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 Committee on Energy and Commerce, and in addition to the Committee on 

the Judiciary, for a period to be subsequently determined by the Speaker, 

in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned 

A BILL

Entitled the ‘‘Greater Access to Affordable Pharmaceuticals 

Act’’.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Greater Access to Af5 fordable Pharmaceuticals Act’’. 
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1 SEC. 2. 30-MONTH STAY-OF-EFFECTIVENESS PERIOD. 

2 (a) ABBREVIATED NEW DRUG APPLICATIONS.—Sec3 tion 505(j) of the Federal Food, Drug, and Cosmetic Act 

4 (21 U.S.C. 355(j)) is amended— 

5 (1) in paragraph (2)(A)(vii), by inserting after 

6 ‘‘each patent’’ the following: ‘‘published by the Sec7 retary under subsection (b)(1) or (c)(2) at least 1 

8 day before the date on which the application is 

9 filed’’; and 

10 (2) in paragraph (5)—

11 (A) in subparagraph (B)(iii)—

12 (i) by striking ‘‘paragraph (2)(B)(i)’’ 

13 each place it appears and inserting ‘‘para14 graph (2)(B)’’; 

15 (ii) in the first sentence, by inserting 

16 after ‘‘of a patent’’ the following: ‘‘pub17 lished by the Secretary under subsection 

18 (b)(1) or (c)(2) at least 1 day before the 

19 date on which the application is filed’’; and 

20 (iii) in subclauses (I), (II), and (III) 

21 of the second sentence, by striking ‘‘the 

22 court’’ and inserting ‘‘the United States 

23 district court presiding over the matter’’; 

24 (B) by redesignating subparagraphs (C) 

25 and (D) as subparagraphs (E) and (F), respec26 tively; and 
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1 (C) by inserting after subparagraph (B) 

2 the following: 

3 ‘‘(C) AVAILABILITY OF 30-MONTH PE4 RIOD.—

5 ‘‘(i) IN GENERAL.—The 30-month pe6 riod provided under subparagraph (B)(iii) 

7 shall be available only with respect to a 

8 patent published by the Secretary under 

9 subsection (b)(1) or (c)(2) at least 1 day 

10 before the date on which the application is 

11 filed. 

12 ‘‘(ii) SUBSEQUENTLY PUBLISHED

13 PATENTS.—

14 ‘‘(I) IN GENERAL.—If a patent is 

15 published by the Secretary under sub16 section (b)(1) or (c)(2) subsequent to 

17 the filing of an application described 

18 in paragraph (2)(A) but before ap19 proval of that application (referred to 

20 in this clause as a ‘subsequently pub21 lished patent’), and the patent claims 

22 the listed drug referred to in para23 graph (2)(A)(i) or a use for the listed 

24 drug for which the applicant is seek25 ing approval under this subsection 
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1 and for which information is required 

2 to be filed under subsection (b) or (c), 

3 the applicant shall amend the applica4 tion to include a certification de5 scribed in paragraph (2)(A)(vii) or a 

6 statement described in paragraph 

7 (2)(A)(viii) for the patent. 

8 ‘‘(II) NO ADDITIONAL 30-MONTH

9 PERIOD.—The 30-month period de10 scribed in subparagraph (B)(iii) shall 

11 not be available with respect to a cer12 tification described in paragraph 

13 (2)(A)(vii)(IV) when the subject of 

14 that certification is a subsequently 

15 published patent. 

16 ‘‘(III) CHALLENGE TO SUBSE17 QUENTLY PUBLISHED PATENT IN SEP18 ARATE PROCEEDING.—If the same ap19 plicant makes a certification described 

20 in paragraph (2)(A)(vii)(IV) with re21 spect to the subsequently published 

22 patent in a separate application under 

23 this subsection, the 30-month period 

24 provided under subparagraph (B)(iii) 
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1 shall be available in connection with 

2 the separate application. 

3 ‘‘(iii) CIVIL ACTION TO OBTAIN PAT4 ENT CERTAINTY.—

5 ‘‘(I) DECLARATORY JUDGMENT

6 ABSENT INFRINGEMENT ACTION.—If 

7 the owner of a patent fails to bring a 

8 civil action against the applicant for 

9 infringement of the patent on or be10 fore the date that is 45 days after the 

11 date on which the notice provided 

12 under paragraph (2)(B) was received, 

13 the applicant may bring a civil action 

14 against the owner of the patent for a 

15 declaratory judgment under section 

16 2201 of title 28, United States Code, 

17 that the patent is invalid, is unen18 forceable, or will not otherwise be in19 fringed by the new drug for which the 

20 person seeks approval. 

