United States Federal Circuit

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Amgen Inc. v. Apotex Inc., 2016-1308

In an infringement suit brought under the Biologics Price Competition and Innovation Act of 2009 (BPCIA), involving a proposed biosimilar product to plaintiff's drug Neulasta, the the district court grant of plaintiff's motion for preliminary injunction, which enjoined defendant from entering the market unless it has given plaintiff notice after receiving the requested FDA license and then waiting 180 days, is affirmed where, under Amgen Inc. v. Sandoz Inc. (Fed. Cir. 2015), the commercial-marketing provision is mandatory and enforceable by injunction even for an applicant in defendant's position.

Appellate Information

  • Argued
  • Submitted
  • Decided
  • Published 2016/07/05

Judges

  • TARANTO

Court

  • United States Federal Circuit

Counsel


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