We previously reported that the FDA approved Celltrion’s Inflectra®, a biosimilar to Janssen’s Remicade® (infliximab). Last week, we also reported that in Janssen v. Celltrion, Janssen filed a letter to the court stating that the “Defendants notified us that they intend to begin commercial sales of their biosimilar in no later than 180 days (on October 2, 2016).” Janssen also requested an earlier, expedited trial in October 2016.
In a letter filed with the Court yesterday, Defendants opposed Janssen’s request for an expedited trial, noting, among other things, that Janssen’s request for an expedited trial only pertained to one of the two patents at issue and that the parties had already stipulated to have the trial in early 2017. Defendants further clarified that its 180-day notice of commercial marketing was “conditional” and “applies only ‘if’ required by the anticipated decision in Amgen Inc. v. Apotex Inc., No. 16-1308 (Fed. Cir.).” Defendants further stated that they previously gave notice to Janssen that they “reserved their right to void this notice and to launch before October 2, 2016.” Defendants did note, however, that they would be open to an earlier dispositive hearing for both patents at issue.