I 
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 En-
ergy 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 jurisdic-
tion 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 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 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
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. 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 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. 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 de-
posit in the fund established under this section all pay-
ments made to the Secretary under an agreement pursu-
ant to section 2902(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 2901.’’. 
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 section 
503(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, 2002.
(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 effec-
tive— 
‘‘(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-
section (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 re-
quired 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 sub-
section (b)(2) or (j) of that section; or 
(ii) manufactures, uses, offers to sell, 
or sells a drug approved under an applica-
tion 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 subpara-
graph (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.’’.
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