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
Stay tuned to Big Molecule Watch for further developments.