II 

115TH CONGRESS 

2D SESSION S. 2476 

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 

FEBRUARY 28, 2018 

Ms. SMITH 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 ‘‘Expanding Access to 

5 Low Cost Generic Drugs Act’’. 

6 SEC. 2. 180-DAY EXCLUSIVITY PERIOD AMENDMENTS RE7 GARDING FIRST APPLICANT STATUS. 

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

9 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 (B) by redesignating clause (v) as clause 

9 (ix); and 

10 (C) by inserting after clause (iv) the fol11 lowing: 

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

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

14 applicant— 

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

16 substantially complete application containing a 

17 certification described in paragraph 

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

19 drug, submits a substantially complete applica20 tion that contains and lawfully maintains a cer21 tification described in paragraph (2)(A)(vii)(IV) 

22 for the drug; and 

23 ‘‘(bb) that has not entered into a disquali24 fying agreement described under clause 

25 (vii)(II); or 


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

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

3 applicant and drug, each requirement described 

4 in clause (vi) is satisfied; and 

5 ‘‘(bb) that has not entered into a disquali6 fying agreement described under clause 

7 (vii)(II). 

8 ‘‘(vi) REQUIREMENT.—The requirements de9 scribed in this clause are the following: 

10 ‘‘(I) The applicant described in clause 

11 (v)(II) submitted and lawfully maintains a cer12 tification described in paragraph (2)(A)(vii)(IV) 

13 or a statement described in paragraph 

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

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

16 submitted a certification described in paragraph 

17 (2)(A)(vii)(IV) on the first day on which a sub18 stantially complete application containing such 

19 a certification was submitted. 

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

21 patent for which the applicant described in 

22 clause (v)(II) submitted a certification de23 scribed in paragraph (2)(A)(vii)(IV), no action 

24 for patent infringement was brought against 

25 such applicant within the 45-day period speciVerDate Sep 11 2014 21:35 Mar 05, 2018 Jkt 079200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S2476.IS S2476

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1 fied in clause (iii); or if an action was brought 

2 within such time period, such an action was 

3 withdrawn or dismissed by a court (including a 

4 district court) without a decision that the pat5 ent was valid and infringed; or if an action was 

6 brought within such time period and was not 

7 withdrawn or so dismissed, such applicant has 

8 obtained the decision of a court (including a 

9 district court) that the patent is invalid or not 

10 infringed (including any substantive determina11 tion that there is no cause of action for patent 

12 infringement or invalidity, and including a set13 tlement order or consent decree signed and en14 tered by the court stating that the patent is in15 valid or not infringed). 

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

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

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

19 does not begin commercial marketing of such 

20 drug until the date that is 30 days after the 

21 date on which the applicant described in clause 

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

23 (2) CONFORMING AMENDMENT.—Section 

24 505(j)(5)(D)(i)(IV) of such Act (21 U.S.C. 

25 355(j)(5)(D)(i)(IV)) is amended by striking ‘‘The 


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

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

3 (b) APPLICABILITY.—The amendments made by sub4 section (a) shall apply only with respect to an application 

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

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

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

8 Drug, Improvement, and Modernization Act of 2003 (Pub9 lic Law 108–173) apply. 

10 SEC. 3. 180-DAY EXCLUSIVITY PERIOD AMENDMENTS RE11 GARDING AGREEMENTS TO DEFER COMMER12 CIAL MARKETING. 

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

14 COSMETIC ACT.— 

15 (1) LIMITATIONS ON AGREEMENTS TO DEFER

16 COMMERCIAL MARKETING DATE.—Section 

17 505(j)(5)(B) of the Federal Food, Drug, and Cos18 metic Act (21 U.S.C. 355(j)(5)(B)), as amended by 

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

20 the following: 

21 ‘‘(vii) AGREEMENT BY FIRST APPLICANT TO

22 DEFER COMMERCIAL MARKETING; LIMITATION ON

23 ACCELERATION OF DEFERRED COMMERCIAL MAR24 KETING DATE.— 


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1 ‘‘(I) AGREEMENT TO DEFER APPROVAL OR

2 COMMERCIAL MARKETING DATE.—An agree3 ment described in this subclause is an agree4 ment between a first applicant and the holder 

5 of the application for the listed drug or an 

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

7 any applicant submitted a certification quali8 fying such applicant for the 180-day exclusivity 

9 period whereby that applicant agrees, directly 

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

11 application that is made effective on the earliest 

12 possible date under this subparagraph, subpara13 graph (F) of this paragraph, section 505A, or 

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

15 marketing of its drug on the earliest possible 

16 date after receiving an approval of its applica17 tion that is made effective under this subpara18 graph, subparagraph (F) of this paragraph, sec19 tion 505A, or section 527, or (cc) to both items 

20 (aa) and (bb). 

21 ‘‘(II) AGREEMENT THAT DISQUALIFIES AP22 PLICANT FROM FIRST APPLICANT STATUS.—An 

23 agreement described in this subclause is an 

24 agreement between an applicant and the holder 

25 of the application for the listed drug or an 


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

2 any applicant submitted a certification quali3 fying such applicant for the 180-day exclusivity 

4 period whereby that applicant agrees, directly 

5 or indirectly, not to seek an approval of its ap6 plication or not to begin the commercial mar7 keting of its drug until a date that is after the 

8 expiration of the 180-day exclusivity period 

9 awarded to another applicant with respect to 

10 such drug (without regard to whether such 180- 

11 day exclusivity period is awarded before or after 

12 the date of the agreement). 

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

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

15 than 1 possible date when an applicant may seek an 

16 approval of its application or begin the commercial 

17 marketing of its drug— 

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

19 its application or begin such commercial mar20 keting on the date that is the earlier of— 

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

22 agreement on which that applicant can re23 ceive an approval that is made effective 

24 under this subparagraph, subparagraph 

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


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1 section 527, or begin the commercial mar2 keting of such drug, without regard to any 

3 other provision of such agreement pursu4 ant to which the commercial marketing 

5 could begin on an earlier date; or 

6 ‘‘(bb) 180 days after another first ap7 plicant begins commercial marketing of 

8 such drug; and 

9 ‘‘(II) the latest date set forth in the agree10 ment on which that applicant can receive an ap11 proval that is made effective under this sub12 paragraph, subparagraph (F) of this paragraph, 

13 section 505A, or section 527, or begin the com14 mercial marketing of such drug, without regard 

15 to any other provision of such agreement pursu16 ant to which commercial marketing could begin 

17 on an earlier date, shall be the date used to de18 termine whether an applicant is disqualified 

19 from first applicant status pursuant to clause 

20 (vii)(II).’’. 

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

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

23 at the end the following: 


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1 ‘‘(14)(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)(14), 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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