108th CONGRESS
1st Session
H. R. 2640
To provide greater access to affordable pharmaceuticals, and for other
purposes.
IN THE HOUSE OF REPRESENTATIVES
June 26, 2003
Mr. KENNEDY of Rhode Island (for himself, Mr. FROST, and Ms. NORTON) introduced
the following bill; which was referred to the Committee on Energy and Commerce,
and in addition to the Committee on Ways and Means, 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 provide greater access to affordable pharmaceuticals, 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 `Prescription Affordability and Medicine Safety
Act of 2003'.
SEC. 2. FINDINGS.
The Congress finds as follows:
(1) Although prescription drugs represent one of the increasingly used medical
care interventions in treating common acute and chronic diseases, many Americans,
especially the elderly and other vulnerable populations, are often unable
to afford their medication because of excessive and persistent drug price
inflation.
(2) In 1999, the top 5 pharmaceutical companies allocated a higher proportion
of their revenue to their income than to research and development.
(3) In 2000, over 1/3 of the most frequently prescribed drugs for seniors
rose in price at a rate that was 3 times the rate of inflation.
(4) Prescription drug manufacturers continue to make enormous profits on the
backs of Americans.
(5) Because of the limited availability of private or public prescription
drug coverage for the elderly, prescription drugs represent the highest out-of-pocket
medical care cost for 3 of 4 elderly patients, surpassed only by the cost
of long-term care services.
(6) Ninety percent of Americans who are 60 years of age or older take 1 or
more medications daily.
(7) According to a recent study, around 60 percent of doctors say that patients
somewhat often talk with them about specific disease or treatment they heard
about from prescription drug advertisements.
(8) The National Institutes of Health, the Government's most important health
research arm, has helped develop almost all of the 50 top-selling drugs from
1992 through 1997 for a cost of over $175,000,000.
(9) The pharmaceutical industry makes large profits off the sale of drugs
produced from the benefit of research paid for by the United States and, aside
from royalties, none of such profits are reimbursed to United States taxpayers.
(10) Only 24 percent of people over age 45 always ask their pharmacist about
drug side effects.
(11) Only 31 percent of people over age 45 always ask their pharmacists about
cost-saving generic equivalents for new prescriptions.
SEC. 3. GENERIC DRUG APPLICATION REVIEW.
For the purpose of enabling the Food and Drug Administration to employ additional
staff for the Office of Generic Drugs to review abbreviated applications for
the approval of new drugs under section 505(j) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(j)), and for the purpose of otherwise providing
for accelerated reviews of such applications, there is authorized to be appropriated
$5,000,000 for each fiscal year, in addition to other authorizations of appropriations
that are available for such purposes.
SEC. 4. GENERIC DRUG EDUCATION.
For the purpose of enabling the Food and Drug Administration, through the Office
of Generic Drugs, to continue the education program started in fiscal year 2001
on the use and therapeutic equivalency of drugs approved under section 505(j)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)), there is authorized
to be appropriated $1,000,000 for each fiscal year, in addition to other authorizations
of appropriations that are available for such purpose.
SEC. 5. PRESCRIPTION DRUG ASSISTANCE PROGRAM; PROFITS FROM RESEARCH.
The Public Health Service Act (42 U.S.C. 201 et seq.) is amended by adding at
the end the following:
`TITLE XXIX--PHARMACY ASSISTANCE
`SEC. 2901. GRANTS.
`(a) AUTHORIZATION- From amounts available from the revolving fund established
under section 2903, the Secretary may make grants to States for the purpose
of providing pharmacy assistance as described in subsection (b).
`(b) USE OF FUNDS- A grant may be made under subsection (a) only if the State
involved agrees that funds received under the grant will be used--
`(1) to provide outreach services and education regarding an existing State
pharmacy benefit assistance program; or
`(2) to establish or expand such a program.
`(c) APPLICATION- To seek a grant under this section, a State shall submit an
application to the Secretary at such time, in such manner, and accompanied by
such information as the Secretary may reasonably require.
