More than a dozen BPCIA patent litigations are currently pending in various U.S. district courts. Below are some highlights of activity in some of those cases from this month. Genentech v. Amgen (D. Del.): bevacizumab On August 2, 2018, Judge Sleet issued a memorandum in response to the parties’ ongoing…
Below is an update on recent developments in several litigations involving biosimilar products. Amgen v. Sandoz (filgrastim, pegfilgrastim): As we previously reported, the district court granted summary judgment of non-infringement in favor of Sandoz in the Amgen v. Sandoz litigation, which relates to Sandoz’s filgrastim and pegfilgrastim biosimilars. Amgen filed…
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: July 7, 2025
As we previously reported, on May 22, 2018 in Genentech v. Amgen, which concerns Amgen’s Mvasi® (bevacizumab-awwb) biosimilar, Genentech filed a motion to dismiss and to strike Amgen’s counterclaims and certain affirmative defenses. On June 19, 2018, after Amgen filed under seal an amended answer and counterclaim, Genentech filed updated…
We previously reported that in the ongoing Genentech v. Amgen litigation regarding Amgen’s proposed bevacizumab biosimilar, Mvasi™, Amgen moved to dismiss Genentech’s declaratory judgement counts relating to when Amgen could begin commercial marketing of its product. In particular, Genentech had sought a judgment that Amgen could not market its product…
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).
Genentech v. Pfizer (trastuzumab): On February 12, 2018, the parties filed a joint status report. Among other things, the parties offered their competing proposals for discovery deadlines. The parties stated that they have been “engaged in the exchanges of information provided under the” BPCIA and that Pfizer provided its notice of…
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 2016, Fall 2016, Midwinter 2017, Spring 2017, Summer 2017).
Below is an update on recent developments in several litigations involving biosimilar products. AbbVie v. Boehringer Ingelheim (adalimumab): On October 23, the parties filed a joint status report. Among other things, the parties offered their competing proposals for the schedule and the scope of discovery, including limits on the number…