; and (II) in the case of an applicable patent issued before such date of enactment, only to submissions and communications described in clauses (i) and (ii) of subparagraph (A) made on or after such date of enactment. . (2) Condition for approval Section 505(d)(6) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 505(d)(6) ) is amended by inserting , or the sponsor failed to comply with a requirement of subsection (b)(7)(A)(i) after subsection (b) . (b) Biological product applications Section 351(a)(2) of the Public Health Service Act ( 42 U.S.C. 262(a)(2) ) is amended by adding at the end the following: (F) (i) With respect to any application submitted under this subsection or biological product licensed under this subsection, the sponsor of the application or holder of the licensure shall, for any applicable patent— (I) certify to the Food and Drug Administration that the information described in clause (ii) that is submitted to the Secretary is complete and consistent with the information such sponsor or holder provided to the United States Patent and Trademark Office and any communications such sponsor or holder had with the United States Patent and Trademark Office; and (II) (aa) submit to the United States Patent and Trademark Office any information material to patentability with respect to such applicable patent that the sponsor or holder submits to the Food and Drug Administration, and any communications with the Food and Drug Administration that are related to such submissions