II 

113TH CONGRESS 

1ST SESSION S. 504 

To amend the Federal Food, Drug, and Cosmetic Act to ensure that valid 

generic drugs may enter the market. 

IN THE SENATE OF THE UNITED STATES 

MARCH 7, 2013 

Mr. FRANKEN (for himself, Mr. VITTER, Mr. DURBIN, Mrs. SHAHEEN, and 

Mr. SANDERS) 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 

ensure that valid generic drugs may enter the market. 

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 ‘‘Fair And Immediate 

5 Release of Generic Drugs Act’’ or the ‘‘FAIR Generics 

6 Act’’. 

7 SEC. 2. 180-DAY EXCLUSIVITY PERIOD AMENDMENTS RE8 GARDING FIRST APPLICANT STATUS. 

9 (a) AMENDMENTS TO FEDERAL FOOD, DRUG, AND

10 COSMETIC ACT.— 


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1 (1) IN GENERAL.—Section 505(j)(5)(B) of the 

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

3 355(j)(5)(B)) is amended— 

4 (A) in clause (iv)(II)— 

5 (i) by striking item (bb); and 

6 (ii) by redesignating items (cc) and 

7 (dd) as items (bb) and (cc), respectively; 

8 and 

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

10 ‘‘(v) FIRST APPLICANT DEFINED.—As used in this 

11 subsection, the term ‘first applicant’ means an applicant— 

12 ‘‘(I)(aa) that, on the first day on which a sub13 stantially complete application containing a certifi14 cation described in paragraph (2)(A)(vii)(IV) is sub15 mitted for approval of a drug, submits a substan16 tially complete application that contains and lawfully 

17 maintains a certification described in paragraph 

18 (2)(A)(vii)(IV) for the drug; and 

19 ‘‘(bb) that has not entered into a disqualifying 

20 agreement described under clause (vii)(II); or 

21 ‘‘(II)(aa) for the drug that is not described in 

22 subclause (I) and that, with respect to the applicant 

23 and drug, each requirement described in clause (vi) 

24 is satisfied; and 


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1 ‘‘(bb) that has not entered into a disqualifying 

2 agreement described under clause (vii)(II). 

3 ‘‘(vi) REQUIREMENT.—The requirements described in 

4 this clause are the following: 

5 ‘‘(I) The applicant described in clause (v)(II) 

6 submitted and lawfully maintains a certification de7 scribed in paragraph (2)(A)(vii)(IV) or a statement 

8 described in paragraph (2)(A)(viii) for each unex9 pired patent for which a first applicant described in 

10 clause (v)(I) had submitted a certification described 

11 in paragraph (2)(A)(vii)(IV) on the first day on 

12 which a substantially complete application contain13 ing such a certification was submitted. 

14 ‘‘(II) With regard to each such unexpired pat15 ent for which the applicant described in clause 

16 (v)(II) submitted a certification described in para17 graph (2)(A)(vii)(IV), no action for patent infringe18 ment was brought against such applicant within the 

19 45-day period specified in paragraph (5)(B)(iii); or 

20 if an action was brought within such time period, 

21 such an action was withdrawn or dismissed by a 

22 court (including a district court) without a decision 

23 that the patent was valid and infringed; or if an ac24 tion was brought within such time period and was 

25 not withdrawn or so dismissed, such applicant has 


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1 obtained the decision of a court (including a district 

2 court) that the patent is invalid or not infringed (in3 cluding any substantive determination that there is 

4 no cause of action for patent infringement or inva5 lidity, and including a settlement order or consent 

6 decree signed and entered by the court stating that 

7 the patent is invalid or not infringed). 

8 ‘‘(III) If an applicant described in clause (v)(I) 

9 has begun commercial marketing of such drug, the 

10 applicant described in clause (v)(II) does not begin 

11 commercial marketing of such drug until the date 

12 that is 30 days after the date on which the applicant 

13 described in clause (v)(I) began such commercial 

14 marketing.’’. 

15 (2) CONFORMING AMENDMENT.—Section 

16 505(j)(5)(D)(i)(IV) of such Act (21 U.S.C. 

17 355(j)(5)(D)(i)(IV)) is amended by striking ‘‘The 

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

19 as defined in subparagraph (B)(v)(I),’’. 