`(d) STATE DEFINED- For purposes of this section, the term `State' means any
of the several States, the District of Columbia, the Commonwealth of Puerto
Rico, the Commonwealth of the Northern Mariana Islands, American Samoa, Guam,
the Virgin Islands, or any other territory or possession of the United States.
`SEC. 2902. PROFITS FROM RESEARCH.
`(a) IN GENERAL- Subject to subsection (b), the Secretary shall not approve
any covered application for the approval of a biological product under section
351 of this Act or of a drug under section 505 of the Federal Food, Drug, and
Cosmetic Act unless the manufacturer submitting the application enters into
an agreement with the Secretary that--
`(1) requires the manufacturer to pay the Secretary 7 percent of the gross
amount received by the manufacturer from sales of such biological product
or drug; and
`(2) specifies the manner in which such gross amount will be determined.
`(b) EXCEPTION- The Secretary may waive the application of subsection (a) to
a manufacturer of a biological product or drug when the Secretary determines
that it would be in the public interest to exempt such manufacturer.
`(c) COVERED APPLICATION- For purposes of this section, the term `covered application'
means an application that includes the results of research carried out--
`(1) by an entity of the National Institutes of Health; or
`(2) under an agreement under section 12 of the Stevenson-Wydler Technology
Innovation Act of 1980.
`SEC. 2903. REVOLVING FUND.
`(a) ESTABLISHMENT- There is hereby established in the Treasury a revolving
fund which shall consist of the amounts deposited by the Secretary under subsection
(b).
`(b) DEPOSIT OF FUNDS- The Secretary shall deposit in the fund established under
this section all payments made to the Secretary under an agreement pursuant
to section 2902(a)(1).
`(c) USE OF AMOUNTS IN FUND- To the extent or in the amounts made available
in advance in appropriations Acts, amounts in the fund established under this
section shall be available to the Secretary to make grants under section 2901.'.
SEC. 6. LIMITATION ON DEDUCTIONS FOR ADVERTISING BY PRESCRIPTION DRUG MANUFACTURERS.
(a) IN GENERAL- Part IX of subchapter B of chapter 1 of subtitle A of the Internal
Revenue Code of 1986 (relating to items not deductible) is amended by adding
at the end the following:
`SEC. 280I. LIMITATION ON DEDUCTIONS FOR ADVERTISING BY PRESCRIPTION DRUG
MANUFACTURERS.
`(a) IN GENERAL- No deduction shall be allowed under this chapter for any taxable
year for any expenditure relating to the advertising, promoting, or marketing
(in any medium) of any prescription drug manufactured by the taxpayer to the
extent the aggregate amount of such expenditures exceeds 50 percent of the taxpayer's
aggregate research and development expenditures for such taxable year.
`(b) DEFINITIONS AND SPECIAL RULES- For purposes of this section:
`(1) PRESCRIPTION DRUGS- The term `prescription drug' means any drug subject
to section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act.
`(2) RESEARCH AND DEVELOPMENT EXPENDITURES- The term `research and development
expenditures' means any expenditures that may be treated as expenses under
section 174.
`(3) AGGREGATION RULES- All members of the same controlled group of corporations
(within the meaning of section 52(a)) and all persons under common control
(within the meaning of section 52(b)) shall be treated as 1 person.'.
(b) CLERICAL AMENDMENT- The table of sections for such part IX is amended by
adding after the item relating to section 280H the following:
`Sec. 280I. Limitation on deductions for advertising by prescription drug manufacturers.'.
(c) EFFECTIVE DATE- The amendments made by this section shall apply to taxable
years beginning after December 31, 2002.
(d) TRANSFER TO THE FEDERAL HOSPITAL INSURANCE TRUST FUND OF RESULTING BUDGETARY
SAVINGS- There are authorized to be appropriated to the Federal Hospital Insurance
Trust Fund established under section 1817 of the Social Security Act amounts
equal to the increase in Federal revenues resulting from the amendment made
by subsection (a). Such appropriated amounts may be transferred from the general
fund of the Treasury on the basis of estimates of such revenues made by the
Secretary of the Treasury.
SEC. 7. LIMITATION OF 30-MONTH STAY TO CERTAIN PATENTS.
