S. 150Senate118th Congress (2023-2025)Passed Senate

Affordable Prescriptions for Patients Act of 2023

Introduced January 30, 2023

AI-Generated Summary

Updated January 20, 2026 at 2:42 AM UTC

The Affordable Prescriptions for Patients Act of 2023 changes patent rules for biologic drugs. It limits how many patents a maker of an original biologic can use to sue a competitor seeking approval for a similar product, and sets conditions for which patents count. It also directs $1.8 billion to the Medicare Improvement Fund. The changes affect drug makers, patent owners, and the courts handling these cases.

Key Provisions

  • Adds infringement coverage to patents that claim a biological product, its use, or its manufacturing method.
  • Limits a reference‑product sponsor to asserting no more than 20 patents in an infringement suit, with at most 10 issued after a set date.
  • Defines eligible patents as those filed more than four years after the reference product is approved or that claim a manufacturing method not used by the reference sponsor.
  • Allows a court to increase the patent limit if the request is timely and justified by justice, lack of information, material product changes, or other good cause.
  • Makes the patent limits apply only if the new biologic applicant completes required regulatory steps, and excludes patents covering therapeutic or diagnostic uses of the product.
  • Amends the Social Security Act to allocate $1.8 billion to the Medicare Improvement Fund.

Legislative Activity

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9 earlier actions
HouseFloor Latest Action

Held at the desk.

July 15, 2024 • 2:03 PM

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SenateIntro Referral

Introduced in Senate

January 30, 2023

SenateIntro Referral

Read twice and referred to the Committee on the Judiciary.

January 30, 2023

SenateCommittee

Committee on the Judiciary. Ordered to be reported without amendment favorably.

February 9, 2023

SenateCommittee

Committee on the Judiciary. Reported by Senator Durbin without amendment. Without written report.

March 1, 2023

SenateCalendars

Placed on Senate Legislative Calendar under General Orders. Calendar No. 22.

March 1, 2023

SenateFloor

Measure laid before Senate by unanimous consent. (consideration: CR S4537-4538)

July 11, 2024

SenateFloor

Passed Senate with an amendment by Unanimous Consent. (text of amendment in the nature of a substitute: CR S4537-4538)

July 11, 2024

SenateFloor

Message on Senate action sent to the House.

July 12, 2024

HouseFloor

Received in the House.

July 15, 2024 • 2:02 PM

HouseFloor

Held at the desk.

July 15, 2024 • 2:03 PM

Floor Debate

3 members

What members said about S. 150 on the floor

1 Republican2 Democrats
Morgan McGarvey
Rep. Morgan McGarveyD-KY-3 · Jun 22, 2023

Madam Speaker, I ask unanimous consent that all Members may have 5 legislative days in which to revise and extend their remarks and include extraneous material in the Record. Madam Speaker, I rise…

Becca Balint
Rep. Becca BalintD-VT · Jun 22, 2023

Madam Speaker, I just want to start by giving a heartfelt thank you to my colleague, Morgan McGarvey, a dear friend whose family has become close to my family. Our wives have become close. It just…

John Cornyn
Sen. John CornynR-TX · Jul 11, 2024

Madam President, I am glad the Presiding Officer is in the Chair because, committed as I know she is to solving real problems, the legislation that we are going to pass here momentarily by unanimous…

Bill Text

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Latest
Engrossed in SenateIssued July 11, 2024

118th CONGRESS

2d Session

S. 150

AN ACT

To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes.

1.

Short title

This Act may be cited as the Affordable Prescriptions for Patients Act of 2023.

2.

Title 35 amendments

(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 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.

(c)

Medicare Improvement Fund

Section 1898(b)(1) of the Social Security Act (42 U.S.C. 1395iii(b)(1)) is amended by striking $0 and inserting $1,800,000,000.

Passed the Senate July 11 (legislative day, July 10), 2024.

Secretary