Biotech Values

[DewDiligence]

Another “post-Chevron” case—NVS sues FDA re generic Entresto:

https://www.fiercepharma.com/pharma/novartis-sues-fda-over-approval-generic-version-its-bell-cow-entresto

On Wednesday afternoon in federal court in Washington, D.C., [Novartis] filed a lawsuit against the FDA, claiming that the U.S. regulator’s approval of a generic version of Entresto is unlawful.

The complaint comes a week after the FDA approved an Entresto generic from MSN Laboratories. The agency also rejected a Novartis-orchestrated Citizen Petition, which asked it to block the entry of generic versions of Entresto…generics that would violate Novartis patents due to expire in 2033 and 2036. The FDA…said that generics can avoid infringement simply by adjusting their labels.

NVS’ lawsuit would never have been filed absent the Supreme Court’s reversal of the Chevron doctrine, IMO.