A couple of updates on Amgen v. Hospira (epoetin alfa): Amgen has requested that the district court (D. Del., J. Andrews) grant it leave to file a second amended complaint “to add three additional defendants” who, Amgen alleges, “have directly or indirectly infringed Amgen’s patent-in-suit, United States Patent No. 5,756,349.” Meanwhile, Hospira…
Below is a brief summary of each of the U.S. patent litigations concerning a proposed or approved biosimilar product. Please also consult our BPCIA Litigation Summary Chart for additional details.
As we reported, in a litigation regarding Hospira’s planned biosimilar for Amgen’s epoetin alfa, sold under the brand names Epogen and Procrit, in May, 2016, the District Court (D.Del., J. Andrews) denied Amgen’s motion to compel Hospira to produce two contested categories of documents, finding that Amgen had not shown…
The District Court (D. Del., J. Andrews) has denied Hospira’s Motion to Dismiss in Amgen v. Hospira. As we’ve covered previously (see our posts here and here), Hospira moved to dismiss Count I of Amgen’s amended complaint, in which Amgen seeks both a declaratory judgment that Hospira’s alleged refusal to provide Amgen with 180-days’ post-licensure notice of…
As we covered in a previous post, the Court in Amgen v. Hospira ruled on some novel issues relating to litigation under the BPCIA during a hearing on discovery issues a few months ago. Background: To recap: this past May, the district court for the District of Delaware (Judge Andrews) held a hearing to…
In the Amgen v. Hospira litigation, Amgen has filed a Notice of Appeal relating to Judge Andrew’s oral ruling denying Amgen’s request to compel Hospira to produce certain manufacturing information related to its Epogen® (epoetin alfa) biosimilar product. We previously covered the discovery dispute in detail here. The appeal was placed on…
In a recent hearing held in Amgen v. Hospira, the parties offered arguments on some novel issues relating to litigation under the BPCIA, particularly: Whether a reference product sponsor (“RPS”) can compel a biosimilar applicant to produce manufacturing information that may be relevant to other patents it holds, but is…
Last week, Judge Richard Andrews in the District of Delaware heard argument in Amgen v. Hospira on Hospira’s motion to dismiss Amgen’s action over notice provisions in the Biologics Price Competition and Innovation Act (“BPCIA”). Hospira, now owned by Pfizer Inc., argued that Amgen cannot seek an injunction to enforce…
February will be a busy month for pending BPCIA cases, with activity on the horizon in Amgen v. Apotex, Amgen v. Hospira, and Janssen v. Celltrion: Amgen v. Apotex (Fed. Cir.) As we covered previously, Apotex appealed the district court’s order granting Amgen a preliminary injunction in Amgen v. Apotex. Apotex requested an expedited briefing…
Amgen today announced the submission of its first biosimilar application to FDA. The application seeks approval for a biosimilar version of Humira®(adalimumab). As we’ve covered extensively, Amgen is the biologic reference product sponsor and plaintiff in a number of BPCIA cases: Amgen v. Sandoz, Amgen v. Hospira, and Amgen v. Apotex. This is the first time Amgen has formally appeared on…