(a) ABBREVIATED NEW DRUG APPLICATIONS-
(1) IN GENERAL- Clause (iii) of section 505(j)(5)(B) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(B)) is amended to read as follows:
`(iii) If the applicant made a certification described in subclause (IV) of
paragraph (2)(A)(vii):
`(I) If such certification concerns a patent (other than a patent that claims
a process for manufacturing the listed drug) for which patent information
was submitted under subsection (b), the approval shall be made effective
immediately unless an action is brought for infringement of a patent which
is the subject of the certification before the expiration of 45 days from
the date the notice provided under paragraph (2)(B)(i) is received. If such
an action is brought before the expiration of such days, the approval shall
be made effective upon the expiration of the 30-month period beginning on
the date of the receipt of the notice provided under paragraph (2)(B)(i)
or such shorter or longer period as the court may order because either party
to the action failed to reasonably cooperate in expediting the action, except
that--
`(aa) if before the expiration of such period the court decides that such
patent is invalid or not infringed, the approval shall be made effective
on the date of the court decision;
`(bb) if before the expiration of such period the court decides that such
patent has been infringed, the approval shall be made effective on such
date as the court orders under section 271(e)(4)(A) of title 35, United
States Code; or
`(cc) if before the expiration of such period the court grants a preliminary
injunction prohibiting the applicant from engaging in the commercial manufacture
or sale of the drug until the court decides the issues of patent validity
and infringement and if the court decides that such patent is invalid
or not infringed, the approval shall be made effective on the date of
such court decision.
`In such an action, each of the parties shall reasonably cooperate in expediting
the action. Until the expiration of 45 days from the date the notice made
under paragraph (2)(B)(i) is received, no action may be brought under section
2201 of title 28, United States Code, for a declaratory judgment with respect
to the patent. Any action brought under such section 2201 shall be brought
in the judicial district where the defendant has its principal place of
business or a regular and established place of business. The 30-month period
provided under the second sentence of this clause shall not apply to a certification
under paragraph (2)(A)(vii)(IV) made with respect to a patent for which
patent information was submitted under subsection (c)(2).
`(II) If the certification referred to at the beginning of this clause concerns
a patent (other than a patent that claims a process for manufacturing the
listed drug) for which patent information was submitted under subsection
(c)(2), the approval shall be made effective on the date that is 45 days
after the date on which the notice provided under paragraph (2)(B) is received,
unless a civil action for infringement of the patent, accompanied by a motion
for preliminary injunction to enjoin the applicant from engaging in the
commercial manufacture or sale of the drug, is filed on or before such date,
in which case the approval shall be made effective--
`(aa) on the date of a court action declining to grant a preliminary injunction;
or
`(bb) if the court has granted a preliminary injunction prohibiting the
applicant from engaging in the commercial manufacture or sale of the drug--
`(AA) on issuance by a court of a determination that the patent is invalid
or is not infringed;
`(BB) on issuance by a court of an order revoking the preliminary injunction
or permitting the applicant to engage in the commercial manufacture
or sale of the drug; or
`(CC) on the date specified in a court order under section 271(e)(4)(A)
of title 35, United States Code, if the court determines that the patent
is infringed.
`Each of the parties shall reasonably cooperate in expediting a civil action
under this subclause. If the notice under paragraph (2)(B) contains an address
for the receipt of expedited notification of a civil action under this subclause,
the plaintiff shall, on the date on which the complaint is filed, simultaneously
cause a notification of the civil action to be delivered to that address
by the next business day.'.
(2) FAILURE TO BRING INFRINGEMENT ACTION- Paragraph (5) of section 505(j)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) is amended
by adding at the end the following:
`(E) If, in connection with an application under this subsection, the applicant
provides an owner of a patent notice under paragraph (2)(B) with respect to
the patent, and the owner of the patent fails to bring a civil action against
the applicant for infringement of the patent on or before the date that is 45
days after the date on which the notice is received, the owner of the patent
shall be barred from bringing a civil action for infringement of the patent
in connection with the development, manufacture, use, offer to sell, or sale
of the drug for which the application was filed or approved under this subsection.'.
