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…
As we reported in an earlier post, the 180-day commercial notice provisions of the BPCIA at issue in Amgen v. Sandoz are also being litigated in Janssen v. Celltrion, an action pending in the District of Massachusetts. The parties’ cross-motions for partial summary judgment [here and here] on whether Celltrion’s pre-FDA-licensure…
Following the parties’ petitions for rehearing en banc in Amgen v. Sandoz, Amgen has filed an emergency motion for an injunction to block the launch of Sandoz’s FDA-approved biosimilar filgrastim product, pending the Federal Circuit’s en banc consideration and review. Sandoz is currently enjoined from marketing its biosimilar product, Zarxio,…
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…
IPR2015-01792 (Coalition for Affordable Drugs V LLC, et al.) (U.S. Patent No. 8,163,522) Petitioners: Coalition for Affordable Drugs V LLC; Erich Spangenberg; Hayman Capital Management, LP; Hayman Captial Master Fund, LP; Hayman Credes Master Fund, LP; Hayman Investments, LLC; Hayman Offshore Management, Inc.; Hayman Orange Fund SPC – Portfolio A;…
In the latest development in the closely-watched Amgen v. Sandoz appeal, Amgen and Sandoz have filed cross-petitions seeking en banc review of the panel’s July 21, 2015 decision holding that (1) a biosimilar applicant may opt out of the BPCIA “patent dance”; and (2) when the applicant opts out, the 180…
As we covered in an earlier post, the PTAB has instituted two IPR proceedings concerning patents related to Rituxan® (rituximab) (see IPR2015-00417 (U.S. Patent No. 7,976,838) and IPR 2015-00415 (U.S. Patent No. 7,820,161)). The PTAB had denied institution on a third rituximab IPR petition filed by Boehringer Ingelheim (see IPR2015-00418 (U.S. Patent No. 8,329,172))….