As we previously reported, last September a District of Delaware jury issued a verdict that Hospira’s manufacture of 14 batches of drug substance in connection with its proposed biosimilar of Amgen’s Epogen® (epoetin alfa) was not protected activity under the § 271(e)(1) safe harbor and infringed Amgen’s ’298 patent, and…
Below is our second quarter update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our previous quarterly updates (Q3 2016, Q4 2016, Q1 2017, Q2 2017, Q3 2017, Q4 2017, Q1 2018). Please also refer to our BPCIA Patent Litigation and Federal…
Pending U.S. District Court BPCIA Litigations Resolved U.S. District Court BPCIA Litigations Last updated: April 16, 2024
Below is our first quarter update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our previous quarterly updates (Q3 2016, Q4 2016, Q1 2017, Q2 2017, Q3 2017, Q4 2017).
As we previously reported, Amgen and Hospira both filed motions asking the Court to partially set aside the jury verdict in the Amgen v. Hospira litigation. In its motion, Hospira had asked the Court to set aside the jury verdict as to its accused batches under the § 271(e)(1) safe harbor, and…
Below is our fall update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly updates (Summer 2016, Fall 2016, Midwinter 2017, Spring 2017, Summer 2017).
Further to our update yesterday on the Amgen v. Hospira litigation, the parties in the case filed several additional motions yesterday. Following its filing of a motion for judgment as a matter of law under Federal Rule of Civil Procedure 50(a) last month, Hospira has now filed a renewed motion for judgment as a…
As we previously reported, on September 22, 2017, a Delaware federal jury awarded Amgen $70 million in damages after finding that Hospira infringed one of Amgen’s Epogen® (EPO) patents (the ’298 patent). Five days later, Hospira filed a motion under FRCP 50(a) for judgment as a matter of law that…
As we reported yesterday in the Amgen v. Hospira litigation, Amgen filed a motion for leave to file an amended brief in support of its Motion for a Preliminary Injunction, in light of the Supreme Court’s ruling in Sandoz v. Amgen. That same day, the Court entered an order granting…
On Friday, in the ongoing Amgen v. Hospira district court litigation regarding Hospira’s proposed biosimilar of Epogen®/Procrit® (epoetin alfa), Amgen filed a motion for preliminary injunction seeking to enjoin Hospira from launching its biosimilar “until Hospira has complied with the requirement of 42 U.S.C. § 262(l)(8)(A), which states that ‘[t]he subsection…