Biosimilar Litigation Updates

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 of deposition hours, deponents, document custodians, written discovery requests, and similar issues.  Today, the court entered a scheduling order resolving the issues presented by the joint status report.  Under the current schedule, expert discovery will close on May 29, 2020, and the court will hold an in-person status conference on June 4, 2020 at 11:00 a.m., during which a schedule for dispositive motions and trial will be discussed.

Immunex v. Sanofi (dupilumab):  As we previously reported, Sanofi moved for leave to file an amended answer to assert a defense of inequitable conduct.  On October 24, the court granted Sanofi’s motion.  Sanofi filed an amended answer on October 31, which includes the inequitable conduct defense.  The facts supporting Sanofi’s defense have been redacted from the public version of the filing.

Genentech v. Amgen (bevacizumab):  As we have previously reported, Genentech brought two suits against Amgen in the District of Delaware based on Amgen’s approved biosimilar of Avastin®.  On October 27, the parties filed a stipulation and proposed order extending Amgen’s time to answer or otherwise respond to the complaints in these cases.  The court “so ordered” the stipulation on October 30.  Amgen’s answer or other response is now due on November 22, 2017 in case no. 17-1407 and November 23, 2017 in case no. 17-1471.

In the related declaratory judgment action pending before the Central District of California, the parties filed a corrected stipulation for the briefing and hearing schedule on Genentech’s pending motion to dismiss.  Under the parties’ proposed schedule, Amgen’s opposition would be filed on or before December 15, 2017; Genentech’s reply would be filed on or before December 28, 2017; and the hearing would be held on January 11, 2018.  The new schedule has not yet been approved by the court.