I 
108TH CONGRESS 
1ST SESSION H. R. 2491
Entitled the ‘‘Greater Access to Affordable Pharmaceuticals Act’’. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 17, 2003
Mrs. EMERSON (for herself, Mr. BROWN of Ohio, Mr. WAMP, Mr. WAXMAN, 
Mrs. BONO, Mr. EDWARDS, Mr. GUTKNECHT, Mr. EMANUEL, Mrs. 
NORTHUP, Mr. PALLONE, Mr. BRADLEY of New Hampshire, Mrs. 
LOWEY, Mr. BEREUTER, Mr. SERRANO, Mr. KINGSTON, Mr. WEXLER, 
Mr. JANKLOW, Ms. ROYBAL-ALLARD, Mr. OSBORNE, Mr. LANGEVIN, Mr. 
CALVERT, Mr. COOPER, Mr. MARKEY, Mr. ALLEN, and Mr. BURTON of 
Indiana) introduced the following bill; which was referred to the Com-
mittee on Energy and Commerce, and in addition to the Committee on 
the Judiciary, for a period to be subsequently determined by the Speaker, 
in each case for consideration of such provisions as fall within the juris-
diction of the committee concerned 
A BILL 
Entitled the ‘‘Greater Access to Affordable Pharmaceuticals 
Act’’.
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 ‘‘Greater Access to Af-
fordable Pharmaceuticals Act’’.
SEC. 2. 30-MONTH STAY-OF-EFFECTIVENESS PERIOD. 
(a) ABBREVIATED NEW DRUG APPLICATIONS.—Sec-
tion 505(j) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355(j)) is amended— 
(1) in paragraph (2)(A)(vii), by inserting after 
‘‘each patent’’ the following: ‘‘published by the Sec-
retary under subsection (b)(1) or (c)(2) at least 1 
day before the date on which the application is 
filed’’; and 
(2) in paragraph (5)—
(A) in subparagraph (B)(iii)—
(i) by striking ‘‘paragraph (2)(B)(i)’’ 
each place it appears and inserting ‘‘para-
graph (2)(B)’’; 
(ii) in the first sentence, by inserting 
after ‘‘of a patent’’ the following: ‘‘pub-
lished by the Secretary under subsection 
(b)(1) or (c)(2) at least 1 day before the 
date on which the application is filed’’; and 
(iii) in subclauses (I), (II), and (III) 
of the second sentence, by striking ‘‘the 
court’’ and inserting ‘‘the United States 
district court presiding over the matter’’; 
(B) by redesignating subparagraphs (C) 
and (D) as subparagraphs (E) and (F), respec-
tively; and
(C) by inserting after subparagraph (B) 
the following: 
‘‘(C) AVAILABILITY
OF
30-MONTH
PE-
RIOD.—
‘‘(i) IN GENERAL.—The 30-month pe-
riod provided under subparagraph (B)(iii) 
shall be available only with respect to a 
patent published by the Secretary under 
subsection (b)(1) or (c)(2) at least 1 day 
before the date on which the application is 
filed. 
‘‘(ii) 
SUBSEQUENTLY
PUBLISHED 
PATENTS.—
‘‘(I) IN GENERAL.—If a patent is 
published by the Secretary under sub-
section (b)(1) or (c)(2) subsequent to 
the filing of an application described 
in paragraph (2)(A) but before ap-
proval of that application (referred to 
in this clause as a ‘subsequently pub-
lished patent’), and the patent claims 
the listed drug referred to in para-
graph (2)(A)(i) or a use for the listed 
drug for which the applicant is seek-
ing approval under this subsection
and for which information is required 
to be filed under subsection (b) or (c), 
the applicant shall amend the applica-
tion to include a certification de-
scribed in paragraph (2)(A)(vii) or a 
statement described in paragraph 
(2)(A)(viii) for the patent. 
‘‘(II) NO ADDITIONAL 30-MONTH 
PERIOD.—The 30-month period de-
scribed in subparagraph (B)(iii) shall 
not be available with respect to a cer-
tification 
described 
in 
paragraph 
(2)(A)(vii)(IV) when the subject of 
that certification is a subsequently 
published patent. 
