In June 2017, the Supreme Court announced its decisions in Sandoz v. Amgen and Amgen v. Sandoz – cases that examined how makers of biosimilars and branded biologic drugs bring products to market. At issue was the so-called “patent dance,” a complex series of disclosures between biosimilar makers and the manufacturers of branded versions. In its decision, the Court left it up to states to decide whether to enforce the patent dance and how.
Then, in December, the Federal Circuit ruled unanimously, siding with Sandoz and affirming the district court’s dismissal of Amgen’s unfair competition and conversion claims. As a result, state law claims are now preempted by the Biologics Price Competition and Innovation Act on both field and conflict grounds.