; and (II) in making the certification required under clause (vii), the applicant is not relying in whole or in part on any decision issued by the Patent Trial and Appeal Board in an inter partes review or post-grant review under chapter 31 or 32, respectively, of title 35, United States Code. ; and (4) in the flush text following clause (ix), as added by paragraph (3), by striking (viii) and inserting (ix) . (c) Biosimilar drugs; evaluation by the Secretary Section 351(k) of the Public Health Service Act ( 42 U.S.C. 262(k) ) is amended— (1) in paragraph (2)(A)(iii)— (A) by redesignating subclauses (I) and (II) as items (aa) and (bb), respectively, and adjusting the margins accordingly; (B) in the matter preceding item (aa), as so redesignated, by striking An application and inserting the following: (I) In general An application ; (C) in subclause (I), as so designated— (i) in item (aa), as so redesignated, by striking and at the end; (ii) in item (bb), as so redesignated, by striking the period at the end and inserting ; and ; and (iii) by adding at the end the following: (cc) shall, with respect to a patent described in subclause (II), include a certification that neither the applicant nor any party in privity with, related to, or cooperating with the applicant has filed, or will file, a petition to institute inter partes review or post-grant review of the patent under chapter 31 or 32, respectively, of title 35, United States Code. ; and (D) by adding at the end the following: (II) Patent described A patent is described in this subclause if— (aa) the patent covers the reference product or a method for using the reference product; and (bb) (AA) the reference product described in item (aa) is marked under section 287(a) of title 35, United States Code; or (BB) there is otherwise public notice regarding the applicability of the reference product described in item (aa). ; and (2) in paragraph (3)— (A) in subparagraph (A)(ii), by striking and at the end