Novartis plans to appeal a U.S. district court ruling that invalidated a key patent protecting the Swiss pharmaceutical company’s top-selling medicine, the heart drug Entresto.
The U.S. District Court for the District of Delaware struck down the patent, which is set to expire in 2025 and covers combinations of the two active pharmaceutical ingredients contained in Entresto. The decision, which Novartis disclosed Friday, could open the door to generic versions of the heart failure treatment, although none are currently approved in the U.S.
In a statement, Novartis said any generic drugmaker that launches an Entresto copy while its appeal is pending would do so “at risk” of litigation. Despite the district court verdict, the company is maintaining its sales forecast for the year as well as its mid-term outlook.
Launched in the U.S. in 2015, Entresto has become a blockbuster for Novartis, earning $1.4 billion globally during the first quarter. While adoption of the treatment was slow initially, Novartis invested heavily in sales and marketing and later won broader labeling that dramatically expanded the number of patients eligible for the drug. More than 11 million people now take Entresto worldwide, the company estimates.
Currently, Novartis is planning for “loss of exclusivity” in the U.S. in 2025, when the patent just invalidated is set to expire. Four other patents, with expiration dates between 2023 and 2026, also protect Entresto. Novartis is fighting the challenges of those in court as well.
The pharma previously entered into settlements with “several” generic companies that will allow those firms to launch copycat versions of Entresto at an agreed-upon, confidential date.
Novartis’ appeal will take the case to the U.S. Court of Appeals for the Federal Circuit, where last year the pharma was defeated in a separate attempt to defend another top drug, the multiple sclerosis treatment Gilenya.