After seeking to block the launch of MSN Pharmaceuticals’ recently approved Entresto generic, Novartis has hit a snag in its multiyear crusade to thwart copycats of its top-selling heart failure drug.
Monday, Delaware District Judge Richard Andrews rejected Novartis’ infringement claims against MSN and denied the Swiss Pharma’s bid for an injunction on the generic maker’s launch. MSN received FDA approval for its Entresto generic July 24, according to court documents published (PDF) this week.
Novartis first sued MSN and a clutch of other drugmakers over plans to approve generics to Entresto back in 2022. The company claims infringement of the so-called ‘918 patent—set to expire in November 2026—which covers the amorphous solid form of a compound in Entresto, according to the court documents.
To hear Andrews tell it, “Novartis bears the burden of proof, both on infringement and on showing likelihood of success.” That said, the judge argued that Novartis “has not met the burden it bears at this stage” regarding MSN’s alleged infringement.
Aside from the infringement claim, Novartis has also argued it will suffer irreparable harm if MSN is allowed to launch its heart failure copycat.
“As an initial matter, I am skeptical about Novartis’ characterization of its many harms,” the judge wrote in his decision.
In particular, Novartis has contended that an at-risk launch by MSN would kick off a wave of generic Entresto rollouts by other drugmakers, “thereby destroying Entresto’s market momentum” and causing lost sales, lost market share, loss of formulary position and price erosion.
In rejecting Novartis’ request for an injunction, Andrews said he didn’t find it “reasonable” to attribute harm from other companies’ actions to MSN’s launch of its own product. Additionally, the judge thought it was unfair to blame MSN for the “impaired promotion” of Novartis’ other cardiovascular drugs, which he argued would result from Novartis’ own “profit-maximizing business decision to decrease its cardiovascular products salesforce in response to MSN’s launch.”
While Andrews blocked the request for an injunction, he granted a three-day stay to provide time for Novartis to appeal the decision.
In a statement provided to Reuters, Novartis said it’s now “considering all available options” and will maintain its financial guidance for the year.
Beyond the Delaware case, Novartis earlier this month filed a lawsuit against the FDA in federal court in Washington, D.C., arguing that the regulator’s decision to approve MSN’s generic was unlawful.
The Swiss pharma specifically alleged that the FDA’s conduct was unlawful because it promotes labeling that “inappropriately rewrites Entresto’s approved indication.” Novartis further argued that MSN’s label for its copycat medicine “deletes critical safety information contained in the Entresto labeling.”
During its latest earnings call, Novartis said it currently expects Entresto generics to hit in mid-2025, though the company is defending against that possibility on multiple patent fronts in a bid to extend Entresto’s market exclusivity.
Entresto is also one of 10 meds up for Medicare price negotiations under 2022’s Inflation Reduction Act. The negotiated prices are set to be announced Sept. 1 and will go into effect in 2026.
Despite being approved almost a decade ago, Entresto continues to generate major cash for Novartis.
As the company’s best-selling drug, Entresto brought home a little over $6 billion in global sales last year. Over the first half of 2024, the medicine has generated sales of nearly $3.8 billion.