[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 1041 Introduced in Senate (IS)]
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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
_______________________________________________________________________
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
(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 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 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.
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