Novartis is already suing a long list of generics producers that aim to bring copycats of the company's popular heart failure drug Entresto to market. Now, the Swiss pharma itself has become target in a patent infringement lawsuit.
Entresto infringes a co-crystal patent held by the University of Michigan and the University of South Florida, the two institutions alleged in a complaint filed Monday in the U.S. District Court for the Northern District of California.
The universities are seeking a jury trial and damages to compensate for the alleged patent infringement. Since Entresto is a blockbuster that generated $3.55 billion worldwide last year, the damages, if awarded, could wind up being significant.
Entresto is a combination of sacubitril and valsartan. Thanks to an expanded FDA nod in 2021 to treat patients with heart failure with preserved ejection fraction (HFpEF), Entresto saw sales jump 37% at constant currencies in the first half of 2022 to $2.22 billion. Novartis has said the combo therapy could reach $5 billion in peak sales.
At the center of the new lawsuit is U.S. Patent No. 10,633,344, which was awarded in April 2020. It covers a technology of making multicomponent solid drugs with “improved drug solubility, dissolution rate, stability and bioavailability,” according to the complaint.
The Entresto co-crystals of sacubitril and valsartan comprise “supramolecular synthons,” which touched on the patented supramolecular technology, the universities argue.
Novartis didn't immediately respond to a request for comment on the lawsuit.
The new suit against Novartis comes as the Swiss pharma is trying to fend off several Entresto generic contenders, including Teva, Viatris, Aurobindo and Lupin, among others. In the U.S., Entresto boasts patents protecting various aspects of its formulation into as late as 2036. For example, Novartis in December sued Torrent Pharma for infringing on an Entresto dosage regimen patent, which expires in May 2036.
In late 2021, Novartis also filed a citizen petition asking the FDA not to approve any Entresto copycats until at least February 2024. The timeline was drawn from an additional three-year exclusivity period that came with the HFpEF nod in 2021. Greenlighting any generic before 2024 would go against FDA’s “same labeling” standards for generics, the company argued.
At that time, Novartis noted at least 18 drugmakers had submitted applications seeking approval of a generic Entresto product. Those companies are looking to bring their copycat versions to the market in July 2023, when a regulatory stay that prevents the FDA from granting final generic approvals lifts.