‘‘(III) CHALLENGE
TO
SUBSE-
QUENTLY PUBLISHED PATENT IN SEP-
ARATE PROCEEDING.—If the same ap-
plicant makes a certification described 
in paragraph (2)(A)(vii)(IV) with re-
spect to the subsequently published 
patent in a separate application under 
this subsection, the 30-month period 
provided under subparagraph (B)(iii)
shall be available in connection with 
the separate application. 
‘‘(iii) CIVIL ACTION TO OBTAIN PAT-
ENT CERTAINTY.—
‘‘(I) DECLARATORY
JUDGMENT 
ABSENT
INFRINGEMENT
ACTION.—If 
the owner of a patent fails to bring a 
civil action against the applicant for 
infringement of the patent on or be-
fore the date that is 45 days after the 
date on which the notice provided 
under paragraph (2)(B) was received, 
the applicant may bring a civil action 
against the owner of the patent for a 
declaratory judgment under section 
2201 of title 28, United States Code, 
that the patent is invalid, is unen-
forceable, or will not otherwise be in-
fringed by the new drug for which the 
person seeks approval. 
‘‘(II) COUNTERCLAIM
TO
IN-
FRINGEMENT ACTION.—
‘‘(aa) IN GENERAL.—If the 
owner of the patent brings a pat-
ent infringement action against
the applicant, the applicant may 
assert a counterclaim seeking an 
order requiring the patent owner 
to correct or delete patent infor-
mation filed by the patent owner 
under subsection (b) or (c) on 
the ground that the patent does 
not claim—
‘‘(AA) the drug for 
which the application was 
approved; or 
‘‘(BB) 
an 
approved 
method of using the drug. 
‘‘(bb) 
NO
DAMAGES.—An 
applicant shall not be entitled to 
damages on a counterclaim under 
item (aa). 
‘‘(cc) 
NO
INDEPENDENT 
CAUSE
OF
ACTION.—Item (aa) 
does not authorize the assertion 
of a claim described in item (aa) 
in any civil action or proceeding 
other than a counterclaim de-
scribed in item (aa).’’.
(b) APPLICATIONS GENERALLY.—Section 505 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) 
is amended—
(1) in subsection (b)(2)(A), by inserting after 
‘‘each patent’’ the following: ‘‘published by the Sec-
retary under paragraph (1) or subsection (c)(2) at 
least 1 day before the date on which the application 
is filed’’; and 
(2) in subsection (c)—
(A) in paragraph (3)(C)—
(i) by striking ‘‘paragraph (3)(B)’’ 
each place it appears and inserting ‘‘para-
graph (3)’’; 
(ii) in the first sentence, by inserting 
after ‘‘of a patent’’ the following: ‘‘pub-
lished by the Secretary under paragraph 
(2) or subsection (b)(1) at least 1 day be-
fore the date on which the application is 
filed’’; and 
(iii) in clauses (i), (ii), and (iii) of the 
second sentence, by striking ‘‘the court’’ 
and inserting ‘‘the United States district 
court presiding over the matter’’; 
(B) by redesignating paragraph (4) as 
paragraph (5); and
(C) by inserting after paragraph (3) the 
following: 
‘‘(4) AVAILABILITY OF 30-MONTH PERIOD.—
‘‘(A) IN GENERAL.—The 30-month period 
provided under paragraph (3)(C) shall be avail-
able only with respect to a patent published by 
the Secretary under paragraph (2) or sub-
section (b)(1) at least 1 day before the date on 
which the application is filed. 
‘‘(B) SUBSEQUENTLY
PUBLISHED
PAT-
ENTS.—
‘‘(i) IN GENERAL.—If a patent is pub-
lished by the Secretary under paragraph 
(2) or subsection (b)(1) subsequent to the 
filing of an application described in sub-
section (b)(2) but before approval of that 
application (referred to in this subpara-
graph as a ‘subsequently published pat-
ent’), and the patent claims the listed drug 
or a use for the listed drug for which the 
applicant is seeking approval, the applicant 
shall amend the application to include a 
certification 
described 
in 
subsection 
(b)(2)(A) or a statement described in sub-
section (b)(2)(B) for the patent.
