Affordable Prescriptions for Patients Act of 2023

Subjects: Health, Administrative remedies, Civil actions and liability, Competition and antitrust, Consumer affairs, Drug safety, medical device, and laboratory regulation, Federal Trade Commission (FTC), Health care costs and insurance, Inflation and prices, Intellectual property, Judicial review and appeals, Manufacturing, Prescription drugs

Summary:  <p><strong>Affordable Prescriptions for Patients Act of 2023 </strong></p> <p>This bill prohibits product hopping by drug manufacturers, authorizes the Federal Trade Commission to enforce this prohibition, and imposes limits on patent litigation involving biological products. </p> <p>Generally, <em>product-hopping</em> describes a situation where, when the patents on a reference drug (or biological product) expire, the manufacturer switches to a follow-on product that is covered by a later-expiring patent. Under this bill, a <em>follow-on product</em> is a modified version of the reference drug that has an indication (what the drug is used for) that is identical or substantially similar to an indication of the reference drug.</p> <p>The bill presumes product hopping has occurred when a reference drug manufacturer, after receiving notice that the Food and Drug Administration (FDA) has received an application to market a competing generic (or biosimilar) version, takes certain actions such as withdrawing the reference drug from the market and selling a follow-on product. </p> <p>A drug manufacturer may rebut these presumptions by demonstrating that its conduct was not intended to limit competition.</p> <p>The bill also limits in certain instances the number of patents that a reference biological product manufacturer can assert in a patent infringement lawsuit against a company seeking to sell a biosimilar version. Specifically, if the biosimilar manufacturer completes certain actions as part of an abbreviated pathway to get FDA market approval, the bill limits, subject to exceptions and waivers, the number of certain types of patents that the reference product manufacturer may assert, such as patents filed more than four years after the reference product received market approval. </p> </p> <p>

<html><body><pre>[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 150 Introduced in Senate (IS)]

&lt;DOC&gt;






118th CONGRESS
  1st Session
                                 S. 150

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


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            January 30, 2023

Mr. Cornyn (for himself, Mr. Blumenthal, Mr. Grassley, Mr. Durbin, Mr. 
Cruz, and Ms. Klobuchar) introduced the following bill; which was read 
          twice and referred to the Committee on the Judiciary

_______________________________________________________________________

                                 A BILL


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

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

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

SEC. 2. PRODUCT HOPPING.

    (a) In General.--The Federal Trade Commission Act (15 U.S.C. 41 et 
seq.) is amended by inserting after section 26 (15 U.S.C. 57c-2) the 
following:

``SEC. 27. PRODUCT HOPPING.

