Today, the PTAB instituted IPR proceedings on claims 1-5 of U.S. Patent No. 8,889,135, drawn to a method of treating a rheumatoid arthritis patient with a TNFα-inhibitor. Humira®, marketed…
Today, the PTAB instituted IPR proceedings on claims 1-5 of U.S. Patent No. 8,889,135, drawn to a method of treating a rheumatoid arthritis patient with a TNFα-inhibitor. Humira®, marketed…
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…
In a recent hearing held in Amgen v. Hospira, the parties offered arguments on some novel issues relating to litigation under the BPCIA, particularly: Whether a reference product sponsor…
IPR2016-01018 (Coherus BioSciences Inc.) (U.S. Patent No. 9,114,166) Petitioner: Coherus BioSciences Inc. Patent: U.S. Patent No. 9,114,166 Title: Formulation of human antibodies for treating…
We previously reported that the FDA approved Celltrion’s Inflectra®, a biosimilar to Janssen’s Remicade® (infliximab). Last week, we also reported that in Janssen v. Celltrion, Janssen…
As we previously reported, AbbVie filed a citizen petition in December, asking the FDA to convene a Part 15 hearing on interchangeability determinations and to tighten the standards for that…
Attorneys for Amgen and Apotex appeared before the Federal Circuit yesterday to argue about whether the notice of commercial marketing provision, 42 U.S.C. § 262(l)(8)(A), is optional when a…
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®…
In December, AbbVie filed a citizen petition on interchangeability. In its citizen petition, AbbVie argued that before a biosimilar can be designated interchangeable, the FDA should: Require…
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…