legal’s Kevin E. Warner.