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Text: The Federal Circuit rejected Amgen’s request for an injunction under state law for two reasons. First, it interpreted California’s unfair competition law not to provide a remedy when the underlying statute specifies an “expressly . . . exclusive” remedy. 794 F.3d, at 1360 (citing Cal. Bus. & Prof. Code Ann. §17205; Loeffler v. Target Corp., 58 Cal. 4th 1081, 1125–1126, 324 P.3d 50, 76 (2014)). It further held that §271(e)(4), by its text, “provides ‘the only remedies’ ” for an applicant’s failure to disclose its application and manufacturing information. 794 F.3d, at 1360 (quoting §271(e)(4)). The court thus concluded that no state remedy was available for Sandoz’s alleged violation of §262(l)(2)(A) under the terms of California’s unfair competition law.

This state-law holding rests on an incorrect interpretation of federal law. As we have explained, failure to comply with §262(l)(2)(A) is not an act of artificial infringement. Because §271(e)(4) provides remedies only for artificial infringement, it provides no remedy at all, much less an “expressly . . . exclusive” one, for Sandoz’s failure to comply with §262(l)(2)(A).

Second, the Federal Circuit held in the alternative that Sandoz’s failure to disclose its application and manufacturing information was not “unlawful” under California’s unfair competition law. In the court’s view, when an applicant declines to provide its application and manufacturing information to the sponsor, it takes a path “expressly contemplated by” §262(l)(9)(C) and §271(e)(2)(C)(ii) and thus does not violate the BPCIA. 794 F.3d, at 1357, 1360. In their briefs before this Court, the parties frame this issue as whether the §262(l)(2)(A) requirement is mandatory in all circumstances, see Brief for Amgen Inc. et al. 58, or merely a condition precedent to the information exchange process, see Reply Brief for Sandoz Inc. 33. If it is only a condition precedent, then an applicant effectively has the option to withhold its application and manufacturing information and does not commit an “unlawful” act in doing so.

We decline to resolve this particular dispute definitively because it does not present a question of federal law. The BPCIA, standing alone, does not require a court to decide whether §262(l)(2)(A) is mandatory or conditional; the court need only determine whether the applicant supplied the sponsor with the information required under §262(l)(2)(A). If the applicant failed to provide that information, then the sponsor, but not the applicant, could bring an immediate declaratory-judgment action pursuant to §262(l)(9)(C). The parties in these cases agree—as did the Federal Circuit—that Sandoz failed to comply with §262(l)(2)(A), thus subjecting itself to that consequence. There is no dispute about how the federal scheme actually works, and thus nothing for us to decide as a matter of federal law. The mandatory or conditional nature of the BPCIA’s requirements matters only for purposes of California’s unfair competition law, which penalizes “unlawful” conduct. Whether Sandoz’s conduct was “unlawful” under the unfair competition law is a state-law question, and the court below erred in attempting to answer that question by referring to the BPCIA alone.

On remand, the Federal Circuit should determine whether California law would treat noncompliance with §262(l)(2)(A) as “unlawful.” If the answer is yes, then the court should proceed to determine whether the BPCIA pre-empts any additional remedy available under state law for an applicant’s failure to comply with §262(l)(2)(A) (and whether Sandoz has forfeited any pre-emption defense, see 794 F.3d, at 1360, n. 5). The court is also of course free to address the pre-emption question first by assuming that a remedy under state law exists.