As we previously reported, on February 16, 2016, Sandoz petitioned the United States Supreme Court for a writ of certiorari regarding the Federal Circuit’s interpretation of the BPCIA’s…
As we previously reported, on February 16, 2016, Sandoz petitioned the United States Supreme Court for a writ of certiorari regarding the Federal Circuit’s interpretation of the BPCIA’s…
Yesterday, the PTAB instituted IPRs on two of Abbvie’s Humira patents, U.S. Patent Nos. 9,017,680 and 9,073,987, which are drawn to dosing regimens for AbbVie’s Humira (adalimumab) for the…
In the Amgen v. Hospira litigation, Amgen has filed a Notice of Appeal relating to Judge Andrew’s oral ruling denying Amgen’s request to compel Hospira to produce certain manufacturing…
We previously reported on Sandoz’s aBLA for a biosimilar of Amgen’s ENBREL (etanercept) and the related BPCIA litigation. The FDA’s Arthritis Advisory Committee announced this morning that it…
We previously reported that the FDA approved Celltrion’s Inflectra®, a biosimilar to Janssen’s Remicade® (infliximab) on April 5, 2016. A year prior to the approval, Janssen filed a…
As we previously reported, in late 2015, the Pharmaceutical Research and Manufacturers of America (“PhRMA”) and Biotechnology Industry Organization (“BIO”) trade associations…
As we previously reported, the PTAB instituted IPR on U.S. Patent 8,889,135, which is drawn to a method of treating rheumatoid arthritis (“RA”) with Humira®, a TNFα-inhibitor. Claim 1…
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…
The District Court for the District of Massachusetts (Judge Wolf) yesterday decided two pending motions in Janssen v. Celltrion: Plaintiffs’ motion to stay litigation on the ‘471…
As we reported earlier, Amgen recently filed suit under the BPCIA against Sandoz and Lek Pharmaceuticals in the Northern District of California. Amgen alleges that Sandoz’s submission of an aBLA…