As we previously reported, Judge Connolly of the District of Delaware stayed the dispute between Amgen and Hospira last month, pending a determination on whether the Court should entertain summary judgment practice on the...more
On December 6, 2019, the Federal Circuit will hear oral argument in a rituximab-related appeal by Biogen. The appeal stems from a final written decision of the Patent Trial and Appeal Board (PTAB) in an inter partes review...more
A recent case at the U.S. District Court for the District of Delaware demonstrates how nuanced safe harbor protection under 35 U.S.C. § 271(e)(1) "non-infringement" can be for a pharmaceutical company developing a biosimilar...more
We reported earlier this week that the district court in Amgen v. Hospira denied Hospira’s motion for summary judgment of non-infringement of its proposed biosimilar of Epogen®/Procrit® (epoetin alfa) and granted-in-part and...more
Last week, Hospira filed a motion for summary judgment of non-infringement asserting that “all of Hospira’s accused erythropoietin drug substance batches are protected by the safe harbor provisions of 35 U.S.C. § 271(e)(1)...more