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Janssen Files Motion to Dismiss Celltrion's DJ Complaint, Claiming Celltrion is Trying to "Side-Step" the BPCIA

Date: March 29, 2014 || IP Updates

As we previously reported, Celltrion filed a Complaint for Declaratory Judgmentagainst Janssen Biotech on March 31, seeking a declaration of invalidity and unenforceability of three Janssen patents.  In its complaint, Celltrion alleged that Remsima®, a biosimilar version of Janssen's Remicade® (infliximab), "will become the first biosimilar of an antibody drug ever approved in the United States."  Celltrion's DJ complaint, filed before its biosimilar application, states that Celltrion intends to apply for marketing approval of Remsima® during the first half of 2014 and expects FDA approval by early 2015.  Celltrion alleges that because "it expects to face infringement allegations from Janssen, Celltrion wants to start the adjudicative process regarding the invalidity and unenforceability of Janssen's patents."

Last Friday, May 23, Janssen Biotech filed a motion to dismiss Celltrion’s complaint, alleging that subject matter jurisdiction does not exist under the Declaratory Judgment Act because Celltrion "has not established a real and immediate injury or threat of injury."  Janssen claims that Celltrion "is still in negotiations over the content of its application and that the FDA has already required additional clinical testing of Remsima."  Janssen further argues that "there is no way to know when, if ever, Remsima® will be approved for a use that could potentially infringe" one of its patents, claiming that Health Canada "refused to approve Remsima® for treatment of Crohn's disease."  Janssen also argues that the court should exercise its discretionary authority to decline jurisdiction because "the BPCIA [Biologics Price Competition and Innovation Act] is the appropriate way to resolve any future patent disputes between Janssen and Celltrion."

The BPCIA created an abbreviated regulatory pathway (the "subsection (k) pathway") for the approval of biosimilar drugs.  Under the BPCIA, a company developing a biosimilar version of a licensed biologic product (or "reference product") may file a subsection (k) application with the FDA for licensure.  Once the FDA notifies the company that its application has been accepted for review, the applicant must then provide certain information about its product and manufacturing process to the reference product sponsor.  Under the BPCIA, the parties then engage in a patent information exchange process which may culminate in a patent lawsuit.  As part of this exchange process, the BPCIA provides limitations on declaratory judgment filings under certain circumstances.

In its motion to dismiss, Janssen argues that Celltrion should not be permitted "to claim there is jurisdiction for this suit based on Celltrion's status as a future262(k) applicant just so Celltrion can skirt the express limits on declaratory judgment actions Congress deemed appropriate for 262(k) applicants."  Janssen alleged that "[i]f Celltrion is allowed to side-step the patent dispute procedures of the BPCIA, then every prospective biosimilar applicant will be able to evade the statutory regime by filing a declaratory judgment action immediately before filings its biosimilar application with the FDA."  According to Janssen, "[t]his would clearly frustrate the intent of the BPCIA provisions."

As noted in our prior posting, Celltrion was the second biosimilar company to file a declaratory judgment action in advance of its biosimilar application.  In the first case, Sandoz v. Amgen, the district court dismissed Sandoz's DJ action on jurisdictional grounds.  An appeal is pending at the Federal Circuit and Amgen recently filed its opposition brief.  Celltrion also filed a DJ complaint relating to Remsima® against Kennedy Trust on March 31.  Kennedy's response is due in July.

Originally published on the Orange Book Blog. http://www.orangebookblog.com/2014/05/janssen-files-motion-to-dismiss-celltrions-dj-complaint-claiming-celltrion-is-trying-to-side-step-th.html