US appeals court reinstates pause on generic version of Novartis' Entresto

By Blake Brittain

WASHINGTON -Novartis won an order from a U.S. appeals court in Washington on Thursday temporarily blocking drugmaker MSN Pharmaceuticals from launching a generic version of Novartis' blockbuster heart-failure drug Entresto.

The U.S. Court of Appeals for the Federal Circuit ordered MSN not to launch its drug while it considers Novartis' request for a longer ban on the generic version.

The decision marks the latest change in fortune for Novartis amid multiple eleventh-hour bids to block MSN's generic, which Novartis said MSN could launch as early as Thursday.

The Federal Circuit's ruling comes hours after the U.S. Court of Appeals for the District of Columbia Circuit lifted a similar pause on the launch that had gone into effect Wednesday night.

Spokespeople and an attorney for Novartis did not immediately respond to requests for comment and more information on the rulings. An attorney for MSN declined to comment.

India-based MSN's version of Entresto was approved by the U.S. Food and Drug Administration last year. Novartis sued MSN and others seeking to launch Entresto generics for patent infringement.

Entresto is Switzerland-based Novartis' best-selling drug, which brought the company more than $6 billion in revenue in 2023.

The Federal Circuit last week reversed a 2023 decision that invalidated one of the patents. Novartis argued in a court filing that the ruling maintained the company's exclusive rights to sell Entresto until July.

The company said MSN was preparing to launch its generic on Thursday, the day Novartis' patent expired.

U.S. district courts in Washington and Delaware rejected Novartis' requests on Wednesday for a mandate that would immediately block the generic.

(Reporting by Blake Brittain in Washington; Editing by David Bario, Rod Nickel and Deepa Babington)