(1) IN GENERAL- Subparagraph (C) of section 505(c)(3) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(c)(3)) is amended to read as follows:
`(C) If the applicant made a certification described in subsection (b)(2)(A)(iv):
`(i) If such certification concerns a patent (other than a patent that claims
a process for manufacturing the listed drug) for which patent information
was submitted under subsection (b), the approval shall be made effective
immediately unless an action is brought for infringement of a patent which
is the subject of the certification before the expiration of 45 days from
the date the notice provided under subsection (b)(3)(A) is received. If
such an action is brought before the expiration of such days, the approval
may be made effective upon the expiration of the 30-month period beginning
on the date of the receipt of the notice provided under subsection (b)(3)(A)
or such shorter or longer period as the court may order because either party
to the action failed to reasonably cooperate in expediting the action, except
that--
`(I) if before the expiration of such period the court decides that such
patent is invalid or not infringed, the approval shall be made effective
on the date of the court decision;
`(II) if, before the expiration of such period, the court decides that
such patent has been infringed, the approval shall be made effective on
such date as the court orders under section 271(e)(4)(A) of title 35,
United States Code; or
`(III) if before the expiration of such period the court grants a preliminary
injunction prohibiting the applicant from engaging in the commercial manufacture
or sale of the drug until the court decides the issues of patent validity
and infringement and if the court decides that such patent is invalid
or not infringed, the approval shall be made effective on the date of
such court decision.
`In such an action, each of the parties shall reasonably cooperate in expediting
the action. Until the expiration of 45 days from the date the notice made
under subsection (b)(3)(A) is received, no action may be brought under section
2201 of title 28, United States Code, for a declaratory judgment with respect
to the patent. Any action brought under such section 2201 shall be brought
in the judicial district where the defendant has its principal place of
business or a regular and established place of business. The 30-month period
provided under the second sentence of this subparagraph shall not apply
to a certification under subsection (b)(2)(A)(iv) made with respect to a
patent for which patent information was submitted under subsection (c)(2).
`(ii) If the certification referred to at the beginning of this subparagraph
concerns a patent (other than a patent that claims a process for manufacturing
the listed drug) for which patent information was submitted under subsection
(c)(2), the approval shall be made effective on the date that is 45 days
after the date on which the notice provided under subsection (b)(3) is received,
unless a civil action for infringement of the patent, accompanied by a motion
for preliminary injunction to enjoin the applicant from engaging in the
commercial manufacture or sale of the drug, is filed on or before such date,
in which case the approval shall be made effective--
`(I) on the date of a court action declining to grant a preliminary injunction;
or
`(II) if the court has granted a preliminary injunction prohibiting the
applicant from engaging in the commercial manufacture or sale of the drug--
`(aa) on issuance by a court of a determination that the patent is invalid
or is not infringed;
`(bb) on issuance by a court of an order revoking the preliminary injunction
or permitting the applicant to engage in the commercial manufacture
or sale of the drug; or
`(cc) on the date specified in a court order under section 271(e)(4)(A)
of title 35, United States Code, if the court determines that the patent
is infringed.
`Each of the parties shall reasonably cooperate in expediting a civil action
under this clause. If the notice under subsection (b)(3) contains an address
for the receipt of expedited notification of a civil action under this clause,
the plaintiff shall, on the date on which the complaint is filed, simultaneously
cause a notification of the civil action to be delivered to that address
by the next business day.'.
(2) FAILURE TO BRING INFRINGEMENT ACTION- Subsection (c) of section 505 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(c)(3)) is amended
by adding at the end the following:
`(5) If, in connection with an application under subsection (b)(2), the applicant
provides an owner of a patent notice under subsection (b)(3) with respect to
the patent, and the owner of the patent fails to bring a civil action against
the applicant for infringement of the patent on or before the date that is 45
days after the date on which the notice is received, the owner of the patent
shall be barred from bringing a civil action for infringement of the patent
in connection with the development, manufacture, use, offer to sell, or sale
of the drug for which the application was filed or approved under subsection
(b)(2).'.
