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Text: The second question at issue in these cases is whether an applicant must provide notice after the FDA licenses its biosimilar, or if it may also provide effective notice before licensure. Section 262(l)(8)(A) states that the applicant “shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k).” The Federal Circuit held that an applicant’s biosimilar must already be “licensed” at the time the applicant gives notice. 794 F.3d, at 1358.

We disagree. The applicant must give “notice” at least 180 days “before the date of the first commercial marketing.” “[C]ommercial marketing,” in turn, must be “of the biological product licensed under subsection (k).” §262(l)(8)(A). Because this latter phrase modifies “commercial marketing” rather than “notice,” “commercial marketing” is the point in time by which the biosimilar must be “licensed.” The statute’s use of the word “licensed” merely reflects the fact that, on the “date of the first commercial marketing,” the product must be “licensed.” See §262(a)(1)(A). Accordingly, the applicant may provide notice either before or after receiving FDA approval.

Statutory context confirms this interpretation. Section 262(l)(8)(A) contains a single timing requirement: The applicant must provide notice at least 180 days prior to marketing its biosimilar. The Federal Circuit, however, interpreted the provision to impose two timing requirements: The applicant must provide notice after the FDA licenses the biosimilar and at least 180 days before the applicant markets the biosimilar. An adjacent provision expressly sets forth just that type of dual timing requirement. See §262(l)(8)(B) (“After receiving notice under subparagraph (A) and before such date of the first commercial marketing of such biological product, the reference product sponsor may seek a preliminary injunction” (emphasis added)). But Congress did not use that structure in §262(l)(8)(A). “Had Congress intended to” impose two timing requirements in §262(l)(8)(A), “it presumably would have done so expressly as it did in the immediately following” subparagraph. Russello v. United States, 464 U.S. 16, 23 (1983).

We are not persuaded by Amgen’s arguments to the contrary. Amgen points out that other provisions refer to “ ‘the biological product that is the subject of ’ ” the application, rather than the “ ‘biological product licensed under subsection (k).’ ” Brief for Amgen Inc. et al. 28 (emphasis added). In its view, this variation “is a strong textual indication that §262(l)(8)(A), unlike the other provisions, refers to a product that has already been ‘licensed’ by the FDA.” Ibid.

Amgen’s interpretation is not necessary to harmonize Congress’ use of the two different phrases. The provision upon which Amgen primarily relies (and that is generally illustrative of the other provisions it cites) requires the applicant to explain why the sponsor’s patents are “ ‘invalid, unenforceable, or will not be infringed by the commercial marketing of the biological product that is the subject of the subsection (k) application.’ ” Id., at 29–30 (quoting §262(l)(3)(B)(ii)(I); emphasis deleted). This provision uses the phrase “subject of the subsection (k) application” rather than “product licensed under subsection (k)” because the applicant can evaluate validity, enforceability, and infringement with respect to the biosimilar only as it exists when the applicant is conducting the evaluation, which it does before licensure. The applicant cannot make the same evaluation with respect to the biosimilar as it will exist after licensure, because the biosimilar’s specifications may change during the application process. See, e.g., 794 F.3d, at 1358. In contrast, nothing in §262(l)(8)(A) turns on the precise status or characteristics of the biosimilar application.

Amgen also advances a host of policy arguments that prelicensure notice is undesirable. See Brief for Amgen Inc. et al. 35–42. Sandoz and the Government, in turn, respond with their own bevy of arguments that Amgen’s concerns are misplaced and that prelicensure notice affirmatively furthers Congress’ intent. See Brief for Sandoz Inc. 39–42, 56; Brief for United States as Amicus Curiae 28–29. The plausibility of the contentions on both sides illustrates why such disputes are appropriately addressed to Congress, not the courts. Even if we were persuaded that Amgen had the better of the policy arguments, those arguments could not overcome the statute’s plain language, which is our “primary guide” to Congress’ preferred policy. McFarland v. Scott, 512 U.S. 849, 865 (1994) (THOMAS, J., dissenting).

In sum, because Sandoz fully complied with §262(l)(8)(A) when it first gave notice (before licensure) in July 2014, the Federal Circuit erred in issuing a federal injunction prohibiting Sandoz from marketing Zarxio until 180 days after licensure. Furthermore, because Amgen’s request for state-law relief is predicated on its argument that the BPCIA forbids prelicensure notice, its claim under California’s unfair competition law also fails. We accordingly reverse the Federal Circuit’s judgment as to the notice provision.