A federal judge in Washington, D.C., on Wednesday denied Novartis’ last-minute effort to prevent MSN Pharmaceuticals from launching a generic version of its blockbuster heart-failure drug, Entresto.
The ruling by U.S. District Judge Dabney Friedrich removes a significant obstacle for MSN Pharmaceuticals, paving the way for the introduction of the first generic version of the drug in the United States. Entresto, Novartis’ top-selling medication, generated over $6 billion in revenue in 2023.
Neither MSN’s legal representatives nor Novartis’ attorneys and spokespeople provided immediate comments on the decision.
Legal Battle Over Patent Rights
MSN’s generic version of Entresto received approval from the U.S. Food and Drug Administration (FDA) in 2022. However, Novartis initiated multiple lawsuits against MSN and other companies pursuing Entresto generics, alleging patent infringement.
Last week, the U.S. Court of Appeals for the Federal Circuit overturned a 2023 ruling by a Delaware judge that had invalidated one of Novartis’ patents on the drug. Following the appeals court’s decision, Novartis claimed in court filings that it retained exclusive rights to market Entresto until July 2024.
The pharmaceutical giant argued that MSN was preparing to launch its generic version on Thursday, coinciding with the expiration of another Novartis patent. The company also contended that the appeals court ruling sustained its exclusivity until the new patent expiration.
MSN countered, asserting that the prohibition on its generic would lapse on Thursday regardless of the court’s decision. The Federal Circuit on Tuesday declined Novartis’ request to issue an immediate mandate blocking the generic launch.
FDA and Court Reject Novartis’ Appeal
Separately, Novartis filed a lawsuit against the FDA earlier this week, seeking to halt the approval process for the generic launch. The FDA, in its response, maintained that jurisdiction over the matter rested with the courts hearing the patent dispute.
Judge Friedrich sided with the FDA during a Wednesday hearing, denying Novartis’ request to block the generic.
Meanwhile, Novartis’ emergency petition for a stay on the generic release remains pending before the U.S. Court of Appeals for the District of Columbia Circuit.
The outcome of these legal challenges could have significant implications for Novartis, MSN Pharmaceuticals, and the broader pharmaceutical market as Entresto’s exclusivity period nears its end.
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