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…
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,…
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…
Please join us on August 12, 2015 at 12:30 pm EDT for a lively discussion about the Amgen v. Sandoz Federal Circuit decision as Goodwin Procter partners Elaine Herrmann Blais and Robert Cerwinski analyze the outcome and discuss what is likely to happen next, along with how the decision impacts biosimilars strategy…
On July 21, 2015, the Federal Circuit issued a split decision in the Amgen v. Sandoz appeal. As we anticipated in our analysis of the oral argument, Sandoz won with its interpretation of the first issue: an applicant can choose between disclosing its (k) application and manufacturing information, or not disclosing such…
The Federal Circuit issued a split decision on the appeal in Amgen v. Sandoz today, July 21, 2015. As we’ve covered in previous posts (here, here, and here), the questions at issue in Amgen v. Sandoz were: Whether a subsection (k) (biosimilar) applicant “may elect not to disclose its [abbreviated biologic…
BREAKING NEWS – Split decision in Amgen v. Sandoz – the dance is “optional” but notice of commercial marketing can only be given after approval. Decision here. Our summary of oral argument here. Detailed discussion of today’s decision to follow later today.
The Federal Circuit recently received additional briefing on the bond issue from the parties in Amgen v. Sandoz, which remains under advisement. Our earlier posts on Amgen, which can be found here, here, and here, describe the issues raised and the procedural background of this case of first-impression involving the patent…
Amgen appealed the district court order on March 25, 2015, and sought an expedited briefing schedule and an injunction to delay the launch of Sandoz’s Zarxio product while the Court considers Amgen’s appeal. The Federal Circuit granted the motion for an expedited schedule, and set oral argument for June 3,…