As we covered in a previous post, following the Federal Circuit’s decision in Amgen v. Sandoz, Sandoz filed a petition for a writ of certiorari asking the Supreme Court to review the Federal Circuit’s interpretation of the BPCIA’s “notice of commercial marketing” provision. Sandoz’s petition also asks the Court to consider whether the Federal…
Yesterday, Amgen filed suit in an action for patent infringement arising under the Biologics Price Competition and Innovation Act of 2009 (“the BPCIA”), following Sandoz’s submission of an abbreviated Biologics License Application through subsection (k) pathway to license a pegfilgrastim product. The patents at issue, U.S. Patent Nos. 8,940,878 and…
This is an update on the latest activity before the United States Supreme Court in the ongoing dispute between Amgen and Sandoz regarding Sandoz’s biosimilar application for Zarxio® (filgrastim-sndz). Federal Circuit Proceedings As we previously reported, in May last year, a split Federal Circuit panel held that the patent dance…
As we posted yesterday, Amgen has filed a brief in opposition to Sandoz’s petition to the Supreme Court for review of the Federal Circuit’s decision in Amgen v. Sandoz. Amgen’s brief is now available here. The Biosimilars Council also filed a brief, as amicus curiae in support of Sandoz’s petition. Their…
We recently posted about Sandoz’s petition to the Supreme Court for review of the Federal Circuit’s decision in Amgen v. Sandoz here. In their opposition brief filed Monday, Amgen argued that delaying the 180-day notice until after approval would confirm that any requested injunction blocking the biosimilar is factually based….
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…
Goodwin Procter announced today the release of the 2016 edition of Biosimilars: A Guide to Regulatory and Intellectual Property Issues. The guide provides clarity to the complex, developing regulatory and legal framework around biosimilars, and the 2016 update offers analysis on the first waves of patent litigation related to biosimilars…
2015 was a milestone year for biosimilars in the U.S. It was also our first year bringing you the latest biosimilars news and analysis. Here are our picks for the top-five most significant events in the world of biosimilars this year: 5) 2015 saw a marked increase in inter partes review…
Sandoz has requested an extension of its deadline to file a petition for a writ of certiorari in Amgen v. Sandoz. As we covered previously, after the Federal Circuit denied the parties’ petitions for rehearing en banc in Amgen v. Sandoz, a 90-day clock began running on the parties’ time to file…
As part of our continuing coverage, we are following the parties’ briefing in the appeal of the preliminary injuction, which prohibits Apotex’s launch of its pegfilgrastim biosimilars, in Amgen v. Sandoz. As we have previously reported, Apotex filed a motion to expedite the appeal of the preliminary injunction. Last week,…