; and (2) by adding at the end the following: (7) (A) Subject to subparagraphs (C), (D), and (E), if the sponsor of an approved application for a reference product, as defined in section 351(i) of the Public Health Service Act ( 42 U.S.C. 262(i) ) (referred to in this paragraph as the reference product sponsor ), brings an action for infringement under this section against an applicant for approval of a biological product under section 351(k) of such Act that references that reference product (referred to in this paragraph as the subsection (k) applicant ), the reference product sponsor may assert in the action a total of not more than 20 patents of the type described in subparagraph (B), not more than 10 of which shall have issued after the date specified in section 351(l)(7)(A) of such Act. (B) The patents described in this subparagraph are patents that satisfy each of the following requirements: (i) Patents that claim the biological product that is the subject of an application under section 351(k) of the Public Health Service Act ( 42 U.S.C. 262(k) ) (or a use of that product) or a method or product used in the manufacture of such biological product. (ii) Patents that are included on the list of patents described in paragraph (3)(A) of section 351(l) of the Public Health Service Act ( 42 U.S.C. 262(l) ), including as provided under paragraph (7) of such section 351(l). (iii) Patents that— (I) have an actual filing date of more than 4 years after the date on which the reference product is approved; or (II) include a claim to a method in a manufacturing process that is not used by the reference product sponsor. (C) The court in which an action described in subparagraph (A) is brought may increase the number of patents limited under that subparagraph— (i) if the request to increase that number is made without undue delay; and (ii) (I) if the interest of justice so requires