II
119THCONGRESS
1
STSESSION 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
MARCH13, 2025
Mr. C
ORNYN(for himself, Mr. BLUMENTHAL, Mr. GRASSLEY, and Mr. DUR-
BIN) 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 in-
fringement of patents that claim biological products, and
for other purposes.
Be it enacted by the Senate and House of Representa-1
tives of the United States of America in Congress assembled, 2
SECTION 1. SHORT TITLE. 3
This Act may be cited as the ‘‘Affordable Prescrip-4
tions for Patients Act’’. 5
SEC. 2. PATENT INFRINGEMENT; MEDICARE IMPROVEMENT 6
FUND. 7
(a) I
NGENERAL.—Section 271(e) of title 35, United 8
States Code, is amended— 9
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(1) in paragraph (2)(C), in the flush text fol-1
lowing clause (ii), by adding at the end the fol-2
lowing: ‘‘With respect to a submission described in 3
clause (ii), the act of infringement shall extend to 4
any patent that claims the biological product, a 5
method of using the biological product, or a method 6
or product used to manufacture the biological prod-7
uct.’’; and 8
(2) by adding at the end the following: 9
‘‘(7)(A) Subject to subparagraphs (C), (D), and (E), 10
if the sponsor of an approved application for a reference 11
product, as defined in section 351(i) of the Public Health 12
Service Act (42 U.S.C. 262(i)) (referred to in this para-13
graph as the ‘reference product sponsor’), brings an action 14
for infringement under this section against an applicant 15
for approval of a biological product under section 351(k) 16
of such Act that references that reference product (re-17
ferred to in this paragraph as the ‘subsection (k) appli-18
cant’), the reference product sponsor may assert in the 19
action a total of not more than 20 patents of the type 20
described in subparagraph (B), not more than 10 of which 21
shall have issued after the date specified in section 22
351(l)(7)(A) of such Act. 23
‘‘(B) The patents described in this subparagraph are 24
patents that satisfy each of the following requirements: 25
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‘‘(i) Patents that claim the biological product 1
that is the subject of an application under section 2
351(k) of the Public Health Service Act (42 U.S.C. 3
262(k)) (or a use of that product) or a method or 4
product used in the manufacture of such biological 5
product. 6
‘‘(ii) Patents that are included on the list of 7
patents described in paragraph (3)(A) of section 8
351(l) of the Public Health Service Act (42 U.S.C. 9
262(l)), including as provided under paragraph (7) 10
of such section 351(l). 11
‘‘(iii) Patents that— 12
‘‘(I) have an actual filing date of more 13
than 4 years after the date on which the ref-14
erence product is approved; or 15
‘‘(II) include a claim to a method in a 16
manufacturing process that is not used by the 17
reference product sponsor. 18
‘‘(C) The court in which an action described in sub-19
paragraph (A) is brought may increase the number of pat-20
ents limited under that subparagraph— 21
‘‘(i) if the request to increase that number is 22
made without undue delay; and 23
‘‘(ii)(I) if the interest of justice so requires; or 24
‘‘(II) for good cause shown, which— 25
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‘‘(aa) shall be established if the subsection 1
(k) applicant fails to provide information re-2
quired by section 351(k)(2)(A) of the Public 3
Health Service Act (42 U.S.C. 262(k)(2)(A)) 4
that would enable the reference product sponsor 5
to form a reasonable belief with respect to 6
whether a claim of infringement under this sec-7
tion could reasonably be asserted; and 8
‘‘(bb) may be established— 9
‘‘(AA) if there is a material change to 10
the biological product (or process with re-11
spect to the biological product) of the sub-12
section (k) applicant that is the subject of 13
the application; 14
‘‘(BB) if, with respect to a patent on 15
the supplemental list described in section 16
351(l)(7)(A) of Public Health Service Act 17
(42 U.S.C. 262(l)(7)(A)), the patent would 18
have issued before the date specified in 19
such section 351(l)(7)(A) but for the fail-20
ure of the Office to issue the patent or a 21
delay in the issuance of the patent, as de-22
scribed in paragraph (1) of section 154(b) 23
and subject to the limitations under para-24
graph (2) of such section 154(b); or 25
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‘‘(CC) for another reason that shows 1
good cause, as determined appropriate by 2
the court. 3
‘‘(D) In determining whether good cause has been 4
shown for the purposes of subparagraph (C)(ii)(II), a 5
court may consider whether the reference product sponsor 6
has provided a reasonable description of the identity and 7
relevance of any information beyond the subsection (k) ap-8
plication that the court believes is necessary to enable the 9
court to form a belief with respect to whether a claim of 10
infringement under this section could reasonably be as-11
serted. 12
‘‘(E) The limitation imposed under subparagraph 13
(A)— 14
‘‘(i) shall apply only if the subsection (k) appli-15
cant completes all actions required under paragraphs 16
(2)(A), (3)(B)(ii), (5), (6)(C)(i), (7), and (8)(A) of 17
section 351(l) of the Public Health Service Act (42 18
U.S.C. 262(l)); and 19
‘‘(ii) shall not apply with respect to any patent 20
that claims, with respect to a biological product, a 21
method for using that product in therapy, diagnosis, 22
or prophylaxis, such as an indication or method of 23
treatment or other condition of use.’’. 24
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(b) APPLICABILITY.—The amendments made by sub-1
section (a) shall apply with respect to an application sub-2
mitted under section 351(k) of the Public Health Service 3
Act (42 U.S.C. 262(k)) on or after the date of enactment 4
of this Act. 5
Æ
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