20 (b) APPLICABILITY.—The amendments made by sub21 section (a) shall apply only with respect to an application 

22 filed under section 505(j) of the Federal Food, Drug, and 

23 Cosmetic Act (21 U.S.C. 355(j)) to which the amendments 

24 made by section 1102(a) of the Medicare Prescription 


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1 Drug, Improvement, and Modernization Act of 2003 (Pub2 lic Law 108–173) apply. 

3 SEC. 3. 180-DAY EXCLUSIVITY PERIOD AMENDMENTS RE4 GARDING AGREEMENTS TO DEFER COMMER5 CIAL MARKETING. 

6 (a) AMENDMENTS TO FEDERAL FOOD, DRUG, AND

7 COSMETIC ACT.— 

8 (1) LIMITATIONS ON AGREEMENTS TO DEFER

9 COMMERCIAL MARKETING DATE.—Section 

10 505(j)(5)(B) of the Federal Food, Drug, and Cos11 metic Act (21 U.S.C. 355(j)(5)(B)), as amended by 

12 section 2, is further amended by adding at the end 

13 the following: 

14 ‘‘(vii) AGREEMENT BY FIRST APPLICANT TO

15 DEFER COMMERCIAL MARKETING; LIMITATION ON

16 ACCELERATION OF DEFERRED COMMERCIAL MAR17 KETING DATE.— 

18 ‘‘(I) AGREEMENT TO DEFER APPROVAL OR

19 COMMERCIAL MARKETING DATE.—An agree20 ment described in this subclause is an agree21 ment between a first applicant and the holder 

22 of the application for the listed drug or an 

23 owner of one or more of the patents as to which 

24 any applicant submitted a certification quali25 fying such applicant for the 180-day exclusivity 


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1 period whereby that applicant agrees, directly 

2 or indirectly, (aa) not to seek an approval of its 

3 application that is made effective on the earliest 

4 possible date under this subparagraph, subpara5 graph (F) of this paragraph, section 505A, or 

6 section 527, (bb) not to begin the commercial 

7 marketing of its drug on the earliest possible 

8 date after receiving an approval of its applica9 tion that is made effective under this subpara10 graph, subparagraph (F) of this paragraph, sec11 tion 505A, or section 527, or (cc) to both items 

12 (aa) and (bb). 

13 ‘‘(II) AGREEMENT THAT DISQUALIFIES AP14 PLICANT FROM FIRST APPLICANT STATUS.—An 

15 agreement described in this subclause is an 

16 agreement between an applicant and the holder 

17 of the application for the listed drug or an 

18 owner of one or more of the patents as to which 

19 any applicant submitted a certification quali20 fying such applicant for the 180-day exclusivity 

21 period whereby that applicant agrees, directly 

22 or indirectly, not to seek an approval of its ap23 plication or not to begin the commercial mar24 keting of its drug until a date that is after the 

25 expiration of the 180-day exclusivity period 


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1 awarded to another applicant with respect to 

2 such drug (without regard to whether such 180- 

3 day exclusivity period is awarded before or after 

4 the date of the agreement). 

5 ‘‘(viii) LIMITATION ON ACCELERATION.—If an 

6 agreement described in clause (vii)(I) includes more 

7 than 1 possible date when an applicant may seek an 

8 approval of its application or begin the commercial 

9 marketing of its drug— 

10 ‘‘(I) the applicant may seek an approval of 

11 its application or begin such commercial mar12 keting on the date that is the earlier of— 

13 ‘‘(aa) the latest date set forth in the 

14 agreement on which that applicant can re15 ceive an approval that is made effective 

16 under this subparagraph, subparagraph 

17 (F) of this paragraph, section 505A, or 

18 section 527, or begin the commercial mar19 keting of such drug, without regard to any 

20 other provision of such agreement pursu21 ant to which the commercial marketing 

22 could begin on an earlier date; or 

23 ‘‘(bb) 180 days after another first ap24 plicant begins commercial marketing of 

25 such drug; and 


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1 ‘‘(II) the latest date set forth in the agree2 ment on which that applicant can receive an ap3 proval that is made effective under this sub4 paragraph, subparagraph (F) of this paragraph, 

5 section 505A, or section 527, or begin the com6 mercial marketing of such drug, without regard 

7 to any other provision of such agreement pursu8 ant to which commercial marketing could begin 

9 on an earlier date, shall be the date used to de10 termine whether an applicant is disqualified 

11 from first applicant status pursuant to clause 

12 (vii)(II).’’. 

