[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6275 Introduced in House (IH)]
<DOC>
118th CONGRESS
1st Session
H. R. 6275
To prohibit brand name drug manufacturers from compensating generic
drug manufacturers to delay the entry of a generic drug into the
market, and to prohibit biological product manufacturers from
compensating biosimilar and interchangeable product manufacturers to
delay entry of biosimilar and interchangeable products, and for other
purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
November 7, 2023
Ms. Perez (for herself, Mr. Casten, and Mr. Connolly) introduced the
following bill; which was referred to the Committee on Energy and
Commerce, and in addition to the Committee on the Judiciary, for a
period to be subsequently determined by the Speaker, in each case for
consideration of such provisions as fall within the jurisdiction of the
committee concerned
_______________________________________________________________________
A BILL
To prohibit brand name drug manufacturers from compensating generic
drug manufacturers to delay the entry of a generic drug into the
market, and to prohibit biological product manufacturers from
compensating biosimilar and interchangeable product manufacturers to
delay entry of biosimilar and interchangeable products, 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 ``Protecting Consumer Access to
Generic Drugs Act of 2023''.
SEC. 2. UNLAWFUL AGREEMENTS.
(a) Agreements Prohibited.--Subject to subsections (b) and (c), it
shall be unlawful for an NDA or BLA holder and a subsequent filer (or
for two subsequent filers) to enter into, or carry out, an agreement
resolving or settling a covered patent infringement claim on a final or
interim basis if under such agreement--
(1) a subsequent filer directly or indirectly receives from
such holder (or in the case of such an agreement between two
subsequent filers, the other subsequent filer) anything of
value, including a license; and
(2) the subsequent filer agrees to limit or forego research
on, or development, manufacturing, marketing, or sales, for any
period of time, of the covered product that is the subject of
the application described in subparagraph (A) or (B) of
subsection (g)(8).
(b) Exclusion.--It shall not be unlawful under subsection (a) if a
party to an agreement described in such subsection demonstrates by
clear and convincing evidence that the value described in subsection
(a)(1) is compensation solely for other goods or services that the
subsequent filer has promised to provide.
(c) Limitation.--Nothing in this section shall prohibit an
agreement resolving or settling a covered patent infringement claim in
which the consideration granted by the NDA or BLA holder to the
subsequent filer (or from one subsequent filer to another) as part of
the resolution or settlement includes only one or more of the
following:
(1) The right to market the covered product that is the
subject of the application described in subparagraph (A) or (B)
of subsection (g)(8) in the United States before the expiration
of--
(A) any patent that is the basis of the covered
patent infringement claim; or
(B) any patent right or other statutory exclusivity
that would prevent the marketing of such covered
product.
(2) A payment for reasonable litigation expenses not to
exceed $7,500,000 in the aggregate.
(3) A covenant not to sue on any claim that such covered
product infringes a patent.
(d) Enforcement by Federal Trade Commission.--
(1) General application.--The requirements of this section
apply, according to their terms, to an NDA or BLA holder or
subsequent filer that is--
(A) a person, partnership, or corporation over
which the Commission has authority pursuant to section
5(a)(2) of the Federal Trade Commission Act (15 U.S.C.
45(a)(2)); or
(B) a person, partnership, or corporation over
which the Commission would have authority pursuant to
such section but for the fact that such person,
partnership, or corporation is not organized to carry
on business for its own profit or that of its members.
(2) Unfair or deceptive acts or practices enforcement
authority.--
(A) In general.--A violation of this section shall
be treated as an unfair or deceptive act or practice in
violation of section 5(a)(1) of the Federal Trade
Commission Act (15 U.S.C. 45(a)(1)).
(B) Powers of commission.--Except as provided in
subparagraph (C) and paragraphs (1)(B) and (3)--
(i) the Commission shall enforce this
section in the same manner, by the same means,
and with the same jurisdiction, powers, and
duties as though all applicable terms and
provisions of the Federal Trade Commission Act
(15 U.S.C. 41 et seq.) were incorporated into
and made a part of this section; and
(ii) any NDA or BLA holder or subsequent
filer that violates this section shall be
subject to the penalties and entitled to the
privileges and immunities provided in the
Federal Trade Commission Act.
