Janssen Requests Conference in View of Imminent Launch of Celltrion’s Generic Infliximab Product

We previously reported that the FDA approved Celltrion’s Inflectra®, a biosimilar to Janssen’s Remicade® (infliximab). We also reported on a series of letters concerning Janssen’s request for an expedited trial in view of a possible Celltrion launch in October of 2016.

In a letter filed with the court yesterday, Janssen asked the Court for a conference in view of Celltrion’s representation that it may launch as soon as June 30, 2016.

Janssen argued that Celltrion is not permitted to launch under the BPCIA until October 2, 2016, but in view of Celltrion’s imminent launch, and in the absence of an injunction, Janssen asked for a hearing on the following three issues:

    • Oral argument on Janssen’s Motion to Stay proceedings on U.S. Patent No. 6,284,471 and Motion to Modify Proposed Protective Order;
  • Janssen’s request to move the trial date on U.S. Patent No. 7,598,083 from February, 2017 to September, 2016 to allow trial to occur before October 2, 2016; and
  • Janssen’s potential renewed motion for a preliminary injunction, necessitated by Celltrion’s indication that it may launch as early as June 30, 2016.

Earlier today, Judge Wolf handed down an order scheduling a conference for May 19, 2016 at 2 pm to address these issues.

We’ll continue to monitor Janssen v. Celltrion as it develops.