Novartis will appeal Entresto patent setback

Novartis has suffered a defeat in its legal defence of chronic heart failure therapy Entresto, which accounted for around 11% of its revenues last year, but has vowed to take the case to appeal.

Shares in the pharma group came under pressure ahead of the weekend after a US district court in Delaware ruled that a patent covering Entresto (valsartan/sacubitril) that expires in 2025 was invalid, raising the possibility of generic competition to the blockbuster drug in that year.

The patent in question (No. 8,101,659) covers the combination of sacubitril with valsartan and includes an extension awarded in return for carrying out studies of the drug in paediatric populations. It is due to expire on 15th July 2025.

The ‘659 patent is one of a series of patents expiring between 2023 and 2036 that Novartis says protect its brand in the US market, and the company immediately said it intended to elevate the case to the US Court of Appeals for the Federal Circuit in an attempt to reverse the ruling.

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). Litigation against Mylan and other companies hoping to bring generic versions of Entresto to the US market has been ongoing since 2019.

Shares in Novartis, nevertheless, fell around 3% in both the US and Europe as investors fretted that competition to Entresto could emerge in the US earlier than expected. The drug brought in $4.6 billion for Novartis last year - up by around a third on the prior year, with the increase fuelled by use in heart failure with preserved ejection fraction (HFpEF), which was added to the drug’s label in 2021.

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”.

It also said that, despite the potential for earlier-than-expected arrival of generics, it is maintaining its 2023 guidance of group sales growing at a mid-single-digit rate, with average increases of 4% between 2022 and 2027.

The company pledged to “continue to defend vigorously its intellectual property rights relating to Entresto, including the combination patent, as well as multiple patents covering additional innovations.”

Bank of America analyst Graham Parry said in a research note that generic Entresto launches ahead of the expiry of the ‘659 patent in 2025 “still seem unlikely”, despite the Delaware judgment.