All nine U.S. Supreme Court justices heard argument on Wednesday April 26th, in Sandoz Inc., v. Amgen Inc. The Supreme Court is reviewing interpretations of the Biologics Price Competition and Innovation Act (BPCIA) made by the U.S. Court of Appeals for the Federal Circuit. Wednesday’s arguments focused on four main issues:
- whether the FDA could preliminarily grant licensure prior to the expiration of the 12 year statutory period;
- whether the notice of commercial marketing requires official licensure to be made;
- whether the “patent dance” was required by the BPCIA; and
- whether state law could be used to enforce compliance with the “patent dance” elements of the BPCIA.
Industry watchers hope that the Supreme Court will streamline the process for getting biosimilars to market by providing increased certainty.
To read the full alert, click here.