FDAnews Drug Daily Bulletin
Pharmaceuticals / Commercial Operations

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

Dec. 27, 2017
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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.

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