21 ‘‘(II) COUNTERCLAIM TO IN22 FRINGEMENT ACTION.—

23 ‘‘(aa) IN GENERAL.—If the 

24 owner of the patent brings a pat25 ent infringement action against 
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1 the applicant, the applicant may 

2 assert a counterclaim seeking an 

3 order requiring the patent owner 

4 to correct or delete patent infor5 mation filed by the patent owner 

6 under subsection (b) or (c) on 

7 the ground that the patent does 

8 not claim—

9 ‘‘(AA) the drug for 

10 which the application was 

11 approved; or 

12 ‘‘(BB) an approved 

13 method of using the drug. 

14 ‘‘(bb) NO DAMAGES.—An 

15 applicant shall not be entitled to 

16 damages on a counterclaim under 

17 item (aa). 

18 ‘‘(cc) NO INDEPENDENT

19 CAUSE OF ACTION.—Item (aa) 

20 does not authorize the assertion 

21 of a claim described in item (aa) 

22 in any civil action or proceeding 

23 other than a counterclaim de24 scribed in item (aa).’’. 
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1 (b) APPLICATIONS GENERALLY.—Section 505 of the 

2 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) 

3 is amended—

4 (1) in subsection (b)(2)(A), by inserting after 

5 ‘‘each patent’’ the following: ‘‘published by the Sec6 retary under paragraph (1) or subsection (c)(2) at 

7 least 1 day before the date on which the application 

8 is filed’’; and 

9 (2) in subsection (c)—

10 (A) in paragraph (3)(C)—

11 (i) by striking ‘‘paragraph (3)(B)’’ 

12 each place it appears and inserting ‘‘para13 graph (3)’’; 

14 (ii) in the first sentence, by inserting 

15 after ‘‘of a patent’’ the following: ‘‘pub16 lished by the Secretary under paragraph 

17 (2) or subsection (b)(1) at least 1 day be18 fore the date on which the application is 

19 filed’’; and 

20 (iii) in clauses (i), (ii), and (iii) of the 

21 second sentence, by striking ‘‘the court’’ 

22 and inserting ‘‘the United States district 

23 court presiding over the matter’’; 

24 (B) by redesignating paragraph (4) as 

25 paragraph (5); and 
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1 (C) by inserting after paragraph (3) the 

2 following: 

3 ‘‘(4) AVAILABILITY OF 30-MONTH PERIOD.—

4 ‘‘(A) IN GENERAL.—The 30-month period 

5 provided under paragraph (3)(C) shall be avail6 able only with respect to a patent published by 

7 the Secretary under paragraph (2) or sub8 section (b)(1) at least 1 day before the date on 

9 which the application is filed. 

10 ‘‘(B) SUBSEQUENTLY PUBLISHED PAT11 ENTS.—

12 ‘‘(i) IN GENERAL.—If a patent is pub13 lished by the Secretary under paragraph 

14 (2) or subsection (b)(1) subsequent to the 

15 filing of an application described in sub16 section (b)(2) but before approval of that 

17 application (referred to in this subpara18 graph as a ‘subsequently published pat19 ent’), and the patent claims the listed drug 

20 or a use for the listed drug for which the 

21 applicant is seeking approval, the applicant 

22 shall amend the application to include a 

23 certification described in subsection 

24 (b)(2)(A) or a statement described in sub25 section (b)(2)(B) for the patent. 
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1 ‘‘(ii) NO ADDITIONAL 30-MONTH PE2 RIOD.—The 30-month period described in 

3 paragraph (3)(C) shall not be available 

4 with respect to a certification described in 

5 subsection (b)(2)(A)(iv) when the subject 

6 of that certification is a subsequently pub7 lished patent. 

8 ‘‘(iii) CHALLENGE TO SUBSEQUENTLY

9 PUBLISHED PATENT IN SEPARATE PRO10 CEEDING.—If the same applicant makes a 

11 certification described in subsection 

12 (b)(2)(A)(iv) with respect to the subse13 quently published patent in a separate ap14 plication under this subsection, the 30-

15 month period provided under paragraph 

16 (3)(C) shall be available in connection with 

17 the separate application. 

