II
Calendar No. 44
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
PRIL10, 2025
Reported by Mr. G
RASSLEY, 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 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
VerDate Sep 11 2014 19:09 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1041.RS S1041
ssavage on LAPJG3WLY3PROD with BILLS 2
•S 1041 RS
SEC. 2. PATENT INFRINGEMENT ;MEDICARE IMPROVEMENT 1
FUND. 2
(a) I
NGENERAL.—Section 271(e) of title 35, United 3
States Code, is amended— 4
(1) in paragraph (2)
(C), in the flush text fol-5
lowing clausesubparagraph (C)(ii), by adding at the 6
end the following: ‘‘With respect to a submission de-7
scribed in clausesubparagraph (C)(ii), the act of in-8
fringement shall extend to any patent that claims 9
the biological product, a method of using the biologi-10
cal product, or a method or product used to manu-11
facture the biological product.’’; and 12
(2) by adding at the end the following: 13
‘‘(7)(A) Subject to subparagraphs (C), (D), and (E), 14
if the sponsor of an approved application for a reference 15
product, as defined in section 351(i) of the Public Health 16
Service Act (42 U.S.C. 262(i)) (referred to in this para-17
graph as the ‘reference product sponsor’), brings an action 18
for infringement under this section against an applicant 19
for approval of a biological product under section 351(k) 20
of such Act that references that reference product (re-21
ferred to in this paragraph as the ‘subsection (k) appli-22
cant’), the reference product sponsor may assert in the 23
action a total of not more than 20 patents of the type 24
described in subparagraph (B), not more than 10 of which 25
VerDate Sep 11 2014 19:09 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1041.RS S1041
ssavage on LAPJG3WLY3PROD with BILLS 3
•S 1041 RS
shall have issued after the date specified in section 1
351(l)(7)(A) of such Act. 2
‘‘(B) The patents described in this subparagraph are 3
patents that satisfy each of the following requirements: 4
‘‘(i) Patents that claim the biological product 5
that is the subject of an application under section 6
351(k) of the Public Health Service Act (42 U.S.C. 7
262(k)) (or a use of that product) or a method or 8
product used in the manufacture of such biological 9
product. 10
‘‘(ii) Patents that are included on the list of 11
patents described in paragraph (3)(A) of section 12
351(l) of the Public Health Service Act (42 U.S.C. 13
262(l)), including as provided under paragraph (7) 14
of such section 351(l). 15
‘‘(iii) Patents that— 16
‘‘(I) have an actual filing date of more 17
than 4 years after the date on which the ref-18
erence product is approved; or 19
‘‘(II) include a claim to a method in a 20
manufacturing process that is not used by the 21
reference product sponsor. 22
‘‘(C) The court in which an action described in sub-23
paragraph (A) is brought may increase the number of pat-24
ents limited under that subparagraph— 25
VerDate Sep 11 2014 19:09 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1041.RS S1041
ssavage on LAPJG3WLY3PROD with BILLS 4
•S 1041 RS
‘‘(i) if the request to increase that number is 1
made without undue delay; and 2
‘‘(ii)(I) if the interest of justice so requires; or 3
‘‘(II) for good cause shown, which— 4
‘‘(aa) shall be established if the subsection 5
(k) applicant fails to provide information re-6
quired by section 351(k)(2)(A) of the Public 7
Health Service Act (42. U.S.C. 262(k)(2)(A)) 8
that would enable the reference product sponsor 9
to form a reasonable belief with respect to 10
whether a claim of infringement under this sec-11
tion could reasonably be asserted; and 12
‘‘(bb) may be established— 13
‘‘(AA) if there is a material change to 14
the biological product (or process with re-15
spect to the biological product) of the sub-16
section (k) applicant that is the subject of 17
the application; 18
‘‘(BB) if, with respect to a patent on 19
the supplemental list described in section 20
351(l)(7) (A) of the Public Health Service 21
Act (42 U.S.C. 262(l)(7) (A)), the patent 22
would have issued before the date specified 23
in such section 351(l)(7)(A) of such Act 24
but for the failure of the Office to issue 25
VerDate Sep 11 2014 19:09 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1041.RS S1041
ssavage on LAPJG3WLY3PROD with BILLS 5
•S 1041 RS
the patent or a delay in the issuance of the 1
patent, as described in paragraph (1) of 2
section 154(b) and subject to the limita-3
tions under paragraph (2) of such section 4
154(b); or 5
‘‘(CC) for another reason that shows 6
good cause, as determined appropriate by 7
the court. 8
‘‘(D) In determining whether good cause has been 9
shown for the purposes of subparagraph (C)(ii)(II), a 10
court may consider whether the reference product sponsor 11
has provided a reasonable description of the identity and 12
relevance of any information beyond the subsection (k) ap-13
plication that the court believes is necessary to enable the 14
court to form a belief with respect to whether a claim of 15
infringement under this section could reasonably be as-16
serted. 17
‘‘(E) The limitation imposed under subparagraph 18
(A)— 19
‘‘(i) shall apply only if the subsection (k) appli-20
cant completes all actions required under paragraphs 21
(2)(A), (3)(B)(ii), (5), (6)(C)(i), (7), and (8)(A) of 22
section 351(l) of the Public Health Service Act (42 23
U.S.C. 262(l)); and 24
VerDate Sep 11 2014 19:09 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S1041.RS S1041
ssavage on LAPJG3WLY3PROD with BILLS 6
•S 1041 RS
‘‘(ii) shall not apply with respect to any patent 1
that claims, with respect to a biological product, a 2
method for using that product in therapy, diagnosis, 3
or prophylaxis, such as an indication or method of 4
treatment or other condition of use.’’. 5
(b) A
PPLICABILITY.—The amendments made by sub-6
section (a) shall apply with respect to an application sub-7
mitted under section 351(k) of the Public Health Service 8
Act (42 U.S.C. 262(k)) on or after the date of enactment 9
of this Act. 10
VerDate Sep 11 2014 19:09 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S1041.RS S1041
ssavage on LAPJG3WLY3PROD with BILLS VerDate Sep 11 2014 19:09 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S1041.RS S1041
ssavage on LAPJG3WLY3PROD with BILLS Calendar No.
44
119
TH
CONGRESS
1
ST
S
ESSION
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.
A
PRIL
10, 2025
Reported with amendments
VerDate Sep 11 2014 19:09 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00008 Fmt 6651 Sfmt 6651 E:\BILLS\S1041.RS S1041
ssavage on LAPJG3WLY3PROD with BILLS