Reference product sponsors (RPSs) and biosimilar manufacturers were hoping the Supreme Court of the United States would clarify two aspects of the Biologics Price Competition and Innovation Act (“BPCIA”) in the Amgen v. Sandoz case: 1) whether the patent dance provisions of the BPCIA are mandatory and enforceable and 2) whether notice of commercialization prior to FDA approval is effective.  In a unanimous decision on June 12, the Supreme Court answered only the second question definitively: notice of commercialization prior to FDA approval is effective, and a biosimilar applicant need not wait for FDA licensure to provide 180-day notice. As to the first question, the Court stated it was not required to decide whether the patent dance (or, more specifically, § 262(l)(2)(A) under which the biosimilar applicant provides a copy of the aBLA to the RPS, starting the patent dance) is mandatory or optional. Instead, it framed the question as “whether 262(l)(2)(A)’s requirement—that the applicant provide its application and manufacturing information to the sponsor—is itself enforceable by injunction.” And the Court decided that an injunction is not available under federal law. Rather, an RPS’s only remedy is to file a declaratory judgment action under §262(l)(9)(C). The Court also remanded to the Federal Circuit to determine if an injunctive remedy was available via state law.

No Injunctive Relief Under Federal Law for Failure to Share the aBLA, But State Law Remedies Remain Uncertain

The Supreme Court agreed with the Federal Circuit’s conclusion, but not its reasoning, that an injunction is unavailable for failure to provide an RPS with a copy of the aBLA and other manufacturing information. The Federal Circuit interpreted §271(e)(2)(C)(ii) to make failure to provide an aBLA an element of the artificial act of infringement. The Federal Circuit reasoned that the remedies available for this artificial act of infringement are limited to the exclusive remedies in §271(e)(4)—which do not provide for an injunction requiring the biosimilar applicant to provide the aBLA. The Supreme Court expressly disagreed. According to the Court, upon a proper reading, only submission of an aBLA constitutes an act of artificial infringement; failing to disclose the application and manufacturing information under §262(l)(2)(A) is not an act of artificial infringement.  Thus, the only remedy for failure to provide information under §262(1)(2)(A) is for the RPS to file a declaratory judgment action under §262(l)(9)(C).

At the same time, the Court remanded to the Federal Circuit to “determine whether California law would treat noncompliance with§262(l)(2)(A) as ‘unlawful,’” and, if so, “whether the BPCIA pre-empts any additional remedy available under state law for an applicant’s failure to comply with §262(l)(2)(A).” The Federal Circuit is therefore left to answer whether §262(l)(2)(A) is mandatory and what remedies are available under California state law.

Although no injunctive remedy is available under federal law, the Supreme Court expressed confidence that biosimilar applicants still had significant incentives to participate in the patent dance. The Court noted that by participating in the dance, biosimilars “will have the opportunity to litigate the relevant patents before the biosimilar is marketed.” In contrast, by failing to provide a copy of the aBLA and other manufacturing information, a biosimilar applicant vests in the RPS “the control that the applicant would otherwise have exercised over the scope and timing of the patent litigation and depriving the applicant of the certainty it could have obtained by bringing a declaratory-judgment action prior to marketing its product.”

Notice Effective Prior to FDA Approval

In reversing the Federal Circuit on the timing of notice of commercial marketing, the Supreme Court based its decision on a  straightforward textual interpretation of section 262(l)(8)(A) of the BPCIA.  According to the Federal Circuit, the provision imposed two timing requirements: the applicant must provide notice after the FDA license the biosimilar and this must be done at least 180 days before the applicant markets the biosimilar. The Supreme Court rejected this interpretation, holding that section 262(l)(8)(A) contains a single timing requirement: the applicant must provide notice at least 180 days prior to marketing its biosimilar.  While acknowledging the numerous and weighty practical ramifications of its interpretation, the Supreme Court explicitly did not take them into account. These policy considerations “could not overcome the statute’s plain language” and, in any event, “are appropriately addressed to Congress, not the courts.”

Justice Breyer Invites the FDA to Weigh in

In a one paragraph concurring opinion, Justice Breyer left open the door for the FDA to modify the Court’s interpretation of the BPCIA.   In Justice Breyer’s view, Congress implicitly delegated authority to the FDA to interpret the terms of the BPCIA.  Thus, in his opinion, if the FDA, after greater experience administering this statute, determines that a different interpretation would better serve the statute’s objectives, it may have authority to depart from, or modify, the Court’s interpretation.

What’s Next?

The Supreme Court’s opinion answered some questions—generally siding with the biosimilar applicant Sandoz’s position—but left much uncertain. Will the patent dance be essentially mandatory under state law? Will availability of an injunction vary by state, perhaps triggering important venue issues? How soon can a biosimilar manufacturer give notice of commercial marketing? Can it be before FDA filing of the aBLA, or is the BPCIA (and its notice provisions) only triggered by the FDA’s acceptance of the aBLA?

In addition, in a footnote, the Court clarified that it expressed no view on whether a district court could take into account an applicant’s violation of §262(l)(2)(A) (or any other BPCIA procedural requirement) in deciding whether to grant a preliminary injunction under 35 U.S.C. § 271(e)(4)(B) or §283 against marketing the biosimilar. Thus, failure to comply with the information exchange provision of §262(l)(2)(A) may still have ramifications beyond those at issue in this case.