18 ‘‘(C) CIVIL ACTION TO OBTAIN PATENT

19 CERTAINTY.—

20 ‘‘(i) DECLARATORY JUDGMENT AB21 SENT INFRINGEMENT ACTION.—If the 

22 owner of a patent fails to bring a civil ac23 tion against the applicant for infringement 

24 of the patent on or before the date that is 

25 45 days after the date on which the notice 
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1 provided under paragraph (2)(B) was re2 ceived, the applicant may bring a civil ac3 tion against the owner of the patent for a 

4 declaratory judgment under section 2201 

5 of title 28, United States Code, that the

6 patent is invalid, is unenforceable, or will 

7 not otherwise be infringed by the new drug 

8 for which the person seeks approval. 

9 ‘‘(ii) COUNTERCLAIM TO INFRINGE10 MENT ACTION.—

11 ‘‘(I) IN GENERAL.—If the owner 

12 of the patent brings a patent infringe13 ment action against the applicant, the 

14 applicant may assert a counterclaim 

15 seeking an order requiring the patent 

16 owner to correct or delete patent in17 formation filed by the patent owner 

18 under subsection (b) or (c) on the 

19 ground that the patent either does not 

20 claim the drug for which the applica21 tion was approved or does not claim—

22 ‘‘(aa) the drug for which the 

23 application was approved; or 

24 ‘‘(bb) an approved method 

25 of using the drug. 
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1 ‘‘(II) NO DAMAGES.—An appli2 cant shall not be entitled to damages 

3 on a counterclaim under subclause (I). 

4 ‘‘(III) NO INDEPENDENT CAUSE

5 OF ACTION.—Subclause (I) does not 

6 authorize the assertion of a claim de7 scribed in subclause (I) in any civil 

8 action or proceeding other than a 

9 counterclaim described in subclause 

10 (I).’’. 

11 (c) INFRINGEMENT ACTIONS.—Section 271(e) of title 

12 35, United States Code, is amended by adding at the end 

13 the following: 

14 ‘‘(5) CASE OR CONTROVERSY.—The filing of an 

15 application described in paragraph (2) that includes 

16 a certification under subsection (b)(2)(A)(iv) or 

17 (j)(2)(A)(vii)(IV) of section 505 of the Federal 

18 Food, Drug, and Cosmetic Act (21 U.S.C. 355), and 

19 the failure of the owner of the patent to bring an 

20 action for infringement of a patent that is the sub21 ject of the certification before the expiration of 45 

22 days after the date on which the notice provided 

23 under subsection (b)(3) or (j)(2)(B) of that section 

24 is received, shall establish an actual controversy be25 tween the applicant and the patent owner sufficient 
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1 to confer subject matter jurisdiction in the courts of 

2 the United States for any action brought by the ap3 plicant under section 2201 of title 28 for a declara4 tory judgment that any patent that is the subject of 

5 the certification is invalid, unenforceable, or not in6 fringed.’’. 

7 (d) EFFECTIVE DATE.—The amendments made by 

8 subsections (a) and (b) shall be effective with respect to 

9 any certification under subsection (b)(2)(A)(iv) or 

10 (j)(2)(A)(vii)(IV) of section 505 of the Federal Food, 

11 Drug, and Cosmetic Act (21 U.S.C. 355) made after the 

12 date of enactment of this Act in an application filed under 

13 subsection (b)(2) or (j) of that section or in an amendment 

14 to an application filed under subsection (b)(2) or (j) of 

15 that section. 

