```

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2486 Engrossed Amendment House (EAH)]

<DOC>
                In the House of Representatives, U. S.,

                                                         July 22, 2020.
    Resolved, That the House agree to the amendment of the Senate to 
the bill (H.R. 2486) entitled ``An Act to reauthorize mandatory funding 
programs for historically Black colleges and universities and other 
minority-serving institutions.'', with the following

                 HOUSE AMENDMENTS TO SENATE AMENDMENT:

(1)In the matter proposed to be inserted by the amendment of the 
Senate, strike sections 1, 2, and 3 and insert the following:

                          TITLE I--NO BAN ACT

SEC. 101. SHORT TITLES.

    This title may be cited as the ``National Origin-Based 
Antidiscrimination for Nonimmigrants Act'' or the ``NO BAN Act''.

SEC. 102. EXPANSION OF NONDISCRIMINATION PROVISION.

    Section 202(a)(1)(A) of the Immigration and Nationality Act (8 
U.S.C. 1152(a)(1)(A)) is amended--
            (1) by inserting ``or a nonimmigrant visa, admission or 
        other entry into the United States, or the approval or 
        revocation of any immigration benefit'' after ``immigrant 
        visa'';
            (2) by inserting ``religion,'' after ``sex,''; and
            (3) by inserting ``, except if expressly required by 
        statute, or if a statutorily authorized benefit takes into 
        consideration such factors'' before the period at the end.

SEC. 103. TRANSFER AND LIMITATIONS ON AUTHORITY TO SUSPEND OR RESTRICT 
              THE ENTRY OF A CLASS OF ALIENS.

    Section 212(f) of the Immigration and Nationality Act (8 U.S.C. 
1182(f)) is amended to read as follows:
    ``(f) Authority to Suspend or Restrict the Entry of a Class of 
Aliens.--
            ``(1) In general.--Subject to paragraph (2), if the 
        Secretary of State, in consultation with the Secretary of 
        Homeland Security, determines, based on specific and credible 
        facts, that the entry of any aliens or any class of aliens into 
        the United States would undermine the security or public safety 
        of the United States or the preservation of human rights, 
        democratic processes or institutions, or international 
        stability, the President may temporarily--
                    ``(A) suspend the entry of such aliens or class of 
                aliens as immigrants or nonimmigrants; or
                    ``(B) impose any restrictions on the entry of such 
                aliens that the President deems appropriate.
            ``(2) Limitations.--In carrying out paragraph (1), the 
        President, the Secretary of State, and the Secretary of 
        Homeland Security shall--
                    ``(A) only issue a suspension or restriction when 
                required to address specific acts implicating a 
                compelling government interest in a factor identified 
                in paragraph (1);
                    ``(B) narrowly tailor the suspension or 
                restriction, using the least restrictive means, to 
                achieve such compelling government interest;
                    ``(C) specify the duration of the suspension or 
                restriction; and
                    ``(D) consider waivers to any class-based 
                restriction or suspension and apply a rebuttable 
                presumption in favor of granting family-based and 
                humanitarian waivers.
            ``(3) Congressional notification.--
                    ``(A) In general.--Prior to the President 
                exercising the authority under paragraph (1), the 
                Secretary of State and the Secretary of Homeland 
                Security shall consult Congress and provide Congress 
                with specific evidence supporting the need for the 
                suspension or restriction and its proposed duration.
                    ``(B) Briefing and report.--Not later than 48 hours 
                after the President exercises the authority under 
                paragraph (1), the Secretary of State and the Secretary 
                of Homeland Security shall provide a briefing and 
                submit a written report to Congress that describes--
                            ``(i) the action taken pursuant to 
                        paragraph (1) and the specified objective of 
                        such action;
                            ``(ii) the estimated number of individuals 
                        who will be impacted by such action;
                            ``(iii) the constitutional and legislative 
                        authority under which such action took place; 
                        and
                            ``(iv) the circumstances necessitating such 
                        action, including how such action complies with 
                        paragraph (2), as well as any intelligence 
                        informing such actions.
                    ``(C) Termination.--If the briefing and report 
                described in subparagraph (B) are not provided to 
                Congress during the 48 hours that begin when the 
                President exercises the authority under paragraph (1), 
                the suspension or restriction shall immediately 
                terminate absent intervening congressional action.
                    ``(D) Congressional committees.--The term 
                `Congress', as used in this paragraph, refers to the 
                Select Committee on Intelligence of the Senate, the 
                Committee on Foreign Relations of the Senate, the 
                Committee on the Judiciary of the Senate, the Committee 
                on Homeland Security and Governmental Affairs of the 
                Senate, the Permanent Select Committee on Intelligence 
                of the House of Representatives, the Committee on 
                Foreign Affairs of the House of Representatives, the 
                Committee on the Judiciary of the House of 
                Representatives, and the Committee on Homeland Security 
                of the House of Representatives.