‘‘(ii) NO ADDITIONAL 30-MONTH PE-
RIOD.—The 30-month period described in 
paragraph (3)(C) shall not be available 
with respect to a certification described in 
subsection (b)(2)(A)(iv) when the subject 
of that certification is a subsequently pub-
lished patent. 
‘‘(iii) CHALLENGE TO SUBSEQUENTLY 
PUBLISHED
PATENT
IN
SEPARATE
PRO-
CEEDING.—If the same applicant makes a 
certification 
described 
in 
subsection 
(b)(2)(A)(iv) with respect to the subse-
quently published patent in a separate ap-
plication under this subsection, the 30-
month period provided under paragraph 
(3)(C) shall be available in connection with 
the separate application. 
‘‘(C) CIVIL
ACTION
TO
OBTAIN
PATENT 
CERTAINTY.—
‘‘(i) DECLARATORY
JUDGMENT
AB-
SENT
INFRINGEMENT
ACTION.—If 
the 
owner of a patent fails to bring a civil ac-
tion against the applicant for infringement 
of the patent on or before the date that is 
45 days after the date on which the notice
provided under paragraph (2)(B) was re-
ceived, the applicant may bring a civil ac-
tion against the owner of the patent for a 
declaratory judgment under section 2201 
of title 28, United States Code, that the
patent is invalid, is unenforceable, or will 
not otherwise be infringed by the new drug 
for which the person seeks approval. 
‘‘(ii) COUNTERCLAIM
TO
INFRINGE-
MENT ACTION.—
‘‘(I) IN GENERAL.—If the owner 
of the patent brings a patent infringe-
ment action against the applicant, the 
applicant may assert a counterclaim 
seeking an order requiring the patent 
owner to correct or delete patent in-
formation filed by the patent owner 
under subsection (b) or (c) on the 
ground that the patent either does not 
claim the drug for which the applica-
tion was approved or does not claim—
‘‘(aa) the drug for which the 
application was approved; or 
‘‘(bb) an approved method 
of using the drug.
‘‘(II) NO
DAMAGES.—An appli-
cant shall not be entitled to damages 
on a counterclaim under subclause (I). 
‘‘(III) NO INDEPENDENT CAUSE 
OF ACTION.—Subclause (I) does not 
authorize the assertion of a claim de-
scribed in subclause (I) in any civil 
action or proceeding other than a 
counterclaim described in subclause 
(I).’’. 
(c) INFRINGEMENT ACTIONS.—Section 271(e) of title 
35, United States Code, is amended by adding at the end 
the following: 
‘‘(5) CASE OR CONTROVERSY.—The filing of an 
application described in paragraph (2) that includes 
a 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), and 
the failure of the owner of the patent to bring an 
action for infringement of a patent that is the sub-
ject of the certification before the expiration of 45 
days after the date on which the notice provided 
under subsection (b)(3) or (j)(2)(B) of that section 
is received, shall establish an actual controversy be-
tween the applicant and the patent owner sufficient
to confer subject matter jurisdiction in the courts of 
the United States for any action brought by the ap-
plicant under section 2201 of title 28 for a declara-
tory judgment that any patent that is the subject of 
the certification is invalid, unenforceable, or not in-
fringed.’’. 
(d) 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 or in an amendment 
to an application filed under subsection (b)(2) or (j) of 
that section. 
SEC. 3. FORFEITURE OF 180-DAY EXCLUSIVITY PERIOD. 
(a) IN GENERAL.—Section 505(j)(5) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)) (as 
amended by section 2) is amended—
(1) in subparagraph (B)(iv), by striking sub-
clause (II) and inserting the following: 
‘‘(II) the earlier of—
‘‘(aa) the date of a final de-
cision of a court from which no 
appeal has or can be taken other
‘‘(aa) the date that is 60 
days after the date on which the 
approval of the application for
the drug is made effective under 
subparagraph (B)(iii); or 
‘‘(bb) if 1 or more civil ac-
tions 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 other-
wise infringed, the date that is 
60 days after 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 Su-
preme Court for a writ of certio-
rari) in the last of those civil ac-
tions to be decided. 
