Today, FDA published notice of Janssen’s lawsuit against Celltrion and Hospira on March 6, 2015 under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) in the Federal Register. Although Janssen’s lawsuit is not the first action under the BPCIA, today marks the first time the FDA published notice of any BPCIA lawsuit.
After a biosimilar applicant is served with a complaint, the applicant has 30 days to notify the FDA of the lawsuit. 42 U.S.C. 262(l)(6)(C)(i). If the biosimilar applicant fails to provide the requisite notice to the FDA, the innovator company (also known as the reference product sponsor) may file a declaratory judgment action that increases the number of patents asserted against the biosimilar applicant in the lawsuit. Section 262(l)(9)(B). Typically, the biosimilar applicant can limit the number of patents that an innovator company can assert in the first phase of a BPCIA lawsuit (the so-called “immediate litigation phase”). Section 262(l)(4) & (5). But if the biosimilar applicant does not comply with certain provisions of the BPCIA, such as the requirement to provide notice of the lawsuit to FDA, the innovator company gains the ability to assert additional patents in the first phase of BPCIA litigation. The notice to FDA has no impact on if or when the biosimilar application is approved. Rather, after the FDA receives notice of a lawsuit under the BPCIA, it simply informs the public of the lawsuit by publishing notice of the complaint as it did today for Janssen’s complaint against Celltrion and Hospira. Section 262(l)(6)(C)(ii). As the FDA states in today’s notice, “FDA only has a ministerial role in publishing notice of a complaint received under [Section 262(l)(6)(C) of the BPCIA] and does not perform a substantive review of the complaint.”