II 

114TH CONGRESS 

1ST SESSION S. 131 

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 

JANUARY 8, 2015 

Mr. VITTER (for himself and Mr. FRANKEN) 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 

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

12 applicant— 

13 ‘‘(I)(aa) that, on the first day on which a 

14 substantially complete application containing a 

15 certification described in paragraph 

16 (2)(A)(vii)(IV) is submitted for approval of a 

17 drug, submits a substantially complete applica18 tion that contains and lawfully maintains a cer19 tification described in paragraph (2)(A)(vii)(IV) 

20 for the drug; and 

21 ‘‘(bb) that has not entered into a disquali22 fying agreement described under clause 

23 (vii)(II); or 

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

25 in subclause (I) and that, with respect to the 


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1 applicant and drug, each requirement described 

2 in clause (vi) is satisfied; and 

3 ‘‘(bb) that has not entered into a disquali4 fying agreement described under clause 

5 (vii)(II). 

6 ‘‘(vi) REQUIREMENT.—The requirements de7 scribed in this clause are the following: 

8 ‘‘(I) The applicant described in clause 

9 (v)(II) submitted and lawfully maintains a cer10 tification described in paragraph (2)(A)(vii)(IV) 

11 or a statement described in paragraph 

12 (2)(A)(viii) for each unexpired patent for which 

13 a first applicant described in clause (v)(I) had 

14 submitted a certification described in paragraph 

15 (2)(A)(vii)(IV) on the first day on which a sub16 stantially complete application containing such 

17 a certification was submitted. 

18 ‘‘(II) With regard to each such unexpired 

19 patent for which the applicant described in 

20 clause (v)(II) submitted a certification de21 scribed in paragraph (2)(A)(vii)(IV), no action 

22 for patent infringement was brought against 

23 such applicant within the 45-day period speci24 fied in paragraph (5)(B)(iii); or if an action 

25 was brought within such time period, such an 


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1 action was withdrawn or dismissed by a court 

2 (including a district court) without a decision 

3 that the patent was valid and infringed; or if an 

4 action was brought within such time period and 

5 was not withdrawn or so dismissed, such appli6 cant has obtained the decision of a court (in7 cluding a district court) that the patent is in8 valid or not infringed (including any substantive 

9 determination that there is no cause of action 

10 for patent infringement or invalidity, and in11 cluding a settlement order or consent decree 

12 signed and entered by the court stating that the 

13 patent is invalid or not infringed). 

14 ‘‘(III) If an applicant described in clause 

15 (v)(I) has begun commercial marketing of such 

16 drug, the applicant described in clause (v)(II) 

17 does not begin commercial marketing of such 

18 drug until the date that is 30 days after the 

19 date on which the applicant described in clause 

20 (v)(I) began such commercial marketing.’’. 

21 (2) CONFORMING AMENDMENT.—Section 

22 505(j)(5)(D)(i)(IV) of such Act (21 U.S.C. 

23 355(j)(5)(D)(i)(IV)) is amended by striking ‘‘The 

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

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


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1 (b) APPLICABILITY.—The amendments made by sub2 section (a) shall apply only with respect to an application 

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

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

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

6 Drug, Improvement, and Modernization Act of 2003 (Pub7 lic Law 108–173) apply. 

8 SEC. 3. 180-DAY EXCLUSIVITY PERIOD AMENDMENTS RE9 GARDING AGREEMENTS TO DEFER COMMER10 CIAL MARKETING. 

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

12 COSMETIC ACT.— 

13 (1) LIMITATIONS ON AGREEMENTS TO DEFER

14 COMMERCIAL MARKETING DATE.—Section 

15 505(j)(5)(B) of the Federal Food, Drug, and Cos16 metic Act (21 U.S.C. 355(j)(5)(B)), as amended by 

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

18 the following: 

19 ‘‘(vii) AGREEMENT BY FIRST APPLICANT TO

20 DEFER COMMERCIAL MARKETING; LIMITATION ON

21 ACCELERATION OF DEFERRED COMMERCIAL MAR22 KETING DATE.— 

23 ‘‘(I) AGREEMENT TO DEFER APPROVAL OR

24 COMMERCIAL MARKETING DATE.—An agree25 ment described in this subclause is an agreeVerDate Sep 11 2014 23:35 Jan 15, 2015 Jkt 049200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S131.IS S131

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1 ment between a first applicant and the holder 

2 of the application for the listed drug or an 

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

4 any applicant submitted a certification quali5 fying such applicant for the 180-day exclusivity 

6 period whereby that applicant agrees, directly 

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

8 application that is made effective on the earliest 

9 possible date under this subparagraph, subpara10 graph (F) of this paragraph, section 505A, or 

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

12 marketing of its drug on the earliest possible 

13 date after receiving an approval of its applica14 tion that is made effective under this subpara15 graph, subparagraph (F) of this paragraph, sec16 tion 505A, or section 527, or (cc) to both items 

17 (aa) and (bb). 

