Road BlockThe PTAB recently granted Celltrion’s motion to dismiss its IPRs without prejudice, after Celltrion suddenly lost its ability to rely on a key expert declaration.  Celltrion had filed IPR petitions against two patents covering use of Rituxan®, and had sought joinder with pending IPRs filed by Boehringer Ingelheim (BI) against the same patents.  Although Celltrion initially had permission to rely on testimony of BI’s expert, that permission was withdrawn after BI unilaterally requested adverse judgment in its IPRs. Left out in the cold, Celltrion requested dismissal without prejudice, to permit it to re-file its petitions with a new expert.  The PTAB granted the request. 

BI, a biosimilar maker, had filed IPR petitions against three patents covering the use of Rituxan®, U.S. Patent Nos. 7,820,161, 7,976,838 and 8,329,172 (IPR2015-00415 and -00417).  The PTAB denied BI’s petition against the ‘172 patent, but instituted IPR on the ‘161 and ‘838 patents on July 14, 2015.  A month later, Celltrion, another biosimilar company, filed two IPR petitions against the same two patents (IPR2015-01734 and -01733).  Celltrion relied on the same grounds, exhibits and expert declaration as BI, and sought joinder with the BI IPRs.  In its motions for joinder, Celltrion argued that it would be prejudiced if it were not permitted to join BI’s IPRs, because if Boehringer settled with the patent owner, the IPRs could terminate without a final decision on patentability.  Celltrion also argued that joinder would not complicate the pending IPRs because their IPR petitions were substantially identical to BI’s.

On September 25, BI requested adverse judgment in both of its IPRs.  There is no indication in the record of a settlement agreement under 35 U.S.C. §317.  On October 1, the PTAB granted the motions and issued judgments terminating the proceedings.  BI was fortunate to be able to terminate the IPR proceedings more than two months after institution.  The PTAB has denied a request for adverse judgment two months after the IPR was instituted, when the request was opposed by patent owner.

Why would BI request adverse judgment rather than proceeding with the IPRs? BI may have wished to avoid the estoppel effect of an adverse “final written decision” under 35 U.S.C. §315(e)(1) & (2).  The PTAB order terminating the proceeding was not a final written decision; thus, BI may be able to argue that it can fully challenge the same claims in subsequent litigation. While estoppel would not technically apply to a re-filed BI IPR petition challenging the same patents, the outcome of such a petition is uncertain; the Board has a great deal of discretion in deciding whether to institute IPR.

On October 2, Celltrion moved to dismiss, without prejudice, its IPR petitions. Celltrion explained that Celltrion, Genentech and BI had been negotiating a stipulation/consent to joinder in which Celltrion would not take an active role unless BI were dismissed from the IPRs.  Apparently, BI had unilaterally requested adverse judgment less than two weeks before the deposition of its expert Dr. Kalden, and had denied permission for Celltrion to retain Dr. Kalden.  Celltrion then sought dismissal without prejudice to permit it to re-file its petitions with a new expert to replace Kalden. Celltrion argued that the patent owner was not prejudiced because its preliminary response was not due for 8 weeks. As an alternative, if the Board was not inclined to dismiss without prejudice, Celltrion had proposed that the schedule regarding the existing IPR petitions be modified to permit Celltrion to correct its petition.  On October 6, the Celltrion IPRs were dismissed without prejudice.