; and (C) claimed in a patent or the use of which is claimed in a patent. (4) Generic drug The term generic drug means a drug approved pursuant to an application under section (b)(2) or (j) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ). (5) Government-granted exclusivity The term government-granted exclusivity means prohibitions on the submission or approval of drug applications granted under any of the following: (A) Clauses (ii) through (v) of section 505(c)(3)(E) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(c)(3)(E) ). (B) Section 505(j)(5)(B)(iv) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(5)(B)(iv) ) or clause (ii), (iii), or (iv) of section 505(j)(5)(F) of such Act. (C) Section 505A of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355a ). (D) Section 505E of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355f ). (E) Section 527 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360cc ). (F) Section 351(k)(7) of the Public Health Service Act ( 42 U.S.C. 262(k)(7) ). (G) Any other provision of law that provides for exclusivity (or extension of exclusivity) with respect to a drug. (6) Manufacturer The term manufacturer means the holder of an application approved under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) or of a license issued under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ). (7) Open, non-exclusive license The term open, non-exclusive license means a license that authorizes any person to use a patent held by a manufacturer that claims a brand name drug or a use of a brand name drug or rely upon regulatory test data for such drug, including patents held in common by the manufacturer and other entities, needed to produce, manufacture, import, export, distribute, offer in liquidation, sell, buy, or use such brand name drug. (8) Secretary The term Secretary means the Secretary of Health and Human Services.