Novartis (NYSE: NVS) has revealed a favorable decision by the US Court of Appeals for the Federal Circuit (CAFC), affirming the validity of the Entresto (sacubitril/valsartan) combination patent. This decision comes as the pediatric exclusivity period for the combination patent is set to expire in July 2025. The Swiss pharmaceutical giant has vowed to continue defending and protecting all its important intellectual property and regulatory rights relating to Entresto, a drug for which no generic version is currently approved in the United States.
Background on Patent Challenge
India-based firm MSN Laboratories previously challenged the Entresto patent in the US. In response, Novartis filed a lawsuit against MSN and other companies planning to produce generic versions of Entresto back in 2022. Novartis claimed that these proposed products infringed a patent that expires in 2026.
Recent CAFC Decision and Novartis Response
According to a Reuters report last month, the CAFC had rejected Novartis’ request to block MSN from launching a generic version of the drug in the United States. Novartis expressed disappointment with the ruling, stating that it “disagrees with this decision” and is “considering all feasible options to actively defend our intellectual property, including the possibility of further appeal.”-Fineline Info & Tech
