Sandoz Inc. v. Amgen Inc., No. 15-1039
The 2009 Biologics Price Competition and Innovation Act, a component of the Affordable Care Act, created an abbreviated regulatory pathway for the FDA to license “biosimilar” products—i.e., products that are “highly similar” to approved biological products. The statute’s “Notice of commercial marketing” provision requires a biosimilar applicant to provide 180 days notice to the existing seller of the biological product before it can engage in commercial marketing for the newly-approved product. The Federal Circuit held that this notice could be given only after the biosimilar product had received FDA approval, creating an additional six-month exclusivity period for incumbent sellers. The Supreme Court granted certiorari to determine whether notice given prior to receiving FDA approval can be effective to satisfy the statute’s 180-day notice requirement.