We previously reported that the FDA approved Celltrion’s Inflectra®, a biosimilar to Janssen’s Remicade® (infliximab) on April 5, 2016. A year prior to the approval, Janssen filed a motion for summary judgment and preliminary and permanent injunction based on the contention that 42 U.S.C. § 262(l)(8)(A) prohibits Celltrion from commercially marketing its biosimilar in the U.S. for 180 days after it is licensed. That motion was denied without prejudice due to the pending appeal in Amgen v. Apotex.
Yesterday, the parties filed a stipulation that sets the stage for Janssen to file a renewed motion for preliminary injunction after the Federal Circuit’s Amgen v. Apotex decision. In the stipulation, the parties agree that Celltrion will not sell its infliximab biosimilar before September 15, 2016 unless:
- the parties agree that the Federal Circuit’s decision in Amgen v. Apotex moots Janssen’s renewed preliminary injunction motion;
- a court denies Janssen’s renewed preliminary injunction motion; or
- Celltrion obtains a court order authorizing an earlier launch date.
Stay tuned for further litigation updates here on the Big Molecule Watch.