In a unanimous decision, the Supreme Court of the United States
explained that under the Biologics Price Competition and Innovation
Act of 2009 (BPCIA), biosimilar makers do not have to wait for
approval before giving 180-day notice of commercial marketing under
the BPCIA, and no federal injunction is available to compel
biosimilar makers to disclose their approval applications to
rivals. Sandoz Inc. v. Amgen Inc., Docket No. 15-1039
(Supr. Ct., June 12, 2017) (Thomas, Justice) (Breyer, Justice,
concurring).
The BPCIA establishes processes both for obtaining US Food and
Drug Administration (FDA) approval of biosimilars and for resolving
patent disputes between manufacturers of licensed biologics and
manufacturers of biosimilars. A manufacturer of a biologic product
must obtain a license from the FDA to market its drug. A
manufacturer may obtain a license either by demonstrating that the
drug is "safe, pure and potent" or by piggybacking on the
showing made by the