(C) Judicial review.--In the case of a cease and
desist order issued by the Commission under section 5
of the Federal Trade Commission Act (15 U.S.C. 45) for
violation of this section, a party to such order may
obtain judicial review of such order as provided in
such section 5, except that--
(i) such review may only be obtained in--
(I) the United States Court of
Appeals for the District of Columbia
Circuit;
(II) the United States Court of
Appeals for the circuit in which the
ultimate parent entity, as defined in
section 801.1(a)(3) of title 16, Code
of Federal Regulations, or any
successor thereto, of the NDA or BLA
holder (if any such holder is a party
to such order) is incorporated as of
the date that the application described
in subparagraph (A) or (B) of
subsection (g)(8) or an approved
application that is deemed to be a
license for a biological product under
section 351(k) of the Public Health
Service Act (42 U.S.C. 262(k)) pursuant
to section 7002(e)(4) of the Biologics
Price Competition and Innovation Act of
2009 (Public Law 111-148; 124 Stat.
817) is submitted to the Commissioner
of Food and Drugs; or
(III) the United States Court of
Appeals for the circuit in which the
ultimate parent entity, as so defined,
of any subsequent filer that is a party
to such order is incorporated as of the
date that the application described in
subparagraph (A) or (B) of subsection
(g)(8) is submitted to the Commissioner
of Food and Drugs; and
(ii) the petition for review shall be filed
in the court not later than 30 days after such
order is served on the party seeking review.
(3) Additional enforcement authority.--
(A) Civil penalty.--The Commission may commence a
civil action to recover a civil penalty in a district
court of the United States against any NDA or BLA
holder or subsequent filer that violates this section.
(B) Special rule for recovery of penalty if cease
and desist order issued.--
(i) In general.--If the Commission has
issued a cease and desist order in a proceeding
under section 5 of the Federal Trade Commission
Act (15 U.S.C. 45) for violation of this
section--
(I) the Commission may commence a
civil action under subparagraph (A) to
recover a civil penalty against any
party to such order at any time before
the expiration of the 1-year period
beginning on the date on which such
order becomes final under section 5(g)
of such Act (15 U.S.C. 45(g)); and
(II) in such civil action, the
findings of the Commission as to the
material facts in such proceeding shall
be conclusive, unless--
(aa) the terms of such
order expressly provide that
the Commission's findings shall
not be conclusive; or
(bb) such order became
final by reason of section
5(g)(1) of such Act (15 U.S.C.
45(g)(1)), in which case such
findings shall be conclusive if
supported by evidence.
(ii) Relationship to penalty for violation
of an order.--The penalty provided in clause
(i) for violation of this section is separate
from and in addition to any penalty that may be
incurred for violation of an order of the
Commission under section 5(l) of the Federal
Trade Commission Act (15 U.S.C. 45(l)).
(C) Amount of penalty.--
(i) In general.--The amount of a civil
penalty imposed in a civil action under
subparagraph (A) on a party to an agreement
described in subsection (a) shall be sufficient
to deter violations of this section, but in no
event greater than--
(I) if such party is the NDA or BLA
holder (or, in the case of an agreement
between two subsequent filers, the
subsequent filer who gave the value
described in subsection (a)(1)), the
greater of--
(aa) 3 times the value
received by such NDA or BLA
holder (or by such subsequent
filer) that is reasonably
attributable to the violation
of this section; or
(bb) 3 times the value
given to the subsequent filer
(or to the other subsequent
filer) reasonably attributable
to the violation of this
section; and
(II) if such party is the
subsequent filer (or, in the case of an
agreement between two subsequent
filers, the subsequent filer who
received the value described in
subsection (a)(1)), 3 times the value
received by such subsequent filer that
is reasonably attributable to the
violation of this section.
(ii) Factors for consideration.--In
determining such amount, the court shall take
into account--
(I) the nature, circumstances,
extent, and gravity of the violation;
(II) with respect to the violator,
the degree of culpability, any history
of violations, the ability to pay, any
effect on the ability to continue doing
business, profits earned by the NDA or
BLA holder (or, in the case of an
agreement between two subsequent
filers, the subsequent filer who gave
the value described in subsection
(a)(1)), compensation received by the
subsequent filer (or, in the case of an
agreement between two subsequent
filers, the subsequent filer who
received the value described in
subsection (a)(1)), and the amount of
commerce affected; and
(III) other matters that justice
requires.
