Novartis’ latest effort to block a generic challenger to blockbuster heart med Entresto has come up short, this time in a federal appeals court.
The company has been defending against what could become the first Entresto generic in the United States for several years. Novartis’ patent infringement claims hinge on the so-called ‘918 patent, which expires in 2026 and covers the amorphous solid form of a compound used in Entresto.
The threat became more real this summer upon the FDA’s approval of MSN's generic in July, prompting Novartis to try for an injunction in a Delaware district court in an attempt to stop MSN from launching the copycat during the litigation.
In seeking the injunction, Novartis argued it was likely to win over the courts with its claims of patent infringement and that it would suffer irreparable harm without an injunction. Ultimately, the district court wasn't convinced.
Upon reviewing the case, the U.S. Court of Appeals for the Federal Circuit sided with the prior ruling, finding Novartis’ arguments “unpersuasive” and opting not to grant the preliminary injunction.
“We see no clear error in the district court’s analysis and consideration of the evidence,” the circuit judges wrote in their opinion (PDF).
The appeal was the most recent of several attempts by the drugmaker to fend off MSN’s generic. In October, Novartis petitioned a Washington, D.C. circuit court to rule the FDA’s approval unlawful. That court ended up finding MSN’s product “consistent with FDA regulatory and statutory requirements” despite the Swiss pharma’s arguments regarding labeling and the active ingredients in the generic. Novartis appealed that ruling, a spokesperson said at the time.
Novartis did not immediately respond to Fierce Pharma’s Thursday request for comment, but the company told Reuters it's “considering all available options to vigorously defend our intellectual property rights, including further appellate options."
Generic competition to Entresto poses a significant financial threat to the company as the 2015-approved heart med remains its top-selling product. During the first 9 months of the year, the drug generated $5.6 billion in global sales.
This summer, Novartis warned that it’s expecting Entresto generics to hit the market in mid-2025.