(c) EFFECTIVE DATE- The amendments made by subsections (a) and (b) shall be
effective with respect to any certification under subsection (b)(2)(A)(iv) or
(j)(2)(A)(vii)(IV) of section 505 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355) made after the date of enactment of this Act in an application
filed under subsection (b)(2) or (j) of that section, including with respect
to patent information that was submitted to the Secretary before such date under
subsection (c)(2) of such Act.
SEC. 8. EXCLUSIVITY FOR ACCELERATED GENERIC DRUG APPLICANTS.
(a) IN GENERAL- Section 505(j)(5) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(j)(5)) is amended--
(1) in subparagraph (B)(iv)--
(A) in the text preceding subclause (I), by inserting `the earlier of--'
after `not earlier than one hundred and eighty days after';
(B) by striking `or' at the end of subclause (I);
(C) by striking subclause (II) and all that follows through the end; and
(D) by adding after subclause (I) the following:
`(II) the date of a final decision of a court (from which no appeal has
been or can be taken, other than a petition to the Supreme Court for a writ
of certiorari) holding that the
patent that is the subject of the certification is invalid or not infringed,
or
`(III) the date of a settlement order or consent decree signed by a Federal
judge that enters a final judgment and includes a finding that the patent
that is the subject of the certification is invalid or not infringed.';
and
(2) by inserting after subparagraph (D) the following:
`(E) Forfeiture of 180-Day Period-
`(i) IN GENERAL- Except as provided in clause (ii), if a forfeiture event
occurs with respect to a first application--
`(I) the 180-day period under subparagraph (B)(iv) shall be forfeited by
the first applicant; and
`(II) any subsequent application shall become effective as provided under
clause (i), (ii), or (iii) of subparagraph (B), and clause (iv) of subparagraph
(B) shall not apply to the subsequent application.
`(ii) FORFEITURE TO FIRST SUBSEQUENT APPLICANT- If the subsequent application
that is the first to be made effective under clause (i) was the first among
a number of subsequent applications to be filed--
`(I) that first subsequent application shall be treated as the first application
under this subparagraph (including clause (i)) and as the previous application
under subparagraph (B)(iv); and
`(II) any other subsequent applications shall become effective as provided
under clause (i), (ii), or (iii) of subparagraph (B), but clause (iv) of
subparagraph (B) shall apply to any such subsequent application.
`(iii) AVAILABILITY- The 180-day period under subparagraph (B)(iv) shall be
available to a first applicant submitting an application for a drug with respect
to any patent without regard to whether an application has been submitted
for the drug under this subsection containing such a certification with respect
to a different patent.
`(iv) APPLICABILITY- The 180-day period described in subparagraph (B)(iv)
shall apply to an application only if a civil action is brought against the
applicant for infringement of a patent that is the subject of the certification.
`(v) DEFINITIONS- In this subparagraph:
`(I) APPLICATION- The term `application' means an application for approval
of a drug under this subsection containing a certification under paragraph
(2)(A)(vii)(IV) with respect to a patent.
`(II) FIRST APPLICATION- The term `first application' means the first application
to be filed for approval of the drug.
`(III) FORFEITURE EVENT- The term `forfeiture event', with respect to an
application under this subsection, means the occurrence of any of the following:
`(aa) FAILURE TO MARKET- The applicant fails to market the drug by the
later of--
`(AA) the date that is 60 days after the date on which the approval
of the application for the drug is made effective under clause (iii)
of subparagraph (B) (unless the Secretary extends the date because of
extraordinary or unusual circumstances); or
`(BB) if 1 or more civil actions have been brought against the applicant
for infringement of a patent subject to a certification under paragraph
(2)(A)(vii)(IV) or 1 or more civil actions have been brought by the
applicant for a declaratory judgment that such a patent is invalid or
not infringed, the date that is 60 days after the date of a final decision
(from which no appeal has been or can be taken, other than a petition
to the Supreme Court for a writ of certiorari) in the last of those
civil actions to be decided (unless the Secretary extends the date because
of extraordinary or unusual circumstances).
`(bb) WITHDRAWAL OF APPLICATION- The applicant withdraws the application.
`(cc) AMENDMENT OF CERTIFICATION- The applicant, voluntarily or as a result
of a settlement or defeat in patent litigation, amends the certification
from a certification under paragraph (2)(A)(vii)(IV) to a certification
under paragraph (2)(A)(vii)(III).