(D) Injunctions and other equitable relief.--In a
civil action under subparagraph (A), the United States
district courts are empowered to grant mandatory
injunctions and such other and further equitable relief
as they deem appropriate.
(4) Remedies in addition.--Remedies provided in this
subsection are in addition to, and not in lieu of, any other
remedy provided by Federal law.
(5) Preservation of authority of commission.--Nothing in
this section shall be construed to affect any authority of the
Commission under any other provision of law.
(e) Federal Trade Commission Rulemaking.--The Commission may, in
its discretion, by rule promulgated under section 553 of title 5,
United States Code, exempt from this section certain agreements
described in subsection (a) if the Commission finds such agreements to
be in furtherance of market competition and for the benefit of
consumers.
(f) Antitrust Laws.--Nothing in 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 such section 5 applies to unfair methods of
competition. Nothing in this section shall modify, impair, limit, or
supersede the right of a subsequent filer to assert claims or
counterclaims against any person, under the antitrust laws or other
laws relating to unfair competition.
(g) Definitions.--In this section:
(1) Agreement resolving or settling a covered patent
infringement claim.--The term ``agreement resolving or settling
a covered patent infringement claim'' means any agreement
that--
(A) resolves or settles a covered patent
infringement claim; or
(B) is contingent upon, provides for a contingent
condition for, or is otherwise related to the
resolution or settlement of a covered patent
infringement claim.
(2) Commission.--The term ``Commission'' means the Federal
Trade Commission.
(3) Covered patent infringement claim.--The term ``covered
patent infringement claim'' means an allegation made by the NDA
or BLA holder to a subsequent filer (or, in the case of an
agreement between two subsequent filers, by one subsequent
filer to another), whether or not included in a complaint filed
with a court of law, that--
(A) the submission of the application described in
subparagraph (A) or (B) of paragraph (8), or the
manufacture, use, offering for sale, sale, or
importation into the United States of a covered product
that is the subject of such an application--
(i) in the case of an agreement between an
NDA or BLA holder and a subsequent filer,
infringes any patent owned by, or exclusively
licensed to, the NDA or BLA holder of the
covered product; or
(ii) in the case of an agreement between
two subsequent filers, infringes any patent
owned by the subsequent filer; or
(B) in the case of an agreement between an NDA or
BLA holder and a subsequent filer, the covered product
to be manufactured under such application uses a
covered product as claimed in a published patent
application.
(4) Covered product.--The term ``covered product'' means a
drug (as defined in section 201(g) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321(g))), including a biological
product (as defined in section 351(i) of the Public Health
Service Act (42 U.S.C. 262(i))).
(5) NDA or bla holder.--The term ``NDA or BLA holder''
means--
(A) the holder of--
(i) an approved new drug application filed
under section 505(b)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(b)(1))
for a covered product; or
(ii) a biologics license application filed
under section 351(a) of the Public Health
Service Act (42 U.S.C. 262(a)) for a covered
product;
(B) a person owning or controlling enforcement of
the patent on--
(i) the list published under section
505(j)(7) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(j)(7)) in
connection with the application described in
subparagraph (A)(i); or
(ii) any list published under section 351
of the Public Health Service Act (42 U.S.C.
262) comprised of patents associated with
biologics license applications filed under
section 351(a) of such Act (42 U.S.C. 262(a));
or
(C) the predecessors, subsidiaries, divisions,
groups, and affiliates controlled by, controlling, or
under common control with any entity described in
subparagraph (A) or (B) (such control to be presumed by
direct or indirect share ownership of 50 percent or
greater), as well as the licensees, licensors,
successors, and assigns of each of the entities.
(6) Patent.--The term ``patent'' means a patent issued by
the United States Patent and Trademark Office.
(7) Statutory exclusivity.--The term ``statutory
exclusivity'' means those prohibitions on the submission or
approval of drug applications under clauses (ii) through (iv)
of section 505(c)(3)(E) (5- and 3-year exclusivity), clauses
(ii) through (iv) of section 505(j)(5)(F) (5-year and 3-year
exclusivity), section 505(j)(5)(B)(iv) (180-day exclusivity),
section 527 (orphan drug exclusivity), section 505A (pediatric
exclusivity), or section 505E (qualified infectious disease
product exclusivity) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(c)(3)(E), 355(j)(5)(B)(iv), 355(j)(5)(F),
360cc, 355a, 355f), or prohibitions on the submission or
licensing of biologics license applications under section
351(k)(6) (interchangeable biological product exclusivity) or
section 351(k)(7) (biological product reference product
exclusivity) of the Public Health Service Act (42 U.S.C.