    ``(a) Definitions.--In this section:
            ``(1) Abbreviated new drug application.--The term 
        `abbreviated new drug application' means any application under 
        subsection (j) of section 505 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 355) or an application under subsection 
        (b)(2) of such section 505 that seeks a therapeutic equivalence 
        rating to the reference product.
            ``(2) Biosimilar biological product.--The term `biosimilar 
        biological product' means a biological product licensed under 
        section 351(k) of the Public Health Service Act (42 U.S.C. 
        262(k)).
            ``(3) Biosimilar biological product license application.--
        The term `biosimilar biological product license application' 
        means an application submitted under section 351(k) of the 
        Public Health Service Act (42 U.S.C. 262(k)).
            ``(4) Follow-on product.--The term `follow-on product'--
                    ``(A) means a drug approved through an application 
                or supplement to an application submitted under section 
                505(b) of the Federal Food, Drug, and Cosmetic Act (21 
                U.S.C. 355(b)) or a biological product licensed through 
                an application or supplement to an application 
                submitted under section 351(a) of the Public Health 
                Service Act (42 U.S.C. 262(a)) for a change or 
                modification to, or reformulation of, the same 
                manufacturer's previously approved drug or biological 
                product that has an indication that is identical or 
                substantively similar to an indication of the same 
                manufacturer's previously approved drug or biological 
                product; and
                    ``(B) excludes such an application or supplement to 
                an application for a change, modification, or 
                reformulation of a drug or biological product that is 
                requested by the Secretary or necessary to comply with 
                law, including sections 505A and 505B of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 355c).
            ``(5) Generic drug.--The term `generic drug' means any drug 
        approved under an application submitted under subsection (j) of 
        section 505 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355) or an application under subsection (b)(2) of such 
        section 505 that seeks a therapeutic equivalence rating to the 
        reference product.
            ``(6) Listed drug.--The term `listed drug' means a drug 
        listed under section 505(j)(7) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 355(j)(7)).
            ``(7) Manufacturer.--The term `manufacturer' means the 
        holder, licensee, or assignee of--
                    ``(A) an approved application for a drug under 
                section 505(c) of the Federal Food, Drug, and Cosmetic 
                Act (21 U.S.C. 355(c)); or
                    ``(B) a biological product license under section 
                351(a) of the Public Health Service Act (42 U.S.C. 
                262(a)).
            ``(8) Reference product.--The term `reference product' has 
        the meaning given the term in section 351(i) of the Public 
        Health Service Act (42 U.S.C. 262(i)).
            ``(9) Ultimate parent entity.--The term `ultimate parent 
        entity' has the meaning given the term in section 801.1 of 
        title 16, Code of Federal Regulations, or any successor 
        regulation.
    ``(b) Prohibition on Product Hopping.--
            ``(1) Prima facie.--A manufacturer of a reference product 
        or listed drug shall be considered to have engaged in an unfair 
        method of competition in or affecting commerce in violation of 
        section 5(a) if complaint counsel or the Commission 
        demonstrates in an action or proceeding initiated by the 
        Commission under subsection (c) that, during the period 
        beginning on the date on which the manufacturer of the 
        reference product or listed drug first receives notice that an 
        applicant has submitted to the Commissioner of Food and Drugs 
        an abbreviated new drug application or biosimilar biological 
        product license application referencing the reference product 
        or listed drug and ending on the date that is the earlier of 
        180 days after the date on which the generic drug or biosimilar 
        biological product that is the subject of the abbreviated new 
        drug application or biosimilar biological product license 
        application or another generic drug or biosimilar biological 
        product referencing the listed drug or reference product is 
        first marketed or 3 years after the date on which the follow-on 
        product is first marketed, the manufacturer engaged in either 
        of the following actions:
                    ``(A) The manufacturer engaged in a hard switch, 
                which shall be established by demonstrating that the 
                manufacturer engaged in either of the following 
                actions:
                            ``(i) Upon the request of the manufacturer 
                        of the listed drug or reference product, the 
                        Commissioner of Food and Drugs withdrew the 
                        approval of the application for the listed drug 
                        or reference product or placed the listed drug 
                        or reference product on the discontinued 
                        products list and the manufacturer marketed or 
                        sold a follow-on product.
                            ``(ii) The manufacturer of the listed drug 
                        or reference product--
                                    ``(I)(aa) withdrew, discontinued 
                                the manufacture of, or announced 
                                withdrawal of, discontinuance of the 
                                manufacture of, or intent to withdraw 
                                the application with respect to the 
