; (BB) significantly improved product purity or potency; (CC) significant gained efficiencies in manufacturing; or (DD) other improved product attributes having substantial benefits for consumers or patients; (bb) a generic drug or biosimilar biological product could be marketed commercially without incorporating the improvements claimed in the additional patents described in item (aa); or (cc) for each of the later filed patents, the manufacturer had substantial financial reason, apart from the financial effects of reduced competition, to file each of the patents; and (II) in making a demonstration under subclause (I), shall submit to the Commission or the court, as applicable, all research and development, manufacturing, marketing, and other costs associated with approval of the original drug under section 505(c) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(c) ) or licensure of the original biological product under section 351(a) of the Public Health Service Act ( 42 U.S.C. 262(a) ), which— (aa) shall include— (AA) any documents relating to the costs and benefits of the later filed patents with respect to patients who use the drug; and (BB) any applications for patents that were filed and rejected