Blog Big Molecule Watch October 11, 2018

Hospira Appeals $80 Million Judgment in Epoetin Alfa Biosimilar Case

As we reported, last month in the Amgen v. Hospira litigation concerning Hospira’s Retacrit (epoetin alfa) biosimilar, the Delaware district court entered final judgment against Hospira, awarding Amgen $70 million in damages and approximately $10 million in pre-judgment interest, plus post-judgment interest in an amount to be determined at a later date.  The damages award was based on a jury verdict last year that Hospira infringed a now-expired Amgen process patent by manufacturing fourteen batches of drug substance in 2013-2015 outside of the protection of the safe harbor of 35 U.S.C. § 271(e)(1), which allows use of patented processes if reasonably related to the development and submission of information to the FDA.

On October 3, 2018, Hospira filed a notice of appeal to the Federal Circuit from the district court’s judgment.  Today, October 11, the Federal Circuit docketed the appeal as Case No. 19-1067.  Based on the docketing date, the deadline for Hospira to file its opening appellate brief is December 10, 2018.

Stay tuned to Big Molecule Watch for further developments.

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