Amgen v Sandoz: marketing exclusivity under the BPCIA

The BPCIA requires a biosimilar applicant to notify the reference product sponsor of its drug no later than 180 days before the first commercial marketing date. Darryl Woo, Erin Ator Thomson, Janice Ta and Wendy Wang of Vinson & Elkins report on some of the pressing issues in this area.

On February 16, 2016, Sandoz filed a petition for a writ of certiorari asking the US Supreme Court to review the case Amgen v Sandoz, in which the US Court of Appeals for the Federal Circuit interpreted key provisions of the Biologics Price Competition and Innovation Act (BPCIA) (codified at 42 USC §262[k]).

The BPCIA was passed as part of the Affordable Care Act in 2010. Its purpose is to balance innovation and consumer interests by creating an abbreviated pathway for a biosimilar applicant to enter the market by relying on safety and efficacy data contained in the Food and Drug Administration (FDA)-approved licence of a reference product.

Under the BPCIA, a biosimilar applicant cannot apply for an abbreviated licence until four years after the reference product was first licensed. Moreover, the FDA’s approval of the biosimilar product cannot be effective until 12 years after the reference product was first licensed, according to 42 USC §§262(k)(7)(A)–(B). So, a reference product sponsor (RPS) enjoys 12 years of marketing exclusivity, irrespective of its patent rights.