Novartis is locked in a legal back-and-forth with MSN Pharma over alleged patent infringement of its heart failure drug Entresto.
Novartis on Thursday secured a last-minute win against MSN Pharmaceuticals and its push to market a generic form of the pharma’s heart failure drug Entresto (sacubitril/valsartan).
Late in the day, the U.S. Court of Appeals for the Federal Circuit temporarily enjoined MSN Pharma from commercializing its Entresto generic “until further notice” while Novartis’ outstanding appeal to bar generics for the drug remains open.
According to reporting from Reuters, this latest court order comes just hours after the appellate court for the District of Columbia Circuit lifted a pause on MSN Pharma’s generic it had placed the day before, writing that Novartis as the appellant “has not satisfied the stringent requirements for a stay pending appeal.”
This latest legal push-and-pull are the latest developments in what has turned out to be a complex court saga between Novartis and MSN Pharma.
The fight dates back to September 2022, when Novartis filed a citizen petition asking the FDA to refrain from approving drugs that referenced Entresto until after Feb. 16, 2024, when its exclusivity was set to expire. Novartis also referenced two additional patents specific to the heart failure treatment, which would expire in 2033 and 2036, respectively.
The FDA in July 2024 rejected the petition. The first request, according to the regulator, was moot given that the date had already lapsed, while the two Entresto-specific patents could be side stepped through labelling tweaks. In addition, a Delaware court in August 2024 denied to grant Novartis’ motion for a preliminary injunction against MSN—a decision that the U.S. Court of Appeals for the Federal Circuit upheld in December of the same year.
Last week, however, the appellate court released a new ruling, handing Novartis a victory and finding that MSN Pharma’s generic infringes on one of Entresto’s patents that is set to expire in July 2025.
Elsewhere in generic approvals, the FDA on Thursday granted tentative approval to Amneal Pharmaceuticals’ generic version of Bausch Health’s Xifaxan (rifaximin). Tentative approval is given to drugs that satisfy the regulator’s requirements for licensing but which cannot otherwise be marketed in the U.S. due to patents, exclusivities and other restrictions.
The branded reference product, Xifaxan, is an oral antibacterial indicated for travelers’ diarrhea, irritable bowel syndrome with diarrhea and to reduce the recurrence risk of overt hepatic encephalopathy.
In an attempt to protect Xifaxan’s market exclusivity, Bausch Health in 2024 sued Amneal for patent infringement, claiming at the time that the New Jersey biotech insisted that some of the drug’s Orange Book patents are “unenforceable, invalid, and/or not infringed” by its generics application.
