any allegation made to an ANDA filer, whether or not included in a complaint filed with a court, that the ANDA filer’s ANDA or ANDA product may infringe any of the following held by, or exclusively licensed to, the NDA holder of the drug product: (A) Any patent. (B) Any filed patent application. (C) Any extension, reissue, renewal, division, continuation, continuation in part, or reexamination of a patent. (D) Any patent term restoration, patents of addition, or extensions thereof. (E) Any other patent interest. (8) Statutory exclusivity The term statutory exclusivity means those prohibitions on the approval of drug applications under clauses (ii) through (iv) of section 505(c)(3)(E) (5- and 3-year data exclusivity), section 527 (orphan drug exclusivity), section 505A (pediatric exclusivity), or section 505E (qualified infectious disease product exclusivity) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(c)(3)(E) , 360cc, 355a, 355f). . (b) Applicability Section 27 of the Federal Trade Commission Act, as added by this section, shall apply to any agreement described in section 27(a)(2)(A) of that Act entered into after June 17, 2013. Section 27(f) of the Federal Trade Commission Act, as added by this section, shall apply to agreements entered into on or after the date of enactment of this Act. 5. Notice and certification of agreements (a) Notice of all agreements Section 1112(c)(2) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 ( 21 U.S.C. 355 note) is amended by— (1) striking the Commission the and inserting the following: “the Commission— (A) the