[Congressional Record Volume 172, Number 119 (Tuesday, July 21, 2026)]
[Senate]
[Pages S4198-S4199]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
AFFORDABLE PRESCRIPTIONS FOR PATIENTS ACT
Mr. CASSIDY. Mr. President, as regards Calendar No. 44, S. 1041, the
Affordable Prescriptions for Patients Act, I ask unanimous consent that
the Senate proceed to the immediate consideration of Calendar No. 44,
S. 1041.
The PRESIDING OFFICER. The clerk will report the bill by title.
The senior assistant legislative clerk read as follows:
A bill (S. 1041) to amend title 35, United States Code, to
address the infringement of patents that claim biological
products, and for other purposes.
There being no objection, the Senate proceeded to consider the bill,
which had been reported from the Committee on the Judiciary with
amendments as follows:
(The parts of the bill intended to be stricken are in boldfaced
brackets and the parts of the bill intended to be inserted are in
italic.)
S. 1041
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
[[Page S4199]]
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.
Mr. CASSIDY. I ask unanimous consent that the committee-reported
amendments be considered and agreed to; that the bill, as amended, be
considered read a third time and passed; and that the motion to
reconsider be considered made and laid upon the table.
The PRESIDING OFFICER. Without objection, it is so ordered.
The committee-reported amendments were agreed to.
The bill (S. 1041), as amended, was ordered to be engrossed for a
third reading, was read the third time, and passed as follows:
S. 1041
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.
(a) In General.--Section 271(e) of title 35, United States
Code, is amended--
(1) in paragraph (2), in the flush text following
subparagraph (C)(ii), by adding at the end the following:
``With respect to a submission described in 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) of the Public Health
Service Act (42 U.S.C. 262(l)(7)), the patent would have
issued before the date specified in 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.
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