[Congressional Record Volume 170, Number 115 (Thursday, July 11, 2024)]
[Senate]
[Page S4737]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

  SA 2399. Mr. CORNYN proposed an amendment to the bill S. 150, to 
amend the Federal Trade Commission Act to prohibit product hopping, and 
for other purposes; as follows:

        Strike all after the enacting clause and insert the 
     following:

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Affordable Prescriptions for 
     Patients Act of 2023''.

     SEC. 2. TITLE 35 AMENDMENTS.

       (a) In General.--Section 271(e) of title 35, United States 
     Code, is amended--
       (1) in paragraph (2)(C), in the flush text following clause 
     (ii), by adding at the end the following: ``With respect to a 
     submission described in clause (ii), the act of infringement 
     shall extend to any patent that claims the biological 
     product, a method of using the biological product, or a 
     method or product used to manufacture the biological 
     product.''; 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; or
       ``(II) for good cause shown, which--
       ``(aa) shall be established if the subsection (k) applicant 
     fails to provide information required section 351(k)(2)(A) of 
     the Public Health Service Act (42 U.S.C. 262(k)(2)(A)) that 
     would enable the reference product sponsor to form a 
     reasonable belief with respect to whether a claim of 
     infringement under this section could reasonably be asserted; 
     and
       ``(bb) may be established--
       ``(AA) if there is a material change to the biological 
     product (or process with respect to the biological product) 
     of the subsection (k) applicant that is the subject of the 
     application;
       ``(BB) if, with respect to a patent on the supplemental 
     list described in section 351(l)(7)(A) of Public Health 
     Service Act (42 U.S.C. 262(l)(7)(A)), the patent would have 
     issued before the date specified in such section 351(l)(7)(A) 
     but for the failure of the Office to issue the patent or a 
     delay in the issuance of the patent, as described in 
     paragraph (1) of section 154(b) and subject to the 
     limitations under paragraph (2) of such section 154(b); or
       ``(CC) for another reason that shows good cause, as 
     determined appropriate by the court.
       ``(D) In determining whether good cause has been shown for 
     the purposes of subparagraph (C)(ii)(II), a court may 
     consider whether the reference product sponsor has provided a 
     reasonable description of the identity and relevance of any 
     information beyond the subsection (k) application that the 
     court believes is necessary to enable the court to form a 
     belief with respect to whether a claim of infringement under 
     this section could reasonably be asserted.
       ``(E) The limitation imposed under subparagraph (A)--
       ``(i) shall apply only if the subsection (k) applicant 
     completes all actions required under paragraphs (2)(A), 
     (3)(B)(ii), (5), (6)(C)(i), (7), and (8)(A) of section 351(l) 
     of the Public Health Service Act (42 U.S.C. 262(l)); and
       ``(ii) shall not apply with respect to any patent that 
     claims, with respect to a biological product, a method for 
     using that product in therapy, diagnosis, or prophylaxis, 
     such as an indication or method of treatment or other 
     condition of use.''.
       (b) Applicability.--The amendments made by subsection (a) 
     shall apply with respect to an application submitted under 
     section 351(k) of the Public Health Service Act (42 U.S.C. 
     262(k)) on or after the date of enactment of this Act.
       (c) Medicare Improvement Fund.--Section 1898(b)(1) of the 
     Social Security Act (42 U.S.C. 1395iii(b)(1)) is amended by 
     striking ``$0'' and inserting ``$1,800,000,000''.
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