Mylan has filed two petitions for inter partes review of Sanofi’s patents related to insulin glargine: IPR2017-01526 on U.S. Patent 7,476,652, and IPR2017-01528 on U.S. Patent 7,713,930. Insulin glargine is marketed under the tradename Lantus®. As we have reported, both the ‘652 and ‘930 patents are the subject of litigation…
The FDA announced today that the Oncologic Drugs Advisory Committee will hold a public meeting on July 13, 2017 in Silver Springs, Maryland to discuss two biosimilar applications. During the morning session, the committee will discuss Amgen’s application for a proposed biosimilar of Genentech/Roche’s AVASTIN (bevacizumab). During the afternoon session, the…
Pfizer, Inc. has filed two petitions (IPR2017-01488 and IPR2017-01489) challenging claims of U.S. Patent No. 6,407,213 (“the’213 patent”). According to the petitions, the ’213 patent is directed to methods of making humanized antibodies. The petitions do not identify a particular product that may use the patented methods. IPR petitions challenging the…
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 (Summer 2016, Fall 2016, Midwinter 2017).
Earlier this week, Celltrion filed two petitions for inter partes review of Genentech’s U.S. Patent No. 6,407,213. According to Celltrion’s petitions, the patent is directed to humanized antibodies. Mylan previously challenged the same patent in two IPR petitions, which terminated in settlement with Genentech. We will continue to monitor and report…
On Thursday, May 4, 2017, Baxalta, a wholly-owned subsidiary of Shire, filed a complaint (available here) against Genentech and Tokyo-based Chugai Pharmaceutical in the U.S. District Court for the District of Delaware. The complaint alleges infringement of Baxalta’s U.S. Patent No. 7,033,590, which Baxalta alleges covers the defendants’ emicizumab product (a/k/a…
Merck Sharpe & Dohme and Genentech have filed a Joint Motion to Terminate IPR2016-00710, relating to U.S. Patent No. 6,331,415. As we reported earlier, the ‘415 patent is known as one of the “Cabilly” patents, and is generally applicable to manufacturing recombinant antibodies. According to the motion, the parties have reached…
As we reported on Friday, Genentech has informed the District of Delaware that it will not file an amended complaint in its declaratory judgment action against Amgen regarding Amgen’s application to market a biosimilar of Avastin® (bevacizumab). Today, Amgen filed a letter in response, informing the court that, on March 24, Genentech…
As we previously reported, the District of Delaware granted a motion to dismiss by Amgen in Genentech v. Amgen, finding a lack of subject matter jurisdiction over Genentech’s declaratory judgment complaint under the Federal Circuit’s holding in Amgen v. Sandoz. The court granted the motion with leave for Genentech to amend its complaint…
FDA announced today that it has approved Genentech’s Ocrevus® (ocrelizumab) for the treatment of adults with relapsing forms of multiple sclerosis and primary progressive multiple sclerosis (“PPMS”). Ocrevus is the first drug approved by the FDA for treatment of PPMS, which the CDC estimates affects 15% of patients with multiple sclerosis….