Big Molecule Watch
September 28, 2015

Dueling Schedules Proposed for District Court Proceedings in Amgen v. Sandoz

As we reported previously, Amgen and Sandoz filed a joint motion to lift the stay of proceedings on Amgen’s patent infringement claims and Sandoz’s related counterclaims in the U.S. District Court for the Northern District of California.  The district court had ordered a stay on the proceedings pending the outcome of the Federal Circuit’s review of the BPCIA issues and state law claims addressed by the district court’s March 19 Order.  The court granted the motion to lift the stay of proceedings on September 9.

The parties have now filed a joint case management statement, which indicates that Amgen intends to amend its complaint to assert U.S. Patent No. 8,940,878 in addition to its previously asserted U.S. Patent No. 6,162,427. The statement also reveals that, to date, the parties have exchanged initial disclosures, requests for production, interrogatories, and responses to each other’s requests for production and interrogatories.  Both parties have also engaged in expert depositions, and Amgen has disclosed its asserted claims and infringement contentions for the ‘427 patent.

The statement also contains dueling proposals for future discovery and trial.  Amgen’s proposed trial date is in mid-October 2016, whereas Sandoz proposes a trial date in late February 2017.  Sandoz states that a later trial date is needed because the ´878 patent that Amgen intends to assert was “not previously identified by Amgen in any prior allegation or communication,” and involves technology that “differs in every possible way from the prior patent. Amgen’s prior patent claims a method of treating patients with filgrastim. The new patent involves technology to perform a purification step during the production of recombinant proteins.”

The court has yet to enter a trial schedule in the case.  We will continue to monitor developments and will post updates here on the Big Molecule Watch.