13 (2) NOTIFICATION OF FDA.—Section 505(j) of 

14 such Act (21 U.S.C. 355(j)) is amended by adding 

15 at the end the following: 

16 ‘‘(11)(A) The holder of an abbreviated application 

17 under this subsection shall submit to the Secretary a noti18 fication that includes— 

19 ‘‘(i)(I) the text of any agreement entered into 

20 by such holder described under paragraph 

21 (5)(B)(vii)(I); or 

22 ‘‘(II) if such an agreement has not been re23 duced to text, a written detailed description of such 

24 agreement that is sufficient to disclose all the terms 

25 and conditions of the agreement; and 


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1 ‘‘(ii) the text, or a written detailed description 

2 in the event of an agreement that has not been re3 duced to text, of any other agreements that are con4 tingent upon, provide a contingent condition for, or 

5 are otherwise related to an agreement described in 

6 clause (i). 

7 ‘‘(B) The notification described under subparagraph 

8 (A) shall be submitted not later than 10 business days 

9 after execution of the agreement described in subpara10 graph (A)(i). Such notification is in addition to any notifi11 cation required under section 1112 of the Medicare Pre12 scription Drug, Improvement, and Modernization Act of 

13 2003. 

14 ‘‘(C) Any information or documentary material filed 

15 with the Secretary pursuant to this paragraph shall be ex16 empt from disclosure under section 552 of title 5, United 

17 States Code, and no such information or documentary ma18 terial may be made public, except as may be relevant to 

19 any administrative or judicial action or proceeding. Noth20 ing in this paragraph is intended to prevent disclosure to 

21 either body of the Congress or to any duly authorized com22 mittee or subcommittee of the Congress.’’. 

23 (3) PROHIBITED ACTS.—Section 301(e) of such 

24 Act (21 U.S.C. 331(e)) is amended by striking ‘‘505 

25 (i) or (k)’’ and inserting ‘‘505 (i), (j)(11), or (k)’’. 


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1 (b) INFRINGEMENT OF PATENT.—Section 271(e) of 

2 title 35, United States Code, is amended by adding at the 

3 end the following: 

4 ‘‘(7) The exclusive remedy under this section for an 

5 infringement of a patent for which the Secretary of Health 

6 and Human Services has published information pursuant 

7 to subsection (b)(1) or (c)(2) of section 505 of the Federal 

8 Food, Drug, and Cosmetic Act shall be an action brought 

9 under this subsection within the 45-day period described 

10 in subsection (j)(5)(B)(iii) or (c)(3)(C) of section 505 of 

11 the Federal Food, Drug, and Cosmetic Act.’’. 

12 (c) APPLICABILITY.— 

13 (1) LIMITATIONS ON ACCELERATION OF DE14 FERRED COMMERCIAL MARKETING DATE.—The 

15 amendment made by subsection (a)(1) shall apply 

16 only with respect to— 

17 (A) an application filed under section 

18 505(j) of the Federal Food, Drug, and Cos19 metic Act (21 U.S.C. 355(j)) to which the 

20 amendments made by section 1102(a) of the 

21 Medicare Prescription Drug, Improvement, and 

22 Modernization Act of 2003 (Public Law 108– 

23 173) apply; and 

24 (B) an agreement described under section 

25 505(j)(5)(B)(vii)(I) of the Federal Food, Drug, 


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1 and Cosmetic Act (as added by subsection 

2 (a)(1)) executed after the date of enactment of 

3 this Act. 

4 (2) NOTIFICATION OF FDA.—The amendments 

5 made by paragraphs (2) and (3) of subsection (a) 

6 shall apply only with respect to an agreement de7 scribed under section 505(j)(5)(B)(vii)(I) of the 

8 Federal Food, Drug, and Cosmetic Act (as added by 

9 subsection (a)(1)) executed after the date of enact10 ment of this Act. 

Æ 


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