What This Bill Does
This bill amends patent law related to biological products, which are medicines made from living organisms. The bill limits the number of patents that original manufacturers can use in lawsuits against companies seeking to make generic versions of these biological products.
Who It Affects
Pharmaceutical companies that make original biological products and companies that want to create generic versions of those products. The Federal Trade Commission and patent courts may also be involved in enforcing these rules.
Key Provisions
* Original product makers can assert no more than 20 patents total in a lawsuit, with no more than 10 being patents issued after a specific date in the Public Health Service Act (Sec. 2(a)(2))
* Patents eligible for these lawsuits must claim the biological product itself, how to use it, or how to manufacture it, AND must be on an official patent list (Sec. 2(a)(2))
* Courts can increase the number of allowed patents if the generic company fails to provide required information or if there are material changes to the product (Sec. 2(a)(2))
* The patent limits do not apply to patents claiming methods for using a biological product in therapy, diagnosis, or treatment (Sec. 2(a)(2))
What Changes
If this becomes law, original drug makers will be restricted in how many patents they can use in court against generic drug makers. This applies to all applications for generic biological products submitted on or after the bill becomes law (Sec. 2(b)).
Important Definitions
Reference product: The original biological product approved by the government (Sec. 2(a)(2))
Subsection (k) applicant: A company seeking approval to make a generic version of a biological product (Sec. 2(a)(2))
Effective Date
The bill applies to applications submitted on or after the date the bill becomes law (Sec. 2(b)). The specific enactment date is not specified in the bill text.
118TH CONGRESS
2D SESSION
S. 150
AN ACT
To amend the Federal Trade Commission Act to prohibit
product hopping, and for other purposes.
Be it enacted by the Senate and House of Representa-
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tives of the United States of America in Congress assembled,
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† S 150 ES
SECTION 1. SHORT TITLE.
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This Act may be cited as the ‘‘Affordable Prescrip-
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tions for Patients Act of 2023’’.
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SEC. 2. TITLE 35 AMENDMENTS.
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(a) IN GENERAL.—Section 271(e) of title 35, United
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States Code, is amended—
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(1) in paragraph (2)(C), in the flush text fol-
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lowing clause (ii), by adding at the end the fol-
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lowing: ‘‘With respect to a submission described in
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clause (ii), the act of infringement shall extend to
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any patent that claims the biological product, a
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method of using the biological product, or a method
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or product used to manufacture the biological prod-
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uct.’’; and
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(2) by adding at the end the following:
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‘‘(7)(A) Subject to subparagraphs (C), (D), and (E),
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if the sponsor of an approved application for a reference
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product, as defined in section 351(i) of the Public Health
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Service Act (42 U.S.C. 262(i)) (referred to in this para-
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graph as the ‘reference product sponsor’), brings an action
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for infringement under this section against an applicant
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for approval of a biological product under section 351(k)
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of such Act that references that reference product (re-
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ferred to in this paragraph as the ‘subsection (k) appli-
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cant’), the reference product sponsor may assert in the
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action a total of not more than 20 patents of the type
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† S 150 ES
described in subparagraph (B), not more than 10 of which
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shall have issued after the date specified in section
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351(l)(7)(A) of such Act.
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‘‘(B) The patents described in this subparagraph are
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patents that satisfy each of the following requirements:
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‘‘(i) Patents that claim the biological product
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that is the subject of an application under section
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351(k) of the Public Health Service Act (42 U.S.C.
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262(k)) (or a use of that product) or a method or
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product used in the manufacture of such biological
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product.
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‘‘(ii) Patents that are included on the list of
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patents described in paragraph (3)(A) of section
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351(l) of the Public Health Service Act (42 U.S.C.
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262(l)), including as provided under paragraph (7)
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of such section 351(l).
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‘‘(iii) Patents that—
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‘‘(I) have an actual filing date of more
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than 4 years after the date on which the ref-
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erence product is approved; or
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‘‘(II) include a claim to a method in a
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manufacturing process that is not used by the
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reference product sponsor.
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† S 150 ES
‘‘(C) The court in which an action described in sub-
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paragraph (A) is brought may increase the number of pat-
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ents limited under that subparagraph—
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‘‘(i) if the request to increase that number is
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made without undue delay; and
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‘‘(ii)(I) if the interest of justice so requires; or
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‘‘(II) for good cause shown, which—
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‘‘(aa) shall be established if the subsection
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(k) applicant fails to provide information re-
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quired section 351(k)(2)(A) of the Public
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Health Service Act (42 U.S.C. 262(k)(2)(A))
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that would enable the reference product sponsor
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to form a reasonable belief with respect to
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whether a claim of infringement under this sec-
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tion could reasonably be asserted; and
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‘‘(bb) may be established—
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‘‘(AA) if there is a material change to
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the biological product (or process with re-
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spect to the biological product) of the sub-
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section (k) applicant that is the subject of
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the application;
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‘‘(BB) if, with respect to a patent on
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the supplemental list described in section
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351(l)(7)(A) of Public Health Service Act
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(42 U.S.C. 262(l)(7)(A)), the patent would
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† S 150 ES
have issued before the date specified in
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such section 351(l)(7)(A) but for the fail-
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ure of the Office to issue the patent or a
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delay in the issuance of the patent, as de-
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scribed in paragraph (1) of section 154(b)
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and subject to the limitations under para-
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graph (2) of such section 154(b); or
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‘‘(CC) for another reason that shows
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good cause, as determined appropriate by
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the court.
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‘‘(D) In determining whether good cause has been
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shown for the purposes of subparagraph (C)(ii)(II), a
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court may consider whether the reference product sponsor
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has provided a reasonable description of the identity and
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relevance of any information beyond the subsection (k) ap-
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plication that the court believes is necessary to enable the
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court to form a belief with respect to whether a claim of
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infringement under this section could reasonably be as-
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serted.
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‘‘(E) The limitation imposed under subparagraph
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(A)—
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‘‘(i) shall apply only if the subsection (k) appli-
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cant completes all actions required under paragraphs
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(2)(A), (3)(B)(ii), (5), (6)(C)(i), (7), and (8)(A) of
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† S 150 ES
section 351(l) of the Public Health Service Act (42
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U.S.C. 262(l)); and
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‘‘(ii) shall not apply with respect to any patent
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that claims, with respect to a biological product, a
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method for using that product in therapy, diagnosis,
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or prophylaxis, such as an indication or method of
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treatment or other condition of use.’’.
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(b) APPLICABILITY.—The amendments made by sub-
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section (a) shall apply with respect to an application sub-
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mitted under section 351(k) of the Public Health Service
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Act (42 U.S.C. 262(k)) on or after the date of enactment
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of this Act.
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(c)
MEDICARE
IMPROVEMENT
FUND.—Section
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1898(b)(1) of the Social Security Act (42 U.S.C.
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1395iii(b)(1)) is amended by striking ‘‘$0’’ and inserting
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‘‘$1,800,000,000’’.
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Passed the Senate July 11 (legislative day, July 10),
2024.
Attest:
Secretary.
118TH CONGRESS
2D SESSION
S. 150
AN ACT
To amend the Federal Trade Commission Act to
prohibit product hopping, and for other purposes.