II 

111TH CONGRESS 

1ST SESSION S. 1315 

To amend the Federal Food, Drug, and Cosmetic Act to define the term 

‘‘first applicant’’ for purposes of filing an abbreviated application for 

a new drug. 

IN THE SENATE OF THE UNITED STATES 

JUNE 22, 2009 

Mr. NELSON of Florida (for himself and Mr. KOHL) introduced the following 

bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act to 

define the term ‘‘first applicant’’ for purposes of filing 

an abbreviated application for a new drug. 

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 ‘‘Drug Price Competi5 tion Act of 2009’’. 

6 SEC. 2. EXCLUSIVITY PERIOD. 

7 (a) FIRST APPLICANT.—Section 505(j)(5) of the 

8 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

9 355(j)(5)) is amended— 


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1 (1) in subparagraph (B)(iv)— 

2 (A) in subclause (II), by striking item (bb) 

3 and inserting the following: 

4 ‘‘(bb) FIRST APPLICANT.— 

5 As used in this subsection, the 

6 term ‘first applicant’ means— 

7 ‘‘(AA) an applicant 

8 that, on the first day on 

9 which a substantially com10 plete application containing 

11 a certification described in 

12 paragraph (2)(A)(vii)(IV) is 

13 submitted for approval of a 

14 drug, submits a substan15 tially complete application 

16 that contains and lawfully 

17 maintains a certification de18 scribed in paragraph 

19 (2)(A)(vii)(IV) for the drug; 

20 or 

21 ‘‘(BB) an applicant for 

22 the drug not described in 

23 item (AA) that satisfies the 

24 requirements of subclause 

25 (III).’’; and 


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1 (B) by adding at the end the following: 

2 ‘‘(III) An applicant described in 

3 subclause (II)(bb)(BB) shall— 

4 ‘‘(aa) submit and lawfully 

5 maintain a certification described 

6 in paragraph (2)(A)(vii)(IV) or a 

7 statement described in paragraph 

8 (2)(A)(viii) for each unexpired 

9 patent for which a first applicant 

10 described in item (AA) had sub11 mitted a certification described in 

12 paragraph (2)(A)(vii)(IV) on the 

13 first day on which a substantially 

14 complete application containing 

15 such a certification was sub16 mitted; 

17 ‘‘(bb) with regard to each 

18 such unexpired patent for which 

19 the applicant submitted a certifi20 cation described in paragraph 

21 (2)(A)(vii)(IV), no action for pat22 ent infringement was brought 

23 against the applicant within the 

24 45-day period specified in para25 graph (5)(B)(iii), or if an action 


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1 was brought within such time pe2 riod, the applicant has obtained 

3 the decision of a court (including 

4 a district court) that the patent 

5 is invalid or not infringed (in6 cluding any substantive deter7 mination that there is no cause 

8 of action for patent infringement 

9 or invalidity, and including a set10 tlement order or consent decree 

11 signed and entered by the court 

12 stating that the patent is invalid 

13 or not infringed); and 

14 ‘‘(cc) but for the effective 

15 date of approval provisions in 

16 subparagraphs (B) and (F) and 

17 sections 505A and 527, be eligi18 ble to receive immediately effec19 tive approval at a time before 

20 any other applicant has begun 

21 commercial marketing.’’; and 

22 (2) in subparagraph (D)— 

23 (A) in clause (i)(IV), by striking ‘‘The first 

24 applicant’’ and inserting ‘‘The first applicant, 


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1 as defined in subparagraph 

2 (B)(iv)(II)(bb)(AA),’’; and 

3 (B) in clause (iii), in the matter preceding 

4 subclause (I)— 

5 (i) by striking ‘‘If all first applicants 

6 forfeit the 180-day exclusivity period under 

7 clause (ii)’’; and 

8 (ii) by inserting ‘‘If all first appli9 cants, as defined in subparagraph 

10 (B)(iv)(II)(bb)(AA), forfeit the 180-day ex11 clusivity period under clause (ii) at a time 

12 at which no applicant has begun commer13 cial marketing’’. 

14 (b) EFFECTIVE DATE AND TRANSITIONAL PROVI15 SION.— 

16 (1) EFFECTIVE DATE.—The amendments made 

17 by subsection (a) shall be effective only with respect 

18 to an application filed under section 505(j) of the 

19 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

20 355(j)) to which the amendments made by section 

21 1102(a) of the Medicare Prescription Drug Improve22 ment and Modernization Act of 2003 (Public Law 

23 108–173) apply. 

24 (2) TRANSITIONAL PROVISION.—An application 

25 filed under section 505(j) of the Federal Food, 


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1 Drug, and Cosmetic Act (21 U.S.C. 355(j)), to 

2 which the 180-day exclusivity period described in 

3 paragraph (5)(iv) of such section does not apply, 

4 and that contains a certification under paragraph 

5 (2)(A)(vii)(IV) of such Act, shall be regarded as a 

6 previous application containing such a certification 

7 within the meaning of section 505(j)(5)(B)(iv) of 

8 such Act (as in effect before the amendments made 

9 by Medicare Prescription Drug Improvement and 

10 Modernization Act of 2003 (Public Law 108–173)) 

11 if— 

12 (A) no action for infringement of the pat13 ent that is the subject of such certification was 

14 brought against the applicant within the 45-day 

15 period specified in section 505(j)(5)(B)(iii) of 

16 the Federal Food, Drug, and Cosmetic Act (21 

17 U.S.C. 355(j)(5)(B)(iii)), or if an action was 

18 brought within such time period, the applicant 

19 has obtained the decision of a court (including 

20 a district court) that the patent is invalid or not 

21 infringed (including any substantive determina22 tion that there is no cause of action for patent 

23 infringement or invalidity, and including a set24 tlement order or consent decree signed and enVerDate Nov 24 2008 02:46 Jun 23, 2009 Jkt 079200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S1315.IS S1315

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1 tered by the court stating that the patent is in2 valid or not infringed); 

3 (B) the application is eligible to receive im4 mediately effective approval, but for the effec5 tive date of approval provisions in sections 

6 505(j)(5)(B) (as in effect before the amend7 ment made by Public Law 108–173), 

8 505(j)(5)(F), 505A, and 527 of the Federal 

9 Food, Drug, and Cosmetic Act (21 U.S.C. 

10 355(j)(5)(B), 355(j)(5)(F), 355a, 360cc); and 

11 (C) no other applicant has begun commer12 cial marketing. 

Æ 


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