On the heels of the FDA’s denial of its petition, a Delaware district court on Monday handed Novartis another loss in its efforts to keep the market free of Entresto copycats.
A federal judge in Delaware on Monday ruled against Novartis, denying the pharma’s attempt to block the entry of a generic competitor to its oral heart failure drug Entresto (sacubitril and valsartan).
District Judge Richard Andrews denied Novartis’ bid for preliminary injunction against MSN Pharmaceuticals, arguing that the pharma did not sufficiently prove that MSN had committed patent infringement in its abbreviated new drug application (ANDA).
Novartis’ case revolves around TVS, an amorphous solid compound found in Entresto and consists of sacubitril, valsartan and sodium cations. In its legal complaint, the pharma alleged that MSN’s generic product contains a high enough amount of amorphous TVS—which is patent-protected until November 2026—and violates its exclusivity protections.
Meanwhile, MSN challenged the allegations by claiming that Novartis used incomplete data to arrive at its conclusions.
Andrews sided with MSN in his ruling, noting that the pharma “bears the burden of proof, both on infringement and showing likelihood of success.” Novartis fell short of “showing it is likely to succeed in proving MSN’s ANDA products contain amorphous TVS,” Andrews wrote.
The judge also rejected Novartis’ claims of irreparable harm if it is not granted an injunction. “I am skeptical about Novartis’s characterization of many of its potential harms,” Andrews wrote, referring to the pharma’s argument that allowing MSN’s generic product to hit the market could embolden other copycats, “thereby destroying Entresto’s market momentum” leading to lost sales, market shares and formulary positioning.
“I do not find it reasonable to attribute harm resulting from the actions taken by other generic drug makers to MSN’s decision to launch its own individual product,” Andrews wrote.
Entresto combines the neprilysin inhibitor sacubitril with the angiotensin receptor blocker valsartan, helping to lower vascular resistance and blood pressure. The drug was first approved in 2015 for heart failure in adults. In 2023, Entresto emerged as Novartis’ top-performing asset with over $6 billion in net sales. In the first six months of 2024, Entresto bagged $3.77 billion.
Monday’s legal loss comes after the FDA two weeks ago denied Novartis’ citizen petition to prevent the approval and entry of Entresto generics.
The pharma launched the petition in September 2022 asking the regulator not to green light any drug application that referenced Entresto until after Feb. 16, 2024, when the drug’s three-year exclusivity period under the Orange Book expires. Novartis also outlined additional requests regarding specific Entresto patents, asking the FDA to block applications that would otherwise breach these protections until after they expire in Aug. 22, 2033 and May 9, 2036, respectively.
In its rebuff, the regulator insisted that drug applicants can tweak their labeling to avoid violating these patent protections. An ANDA “may propose labeling for a generic sacubitril and valsartan product that does not seek approval for the purported use protected” by Novartis’ patents, according to the FDA.