            ``(4) Publication.--The Secretary of State and the 
        Secretary of Homeland Security shall publicly announce and 
        publish an unclassified version of the report described in 
        paragraph (3)(B) in the Federal Register.
            ``(5) Judicial review.--
                    ``(A) In general.--Notwithstanding any other 
                provision of law, an individual or entity who is 
                present in the United States and has been harmed by a 
                violation of this subsection may file an action in an 
                appropriate district court of the United States to seek 
                declaratory or injunctive relief.
                    ``(B) Class action.--Nothing in this Act may be 
                construed to preclude an action filed pursuant to 
                subparagraph (A) from proceeding as a class action.
            ``(6) Treatment of commercial airlines.--Whenever the 
        Secretary of Homeland Security finds that a commercial airline 
        has failed to comply with regulations of the Secretary of 
        Homeland Security relating to requirements of airlines for the 
        detection of fraudulent documents used by passengers traveling 
        to the United States (including the training of personnel in 
        such detection), the Secretary of Homeland Security may suspend 
        the entry of some or all aliens transported to the United 
        States by such airline.
            ``(7) Rule of construction.--Nothing in this section may be 
        construed as authorizing the President, the Secretary of State, 
        or the Secretary of Homeland Security to act in a manner 
        inconsistent with the policy decisions expressed in the 
        immigration laws.
            ``(8) Clarification.--For purposes of paragraph (1), the 
        term `public safety of the United States' includes efforts 
        necessary to contain a communicable disease of public health 
        significance (as defined in section 34.2(b) of title 42, Code 
        of Federal Regulations (or any successor regulation)).''.

SEC. 104. TERMINATION OF CERTAIN EXECUTIVE ACTIONS.

    (a) Termination.--Presidential Proclamations 9645, 9822, and 9983 
and Executive Orders 13769, 13780, and 13815 shall be void beginning on 
the date of the enactment of this Act.
    (b) Effect.--All actions taken pursuant to any proclamation or 
executive order terminated under subsection (a) shall cease on the date 
of the enactment of this Act.

SEC. 105. VISA APPLICANTS REPORT.

    (a) Initial Reports.--
            (1) In general.--Not later than 90 days after the date of 
        the enactment of this Act, the Secretary of State, in 
        coordination with the Secretary of Homeland Security and the 
        heads of other relevant Federal agencies, shall submit a report 
        to the congressional committees referred to in section 
        212(f)(3)(D) of the Immigration and Nationality Act, as amended 
        by section 103 of this title, that describes the implementation 
        of each of the presidential proclamations and executive orders 
        referred to in section 104.
            (2) Presidential proclamation 9645 and 9983.--In addition 
        to the content described in paragraph (1), the report submitted 
        with respect to Presidential Proclamation 9645, issued on 
        September 24, 2017, and Presidential Proclamation 9983, issued 
        on January 31, 2020, shall include, for each country listed in 
        such proclamation--
                    (A) the total number of individuals who applied for 
                a visa during the time period the proclamation was in 
                effect, disaggregated by country and visa category;
                    (B) the total number of visa applicants described 
                in subparagraph (A) who were approved, disaggregated by 
                country and visa category;
                    (C) the total number of visa applicants described 
                in subparagraph (A) who were refused, disaggregated by 
                country and visa category, and the reasons they were 
                refused;
                    (D) the total number of visa applicants described 
                in subparagraph (A) whose applications remain pending, 
                disaggregated by country and visa category;
                    (E) the total number of visa applicants described 
                in subparagraph (A) who were granted a waiver, 
                disaggregated by country and visa category;
                    (F) the total number of visa applicants described 
                in subparagraph (A) who were denied a waiver, 
                disaggregated by country and visa category, and the 
                reasons such waiver requests were denied;
                    (G) the total number of refugees admitted, 
                disaggregated by country; and
                    (H) the complete reports that have been submitted 
                to the President every 180 days in accordance with 
                section 4 of Presidential Proclamation 9645 in its 
                original form, and as amended by Presidential 
                Proclamation 9983.
    (b) Additional Reports.--Not later than 30 days after the date on 
which the President exercises the authority under section 212(f) of the 
Immigration and Nationality Act (8 U.S.C. 1182(f)), as amended by 
section 103 of this title, and every 30 days thereafter, the Secretary 
of State, in coordination with the Secretary of Homeland Security and 
heads of other relevant Federal agencies, shall submit a report to the 
congressional committees referred to in paragraph (3)(D) of such 
section 212(f) that identifies, with respect to countries affected by a 
suspension or restriction, the information described in subparagraphs 
(A) through (H) of subsection (a)(2) of this section and specific 
evidence supporting the need for the continued exercise of presidential 
authority under such section 212(f), including the information 
described in paragraph (3)(B) of such section 212(f). If the report 
described in this subsection is not provided to Congress in the time 
specified, the suspension or restriction shall immediately terminate 
absent intervening congressional action. A final report with such 
information shall be prepared and submitted to such congressional 
committees not later than 30 days after the suspension or restriction 
is lifted.
