We previously reported that on September 12, 2017, the FDA accepted for review Sandoz’s aBLA for a proposed biosimilar of Rituxan® (rituximab), which is indicated for the treatment of certain blood cancers and immunological diseases. Yesterday, Genentech filed a complaint in the District of New Jersey based on Sandoz’s proposed rituximab biosimilar, Rixathon/GP2013. Genentech seeks a declaratory judgment of infringement of 24 patents.
Genentech’s complaint alleges that Sandoz “declined to participate in the Patent Dance.” Genentech alleges that Sandoz instead agreed to provide Genentech with access to Sandoz’s aBLA and “invited this litigation on any patent that Genentech contends will be infringed by Sandoz’s proposed biosimilar product or by the use of such product.”
We will continue to monitor this litigation. Stay tuned to Big Molecule Watch for further updates.