Sandoz Inc. v. Amgen Inc.
Avoiding an interpretation of the Biologics Price Competition
and Innovation Act (BPCIA), the U.S. Court of Appeals for the
Federal Circuit invoked traditional case or controversy principles
to affirm the dismissal of a declaratory judgment suit by a
biosimilar manufacturer. Sandoz Inc. v. Amgen Inc.,
Case No. 14-1693 (Fed. Cir., Dec. 5, 2014) (Taranto, J.).
Sandoz sought a declaration that two patents exclusively
licensed to Amgen were invalid, unenforceable, and not infringed by
its proposed biosimilar to Amgen's Enbrel®. At the
time it brought suit and throughout the case, Sandoz had not yet
submitted an application to the Food and Drug Administration (FDA)
requesting permission to market its biosimilar product. The
district court dismissed the case, determining that no Article III
controversy existed and that the BPCIA-barred declaratory suits by
biosimilar makers prior to filing an FDA biosimilarity
application. Sandoz appealed.
