Print

The BPCIA’s framework for patent dispute resolution counsels against the exercise of declaratory judgment jurisdiction

Celltrion Healthcare Co., Ltd. et al. v. Kennedy Trust for Rheumatology Research; Hospira, Inc. v. Janssen Biotech, Inc. et al.

Case Number: 1:14-cv-02256; 1:14-cv-07049

On the same day, Judge Crotty granted two motions to dismiss premature declaratory judgment actions filed by plaintiffs that were developing biosimilars that would be subject to FDA approval under the Biologics Price Competition and Innovation Act (“BPCIA”). 

Celltrion Healthcare Co., Ltd. et al. v. Kennedy Trust for Rheumatology Research (“Celltrion case”), Celltrion filed a declaratory judgment action to invalidate three patents owned by Kennedy that cover the treatment of rheumatoid arthritis:  U.S. Patent Nos. 7,846,442 (titled, “Methods of treating rheumatoid arthritis with an anti-TNF-alpha antibodies and methotrexate”); 8,298,537 (titled, “Concomitant treatment of rheumatoid arthritis with anti-TNF-α antibodies and methotrexate”); and 8,383,120 (titled, “Concomitant treatment of rheumatoid arthritis with anti-TNF-alpha antibodies and methotrexate”) (collectively, the “Kennedy patents”).

Celltrion, which has spent several years and large sums of money developing a biosimilar, argued that an actual case and controversy exists because it has substantially prepared to bring its biosimilar Remsima to the U.S. market and Kennedy has engaged in prior litigation to protect its patent rights.  In response, Judge Crotty found that Celltrion is “simply too far from receiving FDA approval” and thus any opinion on Celltrion’s present claims would be based on the “hypothetical state of facts.”  Moreover, while Kennedy has engaged in prior litigation (one such factor under the totality-of-the-circumstances test), given that Kennedy has granted licenses to Celltrion outside of the U.S. and has indicated a willingness to grant Celltrion a license in the U.S. and Canada, Judge Crotty found that Celltrion has failed to show that the likelihood by Kennedy to file suit is so great to demonstrate a live case or controversy.

Indeed, even if Celltrion had sufficiently prepared to bring Remsima to market and the threat of injury was sufficient, Judge Crotty found the court would still decline to hear the Celltrion case, because the BPCIA provides a dispute resolution framework to resolve patent disputes so that approved biosimilars may be sold in the U.S. as soon as they are ready for market, and Celltrion’s attempts “to skirt the BPCIA’s dispute resolution mechanism while reaping the benefits of its approval process is improper.”  Under the BPCIA, before Celltrion can market Remsima it must resolve any disputes regarding the Kennedy patents with the reference product sponsor Janssen Biotech, Inc. (“Janssen”), a licensee of the Kennedy patents.  Thus, prior to any dispute between Celltrion and Janssen, Judge Crotty held that subject matter jurisdiction is lacking.

In Hospira, Inc. v. Janssen Biotech, Inc. et al. (“Hospira case”), Plaintiff Hospira filed a declaratory judgment action to invalidate, in addition to the Kennedy patents, patents assigned to Defendants Janssen and New York University that cover the treatment of Crohn’s disease were as follows:  U.S Patent Nos. 6,284,471 (titled, “Anti-TNFα antibodies and assays employing anti-TNFα antibodies”) and 7,223,396 (titled, “Methods of treatment of fistulas in Crohn's disease with anti-TNF antibodies”). 

Judge Crotty found that, in addition to the reasons set forth in his order dismissing the complaint in the Celltrion case, the Hospira case presents an “even more compelling reason for dismissal” because Hospira improperly “seeks to benefit from the BPCIA where it can, and ignore those features of the BPCIA that hinder its ambitions.”  For example, Hospira claims to have engaged in meaningful preparation to sell its Inflectra biosimilar to show a purported actual case and controversy – even though Hospira cites to Celltrion’s preparations and thus treats Celltrion like its alter ego – yet Hospira minimizes the relationship with Celltrion and states that it is not a BPCIA applicant in response to Janssen’s argument that any patent dispute between the parties should be resolved under the BPCIA’s framework for dispute resolution.  Indeed, Hospira’s claim that it is not an FDA applicant subject to the BPCIA suggests that “Hospira’s claims are too attenuated from any crystallized dispute” and further demonstrates that lack of any justiciable case or controversy.

As Judge Crotty found in the Celltrion case, even if Hospira had sufficiently prepared to bring Inflectra to market and the threat of injury was sufficient (which it has not), the BPCIA dispute resolution framework counsel against the exercise of jurisdiction in the Hospira Case.

View Related Document: Pacer-Complaint-20140829-14-cv-07049

The articles on our Website include some of the publications and papers authored by our attorneys, both before and after they joined our firm. The content of these articles should not be taken as legal advice.