1. Teva seeks review of a decision of the Federal Circuit that rewrites the statutory definition of "drug" in the Federal Food, Drug and Cosmetic Act ("FDCA"), see 21 U.S.C. § 321(g)(1)(D), and misconstrues the statutory provision governing listing of patents in the "Orange Book" administered by the Food and Drug Administration ("FDA"). Due to these errors, the Federal Circuit's decision conflicts with this Court's decisions in Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898 (2014), United States v. Generix Drug Corp., 460 U.S. 453, 459 (1983), and United States v. Article of Drug ... Bacto-Unidisk, 394 U.S. 784, 794 (1969).

2. "To facilitate the approval of generic drugs as soon as patents allow, the Hatch-Waxman Amendments and FDA regulations direct brand manufacturers to file information about their patents," which FDA publishes in a volume known as the "Orange Book." Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 566 U.S. 399, 405-06 (2012); 21 C.F.R. § 314.53(e). Specifically, the brand manufacturer "shall submit":

the patent number and expiration date of each patent for which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug, and that —

(D claims the drug for which the applicant submitted the application and is a drug substance (active ingredient) patent or a drug product (formulation or composition) patent; or

(II) claims a method of using such drug for which approval is sought or has been granted in the application.

21 U.S.C. § 355(b)(1)(A)(viii) (the "Listing Statute"). Submission is not discretionary: if a patent meets either prong of the definition, it must be submitted for listing in the Orange Book.

Whether the Federal Circuit properly interpreted the statutory definition of 'drug' under 21 U.S.C. § 321(g)(1)(D) and the Orange Book listing requirements under 21 U.S.C. § 355(b)(1)(A)(viii) in determining which patents must be submitted for listing in the FDA's Orange Book