                                drug or reference product in a manner 
                                that impedes competition from a generic 
                                drug or a biosimilar biological 
                                product, which may be established by 
                                objective circumstances, unless such 
                                actions were taken by the manufacturer 
                                pursuant to a request of the 
                                Commissioner of Food and Drugs; or
                                    ``(bb) destroyed the inventory of 
                                the listed drug or reference product in 
                                a manner that impedes competition from 
                                a generic drug or a biosimilar 
                                biological product, which may be 
                                established by objective circumstances; 
                                and
                                    ``(II) marketed or sold a follow-on 
                                product.
                    ``(B) The manufacturer engaged in a soft switch, 
                which shall be established by demonstrating that the 
                manufacturer engaged in both of the following actions:
                            ``(i) The manufacturer took actions with 
                        respect to the listed drug or reference product 
                        other than those described in subparagraph (A) 
                        that unfairly disadvantage the listed drug or 
                        reference product relative to the follow-on 
                        product described in clause (ii) in a manner 
                        that impedes competition from a generic drug or 
                        a biosimilar biological product, which may be 
                        established by objective circumstances.
                            ``(ii) The manufacturer marketed or sold a 
                        follow-on product.
            ``(2) Exclusions.--Nothing in this section shall prohibit 
        actions that consist solely of--
                    ``(A) truthful, non-misleading promotional 
                marketing; or
                    ``(B) ceasing promotional marketing for the listed 
                drug or reference product.
            ``(3) Justification.--
                    ``(A) In general.--Subject to paragraph (4), the 
                actions described in paragraph (1) by a manufacturer of 
                a listed drug or reference product shall not be 
                considered to be an unfair method of competition in or 
                affecting commerce if the manufacturer demonstrates to 
                the Commission or a district court of the United 
                States, as applicable, in an action, suit or proceeding 
                initiated by the Commission under subsection (c)(1) 
                that--
                            ``(i) the manufacturer would have taken the 
                        actions regardless of whether a generic drug 
                        that references the listed drug or biosimilar 
                        biological product that references the 
                        reference product had already entered the 
                        market; and
                            ``(ii)(I) with respect to a hard switch 
                        under paragraph (1)(A), the manufacturer took 
                        the action for reasons relating to the safety 
                        risk to patients of the listed drug or 
                        reference product;
                            ``(II) with respect to an action described 
                        in paragraph (1)(A)(ii)(I)(aa), there is a 
                        supply disruption that--
                                    ``(aa) is outside of the control of 
                                the manufacturer;
                                    ``(bb) prevents the production or 
                                distribution of the applicable listed 
                                drug or reference product; and
                                    ``(cc) cannot be remedied by 
                                reasonable efforts; or
                            ``(III) with respect to a soft switch under 
                        paragraph (1)(B), the manufacturer had 
                        legitimate pro-competitive reasons, apart from 
                        the financial effects of reduced competition, 
                        to take the action.
                    ``(B) Rule of construction.--Nothing in 
                subparagraph (A) may be construed to limit the 
                information that the Commission may otherwise obtain in 
                any proceeding or action instituted with respect to a 
                violation of this section.
            ``(4) Response.--With respect to a justification offered by 
        a manufacturer under paragraph (3), the Commission may--
                    ``(A) rebut any evidence presented by a 
                manufacturer during that justification; or
                    ``(B) establish by a preponderance of the evidence 
                that--
                            ``(i) on balance, the pro-competitive 
                        benefits from the conduct described in 
                        subparagraph (A) or (B) of paragraph (1), as 
                        applicable, do not outweigh any anticompetitive 
                        effects of the conduct, even in consideration 
                        of the justification so offered; or
                            ``(ii)(I) the conduct described in 
                        paragraph (1) is not reasonably necessary to 
                        address or achieve the justifications described 
                        in clause (ii) of paragraph (3)(A); or
                            ``(II) the justifications described in 
                        clause (ii) of paragraph (3)(A) could be 
                        reasonably addressed or achieved through less 
                        anticompetitive means.
