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.
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…
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…
After winning a preliminary injunction in Amgen v. Apotex, Amgen now hopes to capitalize on that win in another pending BPCIA case, Amgen v. Hospira, which is being litigated in the District of Delaware. Amgen filed a notice of supplemental authority in the Hospira case citing the Florida District Court’s order in Apotex in an attempt to provide further support for…
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…
In the wake of Amgen’s decision to drop Count II from its Complaint, which sought declaratory judgment that Hospira’s failure to provide manufacturing information violates 42 U.S.C. § 262(l)(2)(A), (discussed on the blog here), Hospira has sent a letter to the Court stating that it intends to refile its motion…
Last year, Hospira, Inc. (owned by Pfizer, Inc.) submitted an abbreviated Biologics License Application (aBLA) for its proposed biosimilar to Amgen’s Epogen (epoetin alfa). The biosimilar has been available in Europe since 2008 – under the name of Retacrit – for the treatment of anemia associated with chronic renal failure. On its quarterly…
As we reported in a previous post, Amgen is the plaintiff in another suit litigating the patent information provisions of the BPCIA, this time against Hospira. Amgen’s complaint alleged that Hospira violated the BPCIA by (1) not providing manufacturing information within 20 days of FDA’s acceptance of Hospira’s biosimilar application for review…