On October 5, 2015, Apotex filed its answer and counterclaims in the ongoing Amgen v. Apotex Neulasta® (pegfilgrastim) litigation. As we previously reported, Amgen’s complaint alleged that Apotex provided Amgen with an “ineffective” Notice of Commercial Marketing pursuant to 42 U.S.C. § 262(l)(8)(A), because “a subsection (k) applicant may only give…
It was announced this morning that the U.S. has reached an accord on the Trans-Pacific Partnership Agreement (TPP). As we reported in previous posts on this topic, one major point of dispute between parties to the negotiations was the length of the data exclusivity period that member-states would need to…
On September 24, 2015, the Federal Circuit issued an opinion in Shire LLC v. Amneal Pharm., LLC. The opinion may be of interest to readers of this blog for its holding that a company supplying the active pharmaceutical ingredient to abbreviated new drug application (“ANDA”) filers (so that they can file…
Amgen and Allergan announced their biosimilar candidate ABP 215 “met its primary and secondary endpoints” in a Phase 3 study by demonstrating “clinical equivalence in efficacy, and comparable safety and immunogenicity, to bevacizumab.” ABP 215 is a biosimilar of Avastin (bevacizumab), a recombinant immunoglobulin G1 monoclonal antibody, for treatment of…
As we’ve covered in previous posts (here and here), the parties in Janssen v. Celltrion have been supplementing their briefings on whether Celltrion’s notice of commercial marketing, given before FDA approval of its biosimilar application, was legally effective under the BPCIA as interpreted by the Federal Circuit in Amgen v. Sandoz. Janssen has…
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…