I 

116TH CONGRESS 

1ST SESSION H. R. 1506 

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

generic drugs may enter the market. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 5, 2019 

Ms. BARRAGA ́N 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 

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’’. 


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1 SEC. 2. 180-DAY EXCLUSIVITY PERIOD AMENDMENTS RE2 GARDING FIRST APPLICANT STATUS. 

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

4 COSMETIC ACT.— 

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

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

7 355(j)(5)(B)) is amended— 

8 (A) in clause (iv)(II)— 

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

10 (ii) by redesignating items (cc) and 

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

12 and 

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

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

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

16 applicant— 

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

18 substantially complete application containing a 

19 certification described in paragraph 

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

21 drug, submits a substantially complete applica22 tion that contains and lawfully maintains a cer23 tification described in paragraph (2)(A)(vii)(IV) 

24 for the drug; and 


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1 ‘‘(bb) that has not entered into a disquali2 fying agreement described under clause 

3 (vii)(II); or 

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

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

6 applicant and drug, each requirement described 

7 in clause (vi) is satisfied; and 

8 ‘‘(bb) that has not entered into a disquali9 fying agreement described under clause 

10 (vii)(II). 

11 ‘‘(vi) REQUIREMENT.—The requirements de12 scribed in this clause are the following: 

13 ‘‘(I) The applicant described in clause 

14 (v)(II) submitted and lawfully maintains a cer15 tification described in paragraph (2)(A)(vii)(IV) 

16 or a statement described in paragraph 

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

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

19 submitted a certification described in paragraph 

20 (2)(A)(vii)(IV) on the first day on which a sub21 stantially complete application containing such 

22 a certification was submitted. 

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

24 patent for which the applicant described in 

25 clause (v)(II) submitted a certification deVerDate Sep 11 2014 00:08 Mar 16, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H1506.IH H1506

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1 scribed in paragraph (2)(A)(vii)(IV), no action 

2 for patent infringement was brought against 

3 such applicant within the 45-day period speci4 fied in paragraph (5)(B)(iii); or if an action 

5 was brought within such time period, such an 

6 action was withdrawn or dismissed by a court 

7 (including a district court) without a decision 

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

9 action was brought within such time period and 

10 was not withdrawn or so dismissed, such appli11 cant has obtained the decision of a court (in12 cluding a district court) that the patent is in13 valid or not infringed (including any substantive 

14 determination that there is no cause of action 

15 for patent infringement or invalidity, and in16 cluding a settlement order or consent decree 

17 signed and entered by the court stating that the 

18 patent is invalid or not infringed). 

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

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

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

22 does not begin commercial marketing of such 

23 drug until the date that is 30 days after the 

24 date on which the applicant described in clause 

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


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1 (2) CONFORMING AMENDMENT.—Section 

2 505(j)(5)(D)(i)(IV) of such Act (21 U.S.C. 

3 355(j)(5)(D)(i)(IV)) is amended by striking ‘‘The 

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

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

6 (b) APPLICABILITY.—The amendments made by sub7 section (a) shall apply only with respect to an application 

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

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

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

11 Drug, Improvement, and Modernization Act of 2003 (Pub12 lic Law 108–173) apply. 

13 SEC. 3. 180-DAY EXCLUSIVITY PERIOD AMENDMENTS RE14 GARDING AGREEMENTS TO DEFER COMMER15 CIAL MARKETING. 

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

17 COSMETIC ACT.— 

18 (1) LIMITATIONS ON AGREEMENTS TO DEFER

19 COMMERCIAL MARKETING DATE.—Section 

20 505(j)(5)(B) of the Federal Food, Drug, and Cos21 metic Act (21 U.S.C. 355(j)(5)(B)), as amended by 

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

23 the following: 

24 ‘‘(vii) AGREEMENT BY FIRST APPLICANT TO

25 DEFER COMMERCIAL MARKETING; LIMITATION ON


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1 ACCELERATION OF DEFERRED COMMERCIAL MAR2 KETING DATE.— 

3 ‘‘(I) AGREEMENT TO DEFER APPROVAL OR

4 COMMERCIAL MARKETING DATE.—An agree5 ment described in this subclause is an agree6 ment between a first applicant and the holder 

7 of the application for the listed drug or an 

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

9 any applicant submitted a certification quali10 fying such applicant for the 180-day exclusivity 

11 period whereby that applicant agrees, directly 

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

13 application that is made effective on the earliest 

14 possible date under this subparagraph, subpara15 graph (F) of this paragraph, section 505A, or 

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

17 marketing of its drug on the earliest possible 

18 date after receiving an approval of its applica19 tion that is made effective under this subpara20 graph, subparagraph (F) of this paragraph, sec21 tion 505A, or section 527, or (cc) to both items 

22 (aa) and (bb). 

