As we previously reported here and here, Celltrion filed suit against Genentech seeking declaratory judgment that a host of patents covering Rituxan® and Herceptin® were non-infringed, invalid, and/or unenforceable.  Genentech responded by moving to dismiss, arguing that Celltrion’s claims were statutorily barred by the BPCIA.  As we reported here, the Court agreed with Genentech and dismissed Celltrion’s suits.

On July 11, 2018, Genentech filed new lawsuits for patent infringement in the District of New Jersey (Rituxan® patents) and the District of Delaware (Herceptin® patents).  Genentech previously filed suits in those districts immediately after Celltrion filed its declaratory judgment actions, and those actions are still pending before the respective Courts.  The infringement allegations in the newly filed Complaints are essentially identical to those previously filed.

Genentech asserts that it filed these new actions as a result of Celltrion taking the position that it has now complied with the requirements of the BPCIA’s patent dance.  More specifically, Genentech alleges that following dismissal of Celltrion’s declaratory judgment action, Celltrion attempted to “resurrect the patent dance” and sent Genentech the list of patents it believed should be subject to infringement litigation on June 5, 2018.  Genentech further alleges that shortly after, on June 11, 2018, Celltrion sent Genentech the list of patents that it believed should be included in the first-phase of patent infringement litigation.  Genentech asserts that although it objected to Celltrion’s attempts to reengage in the patent dance, it provided its own list of patents to be included in the first-phase of infringement litigation out of an abundance of caution.

Genentech makes clear in its complaints that it believes Celltrion’s exchange of lists in June 2018 has no legal effect because the deadline for Celltrion to comply with the BPCIA’s requirements passed in January.  Nonetheless, Genentech filed this suit to preclude any argument from Celltrion that Genentech forfeited its right to bring suit and so limited any potential relief to a reasonable royalty, which is the only relief permitted by the BPCIA when the reference product sponsor does not bring suit within 30 days of the parties’ exchange of patents to be included in the first-phase of litigation.  Genentech further asserts that it will file a motion to consolidate the newly filed suits with those filed in January if Celltrion does not stipulate to consolidation.

We will keep you apprised of further developments.