On September 6, 2017, ALJ Dee Lord issued Order No. 4 in Certain Recombinant Factor IX Products (Inv. No. 337-TA-1066).

By way of background, this investigation is based on a July 7, 2017 complaint filed by Bioverativ Inc., Bioverativ Therapeutics Inc., and Bioverativ U.S. LLC—all of Waltham, Massachusetts— alleging violation of Section 337 by way of unlawful importation into the U.S., selling for importation, and/or selling within the U.S. after importation of certain recombinant Factor IX products that infringe one or more claims of U.S. Patent Nos. 9,670,475; 9,623,091; and 9,629,903. See our July 17, 2017 and August 11, 2017 posts for more details on the complaint and Notice of Investigation, respectively.

According to Order No. 4, ALJ Lord set December 14, 2018 as the target date for completing the investigation (which is sixteen months after institution of the investigation). In addition, ALJ Lord noted that the Markman hearing will take place on December 20, 2017; the evidentiary hearing will take place on May 15-18, 2018; and the Initial Determination on alleged violation of Section 337 will be issued on August 14, 2018.