The parties in Janssen v. Celltrion have filed a stipulation of voluntary dismissal narrowing the issues in the litigation. While it does not dispose of all patent infringement claims in suit, the stipulation narrows the case as follows: Defendants will not launch any biosimilar infliximab product in the United States until after September 15, 2015, the date…
As we reported previously, Amgen and Sandoz 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 outcome of…
The PTAB decided today, in IPRs 2015-01092, 2015-01096, 2015-01102, 2015-01103, and 2015-01169, that Patent Owner Celgene failed to meet the evidentiary burden required for its Motions for Sanctions against the Coalition for Affordable Drugs VI, LLC. The PTAB specifically rejected each of Celgene’s bases for seeking sanctions: Profit Motive: “Profit is at the…
On September 17, 2015, Janet Woodcock, M.D., the director of the FDA’s Center for Drug Evaluation and Research, testified at a congressional hearing on the topic of biosimilars. A link to her written testimony is provided here, and a link to the video of the Q&A session is provided here….
In addition to the pending cross-motions for partial summary judgment on which we’ve previously reported, the parties in the Janssen v. Celltrion BPCIA litigation recently completed briefing on the issue of whether the district court should permit Janssen to use confidential information obtained through discovery as a basis for a…
Earlier this month, PTAB asked for additional briefing on whether the two IPRs filed by the Coalition for Affordable Drugs (“Bass Group”, or “CFAD”) against NPS should be dismissed for abuse of process. In its Brief in Response to the Board’s Request for Additional Briefing, NPS responded to the PTAB’s…
We recently posted about the PTAB asking for additional briefing on whether the two IPRs filed by the Coalition for Affordable Drugs (“Bass Group”) against NPS (which was acquired by Shire, LLC) should be dismissed for abuse of process. The two IPRs are directed to the same patent, US 7,056,886,…
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…