II 

116TH CONGRESS 

1ST SESSION S. 1617 

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 

MAY 22, 2019 

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 2019’’. 

6 SEC. 2. AMENDMENTS. 

7 (a) IN GENERAL.—Section 505 of the Federal Food, 

8 Drug, and Cosmetic Act (21 U.S.C. 355) is amended— 


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1 (1) in subsection (b)(1), at the end of the fifth 

2 sentence, by inserting ‘‘subject to subsection 

3 (j)(7)(A)(iii)(II)’’ before the period; and 

4 (2) in subsection (j)(7)(A)(iii)— 

5 (A) by striking ‘‘When patent’’ and insert6 ing ‘‘(I) When patent’’; 

7 (B) by inserting ‘‘, subject to subclauses 

8 (II) and (III),’’ after ‘‘, include’’; and 

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

10 ‘‘(II) The Secretary shall include patent infor11 mation on the list pursuant to subclause (I) if the 

12 following conditions are met: 

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

14 the date on which the application is approved 

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

16 days of the date of such approval, shall submit 

17 to the Under Secretary of Commerce for Intel18 lectual Property and Director of the United 

19 States Patent and Trademark Office (referred 

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

21 that the sponsor has included in its application 

22 information about the patent as required under 

23 subsection (b)(1). 

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

25 on which the application is approved under subVerDate Sep 11 2014 03:51 May 31, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1617.IS S1617

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1 section (c), the sponsor, not later than 30 days 

2 after the date on which the patent is issued, 

3 shall submit to the Director the notification de4 scribed in item (aa). 

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

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

7 shall publish, not later than 30 days of such re8 ceipt, in the Official Gazette of the United 

9 States Patent and Trademark Office, and on an 

10 internet website that the Director shall estab11 lish, maintain, and operate, a notification with 

12 respect to the patent, requesting that any per13 son that is eligible to file a request described in 

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

15 file such a request. 

16 ‘‘(III) A patent included on the list as described 

17 in subclause (II) shall be designated as being provi18 sionally included on such list until either of the fol19 lowing conditions is met: 

20 ‘‘(aa) The Patent Trial and Appeal Board 

21 of the United States Patent and Trademark Of22 fice (referred to in this clause as the ‘Board’) 

23 issues a final written decision with respect to an 

24 inter partes review of all claims of the patent 

25 conducted under chapter 31 of title 35, United 


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1 States Code, and the Director issues and pub2 lishes a certificate confirming those claims to be 

3 patentable. 

4 ‘‘(bb) Notwithstanding the filing deadlines 

5 provided under section 321(c) of title 35, 

6 United States Code, no person files a petition 

7 for inter partes review of any claim of the pat8 ent, with respect to a patent described in sub9 clause (II)(aa), not later than 300 days after 

10 the date on which the application is approved 

11 under subsection (c), or, with respect to a pat12 ent described in subclause (II)(bb), not later 

13 than 15 months after the date on which the ap14 plication is so approved. 

15 ‘‘(IV) With respect to a patent that is included 

16 on the list as described in subclause (II), is des17 ignated as provisionally included on such list under 

18 subclause (III), and, after an inter partes review of 

19 the patent conducted under chapter 31 of title 35, 

20 United States Code, is subject to a final written de21 cision of the Board and a certificate issued and pub22 lished by the Director canceling one or more claims 

23 of the patent finally determined to be unpatentable, 

24 the holder of the approved application, not later 

25 than 30 days after the date on which the Director 


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1 publishes the certificate, shall submit to the Sec2 retary— 

3 ‘‘(aa) if that decision and certificate relate 

4 to all claims of the patent, a request to remove 

5 the patent from the list; and 

6 ‘‘(bb) if that decision and certificate do not 

7 relate to all claims of the patent, a request to 

8 remove the patent information relating to the 

9 claim or claims to which that decision and cer10 tificate relate from the list. 

11 ‘‘(V) If, as of the date on which a drug is ap12 proved under subsection (c), a complaint has been 

13 filed in a district court of the United States chal14 lenging the validity of a patent, a patent submitted 

15 under subsection (b) or (c) respecting such drug in16 cluded on the list shall be included on the list until 

17 the date on which the court invalidates the patent, 

18 if applicable. 

19 ‘‘(VI) Nothing in this clause shall affect the 

20 availability to a first applicant of an exclusivity pe21 riod pursuant to clause (iv) or (v) of paragraph 

22 (5)(B), provided that, at the time that the first ap23 plicant submits an application under this subsection 

24 containing a certification described in paragraph 

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1 cluded on the list or is included on the list on a pro2 visional basis.’’. 

3 (b) EFFECTIVE DATE.—The amendments made by 

4 subsection (a) shall apply only with respect to patents 

5 issued after the date of enactment of this Act. 

Æ 


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