The US Court of Appeals for the Federal Circuit has upheld a lower court's decision denying Novartis' request for an injunction against MSN Pharma's generic version of Entresto, marking a significant setback for the Swiss pharmaceutical giant's market exclusivity strategy.
The legal battle intensified after MSN Pharma received FDA approval for its generic version of Entresto (sacubitril and valsartan) on July 24th. Novartis promptly filed a legal complaint, arguing that MSN's generic formulation contained crystalline forms of the active ingredients that would infringe on Patent No. 11,096,918, which provides protection until November 8th, 2026.
Market Impact and Revenue Implications
The stakes are particularly high for Novartis, as Entresto stands as their leading revenue generator. The heart failure medication contributed more than $5.6 billion in the first nine months of 2024, accounting for 19% of the company's total revenues and showing remarkable growth of nearly 33% compared to the previous year.
Patent Litigation Details
The appeals court maintained that Novartis failed to demonstrate a high likelihood of success in their patent infringement claim, stating they found "no clear error in the district court's analysis." While Novartis has expressed disagreement with the verdict, the company is evaluating further appellate options as the patent infringement lawsuit is set to commence next week.
Broader Patent Challenges
This setback adds to Novartis' patent-related challenges, following a Delaware district court's previous invalidation of a 'combination patent' (No. 8,101,659) on Entresto. The company has also initiated legal action against the FDA, challenging the approval of the generic version after the regulator dismissed Novartis' Citizen's Petition for reconsideration.
Therapeutic Context
Entresto has been a cornerstone treatment for heart failure since its FDA approval in 2015. The drug's indication spans adult patients with chronic heart failure, with expanded approvals for pediatric patients and those with higher left ventricular ejection fraction (LVEF) measures. Its significance in the treatment landscape has contributed to its sustained market success.
Future Outlook
The timing of generic entry could significantly impact Novartis' revenue projections. While the company initially modeled for generic competition to Entresto and other key products like Tasigna and Promacta by mid-2025, the outcome of ongoing litigation could accelerate this timeline. These three products collectively represent a substantial portion of Novartis' revenue, with Tasigna and Promacta generating $1.3 billion and $1.6 billion respectively in the first three quarters of 2024.