262(k)(6), (7)).
(8) Subsequent filer.--The term ``subsequent filer''
means--
(A) in the case of a drug, a party that owns or
controls an abbreviated new drug application submitted
pursuant to section 505(j) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(j)) or a new drug
application submitted pursuant to section 505(b)(2) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(b)(2)) and filed under section 505(b)(1) of such
Act (21 U.S.C. 355(b)(1)) or has the exclusive rights
to distribute the covered product that is the subject
of such application; or
(B) in the case of a biological product, a party
that owns or controls an application filed with the
Food and Drug Administration under section 351(k) of
the Public Health Service Act (42 U.S.C. 262(k)) or has
the exclusive rights to distribute the biological
product that is the subject of such application.
(h) Effective Date.--This section applies with respect to
agreements described in subsection (a) entered into on or after the
date of the enactment of this Act.
SEC. 3. NOTICE AND CERTIFICATION OF AGREEMENTS.
(a) Notice of All Agreements.--Section 1111(7) of the Medicare
Prescription Drug, Improvement, and Modernization Act of 2003 (21
U.S.C. 355 note) is amended by inserting ``or the owner of a patent for
which a claim of infringement could reasonably be asserted against any
person for making, using, offering to sell, selling, or importing into
the United States a biological product that is the subject of a
biosimilar biological product application'' before the period at the
end.
(b) Certification of Agreements.--Section 1112 of such Act (21
U.S.C. 355 note) is amended by adding at the end the following:
``(d) Certification.--The Chief Executive Officer or the company
official responsible for negotiating any agreement under subsection (a)
or (b) that is required to be filed under subsection (c) shall, within
30 days of such filing, execute and file with the Assistant Attorney
General and the Commission a certification as follows: `I declare that
the following is true, correct, and complete to the best of my
knowledge: The materials filed with the Federal Trade Commission and
the Department of Justice under section 1112 of the Medicare
Prescription Drug, Improvement, and Modernization Act of 2003, with
respect to the agreement referenced in this certification--
```(1) represent the complete, final, and exclusive
agreement between the parties;
```(2) include any ancillary agreements that are contingent
upon, provide a contingent condition for, were entered into
within 30 days of, or are otherwise related to, the referenced
agreement; and
```(3) include written descriptions of any oral agreements,
representations, commitments, or promises between the parties
that are responsive to subsection (a) or (b) of such section
1112 and have not been reduced to writing.'.''.
SEC. 4. FORFEITURE OF 180-DAY EXCLUSIVITY PERIOD.
Section 505(j)(5)(D)(i)(V) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(j)(5)(D)(i)(V)) is amended by inserting ``section 2
of the Protecting Consumer Access to Generic Drugs Act of 2023 or''
after ``that the agreement has violated''.
SEC. 5. COMMISSION LITIGATION AUTHORITY.
Section 16(a)(2) of the Federal Trade Commission Act (15 U.S.C.
56(a)(2)) is amended--
(1) in subparagraph (D), by striking ``or'' after the
semicolon;
(2) in subparagraph (E), by inserting ``or'' after the
semicolon; and
(3) by inserting after subparagraph (E) the following:
``(F) under section 2(d)(3)(A) of the Protecting
Consumer Access to Generic Drugs Act of 2023;''.
SEC. 6. STATUTE OF LIMITATIONS.
(a) In General.--Except as provided in subsection (b), the
Commission shall commence any administrative proceeding or civil action
to enforce section 2 of this Act not later than 6 years after the date
on which the parties to the agreement file the Notice of Agreement as
provided by section 1112(c)(2) and (d) of the Medicare Prescription
Drug, Improvement, and Modernization Act of 2003 (21 U.S.C. 355 note).
(b) Civil Action After Issuance of Cease and Desist Order.--If the
Commission has issued a cease and desist order under section 5 of the
Federal Trade Commission Act (15 U.S.C. 45) for violation of section 2
of this Act and the proceeding for the issuance of such order was
commenced within the period required by subsection (a) of this section,
such subsection does not prohibit the commencement, after such period,
of a civil action under section 2(d)(3)(A) against a party to such
order or a civil action under subsection (l) of such section 5 for
violation of such order.
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