II 

116TH CONGRESS 

2D SESSION S. 4253 

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

listing of patents in the Orange Book. 

IN THE SENATE OF THE UNITED STATES 

JULY 21, 2020 

Mrs. MURRAY (for herself and Mr. CORNYN) 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 with 

respect to the listing of patents in the Orange Book. 

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 ‘‘Second Look at Drug 

5 Patents Act of 2020’’. 

6 SEC. 2. AMENDMENTS. 

7 Section 505 of the Federal Food, Drug, and Cosmetic 

8 Act (21 U.S.C. 355) is amended— 

9 (1) in subsection (b)(1), in the fifth sentence, 

10 by inserting ‘‘, subject to the conditions under subVerDate Sep 11 2014 04:59 Aug 04, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S4253.IS S4253

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1 section (j)(7)(A)(iii)(II) being met’’ before the pe2 riod; 

3 (2) in subsection (c)(2), at the end of the third 

4 sentence, by inserting ‘‘subject to the conditions 

5 under subsection (j)(7)(A)(iii)(II) being met’’ before 

6 the period; and 

7 (3) in subsection (j)(7)(A)(iii)— 

8 (A) by striking ‘‘When patent’’ and insert9 ing ‘‘(I) When patent’’; 

10 (B) by inserting ‘‘, subject to subclause 

11 (II),’’ after ‘‘, include’’; and 

12 (C) by adding at the end the following: 

13 ‘‘(II) The Secretary shall include patent infor14 mation on the list pursuant to subclause (I) if the 

15 following conditions are met: 

16 ‘‘(aa) If the patent has been issued as of 

17 the date on which the application is approved 

18 under subsection (c), the sponsor, within 30 

19 days of the date of such approval, shall submit 

20 to the Under Secretary of Commerce for Intel21 lectual Property and Director of the United 

22 States Patent and Trademark Office (referred 

23 to in this clause as the ‘Director’) a notification 

24 that the sponsor has filed with the Secretary inVerDate Sep 11 2014 04:59 Aug 04, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S4253.IS S4253

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1 formation about the patent as required under 

2 subsection (b)(1) or (c)(2), as applicable. 

3 ‘‘(bb) If the patent is issued after the date 

4 on which the application is approved under sub5 section (c), the sponsor, not later than 30 days 

6 after the date on which the patent is issued, 

7 shall submit to the Director a notification that 

8 the sponsor has filed with the Secretary infor9 mation about the patent as required under sub10 section (c)(2). 

11 ‘‘(cc) Upon receipt of a notification under 

12 item (aa) or (bb), as applicable, the Director 

13 shall publish, not later than 30 days of such re14 ceipt, in the Official Gazette of the United 

15 States Patent and Trademark Office, and on an 

16 internet website that the Director shall estab17 lish, maintain, and operate, a notification with 

18 respect to the patent, requesting that any per19 son that is eligible to file a request described in 

20 section 311(b) of title 35, United States Code, 

21 file such a request.’’. 

Æ 


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