16 SEC. 3. FORFEITURE OF 180-DAY EXCLUSIVITY PERIOD. 

17 (a) IN GENERAL.—Section 505(j)(5) of the Federal 

18 Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)) (as 

19 amended by section 2) is amended—

20 (1) in subparagraph (B)(iv), by striking sub21 clause (II) and inserting the following: 

22 ‘‘(II) the earlier of—

23 ‘‘(aa) the date of a final de24 cision of a court from which no 

25 appeal has or can be taken other 
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1 than a petition to the Supreme 

2 Court for a writ of certiorari 

3 holding that the patent that is 

4 the subject of the certification is 

5 invalid or not infringed; or 

6 ‘‘(bb) the date of a settle7 ment order or consent decree 

8 signed by a Federal judge that 

9 enters a final judgment and in10 cludes a finding that the patent 

11 that is the subject of the certifi12 cation is invalid or not otherwise 

13 infringed;’’; and 

14 (2) by inserting after subparagraph (C) the fol15 lowing: 

16 ‘‘(D) FORFEITURE OF 180-DAY EXCLU17 SIVITY PERIOD.—

18 ‘‘(i) DEFINITION OF FORFEITURE

19 EVENT.—In this subparagraph, the term 

20 ‘forfeiture event’, with respect to an appli21 cation under this subsection, means the oc22 currence of any of the following: 

23 ‘‘(I) FAILURE TO MARKET.—The 

24 applicant fails to market the drug by 

25 the later of—
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1 ‘‘(aa) the date that is 60 

2 days after the date on which the 

3 approval of the application for

4 the drug is made effective under 

5 subparagraph (B)(iii); or 

6 ‘‘(bb) if 1 or more civil ac7 tions have been brought against 

8 the applicant for infringement of 

9 a patent subject to a certification 

10 under paragraph (2)(A)(vii)(IV) 

11 or 1 or more civil actions have 

12 been brought by the applicant for 

13 a declaratory judgment that such 

14 a patent is invalid or not other15 wise infringed, the date that is 

16 60 days after the date of a final 

17 decision of a court from which no 

18 appeal has been or can be taken 

19 (other than a petition to the Su20 preme Court for a writ of certio21 rari) in the last of those civil ac22 tions to be decided. 

23 ‘‘(II) WITHDRAWAL OF APPLICA24 TION.—The applicant withdraws the 

25 application. 
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1 ‘‘(III) AMENDMENT OF CERTIFI2 CATION.—The applicant amends the 

3 certification from a certification under 

4 paragraph (2)(A)(vii)(IV) to a certifi5 cation under paragraph 

6 (2)(A)(vii)(III). 

7 ‘‘(IV) FAILURE TO OBTAIN TEN8 TATIVE APPROVAL.—The applicant 

9 fails to obtain tentative approval of an 

10 application within 30 months after the 

11 date on which the application is filed, 

12 unless the failure is caused by a 

13 change in the requirements for ap14 proval of the application imposed after 

15 the date on which the application is 

16 filed. 

17 ‘‘(V) FAILURE TO CHALLENGE

18 PATENT.—In a case in which, after 

19 the date on which the applicant sub20 mitted the application, new patent in21 formation is submitted under sub22 section (c)(2) for the listed drug for a 

23 patent for which certification is re24 quired under paragraph (2)(A), the 

25 applicant fails to submit, not later 
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1 than the date that is 60 days after the 

2 date on which the Secretary publishes 

3 the new patent information under 

4 paragraph (7)(A)(iii)—

5 ‘‘(aa) a certification de6 scribed in paragraph 

7 (2)(A)(vii)(IV) with respect to 

8 the patent to which the new pat9 ent information relates; or 

10 ‘‘(bb) a statement that any 

11 method of use claim of that pat12 ent does not claim a use for 

13 which the applicant is seeking 

14 approval under this subsection in 

15 accordance with paragraph 

16 (2)(A)(viii). 

17 ‘‘(VI) AGREEMENT WITH PATENT

18 OWNER.—The applicant enters into 

19 an agreement with the owner of the 

20 patent—

21 ‘‘(aa) that is the subject of 

22 the certification under paragraph 

23 (2)(A)(vii)(IV); and 

24 ‘‘(bb) that the Federal 

25 Trade Commission determines 
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1 has violated the antitrust laws 

2 (as defined in section 1 of the 

3 Clayton Act (15 U.S.C. 12), ex4 cept that the term includes sec5 tion 5 of the Federal Trade Com6 mission Act (15 U.S.C. 45) to 

7 the extent that that section ap8 plies to unfair methods of com9 petition). 

10 ‘‘(ii) FORFEITURE.—The 180-day ex11 clusivity period described in subparagraph 

12 (B)(iv) shall be forfeited by an applicant if 

13 a forfeiture event occurs. 

