Upper, Lower Federal Courts Favor Sandoz in Amgen Biosimilar Patent Rulings

Sandoz triumphed over Amgen in a biosimilar patent infringement case that went from a Northern California federal court, up the ladder to the Supreme Court and back down again — following victories in both the district court and the Federal Circuit Court of Appeals this past week.

According to the series of rulings, neither state nor federal courts may compel a biosimilar manufacturer to disclose their FDA application to the reference company.

This past summer, the Supreme Court ruled in Sandoz’s favor on two questions: that the 180-day exclusivity period, triggered by notifying a brand-name manufacturer of the intent to market a biosimilar, could begin counting down before FDA approval; and that federal law defining the biosimilar application process does not include the ability for a federal court to compel a biosimilar manufacturer to disclose its application and methods to the brand-name company.