`(dd) FAILURE TO OBTAIN APPROVAL- The applicant fails to obtain tentative
approval of an application within 30 months after the date on which the
application is filed, unless the failure is caused by--
`(AA) a change in the requirements for approval of the application imposed
after the date on which the application is filed; or
`(BB) other extraordinary circumstances warranting an exception, as
determined by the Secretary.
`(ee) FAILURE TO CHALLENGE PATENT- In a case in which, after the date
on which the applicant submitted the application, new patent information
is submitted under subsection (c)(2) for the listed drug for a patent
for which certification is required under paragraph (2)(A), the applicant
fails to submit, not later than the date that is 60 days after the date
on which the Secretary publishes the new patent information under paragraph
(7)(A)(iii) (unless the Secretary extends
the date because of extraordinary or unusual circumstances)--
`(AA) a certification described in paragraph (2)(A)(vii)(IV) with respect
to the patent to which the new patent information relates; or
`(BB) a statement that any method of use claim of that patent does not
claim a use for which the applicant is seeking approval under this subsection
in accordance with paragraph (2)(A)(viii).
`(ff) UNLAWFUL CONDUCT- The Federal Trade Commission determines that the
applicant engaged in unlawful conduct with respect to the application
in violation of section 1 of the Sherman Act.
`(IV) SUBSEQUENT APPLICATION- The term `subsequent application' means an
application for approval of a drug that is filed subsequent to the filing
of a first application for approval of that drug.'.
(b) APPLICABILITY- The amendment made by subsection (a) shall apply only with
respect to an application filed under section 505(j) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(j)) after the date of enactment of this Act
for a listed drug for which no certification under section 505(j)(2)(A)(vii)(IV)
of that Act was made before the date of enactment of this Act, except that if
a forfeiture event described in section 505(j)(5)(E)(v)(III)(ff) of that Act
(as amended by this section) occurs in the case of an applicant, the applicant
shall forfeit the 180-day period under section 505(j)(5)(B)(iv) of that Act
without regard to when the applicant made a certification under section 505(j)(2)(A)(vii)(IV)
of that Act.
SEC. 9. BIOEQUIVALENCE.
(a) IN GENERAL- The amendments to part 320 of title 21, Code of Federal Regulations,
promulgated by the Commissioner of Food and Drugs on July 17, 1991 (57 Fed.
Reg. 17997 (April 28, 1992)), shall continue in effect as an exercise of authorities
under sections 501, 502, 505, and 701 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 351, 352, 355, 371).
(b) EFFECT- Subsection (a) does not affect the authority of the Commissioner
of Food and Drugs to amend part 320 of title 21, Code of Federal Regulations.
(c) EFFECT OF SECTION- This section shall not be construed to alter the authority
of the Secretary of Health and Human Services to regulate biological products
under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). Any
such authority shall be exercised under that Act as in effect on the day before
the date of enactment of this Act.
SEC. 10. FILING OF PATENT INFORMATION WITH THE FOOD AND DRUG ADMINISTRATION.
(a) FILING AFTER APPROVAL OF AN APPLICATION-
(1) IN GENERAL- Section 505 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355) (as amended by section 9(a)(2)(B)(ii)) is amended in subsection
(c) by striking paragraph (2) and inserting the following:
`(A) IN GENERAL- Not later than the date that is 30 days after the date
of an order approving an application under subsection (b) (unless the Secretary
extends the date because of extraordinary or unusual circumstances), the
holder of the application shall file with the Secretary the patent information
described in subparagraph (C) with respect to any patent--
`(i)(I) that claims the drug for which the application was approved; or
`(II) that claims an approved method of using the drug; and
`(ii) with respect to which a claim of patent infringement could reasonably
be asserted if a person not licensed by the owner engaged in the manufacture,
use, or sale of the drug.
`(B) SUBSEQUENTLY ISSUED PATENTS- In a case in which a patent described
in subparagraph (A) is issued after the date of an order approving an application
under subsection (b), the holder of the application shall file with the
Secretary the patent information described in subparagraph (C) not later
than the date that is 30 days after the date on which the patent is issued
(unless the Secretary extends the date because of extraordinary or unusual
circumstances).
