Northern District of California Interprets the Biosimilars Act and Limits Declaratory Relief for Biosimilar Manufacturer: What You Need To Know | Firm Alert
In the first instance of a district court interpreting the patent litigation provisions of the Biologics Price Competition and Innovation Act (“Biosimilars Act”), Judge Maxine E. Chesney (N.D. Cal.) dismissed a declaratory judgment action by Sandoz relating to its biosimilar version of Enbrel® (etanercept). See Sandoz Inc. v. Amgen Inc., 3:13-cv-02904-MMC (N.D. Cal. Nov. 12, 2013). In that action, Sandoz had sought a declaration that its etanercept biosimilar would not infringe two Amgen patents and that the patents were invalid and unenforceable.
Sandoz sought this declaratory relief from the Court prior to seeking any FDA approval for its biosimilar product, and it argued that declaratory judgment jurisdiction was appropriate because it intended to seek FDA approval after the completion of clinical trials. Additionally, Sandoz argued that Amgen had made public statements that the patents at issue covered etanercept and that Amgen routinely defends its patents.
The district court declined to exercise jurisdiction over the dispute and dismissed Sandoz’s lawsuit. The court held that “with limited exceptions not applicable here, neither a reference product sponsor, such as Amgen, nor an applicant, such as Sandoz, may file a lawsuit unless and until they have engaged” in the patent exchanges mandated by the Biosimilars Act. See Op. at 3 (citing 42 U.S.C. §§ 262(l)(2)-(6)).
Sandoz had argued that the Biosimilars Act permits declaratory judgment actions when a Biosimilar applicant has provided a notice of commercial marketing under 42 U.S.C. § 262(l)(8)(A). The court rejected this argument and held that Sandoz could not provide a “notice of commercial marketing” as required under the Biosimilars Act without first filing an application with, and obtaining a license from, the FDA. Given that Sandoz had not filed any applications with the FDA, the court determined that Sandoz could not have complied with the requirements of the Biosimilars Act and that its intention to file such an application in the future “is insufficient to create a case or controversy.” The court also found that neither the statements made by Amgen regarding its patents nor Sandoz’s intent to file a biosimilar application in the future demonstrated that a case or controversy currently existed between the parties.
Although the juridical interpretation of the litigation provisions of the Biosimilars Act will continue, this decision indicates that courts will not allow reference product sponsors or biosimilar applicants to engage in litigation prior to the filing of a biosimilar application with the FDA and the completion of the patent exchanges required under the Biosimilars Act.
For more information on patent strategies under the Biosimilars Act, please contact Sheila Swaroop at 949-760-0404 or Carol Pitzel Cruz at 206-405-2000.
