Below we provide an update on some recent developments from several biosimilar-related cases on appeal before the Federal Circuit. Genentech v. Immunex Rhode Island, Fed. Cir. Case No. 19-2155 – briefing complete in...more
Following last month’s dismissal of the Amgen v. Kashiv filgrastim biosimilar litigation, yesterday Amgen and Tanvex filed a joint stipulation of dismissal in their BPCIA litigation concerning Tanvex’s filgrastim biosimilar...more
On December 6, 2019, the Federal Circuit will hear oral argument in a rituximab-related appeal by Biogen. The appeal stems from a final written decision of the Patent Trial and Appeal Board (PTAB) in an inter partes review...more
Here are some recent developments in U.S. legal proceedings relating to biosimilars: On December 10, 2018, in the Southern District of Florida, Apotex filed a motion to dismiss the patent infringement complaint that Amgen...more
As we have previously covered, last month the court in Janssen v. Celltrion (D. Mass., J. Wolf) issued a memorandum opinion granting Celltrion’s motion for summary judgment of non-infringement of the sole remaining...more
Today, Judge Wolf found in favor of Celltrion, granting its motion for summary judgment of non-infringement of the sole remaining patent-in-suit based on an application of the ensnarement doctrine to Janssen’s infringement...more
The past week saw further developments in the ongoing patent dispute between Janssen and Defendants Celltrion and Hospira relating to Inflectra® (infliximab-dyyb), a biosimilar of Remicade®. First, on May 4, Janssen and...more
Last week, in the ongoing Janssen v. Celltrion litigation concerning Celltrion’s Inflectra®, a biosimilar of Janssen’s Remicade® (infliximab), Judge Wolf of the U.S. District Court for the District of Massachusetts granted...more
Below is our fall update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly updates (Summer...more
As we previously reported, the United States District Court for the District of Massachusetts denied Celltrion’s motion to dismiss for lack of standing in the Janssen v. Celltrion case. On November 14, 2017, Celltrion filed a...more
The United States District Court for the District of Massachusetts has denied Celltrion’s motion to dismiss the action for lack of standing. As we previously reported, Celltrion argued that certain co-owners of the ’083...more
As we noted earlier today, this week the Federal Circuit is holding oral argument at various venues in New York City. Two of today’s oral arguments were in biosimilar cases that we have been closely following on this blog....more
This week, six Federal Circuit panels will hear oral argument on at various venues in New York City. Two of today’s oral arguments are in biosimilar cases that we have been closely following on this blog....more
The Federal Circuit has scheduled the oral argument of Amgen’s appeal from the district court’s judgment of non-infringement of Apotex’s proposed biosimilars of Neupogen® (filgrastim) and Neulasta® (pegfilgrastim) for 2:00pm...more
Below is our summer update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly updates...more
As we previously reported last year, in the ongoing Janssen v. Celltrion litigation concerning Celltrion’s Inflectra®, a biosimilar of Janssen’s Remicade® (infliximab), Janssen appealed the district court’s partial final...more
As we previously reported in the dispute brought by Janssen against Hospira and Celltrion regarding infliximab, Defendants filed a motion to dismiss the 2015 and 2016 consolidated actions for lack of standing. In those...more
In another development in the ongoing dispute between Janssen against Celltrion and Hospira relating to infliximab, Janssen filed a new complaint on May 31, asserting infringement of U.S. Pat. No. 7,598,083. In prior 2015...more
As we previously reported, Celltrion has moved to dismiss Janssen v. Celltrion for lack of standing. On Monday, Celltrion filed its reply brief in further support of that motion. ...more
Below is our spring update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly updates...more
The U.S. Patent and Trademark Office has now filed its response brief in In re: Janssen Biotech, Inc., New York University, No. 2017-1257 (Fed. Cir.), the Federal Circuit appeal involving U.S. Patent No....more
As we previously reported, in Janssen v. Celltrion, Janssen appealed the district court’s partial final judgment that Janssen’s ’471 patent, relating to monoclonal antibodies including infliximab, is invalid. As we also...more
As we previously reported, in Janssen v. Celltrion, Janssen appealed the district court’s partial final judgment that Janssen’s ‘471 patent, relating to monoclonal antibodies including infliximab, is invalid. As we also...more
Last week, a federal judge in Boston answered a question of first impression arising under the patent dispute resolution provisions of the Biological Price Competition and Innovation Act (“BPCIA”), a process commonly known as...more
The court has issued a memorandum and order reflecting the guidance it provided during the Feb. 23 and 24, 2017 hearing concerning the standards for determining damages in the litigation. The guidance is here....more