Celltrion Healthcare v. Janssen Biotech, No. 14-11613 (D. Mass.)
On March 31, Celltrion filed a Complaint for Declaratory Judgment in the District of Massachusetts against Janssen Biotech, seeking a declaration of invalidity and unenforceability of three Janssen patents. In its Complaint, Celltrion alleges that it has developed Remsima®, a biosimilar version of Janssen’s infliximab product, which it claims "will become the first biosimilar of an antibody drug ever approved in the United States." Celltrion's Complaint states that it 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, Celtrion wants to start the adjudicative process regarding the invalidity and unenforceability of Janssen's patents."
Celltrion is the second company developing a biosimilar product to file a declaratory judgment action before filing an application for licensure with the FDA. Last June, Sandoz filed a declaratory judgment action against Amgen and Hoffman-La Roche in the Northern District of California alleging patent invalidity and noninfringement in a case relating to a biosimilar version of Amgen's Enbrel product. Like Celltrion, Sandoz filed its case before filing a marketing application with the FDA. As we discussed in a previous post, the district court dismissed the case, holding that Sandoz's declaratory judgment action was premature as there was not yet a "real and immediate injury" to be addressed. The court further stated that a lawsuit may not be filed "unless and until" a reference product sponsor and biosimilar applicant engage in the "series of statutorily-mandated exchanges of information" under the Biologics Price Competition and Innovation Act ("BPCIA").
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 Act, the parties then engage in a patent information exchange process which may culminate in a patent lawsuit. To date, while two lawsuits involving potential biosimilar products have been filed, no company has publicly announced filing a subsection (k) biosimilar application with the FDA.
The Sandoz v. Amgen case is now on appeal at the Federal Circuit. Sandoz recently filed its principal brief. The Defendants' responsive brief is currently due on May 27.
UPDATE: Celltrion filed a second Complaint for Declaratory Judgment relating to its Remsima® product--this one in the Southern District of New York against Kennedy Trust for Rheumatology Research and seeking a declaration of invalidity of three Kennedy patents. Like its allegations against Janssen, Celltrion alleges that it "expects to face patent infringement allegations from Kennedy" over Remsima® and thus "wants to start the adjudicative process . . . and immediately avail itself of the processes available in the federal judiciary to discover information relating to Kennedy’s patents."