On Friday, Jan. 13, the Supreme Court granted the appellant’s petition and the respondent’s cross-petition for a writ of certiorari in Sandoz Inc. v. Amgen Inc. This is the first time the Court will construe the Biologics Price Competition and Innovation Act of 2009 (BPCIA), the law that established a regulatory pathway for approval of “biosimilar” drugs and set forth a complex scheme for resolving patent disputes between the biosimilar applicant and the sponsor of the reference product. The Court will address whether two key provisions of the BPCIA — the pre-litigation exchange of information (commonly known as the “Patent Dance”) and the biosimilar applicant’s 180-day notice of commercial marketing — are mandatory and enforceable by injunction, and whether the 180-day notice must await biosimilar approval.
In the case below, a majority of the Federal Circuit held that a biosimilar applicant can opt out of the Patent Dance exchanges but must provide 180-day notice of commercial marketing after receiving FDA approval. Amgen, Inc. v. Sandoz, Inc., 794 F.3d 1347 (Fed. Cir. 2015). In particular, the Federal Circuit held that 42 U.S.C. § 262(l)(2)(A), which sets forth that a biosimilar applicant “shall” provide a copy of its application and manufacturing information to the reference product sponsor, the first step of the Patent Dance, is a voluntary provision. Id. at 1357. Thus, a failure of a biosimilar applicant to provide such information is not a violation of the BPCIA, and a reference product sponsor’s only remedy is to bring a declaratory judgment action pursuant to 42 U.S.C. § 262(l)(9)(C) and/or a patent infringement action pursuant to 35 U.S.C. § 271(e)(2)(C)(ii). Id. at 1356-57. The Federal Circuit further held that the 180-day notice of commercial marketing provision of 42 U.S.C. § 262(l)(8)(A) is a “standalone” provision and that such notice is mandatory and may only be given after the FDA approves the biosimilar application, in effect providing an additional 180-day exclusivity to the reference product sponsor. Id. at 1358-59. Judge Newman wrote an opinion concurring in part and dissenting in part, setting forth her view that both the exchange provision of § 262(l)(2)(A) and the notice of commercial marketing provision of § 262(l)(8)(A) are mandatory requirements of the statute. Id. at 1362-63. In contrast, Judge Chen dissented from the court’s opinion regarding the notice of commercial marketing, stating his view that § 262(l)(8)(A) is not a standalone provision, and thus is not mandatory when the applicant fails to comply with § 262(l)(2). Id. at 1367.
In attempting to resolve the split of the Federal Circuit decision, the Supreme Court will consider the following issues: (1) whether a biosimilar applicant is required by 42 U.S.C. § 262(l)(2)(A) to provide the reference product sponsor with a copy of its biologics license application and related manufacturing information; (2) whether a biosimilar applicant’s failure to provide such information is enforceable by injunction or whether the sole remedy is to bring a declaratory judgment action under 42 U.S.C. § 262(l)(9)(C) and/or a patent-infringement action under 35 U.S.C. § 271(e)(2)(C)(ii); (3) whether the notice of commercial marketing set forth in 42 U.S.C. § 262(l)(8)(A) can be effective if given before FDA approval of the biosimilar; and (4) whether the notice of commercial marketing is a standalone requirement enforceable by injunction.
The Honorable Judge Lourie of the Federal Circuit Court of Appeals, quoting Winston Churchill, described the BPCIA as “a riddle, wrapped in a mystery inside an enigma.” The Supreme Court’s decision to grant Amgen’s and Sandoz’s respective petitions is likely to provide at least some clarity in the quest to “unravel the riddle, solve the mystery, and comprehend the enigma.”