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Text: These cases concern filgrastim, a biologic used to stimulate the production of white blood cells. Amgen, the respondent in No. 15–1039 and the petitioner in No. 15– 1195, has marketed a filgrastim product called Neupogen since 1991 and claims to hold patents on methods of manufacturing and using filgrastim. In May 2014, Sandoz, the petitioner in No. 15–1039 and the respondent in No. 15– 1195, filed an application with the FDA seeking approval to market a filgrastim biosimilar under the brand name Zarxio, with Neupogen as the reference product. The FDA informed Sandoz on July 7, 2014, that it had accepted the application for review. One day later, Sandoz notified Amgen both that it had submitted an application and that it intended to begin marketing Zarxio immediately upon receiving FDA approval, which it expected in the first half of 2015. Sandoz later confirmed that it did not intend to provide the requisite application and manufacturing information under §262(l)(2)(A) and informed Amgen that Amgen could sue for infringement immediately under §262(l)(9)(C).

In October 2014, Amgen sued Sandoz for patent infringement. Amgen also asserted two claims under California’s unfair competition law, which prohibits “any unlawful . . . business act or practice.” Cal. Bus. & Prof. Code Ann. §17200 (West 2008). A “business act or practice” is “unlawful” under the unfair competition law if it violates a rule contained in some other state or federal statute. Rose v. Bank of America, N. A., 57 Cal. 4th 390, 396, 304 P.3d 181, 185 (2013). Amgen alleged that Sandoz engaged in “unlawful” conduct when it failed to provide its application and manufacturing information under §262(l)(2)(A), and when it provided notice of commercial marketing under §262(l)(8)(A) before, rather than after, the FDA licensed its biosimilar. Amgen sought injunctions to enforce both requirements. Sandoz counterclaimed for declaratory judgments that the asserted patent was invalid and not infringed and that it had not violated the BPCIA.

While the case was pending in the District Court, the FDA licensed Zarxio, and Sandoz provided Amgen a further notice of commercial marketing. The District Court subsequently granted partial judgment on the pleadings to Sandoz on its BPCIA counterclaims and dismissed Amgen’s unfair competition claims with prejudice. 2015 WL 1264756, *7–*9 (ND Cal., Mar. 19, 2015). After the District Court entered final judgment as to these claims, Amgen appealed to the Federal Circuit, which granted an injunction pending appeal against the commercial marketing of Zarxio.

A divided Federal Circuit affirmed in part, vacated in part, and remanded. First, the court affirmed the dismissal of Amgen’s state-law claim based on Sandoz’s alleged violation of §262(l)(2)(A). It held that Sandoz did not violate the BPCIA in failing to disclose its application and manufacturing information. It further held that the remedies contained in the BPCIA are the exclusive remedies for an applicant’s failure to comply with §262(l)(2)(A). 794 F.3d 1347, 1357, 1360 (2015).

Second, the court held that an applicant may provide effective notice of commercial marketing only after the FDA has licensed the biosimilar. Id., at 1358. Accordingly, the 180-day clock began after Sandoz’s second, postlicensure notice. The Federal Circuit further concluded that the notice requirement is mandatory and extended its injunction pending appeal to bar Sandoz from marketing Zarxio until 180 days after the date it provided its second notice. Id., at 1360–1361.

We granted Sandoz’s petition for certiorari, No. 15– 1039, and Amgen’s conditional cross-petition for certiorari, No. 15–1195, and consolidated the cases. 580 U. S. ___ (2017).