`(C) PATENT INFORMATION- The patent information required to be filed under
subparagraph (A) or (B) includes--
`(ii) the expiration date of the patent;
`(iii) with respect to each claim of the patent--
`(I) whether the patent claims the drug or claims a method of using
the drug; and
`(II) whether the claim covers--
`(aa) a drug substance;
`(bb) a drug formulation;
`(cc) a drug composition; or
`(dd) a method of use;
`(iv) if the patent claims a method of use, the approved use covered by
the claim;
`(v) the identity of the owner of the patent (including the identity of
any agent of the patent owner); and
`(vi) a declaration that the applicant, as of the date of the filing,
has provided complete and accurate patent information for all patents
described in subparagraph (A).
`(D) PUBLICATION- On filing of patent information required under subparagraph
(A) or (B), the Secretary shall--
`(i) immediately publish the information described in clauses (i) through
(iv) of subparagraph (C); and
`(ii) make the information described in clauses (v) and (vi) of subparagraph
(C) available to the public on request.
`(E) CIVIL ACTION FOR CORRECTION OR DELETION OF PATENT INFORMATION-
`(i) IN GENERAL- A person that has filed an application under subsection
(b)(2) or (j) for a drug may bring a civil action against the holder of
the approved application for the drug seeking an order requiring that
the holder of the application amend the application--
`(I) to correct patent information filed under subparagraph (A); or
`(II) to delete the patent information in its entirety for the reason
that--
`(aa) the patent does not claim the drug for which the application
was approved; or
`(bb) the patent does not claim an approved method of using the drug.
`(ii) LIMITATIONS- Clause (i) does not authorize--
`(I) a civil action to correct patent information filed under subparagraph
(B); or
`(II) an award of damages in a civil action under clause (i).
`(F) NO CLAIM FOR PATENT INFRINGEMENT- An owner of a patent with respect
to which a holder of an application fails to file information on or before
the date required under subparagraph (A) or (B) shall be barred from bringing
a civil action for infringement of the patent against a person that--
`(i) has filed an application under subsection (b)(2) or (j); or
`(ii) manufactures, uses, offers to sell, or sells a drug approved under
an application under subsection (b)(2) or (j).'.
(2) TRANSITION PROVISION-
(A) FILING OF PATENT INFORMATION- Each holder of an application for approval
of a new drug under section 505(b) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(b)) that has been approved before the date of enactment
of this Act shall amend the application to include the patent information
required under the amendment made by paragraph (1) not later than the date
that is 30 days after the date of enactment of this Act (unless the Secretary
of Health and Human Services extends the date because of extraordinary or
unusual circumstances).
(B) NO CLAIM FOR PATENT INFRINGEMENT- An owner of a patent with respect
to which a holder of an application under subsection (b) of section 505
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) fails to file
information on or before the date required under subparagraph (A) shall
be barred from bringing a civil action for infringement of the patent against
a person that--
(i) has filed an application under subsection (b)(2) or (j) of that section;
or
(ii) manufactures, uses, offers to sell, or sells a drug approved under
an application under subsection (b)(2) or (j) of that section.
(b) FILING WITH AN APPLICATION- Section 505 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355) is amended--
(1) in subsection (b)(2)--
(A) in subparagraph (A), by striking `and' at the end;
(B) in subparagraph (B), by striking the period at the end and inserting
`; and'; and
(C) by adding at the end the following:
`(C) with respect to a patent that claims both the drug and a method of
using the drug or claims more than 1 method of using the drug for which
the application is filed--
`(i) a certification under subparagraph (A)(iv) on a claim-by-claim basis;
and
`(ii) a statement under subparagraph (B) regarding the method of use claim.';
and
(2) in subsection (j)(2)(A), by inserting after clause (viii) the following:
`With respect to a patent that claims both the drug and a method of using the
drug or claims more than 1 method of using the drug for which the application
is filed, the application shall contain a certification under clause (vii)(IV)
on a claim-by-claim basis and a statement under clause (viii) regarding the
method of use claim.'.
END