    ``(c) Enforcement.--
            ``(1) In general.--If the Commission has reason to believe 
        that any manufacturer has violated, is violating, or is about 
        to violate this section, or a rule promulgated under this 
        section, the Commission may take any of the following actions:
                    ``(A) Institute a proceeding under section 5(b).
                    ``(B) In the same manner and to the same extent as 
                provided in section 13(b), bring suit in a district 
                court of the United States to temporarily enjoin the 
                action of the manufacturer.
                    ``(C) Bring suit in a district court of the United 
                States, in which the Commission may seek--
                            ``(i) to permanently enjoin the action of 
                        the manufacturer;
                            ``(ii) any of the remedies described in 
                        paragraph (3); and
                            ``(iii) any other equitable remedy, 
                        including ancillary equitable relief.
            ``(2) Judicial review.--
                    ``(A) In general.--Notwithstanding any provision of 
                section 5, any manufacturer that is subject to a final 
                cease and desist order issued in a proceeding to 
                enforce this section, or a rule promulgated under this 
                section, may, not later than 30 days after the date on 
                which the Commission issues the order, petition for 
                review of the order in--
                            ``(i) the United States Court of Appeals 
                        for the District of Columbia Circuit; or
                            ``(ii) the court of appeals of the United 
                        States for the circuit in which the ultimate 
                        parent entity of the manufacturer is 
                        incorporated.
                    ``(B) Treatment of findings.--In a review of a 
                final cease and desist order conducted by a court of 
                appeals of the United States under subparagraph (A), 
                the factual findings of the Commission shall be 
                conclusive if those facts are supported by the 
                evidence.
            ``(3) Equitable remedies.--
                    ``(A) Disgorgement.--
                            ``(i) In general.--In a suit brought under 
                        paragraph (1)(C), the Commission may seek, and 
                        the court may order, disgorgement of any unjust 
                        enrichment that a person obtained as a result 
                        of the violation that gives rise to the suit.
                            ``(ii) Calculation.--Any disgorgement that 
                        is ordered with respect to a person under 
                        clause (i) shall be offset by any amount of 
                        restitution ordered under subparagraph (B).
                            ``(iii) Limitations period.--The Commission 
                        may seek disgorgement under this subparagraph 
                        not later than 5 years after the latest date on 
                        which the person from which the disgorgement is 
                        sought receives any unjust enrichment from the 
                        effects of the violation that gives rise to the 
                        suit in which the Commission seeks the 
                        disgorgement.
                    ``(B) Restitution.--
                            ``(i) In general.--In a suit brought under 
                        paragraph (1)(C), the Commission may seek, and 
                        the court may order, restitution with respect 
                        to the violation that gives rise to the suit.
                            ``(ii) Limitations period.--The Commission 
                        may seek restitution under this subparagraph 
                        not later than 5 years after the latest date on 
                        which the person from which the restitution is 
                        sought receives any unjust enrichment from the 
                        effects of the violation that gives rise to the 
                        suit in which the Commission seeks the 
                        restitution.
            ``(4) Rules of construction.--Nothing in this subsection 
        may be construed as--
                    ``(A) requiring the Commission to bring a suit 
                seeking a temporary injunction under paragraph (1)(B) 
                before bringing a suit seeking a permanent injunction 
                under paragraph (1)(C); or
                    ``(B) affecting the authority of the Federal Trade 
                Commission under any other provision of law.''.
    (b) Applicability.--Section 27 of the Federal Trade Commission Act, 
as added by subsection (a), shall apply with respect to any--
            (1) conduct that occurs on or after the date of enactment 
        of this Act; and
            (2) action or proceeding that is commenced on or after the 
        date of enactment of this Act.
    (c) Antitrust Laws.--Except to the extent subsection (a) 
establishes an additional basis for liability under the Federal Trade 
Commission Act (15 U.S.C. 41 et seq.), nothing in this section, or the 
amendments made by this section, shall modify, impair, limit, or 
supersede the applicability of the antitrust laws as defined in 
subsection (a) of the first section of the Clayton Act (15 U.S.C. 12), 
or of section 5 of the Federal Trade Commission Act (15 U.S.C. 45) to 
the extent that it applies to unfair methods of competition.
    (d) Rulemaking.--The Federal Trade Commission may issue rules under 
section 553 of title 5, United States Code, to define any terms used in 
section 27 of the Federal Trade Commission Act, as added by subsection 
(a) (other than terms that are defined in subsection (a) of such 
section 27).

SEC. 3. 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.
                                 &lt;all&gt;
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