On May 17, 2017, Janssen filed a complaint under the BPCIA in the District of New Jersey against Samsung Bioepis Co., Ltd. regarding Renflexis® (infliximab-abda), Samsung Bioepis’s recently approved biosimilar of Remicade®. The complaint alleges infringement of three patents: U.S. Patent No. 7,598,083, 6,900,056 and 6,773,600. According to the complaint, the…
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 previously reported, Janssen filed its opening appeal brief on January 26, 2017. On March 7, 2017, Celltrion filed its response brief. On April 20,…
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 previously reported, Janssen filed its opening appeal brief on January 26, 2017. On March 7, 2017, Celltrion filed its response brief. Celltrion argues that…
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. Stay tuned to Big Molecule Watch for more updates.
As we previously reported regarding Janssen v. Celltrion, after the district court postponed trial and heard oral argument on the damages issues related to Celltrion’s challenge to Janssen’s standing, the Court set a deadline for Celltrion to file a motion to dismiss on that basis. On Friday, February 22, 2017, Celltrion filed its Motion…
Below is our midwinter 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 2016, Fall 2016).
As we previously reported, a jury trial in the ongoing infliximab biosimilar litigation, Janssen v. Celltrion (D. Mass., J. Wolf), was scheduled to begin on February 13, 2017. The district court, however, recently cancelled the originally scheduled trial date and is now scheduled to hold a hearing to address damages…
As we previously reported, in Janssen v. Celltrion, Janssen appealed the district court’s partial final judgment that Janssen’s ‘471 patent, directed to monoclonal antibodies including infliximab or cA2 antibody, is invalid. On January 26, 2017, pursuant to a 30-day extension, Janssen filed its opening appeal brief, in which Janssen challenged the two district…
With the pre-trial conference set to begin on February 6, 2017, the parties in Janssen v. Celltrion have filed several motions seeking to exclude or limit certain evidence and testimony that may be offered at trial. Expert Testimony Celltrion has filed a motion to exclude the opinions of Janssen’s proffered expert…
Yesterday, in the Janssen v. Celltrion action, Janssen filed a supplemental brief on the issue of whether Hospira may be liable for infringement on the theories of joint enterprise, agency, or contract. As we previously reported, the Court ordered the parties to brief this issue after it arose during oral arguments on the motions for…