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# Appeals Court Rules in Amgen’s Favor Over Biosimilar Notice
- URL: https://www.fdaweb.com/appeals-court-rules-in-amgens-favor-over-biosimilar-notice/
- Published: 2016-07-11T12:00:00.000Z
- Updated: 2026-09-14T21:13:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136127

The Federal Circuit Court of Appeals has affirmed a lower court decision granting Amgen a preliminary injunction blocking Apotex from launching its biosimilar pegfilgrastim for 180 days after receiving FDA approval and giving notice of commercial marketing. Apotex had argued that because the two parties completed the Biologics Price Competition and Innovation Act (BPCIA) “patent dance” before a lawsuit was filed, a notice of commercial marketing is not required. Apotex says that the Amgen suit against it is different from *Amgen v. Sandoz*, in which Sandoz chose not to participate in the patent dance and was required to provide 180 days’ notice of commercial marketing. Apotex also argued in its appeal that making the 180-day notice period mandatory in all cases, rather than only in cases when the biosimilar applicant chooses not to participate in the patent dance, would amount to a *de facto* extension of the 12-year exclusivity period provided under the BPCIA.

In [affirming](http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/16-1308.Opinion.6-30-2016.1.PDF?ref=fdaweb.com) the lower court’s decision, the appeals court said BPCIA’s commercial marketing provision “is mandatory and enforceable by injunction even for an applicant in Apotex’s position” — i.e., an applicant that participated in the patent dispute resolution provisions. It also found that an injunction was proper to enforce the provision against Apotex.