Biosimilar applicants and branded biologics have been wondering how the procedures set forth in the Biologics Price Competition and Innovation Act (“BPCIA”) will be implemented since its enactment in 2010. The lack of guidance on this subject has already sparked litigation, including the recent litigation between Amgen Inc. (“Amgen”) and Sandoz Inc. (“Sandoz”) discussed in our previous client alert, Left without a Partner: Amgen Sues Sandoz for Refusing to Dance in Accordance with BPCIA Patent Procedures. However, Amgen and Sandoz are not the only parties that have brought disputes involving the BPCIA to the courts for resolution.

Earlier this year, Celltrion Healthcare Co., Ltd. and Celltrion, Inc. (collectively “Celltrion”) filed a complaint for declaratory judgment against Kennedy Trust for Rheumatology Research (“Kennedy Trust”) in the U.S. District Court for the Southern District of New York seeking to invalidate three of Kennedy Trust’s patents covering Remicade® (infliximab), a biologic approved to treat Crohn’s disease, ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and plaque psoriasis. Celltrion filed its action prior to filing its application for Remsima®, a biosimilar of Remicade®, under the BPCIA, and, therefore, also prior to engaging in the “patent dance” under the BPCIA. The “patent dance” is a procedure set forth in section 351(l) of the BPCIA that requires the holder of a branded biologic and the biosimilar applicant to engage in a series of timed exchanges of information to determine which, if any, of the brand holder’s patents will be litigated by the parties.

In response to Celltrion’s complaint, Kennedy Trust filed a motion to dismiss for lack of subject matter jurisdiction. On December 1, 2014, the Court ruled on Kennedy Trust’s motion, providing some of the first guidance on how courts will interpret the BPCIA. The Hon. Paul A. Crotty granted Kennedy Trust’s motion, terminating Celltrion’s case. In his opinion, Judge Crotty found that Celltrion’s approval preparations were not yet at a stage that could support a declaratory judgment action, and that Celltrion had failed to demonstrate that Kennedy Trust had taken a position that would give rise to a justiciable controversy. Further, Judge Crotty expressly addressed the BPCIA, stating that “The BPCIA purposefully keys its dispute resolution procedures to the occurrence of certain events on the path to FDA approval. Celltrion has failed to show why this carefully crafted and well-timed procedure should be avoided here.” [1]

This ruling suggests that courts are not going to permit potential biosimilar applicants to use pre-filing litigation as a means to escape compliance with the provisions of the BPCIA, particularly with respect to the “patent dance.” In any case, it will be interesting to see how the U.S. District Court for the Northern District of California handles Amgen’s declaratory judgment action against Sandoz based on Sandoz’s refusal to comply with the BPCIA, particularly in view of Judge Crotty’s ruling.

K&L Gates will be closely monitoring the Amgen litigation to see what additional insight, if any, is gained into the BPCIA’s “patent dance” requirements.

Notes:
[1] Celltrion Healthcare Co., Ltd. et al. v. Kennedy Trust for Rheumatology Research, Case No. 14 Civ. 2256 (PAC), Dkt. 32, p. 10 (December 1, 2014).