The Biosimilar User Fee Act (BsUFA) requires FDA to contract with an independent accounting or consulting firm to study the workload volume and full costs associated with the process for the review of biosimilar biological product applications. On February 24, 2016, the FDA released the Final Results Report of its…
On March 7, 2016, AbbVie and Boehringer Ingelheim announced that they have entered into a global collaboration to develop BI 655066, an anti-IL-23 monoclonal biologic antibody that is in Phase 3 development for psoriasis and also being evaluated as a treatment for Crohn’s disease, psoriatic arthritis and asthma. As part…
On Friday, March 4, 2016, Amgen filed a complaint (available here) seeking a declaratory judgment in the U.S. District Court for the District of New Jersey against Sandoz. The complaint accuses Sandoz of violating BPCIA procedures by failing to participate in certain aspects of the patent dance relating to Sandoz’s…
A jury trial starts Monday, March 7, in the patent case between plaintiff Amgen Inc. and defendants Sanofi and Regeneron over two biologic drugs, Amgen’s Repatha and Sanofi/Regeneron’s Praluent. The case is before Judge Sue Robinson in the District of Delaware. Both products, which are monoclonal antibodies used to treat…
Amgen, Hoffmann-La Roche and Immunex have filed a complaint in the District of New Jersey against Sandoz alleging patent infringement of the plaintiffs’ etanercept (ENBREL) patents under the BPCIA provisions of 35 U.S.C. § 271. The plaintiffs are also seeking declaratory judgment of patent infringement on the grounds that Sandoz…
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…
The Federal Circuit announced that oral argument for the Amgen v. Apotex appeal will be held on April 4, 2016. Apotex is seeking to overturn the district court’s injunction against marketing its biosimilar pegfilgrastim product until 180 days after Apotex provides notice of commercial marketing, previously covered here. The briefs and…
Defendants Celltrion and Hospira in Janssen v. Celltrion have moved for summary judgment that U.S. Patent No. 6,264,471, which covers Remicade (infliximab), is invalid for obviousness-type double patenting. At the District Court status conference earlier this month, Celltrion told the court that it expects FDA approval of its infliximab biosimilar product in…
Sandoz has 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. The petition is available here. Sandoz has asked the High Court to decide whether the 180-day notice of commercial marketing can only…
Apotex has filed its reply brief in Amgen v. Apotex, which is currently on appeal before the Federal Circuit. The brief is available here. As we covered previously, the district court granted Amgen a preliminary injunction to prevent Apotex from marketing its biosimilar pegfilgrastim product until 180 days after Apotex provides a…