Aug 12 (Reuters) – Novartis failed to convince a federal court to block generic drugmaker MSN Pharmaceuticals from launching its own version of Novartis’ blockbuster heart-failure drug Entresto, according to a court decision issued on Monday. #NovartisGenericHeartDrug
U.S. District Judge Richard Andrews in Delaware ruled that Novartis’ chance of winning its patent-infringement lawsuit challenging the generic was too low to justify halting MSN’s launch. However, he temporarily ordered MSN not to sell the drug while Novartis appeals to the U.S. Court of Appeals for the Federal Circuit.
Entresto is Switzerland-based Novartis’ best-selling drug, earning the company more than $6 billion in revenue last year. MSN’s version of Entresto was approved by the U.S. Food and Drug Administration last month and would be the first U.S. generic of the drug.
Novartis said in a statmement that it was “considering all available options” to defend its intellectual property and “maintains its financial guidance for 2024.”
Spokespeople for MSN did not immediately respond to a request for comment on the decision.
Novartis sued MSN and others in 2022, claiming they infringed a patent on Entresto set to expire in 2026. On Aug. 2, Novartis requested a preliminary injunction to block MSN’s FDA-approved generic, which was cleared on July 24.
Andrews ruled on Monday that Novartis was not likely enough to win on its infringement claims to justify the injunction. 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. #NovartisGenericHeartDrug
Moreover, this ruling highlights the ongoing battle between brand-name drug manufacturers and generic producers. The Novartis generic heart drug case demonstrates the challenges companies face in protecting their patents. Consequently, other pharmaceutical firms may also face similar legal hurdles.
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