I
107TH CONGRESS
2D SESSION
H. R. 5350
To provide greater access to affordable pharmaceuticals, and for other
purposes.
IN THE HOUSE OF REPRESENTATIVES
SEPTEMBER 9, 2002
Mr. KENNEDY of Rhode Island introduced the following bill; which was re-
ferred to the Committee on Energy and Commerce, and in addition to
the Committee on Ways and Means, for a period to be subsequently de-
termined 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 Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Prescription Afford-
ability and Medicine Safety Act of 2002’’.
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 vulner-
able populations, are often unable to afford their
medication because of excessive and persistent drug
price inflation.
(2) In 1999, the top 5 pharmaceutical compa-
nies 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 pre-
scribed 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 Ameri-
cans.
(5) Because of the limited availability of private
or public prescription drug coverage for the elderly,
prescription drugs represent the highest out-of-pock-
et medical care cost for 3 of 4 elderly patients, sur-
passed 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 per-
cent of doctors say that patients somewhat often
talk with them about specific disease or treatment
they heard about from prescription drug advertise-
ments.
(8) The National Institutes of Health, the Gov-
ernment’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 ben-
efit of research paid for by the United States and,
aside from royalties, none of such profits are reim-
bursed to United States taxpayers.
(10) Only 24 percent of people over age 45 al-
ways ask their pharmacist about drug side effects.
(11) Only 31 percent of people over age 45 al-
ways 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 Ad-
ministration 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 re-
views of such applications, there is authorized to be appro-
priated $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 Ad-
ministration, through the Office of Generic Drugs, to con-
tinue 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 Cos-
metic 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 XXVIII—PHARMACY
ASSISTANCE
‘‘SEC. 2801. GRANTS.
‘‘(a) AUTHORIZATION.—From amounts available
from the revolving fund established under section 2803,
the Secretary may make grants to States for the purpose
of providing pharmacy assistance as described in sub-
section (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 assist-
ance program ; or
‘‘(2) to establish or expand such a program.
‘‘(c) APPLICATION.—To seek a grant under this sec-
tion, 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 Dis-
trict of Columbia, the Commonwealth of Puerto Rico, the
Commonwealth of the Northern Mariana Islands, Amer-
ican Samoa, Guam, the Virgin Islands, or any other terri-
tory or possession of the United States.
‘‘SEC. 2802. 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 submit-
ting the application enters into an agreement with the Sec-
retary that—
‘‘(1) requires the manufacturer to pay the Sec-
retary 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 ap-
plication of subsection (a) to a manufacturer of a biologi-
cal product or drug when the Secretary determines that
it would be in the public interest to exempt such manufac-
turer.
‘‘(c) COVERED APPLICATION.—For purposes of this
section, the term ‘covered application’ means an applica-
tion 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. 2803. 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 de-
posit in the fund established under this section all pay-
ments made to the Secretary under an agreement pursu-
ant to section 2802(a)(1).
‘‘(c) USE OF AMOUNTS IN FUND.—To the extent or
in the amounts made available in advance in appropria-
tions Acts, amounts in the fund established under this sec-
tion shall be available to the Secretary to make grants
under section 2801.’’.
SEC. 6. LIMITATION ON DEDUCTIONS FOR ADVERTISING BY
PRESCRIPTION DRUG MANUFACTURERS.
(a) IN GENERAL.—Part IX of subchapter B of chap-
ter 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 ADVER-
TISING BY PRESCRIPTION DRUG MANUFAC-
TURERS.
‘‘(a) IN GENERAL.—No deduction shall be allowed
under this chapter for any taxable year for any expendi-
ture 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 ag-
gregate research and development expenditures for such
taxable year.
‘‘(b) DEFINITIONS AND SPECIAL RULES.—For pur-
poses of this section—
‘‘(1) PRESCRIPTION
DRUGS.—The term ‘pre-
scription drug’ means any drug subject to subsection
(b)(1) of the Federal Food, Drug, and Cosmetic Act.
‘‘(2) RESEARCH AND DEVELOPMENT EXPENDI-
TURES.—The term ‘research and development ex-
penditures’ 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 re-
lating to section 280H the following:
‘‘Sec. 280I. Limitation on deductions for advertising by pre-
scription drug manufacturers.’’.
(c) EFFECTIVE DATE.—The amendments made by
this section shall apply to taxable years beginning after
December 31, 2001.
(d) TRANSFER TO THE FEDERAL HOSPITAL INSUR-
ANCE TRUST FUND OF RESULTING BUDGETARY SAV-
INGS.—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 PAT-
ENTS.
(a) ABBREVIATED NEW DRUG APPLICATIONS.—
(1) IN
GENERAL.—Clause (iii) of section
505(j)(5)(B) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355(j)(5)(B)) is amended to
read as follows:
‘‘(iii) If the applicant made a certification de-
scribed 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 imme-
diately unless an action is brought for infringe-
ment of a patent which is the subject of the cer-
tification 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 expi-
ration 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 cooper-
ate 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 in-
junction prohibiting the applicant from en-
gaging 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 sec-
tion 2201 of title 28, United States Code, for
a declaratory judgment with respect to the pat-
ent. 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 pre-
liminary 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 de-
clining to grant a preliminary injunction;
or
‘‘(bb) if the court has granted a pre-
liminary injunction prohibiting the appli-
cant from engaging in the commercial
manufacture or sale of the drug—
‘‘(AA) on issuance by a court of
a determination that the patent is in-
valid or is not infringed;
‘‘(BB) on issuance by a court of
an order revoking the preliminary in-
junction or permitting the applicant to
engage in the commercial manufac-
ture 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 notifica-
tion of a civil action under this subclause, the
plaintiff shall, on the date on which the com-
plaint is filed, simultaneously cause a notifica-
tion of the civil action to be delivered to that
address by the next business day.’’.
