Brief Summary: FC issuance of “a federal injunction prohibiting Sandoz from marketing Zarxio until 180 days after licensure” reversed since “the applicant may provide [180 day] notice either before or after receiving FDA approval” (§262(l)(8)(A) provides “a single timing requirement (180 days before marketing) rather than the two requirements posited by the Federal Circuit (after licensing, and 180 days before marketing)”)
Summary: Under the abbreviated pathway for biosimilar approval provided by the Biologics Price Competition and Innovation Act of 2009 (BPCIA), the “submission of a biosimilar application [is] an ‘artificial’ act of infringement, enabling parties to bring patent infringement suits” (§§271(e)(2)(C)(i), (ii)). Under §262(l)(2)(A), the biosimilar applicant “must provide its application and manufacturing information to the sponsor within 20 days of the date the FDA notifies the applicant that it has accepted the application for review.” Then, under §262(l)(3) and §262(l)(8)(A), the parties create lists of relevant patents and “identify patents on the lists for immediate litigation” (the “first phase”). A “second phase” involving “any listed patents not litigated in the first phase” is “triggered when the applicant…gives the sponsor notive at least 180 days before commercially marketing the biosimilar”. The opinion notes that “[t]he applicant has substantial control over the timing and scope of both phases of litigation.” If the applicant does not provide its application and manufacturing information to the sponsor (§262(l)(2)(A)), “then the sponsor, but not the applicant, may immediately bring an action”. Under §262(l)(9)(B), “if an applicant provides the application and manufacturing information but fails to complete a subsequent step in the process, the sponsor, but not the applicant, may bring a declaratory-judgment action with respect to any patent included on the sponsor’s list of relevant patents.” Here, Sandoz sought approval of a biosimilar (Zarxio) for Amgen’s Neupogen. After notifying Amgen of the FDA’s acceptance of its application and its intent to market the product upon FDA approval, “[i]t later notified Amgen that it did not intend to provide the application and manufacturing information…and that Amgen could sue immediately”, which Amgen did (under CA’s unfair competition laws and violations of the BPCIA, Sandoz counterclaimed for invalidity and non-infringement). The CA claim was dismissed and then affirmed by the FC since “the BPCIA provides the exclusive remedies for failure to comply” (§282(l)(2)(A)). SCOTUS agreed, holding the (§282(l)(2)(A) is not enforceable by injunction under federal law” but noted the FC “should determine whether a state-law injunction is available” on remand. SCOTUS found the FC’s “reasoning” on this point, based on §271(e)(4), “was flawed”, that “failing to disclose the application and manufacturing information required by §262(l)(2)(A)” is not an act of infringement, and that the availability of a remedy under §262(l)(9)(C) “indicates that Congress did not intent sponsors to have access to injunctive relief, at least a matter of federal law, to enforce the disclosure requirement.” The FC also enjoined Sandoz from marketing its product “until 180 days after it provided its second notice” (§262(l)(8)(A)). SCOTUS held that under (§262(l)(8)(A), “‘commercial marketing’ is the point in time by which the biosimilar must be ‘licensed’” and “the applicant may provide notice either before or after receiving FDA approval” (i.e., “it may also provide notice before licensure”, “a single timing requirement (180 days before marketing) rather than the two requirements posited by the Federal Circuit (after licensing, and 180 days before marketing)”). Thus, since “Sandoz fully complied with (§262(l)(8)(A) when it first gave notice (before licensure)”, the FC “erred in issuing a federal injunction prohibiting Sandoz from marketing Zarxio until 180 days after licensure” and “Amgen’s reques for state-law relief is predicated on its argument that the BPCIA forbids prelicensure notices, its claim under [CA’s] unfair competition law also fails”, this part of the FC’s decision was reversed.