; and (bb) in the case of an applicable patent issued before such date of enactment, only to submissions and communications described in subclauses (I) and (II) of clause (i) made on or after such date of enactment. (v) Notwithstanding subparagraph (C), the Secretary may not approve an application for a biological product if the sponsor of such application is out of compliance with the requirements of clause (i)(I) with respect to such application. . (c) Enforcement (1) FDA enforcement Section 301 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331 ) is amended by adding at the end the following: (jjj) A failure to comply with a requirement of section 505(b)(7) of this Act or section 351(a)(2)(F) of the Public Health Service Act. . (2) Defense against patent infringement actions (A) In general Chapter 28 of title 35, United States Code, is amended by adding at the end the following: 274. Non-disclosure defense to infringement of drug patent A person shall be entitled to a defense under section 282(b) in an action asserting infringement of an applicable patent (as defined in paragraph (7)(B) of section 505(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(b) ) or subparagraph (F)(ii) of section 351(a)(2) of the Public Health Service Act ( 42 U.S.C. 262(a)(2) )) if the owner or predecessor owner of the applicable patent violated paragraph (7)(A) of such section 505(b) or subparagraph (F)(i) of such section 351(a)(2) with respect to the applicable patent by negligently or intentionally failing to disclose any information required to be disclosed pursuant to such paragraph (7)(A) or such subparagraph (F)(i). . (B) Technical and conforming amendment The table of sections for chapter 28 of title 35, United States Code, is amended by adding at the end the following: 274. Non-disclosure defense to infringement of drug patent. .