18 ‘‘(II) AGREEMENT THAT DISQUALIFIES AP19 PLICANT FROM FIRST APPLICANT STATUS.—An 

20 agreement described in this subclause is an 

21 agreement between an 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, not to seek an approval of its ap3 plication or not to begin the commercial mar4 keting of its drug until a date that is after the 

5 expiration of the 180-day exclusivity period 

6 awarded to another applicant with respect to 

7 such drug (without regard to whether such 180- 

8 day exclusivity period is awarded before or after 

9 the date of the agreement). 

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

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

12 than 1 possible date when an applicant may seek an 

13 approval of its application or begin the commercial 

14 marketing of its drug— 

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

16 its application or begin such commercial mar17 keting on the date that is the earlier of— 

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

19 agreement on which that applicant can re20 ceive an approval that is made effective 

21 under this subparagraph, subparagraph 

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

23 section 527, or begin the commercial mar24 keting of such drug, without regard to any 

25 other provision of such agreement pursuVerDate Sep 11 2014 23:35 Jan 15, 2015 Jkt 049200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S131.IS S131

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1 ant to which the commercial marketing 

2 could begin on an earlier date; or 

3 ‘‘(bb) 180 days after another first ap4 plicant begins commercial marketing of 

5 such drug; and 

6 ‘‘(II) the latest date set forth in the agree7 ment on which that applicant can receive an ap8 proval that is made effective under this sub9 paragraph, subparagraph (F) of this paragraph, 

10 section 505A, or section 527, or begin the com11 mercial marketing of such drug, without regard 

12 to any other provision of such agreement pursu13 ant to which commercial marketing could begin 

14 on an earlier date, shall be the date used to de15 termine whether an applicant is disqualified 

16 from first applicant status pursuant to clause 

17 (vii)(II).’’. 

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

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

20 at the end the following: 

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

22 under this subsection shall submit to the Secretary a noti23 fication that includes— 


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

2 by such holder described under paragraph 

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

4 ‘‘(II) if such an agreement has not been re5 duced to text, a written detailed description of such 

6 agreement that is sufficient to disclose all the terms 

7 and conditions of the agreement; and 

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

9 in the event of an agreement that has not been re10 duced to text, of any other agreements that are con11 tingent upon, provide a contingent condition for, or 

12 are otherwise related to an agreement described in 

13 clause (i). 

14 ‘‘(B) The notification described under subparagraph 

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

16 after execution of the agreement described in subpara17 graph (A)(i). Such notification is in addition to any notifi18 cation required under section 1112 of the Medicare Pre19 scription Drug, Improvement, and Modernization Act of 

20 2003. 

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

22 with the Secretary pursuant to this paragraph shall be ex23 empt from disclosure under section 552 of title 5, United 

24 States Code, and no such information or documentary ma25 terial may be made public, except as may be relevant to 


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1 any administrative or judicial action or proceeding. Noth2 ing in this paragraph is intended to prevent disclosure to 

3 either body of the Congress or to any duly authorized com4 mittee or subcommittee of the Congress.’’. 

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

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

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

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

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

10 end the following: 

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

12 infringement of a patent for which the Secretary of Health 

13 and Human Services has published information pursuant 

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

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

16 under this subsection within the 45-day period described 

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

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

19 (c) APPLICABILITY.— 

20 (1) LIMITATIONS ON ACCELERATION OF DE21 FERRED COMMERCIAL MARKETING DATE.—The 

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

23 only with respect to— 

24 (A) an application filed under section 

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1 metic Act (21 U.S.C. 355(j)) to which the 

2 amendments made by section 1102(a) of the 

3 Medicare Prescription Drug, Improvement, and 

4 Modernization Act of 2003 (Public Law 108– 

5 173) apply; and 

6 (B) an agreement described under section 

7 505(j)(5)(B)(vii)(I) of the Federal Food, Drug, 

8 and Cosmetic Act (as added by subsection 

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

10 this Act. 

11 (2) NOTIFICATION OF FDA.—The amendments 

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

13 shall apply only with respect to an agreement de14 scribed under section 505(j)(5)(B)(vii)(I) of the 

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

16 subsection (a)(1)) executed after the date of enact17 ment of this Act. 

Æ 


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