Sandoz Inc. v. Amgen Inc.
Sandoz Inc. v. Amgen Inc., 15-1039
In a patent infringement suit involving filgrastim drugs, arising in the context of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), which provides an abbreviated pathway for obtaining FDA approval of a drug that is biosimilar to an already licensed biological product, 42 U.S.C. section 262(k), and provides procedures for resolving patent disputes between biosimilar manufacturers (applicants) and manufacturers of reference products (sponsors), section 262(l), the Federal Circuit’s judgment holding — that applicant did not violate the BPCIA in failing to disclose its application and manufacturing information, that the BPCIA provides the exclusive remedies for failure to comply with this requirement, and that under section 262(l)(8)(A) an applicant must provide notice of commercial marketing after obtaining licensure — is vacated and reversed in part where: 1) section 262(l)(2)(A) is not enforceable by injunction under federal law, but the Federal Circuit on remand should determine whether a state-law injunction is available; and 2) an applicant may provide notice under section 262(l)(8)(A) prior to obtaining licensure.
- Published 2017/06/12
- United States Supreme Court