Yesterday in Sandoz Inc. v. Amgen Inc., et al., the Supreme Court ruled that biosimilar makers may give 180-day notice of sales before product approval, and that the failure of a biosimilar maker to provide its application and manufacturing information to the RLD drug maker under the Biologics Price Competition and Innovation Act (“BPCIA”) is not sufficient to enjoin approval of the biosimilar application under federal law.
The case at hand involved Sandoz’s application to market Zarxio®, a biosimilar to Amgen’s filgrastim product (Neupogen®). The day after FDA accepted Sandoz’s application for review, Sandoz notified Amgen that it had submitted an application and intended to begin marketing Zarxio® immediately upon approval, which it expected to receive in less than a year. Sandoz did not provide the application and manufacturing information required under 42 U.S.C. § 262(l)(2)(A), and informed Amgen that it could immediately sue for infringement under 42 U.S.C. § 262(l)(9)(C).
Amgen filed suit for patent infringement and also asserted two claims under California’s unfair competition law. The later claims were predicated on two alleged violations of the BPCIA: (1) Sandoz’s failure to provide its application and manufacturing information under Section 262(l)(2)(A) and (2) its provision of notice of commercial marketing under Section 262(l)(8)(A) prior to obtaining licensure (approval) from the FDA. Amgen sought injunctions to enforce both requirements. Sandoz counterclaimed for declaratory judgments that the asserted patent was invalid and not infringed and that Sandoz had not violated the BPCIA. While the case was pending in the District Court, the FDA licensed Zarxio® and Sandoz provided Amgen notice of commercial marketing.
The first issue addressed by the Supreme Court was whether the requirement that a biosimilar applicant provide its application and manufacturing information to the biologic NDA holder is enforceable by injunction. The Supreme Court agreed with the Federal Circuit—that injunctive relief is not available—but for different reasons. Unlike the submission of a biosimilar application to the FDA, a failure to disclose application and manufacturing information is not an artificial act of infringement, and thus is not remediable under 35 U.S.C.§ 271(e)(4). Accordingly, the Supreme Court affirmed the Federal Circuit’s refusal to grant an injunction under federal law.
The Supreme Court also considered the viability of state law claims based on a failure to comply with the notice provision. The Court declined to decide whether Sandoz’s failure to provide application and manufacturing information was “unlawful” under California law because it did not present a question of federal law. The Court noted that the Federal Circuit erred in attempting to answer the question by referring to the BPCIA alone and remanded the issue to the Federal Circuit to determine whether Sandoz’s noncompliance was “unlawful” under state law.
The second question at issue was whether the applicant must wait until after it has received a license (approval) from the FDA to give notice of commercial marketing. The Federal Circuit said yes, but the Supreme Court disagreed. An applicant need only give notice 180 days prior to marketing its biosimilar and it does not matter whether such notice is given before or after receiving a license from the FDA. The pertinent statutory language requires the applicant to “provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k).” Section 262(l)(8)(A) (emphasis added). Amgen argued, and the Federal Circuit agreed, that the characterization of the biological product as being “licensed” meant that the applicant could not provide notice until after it was licensed. The Supreme Court rejected this interpretation. The phrase “of the biological product licensed under subsection (k)” is in reference to “commercial marketing,” not to the “notice” that must be given before commercial marketing. The use of the word “licensed” merely reflects the fact that the product must be licensed by the date of the first “commercial marketing”. Thus, an applicant need not wait until after it has received FDA approval to provide notice of commercial marketing under Section 262(l)(8)(A).
This decision eliminates the extra 180-day exclusivity the Federal Circuit created with its reading of 262(l)(8)(A), as well as much of the uncertainty that existed for biosimilar makers who refused to provide application and manufacturing information pursuant to the BPCIA. Nonetheless, the Supreme Court did leave unanswered the question of whether a biosimilar maker’s refusal to provide application and manufacturing information under 262(l)(2)(A) may be actionable under state law.