In Amgen v. Sandoz, No. 2015-1499 (Dec. 14, 2017), the Federal Circuit held that 42 U.S.C. § 262 (the “BPCIA”) preempts state law claims for unfair competition.  The BPCIA provides for streamlined FDA approval of drugs that are “biosimilar” to previously approved drugs.  Similar to the Hatch-Waxman Act, a biosimilar application under the BPCIA also gives the owner of a prior FDA-approved drug the right to sue for patent infringement, even before the biosimilar is commercially released.  To facilitate the process, the BPCIA requires that an applicant for biosimilar approval promptly disclose its confidential manufacturing information to the owner of patents that cover the prior FDA-approved drug.  In this case, Sandoz refused to disclose its manufacturing information to Amgen.  Amgen asserted that this violation gave rise to a state law tort claim for unfair competition.  The Federal Circuit ruled that the BPCIA preempted state law claims premised on a failure to disclose manufacturing information under the BPCIA.  In particular, field preemption was held to apply because the regulation of biosimilars is not a traditional state issue and because the BPCIA provides a comprehensive legal framework for applications and any related patent litigation.  In this case, conflict preemption was also held to apply because Amgen sought relief for violations of the BPCIA under state unfair competition law, whereas this type of relief was not available under the BCPIA itself.