Novartis can't block MSN’s generic Entresto
Novartis wasn't successful in convincing a U.S. appeals court to stop MSN Pharmaceuticals' proposed generic of Novartis' Entresto, per a Reuters report.
The U.S. Court of Appeals for the Federal Circuit upheld a Delaware federal judge's August decision that found Novartis was not successful in proving it was likely to win a patent lawsuit against MSN over the drug, removing an obstacle for MSN's launch of what would be the first U.S. Entresto generic, the report noted.
Novartis said in a statement that it disagrees with the ruling and is "considering all available options to vigorously defend our intellectual property rights, including further appellate options." Spokespeople and attorneys for MSN did not immediately respond to a request for comment, Reuters said.
[Read more: Novartis files lawsuit against FDA over generic Entresto]
The Food and Drug Administration gave MSN clearance for the generic version of Entresto in July.
Novartis sued MSN and other companies looking to launch Entresto generics in Delaware federal court in 2022 for allegedly infringing a patent that expires in 2026. It requested a preliminary injunction after the FDA's approval that would block MSN from launching its generic during the case, which is set to go to trial on Monday, per the report.
The Reuters report also noted that U.S. District Judge Richard Andrews rejected Novartis' request in August, ruling that it was not sufficiently likely to win on its infringement claims to justify the injunction. The judge paused MSN's launch of its proposed generic while Novartis appealed to the Federal Circuit.
[Read more: Novartis to separate Sandoz generics drug unit into standalone company]
The Washington-based appeals court affirmed Andrews' decision on Wednesday and said it saw "no clear error in the district court's analysis," per the Reuters report.