14 ‘‘(iii) SUBSEQUENT APPLICANT.—If 

15 an applicant forfeits the 180-day exclu16 sivity period under clause (ii)—

17 ‘‘(I) a subsequent application 

18 containing a certification described in 

19 paragraph (2)(A)(vii)(IV) shall be20 come effective immediately on ap21 proval; and 

22 ‘‘(II) the subsequent applicant 

23 shall not be eligible for a 180-day ex24 clusivity period under subparagraph 

25 (B)(iv). 
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1 ‘‘(E) AVAILABILITY.—The 180-day period 

2 under subparagraph (B)(iv) shall be available to

3 a first applicant submitting an application for 

4 a drug with respect to any patent without re5 gard to whether an application has been sub6 mitted for the drug under this subsection con7 taining such a certification with respect to a 

8 different patent.’’. 

9 (b) APPLICABILITY.—The amendment made by sub10 section (a) shall be effective only with respect to an appli11 cation filed under section 505(j) of the Federal Food, 

12 Drug, and Cosmetic Act (21 U.S.C. 355 (j)) after the date 

13 of enactment of this Act for a listed drug for which no 

14 certification under section 505(j)(2)(A)(vii)(IV) of that 

15 Act was made before the date of enactment of this Act, 

16 except that if a forfeiture event described in section 

17 505(j)(5)(D)(i)(VI) of that Act occurs in the case of an 

18 applicant, the applicant shall forfeit the 180-day period 

19 under section 505(j)(5)(B)(iv) of that Act without regard 

20 to when the applicant made a certification under section 

21 505(j)(2)(A)(vii)(IV). 

22 SEC. 4. BIOAVAILABILITY AND BIOEQUIVALENCE. 

23 (a) IN GENERAL.—Section 505(j)(8) of the Federal 

24 Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(8)) is 

25 amended—
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1 (1) by striking subparagraph (A) and inserting 

2 the following: 

3 ‘‘(A)(i) The term ‘bioavailability’ means the 

4 rate and extent to which the active ingredient or 

5 therapeutic ingredient is absorbed from a drug and 

6 becomes available at the site of drug action. 

7 ‘‘(ii) For a drug that is not intended to be ab8 sorbed into the bloodstream, the Secretary may as9 sess bioavailability by scientifically valid measure10 ments intended to reflect the rate and extent and ex11 tent to which the active ingredient or active moeity 

12 becomes available at the site of drug action.’’; and 

13 (2) by adding at the end the following: 

14 ‘‘(C) For a drug that is not intended to be ab15 sorbed into the bloodstream, the Secretary may es16 tablish alternative, scientifically valid methods to 

17 show bioequivalence if the alternative methods are 

18 expected to detect a significant difference between 

19 the drug and the listed drug in safety and thera20 peutic effect.’’. 

21 (b) EFFECT OF AMENDMENT.—The amendment 

22 made by subsection (a) does not alter the standards for 

23 approval of drugs under section 505(j) of the Federal 

24 Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)). 
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1 SEC. 5. REMEDIES FOR INFRINGEMENT. 

2 Section 287 of title 35, United States Code, is 

3 amended by adding at the end the following: 

4 ‘‘(d) CONSIDERATION.—In making a determination 

5 with respect to remedy brought for infringement of a pat6 ent that claims a drug or a method or using a drug, the 

7 court shall consider whether information on the patent 

8 was filed as required under 21 U.S.C. 355 (b) or (c), and, 

9 if such information was required to be filed but was not, 

10 the court may refuse to award treble damages under sec11 tion 284.’’. 

12 SEC. 6. CONFORMING AMENDMENTS. 

13 Section 505A of the Federal Food, Drug, and Cos14 metic Act (21 U.S.C. 355a) is amended—

15 (1) in subsections (b)(1)(A)(i) and (c)(1)(A)(i), 

16 by striking ‘‘(j)(5)(D)(ii)’’ each place it appears and 

17 inserting ‘‘(j)(5)(F)(ii)’’; 

18 (2) in subsections (b)(1)(A)(ii) and 

19 (c)(1)(A)(ii), by striking ‘‘(j)(5)(D)’’ each place it 

20 appears and inserting ‘‘(j)(5)(F)’’; and 

21 (3) in subsections (e) and (l), by striking 

22 ‘‘505(j)(5)(D)’’ each place it appears and inserting 

23 ‘‘505(j)(5)(F)’’.

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