(2) FAILURE
TO
BRING
INFRINGEMENT
AC-
TION.—Paragraph (5) of section 505(j) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)) is amended by adding at the end the fol-
lowing:
‘‘(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 applica-
tion was filed or approved under this subsection.’’.
(b) OTHER APPLICATIONS.—
(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 fol-
lows:
‘‘(C) If the applicant made a certification de-
scribed 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 imme-
diately unless an action is brought for infringe-
ment of a patent which is the subject of the cer-
tification 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 expi-
ration 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 cooper-
ate 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 in-
junction prohibiting the applicant from en-
gaging 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 sec-
tion 2201 of title 28, United States Code, for
a declaratory judgment with respect to the pat-
ent. 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 pat-
ent (other than a patent that claims a process
for manufacturing the listed drug) for which
patent information was submitted under sub-
section (c)(2), the approval shall be made effec-
tive 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 in-
fringement of the patent, accompanied by a mo-
tion for preliminary injunction to enjoin the ap-
plicant from engaging in the commercial manu-
facture 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 de-
clining to grant a preliminary injunction;
or
‘‘(II) if the court has granted a pre-
liminary injunction prohibiting the appli-
cant from engaging in the commercial
manufacture or sale of the drug—
‘‘(aa) on issuance by a court of a
determination that the patent is in-
valid or is not infringed;
‘‘(bb) on issuance by a court of
an order revoking the preliminary in-
junction or permitting the applicant to
engage in the commercial manufac-
ture 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
AC-
TION.—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 fol-
lowing:
‘‘(5) If, in connection with an application under sub-
section (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 applica-
tion 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 re-
spect to patent information that was submitted to the Sec-
retary 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 sub-
clause (I);
(C) by striking subclause (II) and all that
follows through the end; and
(D) by adding after subclause (I) the fol-
lowing:
‘‘(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 certifi-
cation is invalid or not infringed.’’; and
(2) by inserting after subparagraph (D) the fol-
lowing:
‘‘(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 subpara-
graph (B)(iv) shall be forfeited by the first ap-
plicant; and
‘‘(II) any subsequent application shall be-
come effective as provided under clause (i), (ii),
or (iii) of subparagraph (B), and clause (iv) of
subparagraph (B) shall not apply to the subse-
quent application.
‘‘(ii) FORFEITURE TO FIRST SUBSEQUENT AP-
PLICANT.—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 de-
scribed in subparagraph (B)(iv) shall apply to an ap-
plication 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 ap-
plicant 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 Sec-
retary extends the date because of ex-
traordinary 
or 
unusual 
cir-
cumstances); or
‘‘(BB) if 1 or more civil actions
have been brought against the appli-
cant for infringement of a patent sub-
ject to a certification under paragraph
(2)(A)(vii)(IV) or 1 or more civil ac-
tions have been brought by the appli-
cant for a declaratory judgment that
such a patent is invalid or not in-
fringed, 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 Su-
preme 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
APPLICA-
TION.—The applicant withdraws the appli-
cation.
‘‘(cc) 
AMENDMENT
OF
CERTIFI-
CATION.—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
AP-
PROVAL.—The applicant fails to obtain
tentative approval of an application within
30 months after the date on which the ap-
plication is filed, unless the failure is
caused by—
‘‘(AA) a change in the require-
ments for approval of the application
imposed after the date on which the
application is filed; or
‘‘(BB) other extraordinary cir-
cumstances warranting an exception,
as determined by the Secretary.
‘‘(ee) FAILURE TO CHALLENGE PAT-
ENT.—In a case in which, after the date
on which the applicant submitted the ap-
plication, new patent information is sub-
mitted under subsection (c)(2) for the list-
ed 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 pat-
ent 
information 
under 
paragraph
(7)(A)(iii) (unless the Secretary extends
the date because of extraordinary or un-
usual 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 ap-
plicant is seeking approval under this
subsection in accordance with para-
graph (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 applica-
tion for approval of a drug that is filed subse-
quent to the filing of a first application for ap-
proval of that drug.’’.
(b) APPLICABILITY.—The amendment made by sub-
section (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 enact-
ment 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 au-
thority 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 APPLICA-
TION.—
(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 insert-
ing the following:
‘‘(2) PATENT INFORMATION.—
‘‘(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 Sec-
retary the patent information described in sub-
paragraph (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 sub-
paragraph (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 pat-
ent is issued (unless the Secretary extends the
date because of extraordinary or unusual cir-
cumstances).
‘‘(C) PATENT INFORMATION.—The patent
information required to be filed under subpara-
graph (A) or (B) includes—
‘‘(i) the patent number;
‘‘(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 informa-
tion 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 applica-
tion for the drug seeking an order requir-
ing that the holder of the application
amend the application—
‘‘(I) to correct patent information
filed under subparagraph (A); or
‘‘(II) to delete the patent infor-
mation in its entirety for the reason
that—
‘‘(aa) the patent does not
claim the drug for which the ap-
plication 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 pat-
ent information filed under subpara-
graph (B); or
‘‘(II) an award of damages in a
civil action under clause (i).
‘‘(F) NO CLAIM FOR PATENT INFRINGE-
MENT.—An owner of a patent with respect to
which a holder of an application fails to file in-
formation 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 applica-
tion 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 appli-
cation to include the patent information re-
quired under the amendment made by para-
graph (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 extraor-
dinary or unusual circumstances).
(B) NO
CLAIM
FOR
PATENT
INFRINGE-
MENT.—An owner of a patent with respect to
which a holder of an application under sub-