‘‘(II) WITHDRAWAL OF APPLICA-
TION.—The applicant withdraws the 
application.
‘‘(III) AMENDMENT OF CERTIFI-
CATION.—The applicant amends the 
certification from a certification under 
paragraph (2)(A)(vii)(IV) to a certifi-
cation 
under 
paragraph 
(2)(A)(vii)(III). 
‘‘(IV) FAILURE TO OBTAIN TEN-
TATIVE
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 a 
change in the requirements for ap-
proval of the application imposed after 
the date on which the application is 
filed. 
‘‘(V) FAILURE
TO
CHALLENGE 
PATENT.—In a case in which, after 
the date on which the applicant sub-
mitted the application, new patent in-
formation is submitted under sub-
section (c)(2) for the listed drug for a 
patent for which certification is re-
quired 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)—
‘‘(aa) 
a 
certification 
de-
scribed 
in 
paragraph 
(2)(A)(vii)(IV) with respect to 
the patent to which the new pat-
ent information relates; or 
‘‘(bb) a statement that any 
method of use claim of that pat-
ent does not claim a use for 
which the applicant is seeking 
approval under this subsection in 
accordance 
with 
paragraph 
(2)(A)(viii). 
‘‘(VI) AGREEMENT WITH PATENT 
OWNER.—The applicant enters into 
an agreement with the owner of the 
patent—
‘‘(aa) that is the subject of 
the certification under paragraph 
(2)(A)(vii)(IV); and 
‘‘(bb) 
that 
the 
Federal 
Trade 
Commission 
determines
has violated the antitrust laws 
(as defined in section 1 of the 
Clayton Act (15 U.S.C. 12), ex-
cept that the term includes sec-
tion 5 of the Federal Trade Com-
mission Act (15 U.S.C. 45) to 
the extent that that section ap-
plies to unfair methods of com-
petition). 
‘‘(ii) FORFEITURE.—The 180-day ex-
clusivity period described in subparagraph 
(B)(iv) shall be forfeited by an applicant if 
a forfeiture event occurs. 
‘‘(iii) SUBSEQUENT
APPLICANT.—If 
an applicant forfeits the 180-day exclu-
sivity period under clause (ii)—
‘‘(I) a subsequent application 
containing a certification described in 
paragraph (2)(A)(vii)(IV) shall be-
come effective immediately on ap-
proval; and 
‘‘(II) the subsequent applicant 
shall not be eligible for a 180-day ex-
clusivity period under subparagraph 
(B)(iv).
‘‘(E) 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 re-
gard to whether an application has been sub-
mitted for the drug under this subsection con-
taining such a certification with respect to a 
different patent.’’. 
(b) APPLICABILITY.—The amendment made by sub-
section (a) shall be effective only with respect to an appli-
cation 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)(D)(i)(VI) of that Act 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). 
SEC. 4. BIOAVAILABILITY AND BIOEQUIVALENCE. 
(a) IN GENERAL.—Section 505(j)(8) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(8)) is 
amended—
(1) by striking subparagraph (A) and inserting 
the following: 
‘‘(A)(i) The term ‘bioavailability’ means the 
rate and extent to which the active ingredient or 
therapeutic ingredient is absorbed from a drug and 
becomes available at the site of drug action. 
‘‘(ii) For a drug that is not intended to be ab-
sorbed into the bloodstream, the Secretary may as-
sess bioavailability by scientifically valid measure-
ments intended to reflect the rate and extent and ex-
tent to which the active ingredient or active moeity 
becomes available at the site of drug action.’’; and 
(2) by adding at the end the following: 
‘‘(C) For a drug that is not intended to be ab-
sorbed into the bloodstream, the Secretary may es-
tablish alternative, scientifically valid methods to 
show bioequivalence if the alternative methods are 
expected to detect a significant difference between 
the drug and the listed drug in safety and thera-
peutic effect.’’. 
(b) EFFECT
OF
AMENDMENT.—The amendment 
made by subsection (a) does not alter the standards for 
approval of drugs under section 505(j) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)).