BPCIA Statute: Patent Dance Is Optional, But Opting Out Has Consequences

The Federal Circuit issued a ruling on July 21, 2015 in the Amgen Inc. et al. v. Sandoz Inc., Case No. 2015-1499, appeal after hearing oral arguments on June 3, 2015. See BPCIA: A “Choose Your Own Adventure” Statute? (describing the parties’ oral arguments before the Federal Circuit). Amgen Inc. (“Amgen”) appealed the Northern District of California’s decision holding that the Biologics Price Competition and Innovation Act’s (“BPCIA’s”) “patent dance” provisions are optional and that the 180-day notice provision does not require licensure. See Dancing Not Required: District Court Denies Amgen’s Bid for Preliminary Injunction, Finds BPCIA “Patent Dance” Optional.

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