Novartis loses initial bid to block MSN's generic Entresto
Novartis was unsuccessful in convincing a federal court to block MSN Pharmaceuticals from introducing its own version of Novartis' heart-failure drug Entresto, according to a court decision issued on Monday, per a Reuters report.
U.S. District Judge Richard Andrews in Delaware ruled, Novartis' chance of winning its patent-infringement lawsuit challenging the generic was too low to justify stopping MSN's launch. However, the judge temporarily ordered MSN not to sell the medication while Novartis appeals to the U.S. Court of Appeals for the Federal Circuit.
The FDA approved MSN's version of Entresto in July. It would be the first U.S. generic of the drug.
[Related: Novartis files lawsuit against FDA over generic Entresto]
Novartis said in a statement that it was "considering all available options" to defend its intellectual property and "maintains its financial guidance for 2024," per the report, which also noted that Novartis sued MSN and others seeking to launch Entresto generics in 2022 for infringing a patent that expires in 2026. Novartis asked the court on Aug. 2 for a preliminary injunction blocking MSN from launching its generic, which was approved by the FDA on July 24.
On Monday, the judge ruled that Novartis was not likely enough to win on its infringement claims to justify the injunction, per the report.
The judge also rejected Novartis' argument that a ruling against the company would cause "irreparable harm" by triggering a wave of generic Entresto launches by other drugmakers. Andrews placed a three-day hold on the case while Novartis appeals to the Federal Circuit. Novartis has separately asked a Washington, D.C. district court to block MSN's launch as part of a challenge to the FDA's decision to approve the generic. The Washington court has not yet ruled on Novartis' request, per the report.
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