On January 13, 2017, the Supreme Court granted certiorari in Amgen v. Sandoz, 794. F.3d 1347 (Fed. Cir. 2015) and Sandoz v. Amgen, 773 F.3d 1274 (Fed. Cir. 2014), appealed from the Federal Circuit. The petitions involve the Federal Circuit’s interpretation of certain provisions of the Biologics Price Competition and Innovation Act of 2009 (BPCIA).
The BPCIA provides for an expedited process for licensing biosimilar versions of licensed biologic products. Two specific provisions of the BPCIA are at issue in this litigation. First, the BPCIA provides that the applicant “shall provide to the reference product sponsor a copy of the application submitted . . . and such other information that describes the process or processes used to manufacture the biological product.” 42 U.S.C. § 262(l)(2)(A). Second, the BPCIA states that the applicant “shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k).” 42 U.S.C. § 262(l)(8)(A).
Under the BPCIA, a biological product is a “virus, therapeutic serum, toxin antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein, or analogous product applicable to the prevention, treatment, or cure of a disease or condition of human beings.” 42 U.S.C. § 262(i)(1). Biological products may be licensed by two routes: first, the FDA may license a biologic if the biologic has been demonstrated to be safe, pure, and potent; and second, an abbreviated biologic license application (aBLA) may be approved if the biologic at issue is shown to be a “biosimilar” to a previously approved biologic (reference product). The act of submitting an aBLA is an act of infringement if the purpose of the submission is to obtain approval to engage in the commercial manufacture, use, or sale of a biological product claimed in a patent.
The BPCIA outlines a detailed timeline for the applicant of the aBLA and the reference sponsor to resolve patent disputes. Under this process, the applicant “shall” grant the sponsor confidential access to the aBLA application and manufacturing information no later than 20 days after the FDA accepts the application. The parties then exchange lists of patents that they believe may be asserted, including their positions regarding infringement, validity, and enforceability. The applicant must also give notice of commercial marketing to the sponsor at least 180...
