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Text: We agree with the Federal Circuit that an injunction under federal law is not available to enforce §262(l)(2)(A), though for slightly different reasons than those provided by the court below. The Federal Circuit held that “42 U.S. C. §262(l)(9)(C) and 35 U.S. C. §271(e) expressly provide the only remedies” for a violation of §262(l)(2)(A), 794 F.3d, at 1357, and neither of those provisions authorizes a court to compel compliance with §262(l)(2)(A). In concluding that the remedies specified in the BPCIA are exclusive, the Federal Circuit relied primarily on §271(e)(4), which states that it provides “ ‘the only remedies which may be granted by a court for an act of [artificial] infringement.’ ” Id., at 1356 (emphasis deleted).

The flaw in the Federal Circuit’s reasoning is that Sandoz’s failure to disclose its application and manufacturing information was not an act of artificial infringement, and thus was not remediable under §271(e)(4). Submitting an application constitutes an act of artificial infringement. See §§271(e)(2)(C)(i), (ii) (“It shall be an act of infringement to submit . . . an application seeking approval of a biological product”). Failing to disclose the application and manufacturing information under §262(l)(2)(A) does not.

In reaching the opposite conclusion, the Federal Circuit relied on §271(e)(2)(C)(ii), which states that “[i]t shall be an act of infringement to submit[,] if the applicant for the application fails to provide the application and information required under [§262(l)(2)(A)], an application seeking approval of a biological product for a patent that could be identified pursuant to [§262(l)(3)(A)(i)].” (Emphasis added.) The court appeared to conclude, based on the italicized language, that an applicant’s noncompliance with §262(l)(2)(A) is an element of the act of artificial infringement (along with the submission of the application). 794 F.3d, at 1356. We disagree. The italicized language merely assists in identifying which patents will be the subject of the artificial infringement suit. It does not define the act of artificial infringement itself.

This conclusion follows from the structure of §271(e)(2)(C). Clause (i) of §271(e)(2)(C) defines artificial infringement in the situation where the parties proceed through the list exchange process and the patents subject to suit are those contained in the §262(l)(3) lists, as supplemented under §262(l)(7). That clause provides that it is an act of artificial infringement to submit, “with respect to a patent that is identified in the list of patents described in [§262(l)(3)] (including as provided under [§262(l)(7)]), an application seeking approval of a biological product.” (Emphasis added.) Clause (ii) of §271(e)(2)(C), in contrast, defines artificial infringement in the situation where an applicant fails to disclose its application and manufacturing information altogether and the parties never prepare the §262(l)(3) lists. That clause provides that the submission of the application represents an act of artificial infringement with respect to any patent that could have been included on the lists.

In this way, the two clauses of §271(e)(2)(C) work in tandem. They both treat submission of the application as the act of artificial infringement for which §271(e)(4) provides the remedies. And they both identify the patents subject to suit, although by different means depending on whether the applicant disclosed its application and manufacturing information under §262(l)(2)(A). If the applicant made the disclosures, clause (i) applies; if it did not, clause (ii) applies. In neither instance is the applicant’s failure to provide its application and manufacturing information an element of the act of artificial infringement, and in neither instance does §271(e)(4) provide a remedy for that failure. See Brief for Amgen Inc. et al. 66–67 (conceding both points).

A separate provision of §262, however, does provide a remedy for an applicant’s failure to turn over its application and manufacturing information. When an applicant fails to comply with §262(l)(2)(A), §262(l)(9)(C) authorizes the sponsor, but not the applicant, to bring an immediate declaratory-judgment action for artificial infringement as defined in §271(e)(2)(C)(ii). Section 262(l)(9)(C) thus vests in the sponsor the control that the applicant would otherwise have exercised over the scope and timing of the patent litigation. It also deprives the applicant of the certainty that it could have obtained by bringing a declaratory-judgment action prior to marketing its product.

The remedy provided by §262(l)(9)(C) excludes all other federal remedies, including injunctive relief. Where, as here, “a statute expressly provides a remedy, courts must be especially reluctant to provide additional remedies.” Karahalios v. Federal Employees, 489 U.S. 527, 533 (1989). The BPCIA’s “carefully crafted and detailed enforcement scheme provides strong evidence that Congress did not intend to authorize other remedies that it simply forgot to incorporate expressly.” Great-West Life & Annuity Ins. Co. v. Knudson, 534 U.S. 204, 209 (2002) (internal quotation marks omitted). The presence of §262(l)(9)(C), coupled with the absence of any other textually specified remedies, indicates that Congress did not intend sponsors to have access to injunctive relief, at least as a matter of federal law, to enforce the disclosure requirement.

Statutory context further confirms that Congress did not authorize courts to enforce §262(l)(2)(A) by injunction. Section 262(l)(1)(H) provides that “the court shall consider immediate injunctive relief to be an appropriate and necessary remedy for any violation or threatened violation” of the rules governing the confidentiality of information disclosed under §262(l). We assume that Congress acted intentionally when it provided an injunctive remedy for breach of the confidentiality requirements but not for breach of §262(l)(2)(A)’s disclosure requirement. Cf. Touche Ross & Co. v. Redington, 442 U.S. 560, 572 (1979) (“[W]hen Congress wished to provide a private damage remedy, it knew how to do so and did so expressly”).2 Accordingly, the Federal Circuit properly declined to grant an injunction under federal law.

B