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 application for FDA licensure of a biosimilar version of Amgen’s Epogen (epoetin alfa) product, which was approved by FDA in 1989…
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 pre-FDA-licensure notice of commercial marketing was legally effective under the BPCIA. The parties have filed cross-motions for partial summary judgment on this issue, and these motions were pending when the Federal Circuit issued…
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 the BPCIA and 35 U.S.C. § 271(e)(2)(c)(ii) support the panel majority’s holding that a biosimilar applicant may “opt out” 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 response to Amgen’s petition is available here. We will be posting a summary of these responses later today, and will continue to…
Amgen and Sandoz have 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 Court for the Northern District of California. The district court had ordered a stay on the proceedings pending the Federal Circuit’s opinion on appeal…
Hospira, Inc., Celltrion Healthcare Co., Ltd., and Celltrion Inc. (jointly) and the Biosimilars Council filed amicus briefs today in support of Sandoz’s petition for rehearing en banc in Amgen v. Sandoz. The briefs are now publicly available and are attached here and here. UPDATE: Mylan Inc. has also filed an amicus…
Following the end of the injunction imposed by the Federal Circuit’s July 21st opinion in Amgen v. Sandoz, Sandoz today launched its biosimilar product Zarxio–the first product to be approved under the BPCIA’s abbreviated approval pathway for biosimilars. Zarxio is a biosimilar product referencing Amgen’s Neupogen (filgrastim) product, and will be sold at…
The PTAB is asking for briefing on whether IPRs filed by the Coalition for Affordable Drugs against Shire PLC should be dismissed for abuse of the IPR process. The petitions (Nos. IPR2015-00990 and IPR2015-01093) concern U.S. Patent No. 7,056,886, directed to GLP-2 peptides and analogs thereof, which may be used…
The Federal Circuit has denied Amgen’s Emergency motion for a temporary injunction pending en banc consideration and review in Amgen v. Sandoz. Per the Federal Circuit’s July 21st decision, Sandoz was enjoined from marketing its biosimilar filgrastim product, Zarxio, until 180 days from the date it received FDA approval for its product. That original injunction…
Sandoz has filed its opposition to Amgen’s motion seeking an “emergency” injunction from the Federal Circuit to extend the injunction blocking Sandoz from launching its Zarxio biosimilar past September 2, the date the injunction is currently set to expire. In its opposition, Sandoz blasts Amgen’s motion as “perfunctory” and not meeting…