Novartis AG (NVS) has encountered a legal setback in its attempt to block the launch of a generic version of its top-selling heart-failure drug, Entresto. U.S. District Judge Richard Andrews in Delaware ruled on Monday that Novartis was unlikely to succeed in its patent infringement lawsuit against MSN Pharmaceuticals, thus denying the company’s request to halt the launch of the generic.
Despite the ruling, Judge Andrews temporarily suspended MSN Pharmaceuticals’ sales while Novartis appeals to the U.S. Court of Appeals for the Federal Circuit. This decision comes after the FDA approved MSN Pharmaceuticals’ generic version of Entresto in July, marking the first generic version available in the U.S. market.
Novartis, which initially filed lawsuits against MSN Pharmaceuticals and other companies in 2022 for patent infringement, had requested a preliminary injunction on August 2nd to prevent the launch of the generic. Judge Andrews rejected this request, dismissing Novartis’ concerns about potential harm from a wave of generic launches by other manufacturers if MSN’s version were released.
The judge’s ruling places increased pressure on Novartis, which is now exploring all available options to defend its intellectual property rights. The company maintains its financial outlook for 2024 despite the ongoing legal challenges.
Novartis is also seeking to block MSN Pharmaceuticals’ launch through a separate lawsuit in a Washington, D.C. district court, challenging the FDA’s decision to approve the generic. The outcome of this case remains pending.
On Tuesday, NVS stock rose 0.25% to $111.69 at the last check, despite the legal setback.
