On October 5, 2015, Apotex filed its answer and counterclaims in the ongoing Amgen v. Apotex Neulasta® (pegfilgrastim) litigation. As we previously reported, Amgen’s complaint alleged that Apotex…
On October 5, 2015, Apotex filed its answer and counterclaims in the ongoing Amgen v. Apotex Neulasta® (pegfilgrastim) litigation. As we previously reported, Amgen’s complaint alleged that Apotex…
Last updated: November 28, 2016 Below is a summary of the BPCIA litigations that have been filed to date. Please also read our quarterly BPCIA litigation round-up posts for additional…
Amgen and Allergan announced their biosimilar candidate ABP 215 “met its primary and secondary endpoints” in a Phase 3 study by demonstrating “clinical equivalence in efficacy, and comparable…
As we’ve covered in previous posts (here and here), the parties in Janssen v. Celltrion have been supplementing their briefings on whether Celltrion’s notice of commercial marketing, given…
As we reported previously, Amgen and Sandoz filed a joint motion to lift the stay of proceedings on Amgen’s patent infringement claims and Sandoz’s related counterclaims in the U.S. District…
Amgen has initiated new litigation over the patent provisions of the BPCIA, this time against Hospira in the U.S. District Court for the District of Delaware, regarding Hospira’s biosimilar…
Complaint Hospira’s Motion to Dismiss Count I and Count II Amended Complaint Hospira’s Letter to the Court re: Hospira’s Motion to Dismiss Hospira’s Motion to Dismiss Count…
As we reported in a previous post, the parties in Janssen v. Celltrion–a BPCIA-related case pending in the District of Massachusetts—are currently litigating whether Celltrion’s…
In their reply briefs, Amgen and Sandoz further sharpened their arguments in opposition to the en banc review sought by the other. Sandoz continued to emphasize that the text of…
Amgen and Sandoz have filed responses to each other’s petitions for rehearing en banc in Amgen v. Sandoz. Amgen’s response to Sandoz’s petition is available here, and Sandoz’s…