Blog Big Molecule Watch December 21, 2017

Federal Circuit Issues Mandate in Amgen v. Apotex

As we previously reported, last month a Federal Circuit panel affirmed the district court’s judgment that Apotex’s pegfilgrastim and filgrastim biosimilar candidates do not infringe Amgen’s protein refolding method patent.

Amgen’s time for filing a petition for panel rehearing or rehearing en banc of last month’s panel decision expired on December 13, without Amgen filing a petition.  Yesterday, the Federal Circuit issued its formal mandate, certifying its judgment in favor of Apotex.  Amgen has until February 13, 2018 to file a petition for certiorari with the U.S. Supreme Court.  In the absence of a successful certiorari petition, the Federal Circuit’s judgment will mark the final resolution of the case.

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