S 1041
· 119th Congress
· Commerce
Affordable Prescriptions for Patients Act
Sponsor
Latest action
Placed on Senate Legislative Calendar under General Orders. Calendar No. 44.
Action timeline
Every recorded action on this bill, newest first. Stage badges color-code the legislative path.
Apr 10, 2025
committee
Committee on the Judiciary. Reported by Senator Grassley with amendments. Without written report.
Judiciary Committee
Apr 10, 2025
other
Placed on Senate Legislative Calendar under General Orders. Calendar No. 44.
Apr 03, 2025
committee
Committee on the Judiciary. Ordered to be reported with amendments favorably.
Judiciary Committee
Mar 13, 2025
introduced
Introduced in Senate
Mar 13, 2025
introduced
Read twice and referred to the Committee on the Judiciary.
Judiciary Committee
Text versions
Each stage of the bill — official text published by GPO. Click any format to read on congress.gov / govinfo.
CRS summaries
Plain-English summaries written by the Congressional Research Service — neutral, nonpartisan staff who summarize bills as they advance through stages. The authoritative description of what each version of the bill does.
00
Introduced in Senate
Mar 13, 2025
Affordable Prescriptions for Patients Act
This bill limits in certain instances the number of patents that the manufacturer of a biologic drug can assert in a lawsuit against a company seeking to sell a biosimilar version of that drug. (A biologic drug is produced through natural processes or isolated from natural sources. A biosimilar version is substantially similar to the original biologic, which is the reference product, and is often marketed as a less expensive alternative.)
The bill's provisions apply to an existing framework that gives the biosimilar manufacturer an abbreviated path to Food and Drug Administration approval to sell the biosimilar. Specifically, if the biosimilar manufacturer completes certain actions under the framework, such as sharing certain information about its product with the reference product manufacturer, the bill limits the number of certain patents that the reference product manufacturer may assert in a lawsuit, such as patents that were filed more than four years after the reference product received market approval. The limit shall not apply to patents claiming certain methods for using the biologic drug.
The court in which the infringement lawsuit is filed may increase the limit if justice so requires or if there is good cause for the increase.
via Congressional Research Service · published through congress.gov
Changelog
ⓘ
How a bill moves through Congress. Each stage produces a new official text. The diff between them shows what changed at that step.
ih / is — Introduced in House / Senate. First filed version.rfh / rfs — Referred to a committee for review.rh / rs — Reported back by the committee to the floor (often with amendments — this is where most language changes happen).pcs / pch — Placed on Calendar for floor consideration.eh / es — Engrossed. Passed by the originating chamber. Text is now what was actually voted on.rdh / rds — Received by the other chamber.eah / eas — Engrossed Amendment. The other chamber passed an amended version.ath / ats — Agreed to. Both chambers settled on the same text.enr — Enrolled. Final reconciled text, sent to the President.pl — Public Law. Signed by the President. It's now law.pp — Public Print. Official printing post-enactment.
Most bills die before eh/es. Going from pcs → enr is the full path through both chambers.
ⓘ
How a bill moves through Congress. Each stage produces a new official text. The diff between them shows what changed at that step.
ih/is— Introduced in House / Senate. First filed version.rfh/rfs— Referred to a committee for review.rh/rs— Reported back by the committee to the floor (often with amendments — this is where most language changes happen).pcs/pch— Placed on Calendar for floor consideration.eh/es— Engrossed. Passed by the originating chamber. Text is now what was actually voted on.rdh/rds— Received by the other chamber.eah/eas— Engrossed Amendment. The other chamber passed an amended version.ath/ats— Agreed to. Both chambers settled on the same text.enr— Enrolled. Final reconciled text, sent to the President.pl— Public Law. Signed by the President. It's now law.pp— Public Print. Official printing post-enactment.
Most bills die before eh/es. Going from pcs → enr is the full path through both chambers.
Line-level diff between text versions of this bill — what actually changed at each legislative stage.
+44
−18
34 unchanged
--- Introduced (Senate)
+++ Reported (Senate)
@@ -1,8 +1,9 @@
[From the U.S. Government Publishing Office]
-[S. 1041 Introduced in Senate (IS)]
+[S. 1041 Reported in Senate (RS)]
<DOC>
+Calendar No. 44
119th CONGRESS
1st Session
S. 1041
@@ -19,6 +20,11 @@
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]
_______________________________________________________________________
@@ -39,12 +45,13 @@
(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
+(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
@@ -86,7 +93,7 @@
``(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
+(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
@@ -98,15 +105,15 @@
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
+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
@@ -130,4 +137,23 @@
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.
-<all>
+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
Lobbying activity
Organizations whose LDA filings reference this bill, ranked by filing count. Position not disclosed — LDA does not require lobbyists to report support / oppose / monitor. Bill-number references can be stale (lobbyists sometimes copy text year-over-year), so verify against the filing description.
NOVARTIS
CPT
7
filings · 2026 Q3
7
filings · 2026 Q3
AMGEN INC
CPT
6
filings · 2026 Q3
6
filings · 2026 Q3
5
filings · 2026 Q3
5
filings · 2026 Q3
5
filings · 2026 Q3
AMGEN USA INC.
CPT
5
filings · 2026 Q3
5
filings · 2026 Q3
PFIZER, INC.
CPT
5
filings · 2026 Q3
via Senate LDA · self-reported quarterly. Filing count = filings mentioning this bill (no position required), not money spent on it. Click a client to see all bills they've filed on.
Cosponsors (3)
Members who signed on to support this bill.