23 ‘‘(II) AGREEMENT THAT DISQUALIFIES AP24 PLICANT FROM FIRST APPLICANT STATUS.—An 

25 agreement described in this subclause is an 


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1 agreement between an 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, not to seek an approval of its ap8 plication or not to begin the commercial mar9 keting of its drug until a date that is after the 

10 expiration of the 180-day exclusivity period 

11 awarded to another applicant with respect to 

12 such drug (without regard to whether such 180- 

13 day exclusivity period is awarded before or after 

14 the date of the agreement). 

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

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

17 than 1 possible date when an applicant may seek an 

18 approval of its application or begin the commercial 

19 marketing of its drug— 

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

21 its application or begin such commercial mar22 keting on the date that is the earlier of— 

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

24 agreement on which that applicant can re25 ceive an approval that is made effective 


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1 under this subparagraph, subparagraph 

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

3 section 527, or begin the commercial mar4 keting of such drug, without regard to any 

5 other provision of such agreement pursu6 ant to which the commercial marketing 

7 could begin on an earlier date; or 

8 ‘‘(bb) 180 days after another first ap9 plicant begins commercial marketing of 

10 such drug; and 

11 ‘‘(II) the latest date set forth in the agree12 ment on which that applicant can receive an ap13 proval that is made effective under this sub14 paragraph, subparagraph (F) of this paragraph, 

15 section 505A, or section 527, or begin the com16 mercial marketing of such drug, without regard 

17 to any other provision of such agreement pursu18 ant to which commercial marketing could begin 

19 on an earlier date, shall be the date used to de20 termine whether an applicant is disqualified 

21 from first applicant status pursuant to clause 

22 (vii)(II).’’. 

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

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

25 at the end the following: 


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

2 under this subsection shall submit to the Secretary a noti3 fication that includes— 

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

5 by such holder described under paragraph 

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

7 ‘‘(II) if such an agreement has not been re8 duced to text, a written detailed description of such 

9 agreement that is sufficient to disclose all the terms 

10 and conditions of the agreement; and 

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

12 in the event of an agreement that has not been re13 duced to text, of any other agreements that are con14 tingent upon, provide a contingent condition for, or 

15 are otherwise related to an agreement described in 

16 clause (i). 

17 ‘‘(B) The notification described under subparagraph 

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

19 after execution of the agreement described in subpara20 graph (A)(i). Such notification is in addition to any notifi21 cation required under section 1112 of the Medicare Pre22 scription Drug, Improvement, and Modernization Act of 

23 2003. 

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

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1 empt from disclosure under section 552 of title 5, United 

2 States Code, and no such information or documentary ma3 terial may be made public, except as may be relevant to 

4 any administrative or judicial action or proceeding. Noth5 ing in this paragraph is intended to prevent disclosure to 

6 either body of the Congress or to any duly authorized com7 mittee or subcommittee of the Congress.’’. 

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

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

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

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

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

13 end the following: 

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

15 infringement of a patent for which the Secretary of Health 

16 and Human Services has published information pursuant 

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

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

19 under this subsection within the 45-day period described 

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

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

22 (c) APPLICABILITY.— 

23 (1) LIMITATIONS ON ACCELERATION OF DE24 FERRED COMMERCIAL MARKETING DATE.—The 


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

2 only with respect to— 

3 (A) an application filed under section 

4 505(j) of the Federal Food, Drug, and Cos5 metic Act (21 U.S.C. 355(j)) to which the 

6 amendments made by section 1102(a) of the 

7 Medicare Prescription Drug, Improvement, and 

8 Modernization Act of 2003 (Public Law 108– 

9 173) apply; and 

10 (B) an agreement described under section 

11 505(j)(5)(B)(vii)(I) of the Federal Food, Drug, 

12 and Cosmetic Act (as added by subsection 

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

14 this Act. 

15 (2) NOTIFICATION OF FDA.—The amendments 

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

17 shall apply only with respect to an agreement de18 scribed under section 505(j)(5)(B)(vii)(I) of the 

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

20 subsection (a)(1)) executed after the date of enact21 ment of this Act. 

Æ 


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