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 bevacizumab preliminary injunction appeal On January 21, Genentech filed a reply brief in its appeal to the…
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 (IPR) initiated by Pfizer. In October 2018, Pfizer succeeded in persuading the…
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 filed this past August alleging patent infringement based on Apotex’s filing of aBLAs for pegfilgrastim and filgrastim biosimilar…
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 patent-in-suit, and the next day entered final judgment for Celltrion. The court subsequently entered an amended final judgment to dismiss without prejudice Celltrion’s…
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 theory under the doctrine of equivalents. The Court determined that Celltrion’s infliximab biosimilar does not infringe Janssen’s ’083…
Below is our second quarter update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our previous quarterly updates (Q3 2016, Q4 2016, Q1 2017, Q2 2017, Q3 2017, Q4 2017, Q1 2018). Please also refer to our BPCIA Patent Litigation and Federal…
Pending U.S. District Court BPCIA Litigations Resolved U.S. District Court BPCIA Litigations Last updated: April 16, 2024
As we reported here, in the patent dispute between Janssen and Defendants Celltrion and Hospira relating to Inflectra® (infliximab-dyyb), a biosimilar of Remicade®, there are multiple motions for summary judgment pending before Judge Wolf in the District of Massachusetts. Both parties have filed competing summary judgment motions directed to damages issues. Additionally, Defendants have filed a motion…
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 Defendants’ unopposed motion for leave to file a motion for summary judgment and accompanying briefing schedule. In their summary judgment brief, filed on…
Below is our first quarter update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our previous quarterly updates (Q3 2016, Q4 2016, Q1 2017, Q2 2017, Q3 2017, Q4 2017).