Search Results for: "amgen v apotex"

Update in Amgen v. Apotex: Amgen Files Preliminary Injunction Blocking Apotex from Marketing Neulasta Biosimilar

As discussed in earlier coverage, Amgen has now made good on its intention to seek a preliminary injunction against Apotex.  Amgen looks to block Apotex from marketing its Neulasta biosimilar before the expiration of the 180-day pre-marketing notice following FDA approval. Apotex has previously argued that the Federal Circuit’s panel decision…

Read More

Update in Amgen v. Apotex: Apotex’s Answer and Counterclaims

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 provided Amgen with an “ineffective” Notice of Commercial Marketing pursuant to 42 U.S.C. § 262(l)(8)(A), because “a subsection (k) applicant may only give…

Read More

Update in Amgen v. Apotex: Scheduling Report

As we reported in an earlier post, Amgen v. Apotex is the first biosimilar litigation in which the parties have actually danced the entire “patent dance” through the “first wave.” The case, which concerns Apotex’s application to market a biosimilar version of Neulasta, has already been scheduled for trial beginning July…

Read More