As we have written about extensively, here, here, and here, the Federal Circuit recently interpreted two key provisions of the BPCIA in Amgen v. Sandoz. Three cases currently pending before District Courts raise related issues and each have the potential to reach the Federal Circuit. In this post, we provide…
As we’ve covered previously (here and here), Amgen has moved for a preliminary injunction to prevent Apotex from launching its biosimilar version of Amgen’s Neulasta until at least 180 days after FDA licensure of Apotex’s product. In its reply to Apotex’s opposition to its motion for a preliminary injunction, Amgen reiterates its…
Yesterday, Sandoz announced that the FDA has accepted its Biologics License Application (BLA) under the 351 (k) pathway for its proposed biosimilar to Amgen’s Neulasta® (pegfilgrastim). This is the second of ten proposed regulatory filings Sandoz has promised to make over the next three years (the first of which is…
On Friday, November 16, 2015, Apotex filed its brief in opposition to Amgen’s motion for a preliminary injunction in Amgen v. Apotex. As we’ve discussed previously here, Amgen has moved to enjoin Apotex from marketing its yet-to-be-approved Neulasta biosimilar until at least 180 days after FDA approval. Amgen has taken…
Yesterday Judge Cohn issued a supplemental scheduling order in Amgen v. Apotex. The hearing for Amgen’s Motion for Preliminary Injunction has been rescheduled for December 3, 2015. Claim construction briefing will occur in December and January, and the claim construction hearing will be held on February 5, 2016. Expert reports…
Last Friday, Oct. 30, Janssen filed a motion for leave to file a brief as amicus curiae in support of Amgen in Amgen v. Apotex. As we’ve covered in previous posts, Janssen is one of the plaintiffs litigating the question of what is required under the BPCIA’s 180-day notice of commercial marketing provision in Janssen…
On October 29, 2015, Amgen filed its answer to Apotex’s counterclaims in the Amgen v. Apotex Neulasta® (pegfilgrastim) litigation. As background, 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 effective…
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…
As we’ve reported previously, the parties in Amgen v. Apotex have completed the first wave of the BPCIA patent dance and are now litigating the first round of patent infringement claims. In its complaint, Amgen also alleged that Apotex provided Amgen with an “ineffective” Notice of Commercial Marketing pursuant to 42 U.S.C. §…
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…