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…
Hospira, Inc., Celltrion Healthcare Co., Ltd., and Celltrion Inc. (jointly) and the Biosimilars Council filed amicus briefs today in support of Sandoz’s petition for rehearing en banc in Amgen v. Sandoz. The briefs are now publicly available and are attached here and here. UPDATE: Mylan Inc. has also filed an amicus…
As we reported in an earlier post, the 180-day commercial notice provisions of the BPCIA at issue in Amgen v. Sandoz are also being litigated in Janssen v. Celltrion, an action pending in the District of Massachusetts. The parties’ cross-motions for partial summary judgment [here and here] on whether Celltrion’s pre-FDA-licensure…
On July 23, 2015, Janssen Biotech, Inc. and New York University filed a brief appealing the rejection of all claims of U.S. Patent No. 6,284,471, a patent covering Remicade (infliximab), to the USPTO’s Patent Trial and Appeal Board. The ’471 patent was put into ex parte reexamination in 2013, and…
Amgen appealed the district court order on March 25, 2015, and sought an expedited briefing schedule and an injunction to delay the launch of Sandoz’s Zarxio product while the Court considers Amgen’s appeal. The Federal Circuit granted the motion for an expedited schedule, and set oral argument for June 3,…