Novartis Loses Appeal to Delay US Launch of Entresto Generic

A key patent battle between Novartis and MSN Pharmaceuticals over the heart medication Entresto has tilted in MSN’s favor, according to a Reuters report. The U.S. Court of Appeals for the Federal Circuit upheld an earlier decision by a Delaware federal judge, rejecting Novartis’ bid to block MSN from launching a generic version of the drug in the United States.

The ruling is a significant setback for Switzerland-based Novartis, whose Entresto generated over $6 billion in revenue last year, making it the company’s top-selling product. Novartis had sought a preliminary injunction to delay MSN’s launch of its FDA-approved generic while a patent infringement lawsuit plays out in court. However, U.S. District Judge Richard Andrews previously found that Novartis was unlikely to prevail in its claims, prompting the appeals court to affirm that decision.

Per the court’s opinion, the Federal Circuit saw “no clear error” in Judge Andrews’ analysis, removing a critical legal obstacle for MSN to move forward with its product. This would make MSN’s generic the first U.S. alternative to the brand-name Entresto.

Read more: Novartis Loses Bid to Delay Generic Rival to Best-Selling Heart Drug

Novartis expressed disappointment with the outcome, stating that it “disagrees with the ruling” and is “considering all available options to vigorously defend our intellectual property rights, including further appellate options.” MSN’s representatives have not yet commented on the ruling.

The legal dispute traces back to 2022, when Novartis filed lawsuits against MSN and other companies aiming to produce Entresto generics. The company alleged that the proposed products infringed on a patent set to expire in 2026. MSN’s generic version received FDA approval in July, triggering Novartis’ push for an injunction to delay its launch.

The case is scheduled to proceed to trial on Monday, while industry analysts watch closely to gauge the broader implications for pharmaceutical patent protections and generic drug competition.

Source: Reuters