119-s1041

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 1041 Reported in Senate

    (RS) ]

<DOC>

 Calendar No. 44
119th CONGRESS
 1st Session
 S. 1041

 To amend title 35, United States Code, to address the infringement of 
 patents that claim biological products, and for other purposes.

_______________________________________________________________________

 IN THE SENATE OF THE UNITED STATES

 March 13, 2025

Mr. Cornyn (for himself, Mr. Blumenthal, Mr. Grassley, and Mr. Durbin) 
introduced the following bill; which was read twice and referred to the 
 Committee on the Judiciary

 April 10, 2025

 Reported by Mr. Grassley, with amendments
 [Omit the parts struck through and insert the parts printed in italic]

_______________________________________________________________________

 A BILL

 To amend title 35, United States Code, to address the infringement of 
 patents that claim biological products, and for other purposes.

 Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

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

SEC. 2. PATENT INFRINGEMENT; MEDICARE IMPROVEMENT FUND.

    (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 subparagraph
            (C) 
            (ii) , by adding at the end the 
 following: ``With respect to a submission described in clause 
 subparagraph
            (C) 
            (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 by 
 

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 the 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) of such Act 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.
 Calendar No. 44

119th CONGRESS

 1st Session

 S. 1041

_______________________________________________________________________

 A BILL

 To amend title 35, United States Code, to address the infringement of 
 patents that claim biological products, and for other purposes.

_______________________________________________________________________

 April 10, 2025

 Reported with amendments