On June 12, 2017, the U.S. Supreme Court interpreted two provisions of the Biologics Price Competition & Innovation Act (BPCIA) relating to patent infringement suits. The Court held that, under the BPCIA, (1) a biologic sponsor cannot enjoin a biosimilar applicant for refusing to provide a copy of its application and manufacturing information, and (2) a biosimilar applicant is not required to wait until it receives a license from the U.S. Food and Drug Administration (FDA) before providing 180 days’ notice of its intent to commercially market its biosimilar product.
The BPCIA generally governs the regulatory approval process for biosimilars. Biosimilars are biological products (i.e., those derived from biological sources, such as blood or protein, among other things) that are deemed to be “highly similar” to and have “no clinically meaningful” safety‑, purity- or potency-related differences from a licensed biologic.
The BPCIA outlines the steps to the so-called “patent dance,” under which the biosimilar applicant and the sponsor exchange information and identify patents that may be subject to litigation. The applicant makes the first move; if it provides a copy of the biosimilar application and information about manufacturing within a specified time period, the parties “dance.” No party can file a declaratory judgment infringement action if the applicant provides this notice. If the applicant refuses to provide this information, the sponsor may sue for patent infringement in a declaratory judgment action, without further delay. Neither the BPCIA nor Section 271(e)(2)(C) of the Patent Act, the Supreme Court held, provides for an injunction to address the applicant’s refusal to provide the information.
There is a second opportunity for the parties to litigate even if they choose to sit the first “dance” out. The BPCIA requires the applicant to notify the “sponsor not later than 180 days before the date of the first commercial marketing” of the biosimilar. Either the applicant or the sponsor may file a declaratory judgment action at this point, and the sponsor can seek a preliminary injunction prior to the commercial marketing. While the applicant may not market its product until receiving a license from the FDA, the Supreme Court held that licensure is not a prerequisite to the 180-day notice.
The case citation for this opinion is Sandoz Inc. v. Amgen Inc., 582 U.S. ___ (2017).