US Court Issues Negative Decision On Novartis' Heart-Failure Drug Patent

Swiss pharma giant Novartis AG NVS announced that the U.S. District Court for the District of Delaware issued an unfavorable decision regarding the validity of a patent covering its heart failure treatment Entresto and combinations of sacubitril and valsartan, which expires in 2025 with its pediatric exclusivity.

Novartis says the combination patent is valid and will appeal to the U.S. Court of Appeals for the Federal Circuit to reverse the District Court's decision.

Despite the potential for earlier-than-expected arrival of generics, Novartis backed its outlook for 2023, saying it expects sales to grow mid-single digits and operating income to grow high-single digits in constant currency. The company also backed its mid-term outlook of 4% sales growth between 2022-2027, with a 40% core operating income margin excluding the generics unit Sandoz.

The patent (No. 8,101,659) covers the combination of sacubitril with valsartan. It is due to expire on 15th July 2025.

The decision came a day after Novartis won a patent infringement lawsuit brought against generic drugmaker Mylan in a West Virginia district court, which found that proposed Entresto generics infringed two other patents on the drug (Nos. 8,877,938 and 9,388,134).

Novartis' chronic heart failure therapy Entresto, accounted for around 11% of its revenues last year. The company will appeal to the U.S. Court of Appeals to uphold the validity of the Entresto combination patent.

The drug brought in $4.6 billion for Novartis last year - up by around a third on the prior year.

In a statement, Novartis said there are currently no generic Entresto products with either tentative or final FDA approval, adding that any launch of a copycat drug before the outcome of its appeal would be "at risk of later litigation development."

Price Action: NVS shares are up 2.07% at $96.68 on the last check Monday.