    (c) Form; Availability.--The reports required under subsections (a) 
and (b) shall be made publicly available online in unclassified form.

      TITLE II--AFFORDABLE PRESCRIPTIONS FOR PATIENTS ACT OF 2020

SEC. 201. SHORT TITLE.

    This title may be cited as the ``Affordable Prescriptions for 
Patients Act of 2020''.

SEC. 202. 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 an application under 
        subsection (b)(2) or (j) of section 505 of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 355).
            ``(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, 
                modification, or reformulation to the same 
                manufacturer's previously approved drug or biological 
                product that treats the same medical condition; 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 a drug 
        approved under an application submitted under subsection (b)(2) 
        or (j) of section 505 of the Federal Food, Drug, and Cosmetic 
        Act (21 U.S.C. 355).
            ``(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) Secretary.--The term `Secretary' means the Secretary 
        of Health and Human Services.
            ``(10) 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.--Except as provided in paragraph (2), 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 the 
        Commission demonstrates by a preponderance of the evidence in a 
        proceeding initiated by the Commission under subsection 
        (c)(1)(A), or in a suit brought under subparagraph (B) or (C) 
        of subsection (c)(1), 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 and ending on the date that is 180 days after the 
        date on which that generic drug or biosimilar biological 
        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) 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, as 
                                established by objective circumstances; 
                                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 that is highly 
                        similar to, and has no clinically meaningful 
                        difference with respect to safety, purity, and 
                        potency from, the reference product, which may 
                        be established by objective circumstances.
                            ``(ii) The manufacturer marketed or sold a 
                        follow-on product.
            ``(2) Justification.--
                    ``(A) In general.--Subject to paragraph (3), 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--
                            ``(i) the manufacturer demonstrates to the 
                        Commission or a district court of the United 
                        States, as applicable, by a preponderance of 
                        the evidence in a proceeding initiated by the 
                        Commission under subsection (c)(1)(A), or in a 
                        suit brought under subparagraph (B) or (C) of 
                        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)(aa) 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;
                                    ``(bb) with respect to an action 
                                described in item (aa) or (bb) of 
                                paragraph (1)(A)(ii)(I), 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
                                    ``(cc) 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.
            ``(3) Response.--With respect to a justification offered by 
        a manufacturer under paragraph (2), the Commission may--
                    ``(A) rebut any evidence presented by a 
                manufacturer during that justification; or
                    ``(B) establish by a preponderance of the evidence 
                that, 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.
    ``(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, the Commission may take any of the 
        following actions:
                    ``(A) Institute a proceeding--
                            ``(i) that, except as provided in paragraph 
                        (2), complies with the requirements under 
                        section 5(b); and
                            ``(ii) in which the Commission may impose 
                        on the manufacturer any penalty that the 
                        Commission may impose for a violation of 
                        section 5.
                    ``(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 
                order of the Commission that is issued in a proceeding 
                instituted under paragraph (1)(A) 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 an 
                order issued by the Commission 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 any other authority of the 
                Commission under this Act to seek relief or obtain a 
                remedy with respect to a violation of this Act.''.
    (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.--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(a)), and 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 carry out section 27 of 
the Federal Trade Commission Act, as added by subsection (a), including 
by defining any terms used in such section 27 (other than terms that 
are defined in subsection (a) of such section 27).
    (e) Confirmation.--Upon the request of the Commission, the 
Secretary shall provide confirmation of--
            (1) any request made by the Secretary to the manufacturer 
        for an application or supplement to an application for a 
        change, modification, or reformulation of a drug or biological 
        product;
            (2) any withdrawal by the manufacturer of an application 
        for a drug or reference product; or
            (3) any request made by a manufacturer to the Secretary for 
        withdrawal of an approval of the application for a drug or 
        reference product or a request for placement of a drug or 
        reference product on the discontinued products list.

SEC. 203. 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 section 351(l)(3)(A) of the Public Health Service 
        Act (42 U.S.C. 262(l)(3)(A)), including as provided under 
        section 351(l)(7) of such Act.
            ``(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 under 
                section 351(l)(2)(A) of the Public Health Service Act 
                (42 U.S.C. 262(l)(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.

(2)In the matter proposed to be inserted by the amendment of the 
Senate, strike sections 4, 5, and 6 and insert the following:

                TITLE III--ACCESS TO COUNSEL ACT OF 2020

SEC. 301. SHORT TITLE.

    This title may be cited as the ``Access to Counsel Act of 2020''.

