Big Molecule Watch
November 2, 2018

Amgen Files Cross-Appeal In Epoetin Alfa Biosimilar Case

Early last month, we reported that in the Amgen v. Hospira BPCIA litigation concerning Hospira’s Retacrit (epoetin alfa) biosimilar, Hospira had filed an appeal to the Federal Circuit from the Delaware district court’s final judgment of infringement and validity of one of the patents-in-suit, U.S. Patent No. 5,856,298, and the court’s award to Amgen of about $80 million. Subsequently, on October 15, 2018, Amgen filed a cross-appeal challenging, among other things, the district court’s judgment that Hospira had not infringed the other patent-in-suit, U.S. Patent No. 5,756,349.  On October 23, 2018, the Federal Circuit consolidated Amgen’s cross-appeal (Case No. 19-1102) into Hospira’s appeal (Case No. 19-1067), which is serving as the lead case.

Pursuant to the rules governing Federal Circuit appeals, because Amgen has filed a cross-appeal, there will be four rounds of appellate briefing instead of the usual three, with Hospira’s opening brief due on December 10, 2018, unless otherwise extended.

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