Sandoz, Inc. v. Amgen, Inc., No. 14-1693 (Fed. Cir. 2014)
Annotate this CaseSandoz sought a declaratory judgment that two patents, exclusively licensed to Amgen, were invalid and unenforceable and would not be infringed if Sandoz uses, offers to sell or sells, or imports a drug product “biosimilar” to Amgen’s Enbrel®, which is a drug used for treatment of rheumatoid arthritis. Sandoz has not yet filed an application for approval of its contemplated product by the FDA and had only begun certain testing required for its contemplated FDA filing. The district court dismissed the case, determining that no Article III controversy (yet) existed between the parties and also that the suit was barred by the Biologics Price Competition and Innovation Act of 2009 (BPCIA), 42 U.S.C. 262. The Federal Circuit affirmed, concluding that Sandoz did not allege an injury of sufficient immediacy and reality to create subject matter jurisdiction. The court did not address interpretation of the BPCIA.
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