SEC. 302. ACCESS TO COUNSEL AND OTHER ASSISTANCE AT PORTS OF ENTRY AND 
              DEFERRED INSPECTION.

    (a) Access to Counsel and Other Assistance During Inspection.--
Section 235 of the Immigration and Nationality Act (8 U.S.C. 1225) is 
amended by adding at the end the following:
    ``(e) Access to Counsel and Other Assistance During Inspection.--
            ``(1) In general.--The Secretary of Homeland Security shall 
        ensure that a covered individual has a meaningful opportunity 
        to consult with counsel and an interested party during the 
        inspection process.
            ``(2) Scope of assistance.--The Secretary of Homeland 
        Security shall--
                    ``(A) provide the covered individual a meaningful 
                opportunity to consult with counsel and an interested 
                party not later than one hour after the secondary 
                inspection process commences and as necessary 
                throughout the inspection process, including, as 
                applicable, during deferred inspection;
                    ``(B) allow counsel and an interested party to 
                advocate on behalf of the covered individual, including 
                by providing to the examining immigration officer 
                information, documentation, and other evidence in 
                support of the covered individual; and
                    ``(C) to the greatest extent practicable, 
                accommodate a request by the covered individual for 
                counsel or an interested party to appear in-person at 
                the secondary or deferred inspection site.
            ``(3) Special rule for lawful permanent residents.--
                    ``(A) In general.--The Secretary of Homeland 
                Security may not accept Form I-407 Record of 
                Abandonment of Lawful Permanent Resident Status (or a 
                successor form) from a lawful permanent resident 
                subject to secondary or deferred inspection without 
                providing such lawful permanent resident a reasonable 
                opportunity to seek advice from counsel prior to the 
                submission of the form.
                    ``(B) Exception.--The Secretary of Homeland 
                Security may accept Form I-407 Record of Abandonment of 
                Lawful Permanent Resident Status (or a successor form) 
                from a lawful permanent resident subject to secondary 
                or deferred inspection if such lawful permanent 
                resident knowingly, intelligently, and voluntarily 
                waives, in writing, the opportunity to seek advice from 
                counsel.
            ``(4) Definitions.--In this section:
                    ``(A) Counsel.--The term `counsel' means--
                            ``(i) an attorney who is a member in good 
                        standing of the bar of any State, the District 
                        of Columbia, or a territory or a possession of 
                        the United States and is not under an order 
                        suspending, enjoining, restraining, disbarring, 
                        or otherwise restricting the attorney in the 
                        practice of law; or
                            ``(ii) an individual accredited by the 
                        Attorney General, acting as a representative of 
                        an organization recognized by the Executive 
                        Office for Immigration Review, to represent a 
                        covered individual in immigration matters.
                    ``(B) Covered individual.--The term `covered 
                individual' means an individual subject to secondary or 
                deferred inspection who is--
                            ``(i) a national of the United States;
                            ``(ii) an immigrant, lawfully admitted for 
                        permanent residence, who is returning from a 
                        temporary visit abroad;
                            ``(iii) an alien seeking admission as an 
                        immigrant in possession of a valid unexpired 
                        immigrant visa;
                            ``(iv) an alien seeking admission as a non-
                        immigrant in possession of a valid unexpired 
                        non-immigrant visa;
                            ``(v) a refugee;
                            ``(vi) a returning asylee; or
                            ``(vii) an alien who has been approved for 
                        parole under section 212(d)(5)(A), including an 
                        alien who is returning to the United States in 
                        possession of a valid advance parole document.
                    ``(C) Interested party.--The term `interested 
                party' means--
                            ``(i) a relative of the covered individual;
                            ``(ii) in the case of a covered individual 
                        to whom an immigrant or non-immigrant visa has 
                        been issued, the petitioner or sponsor thereof 
                        (including an agent of such petitioner or 
                        sponsor); or
                            ``(iii) a person, organization, or entity 
                        in the United States with a bona fide 
                        connection to the covered individual.''.
    (b) Effective Date.--The amendment made by subsection (a) shall 
take effect 180 days after the date of the enactment of this Act.
    (c) Savings Provision.--Nothing in this title, or in any amendment 
made by this title, may be construed to limit a right to counsel or any 
right to appointed counsel under--
            (1) section 240(b)(4)(A) (8 U.S.C. 1229a(b)(4)(A)),
            (2) section 292 of the Immigration and Nationality Act (8 
        U.S.C. 1362), or
            (3) any other provision of law, including any final court 
        order securing such rights,
as in effect on the day before the date of the enactment of this Act.

            Attest:

                                                                 Clerk.
116th CONGRESS

  2d Session

                               H.R. 2486

_______________________________________________________________________

                  HOUSE AMENDMENTS TO SENATE AMENDMENT
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