Second Look at Drug Patents Act of 2019

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, Edu- cation, 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. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Second Look at Drug 4 Patents Act of 2019’’. 5 SEC. 2. AMENDMENTS. 6 (a) IN GENERAL.—Section 505 of the Federal Food, 7 Drug, and Cosmetic Act (21 U.S.C. 355) is amended— 8 VerDate Sep 11 2014 03:51 May 31, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1617.IS S1617 kjohnson on DSK79L0C42 with BILLS 2 •S 1617 IS (1) in subsection (b)(1), at the end of the fifth 1 sentence, by inserting ‘‘subject to subsection 2 (j)(7)(A)(iii)(II)’’ before the period; and 3 (2) in subsection (j)(7)(A)(iii)— 4 (A) by striking ‘‘When patent’’ and insert- 5 ing ‘‘(I) When patent’’; 6 (B) by inserting ‘‘, subject to subclauses 7 (II) and (III),’’ after ‘‘, include’’; and 8 (C) by adding at the end the following: 9 ‘‘(II) The Secretary shall include patent infor- 10 mation on the list pursuant to subclause (I) if the 11 following conditions are met: 12 ‘‘(aa) If the patent has been issued as of 13 the date on which the application is approved 14 under subsection (c), the sponsor, within 30 15 days of the date of such approval, shall submit 16 to the Under Secretary of Commerce for Intel- 17 lectual Property and Director of the United 18 States Patent and Trademark Office (referred 19 to in this clause as the ‘Director’) a notification 20 that the sponsor has included in its application 21 information about the patent as required under 22 subsection (b)(1). 23 ‘‘(bb) If the patent is issued after the date 24 on which the application is approved under sub- 25 VerDate Sep 11 2014 03:51 May 31, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1617.IS S1617 kjohnson on DSK79L0C42 with BILLS 3 •S 1617 IS section (c), the sponsor, not later than 30 days 1 after the date on which the patent is issued, 2 shall submit to the Director the notification de- 3 scribed in item (aa). 4 ‘‘(cc) Upon receipt of a notification under 5 item (aa) or (bb), as applicable, the Director 6 shall publish, not later than 30 days of such re- 7 ceipt, in the Official Gazette of the United 8 States Patent and Trademark Office, and on an 9 internet website that the Director shall estab- 10 lish, maintain, and operate, a notification with 11 respect to the patent, requesting that any per- 12 son that is eligible to file a request described in 13 section 311(b) of title 35, United States Code, 14 file such a request. 15 ‘‘(III) A patent included on the list as described 16 in subclause (II) shall be designated as being provi- 17 sionally included on such list until either of the fol- 18 lowing conditions is met: 19 ‘‘(aa) The Patent Trial and Appeal Board 20 of the United States Patent and Trademark Of- 21 fice (referred to in this clause as the ‘Board’) 22 issues a final written decision with respect to an 23 inter partes review of all claims of the patent 24 conducted under chapter 31 of title 35, United 25 VerDate Sep 11 2014 03:51 May 31, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1617.IS S1617 kjohnson on DSK79L0C42 with BILLS 4 •S 1617 IS States Code, and the Director issues and pub- 1 lishes a certificate confirming those claims to be 2 patentable. 3 ‘‘(bb) Notwithstanding the filing deadlines 4 provided under section 321(c) of title 35, 5 United States Code, no person files a petition 6 for inter partes review of any claim of the pat- 7 ent, with respect to a patent described in sub- 8 clause (II)(aa), not later than 300 days after 9 the date on which the application is approved 10 under subsection (c), or, with respect to a pat- 11 ent described in subclause (II)(bb), not later 12 than 15 months after the date on which the ap- 13 plication is so approved. 14 ‘‘(IV) With respect to a patent that is included 15 on the list as described in subclause (II), is des- 16 ignated as provisionally included on such list under 17 subclause (III), and, after an inter partes review of 18 the patent conducted under chapter 31 of title 35, 19 United States Code, is subject to a final written de- 20 cision of the Board and a certificate issued and pub- 21 lished by the Director canceling one or more claims 22 of the patent finally determined to be unpatentable, 23 the holder of the approved application, not later 24 than 30 days after the date on which the Director 25 VerDate Sep 11 2014 03:51 May 31, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1617.IS S1617 kjohnson on DSK79L0C42 with BILLS 5 •S 1617 IS publishes the certificate, shall submit to the Sec- 1 retary— 2 ‘‘(aa) if that decision and certificate relate 3 to all claims of the patent, a request to remove 4 the patent from the list; and 5 ‘‘(bb) if that decision and certificate do not 6 relate to all claims of the patent, a request to 7 remove the patent information relating to the 8 claim or claims to which that decision and cer- 9 tificate relate from the list. 10 ‘‘(V) If, as of the date on which a drug is ap- 11 proved under subsection (c), a complaint has been 12 filed in a district court of the United States chal- 13 lenging the validity of a patent, a patent submitted 14 under subsection (b) or (c) respecting such drug in- 15 cluded on the list shall be included on the list until 16 the date on which the court invalidates the patent, 17 if applicable. 18 ‘‘(VI) Nothing in this clause shall affect the 19 availability to a first applicant of an exclusivity pe- 20 riod pursuant to clause (iv) or (v) of paragraph 21 (5)(B), provided that, at the time that the first ap- 22 plicant submits an application under this subsection 23 containing a certification described in paragraph 24 (2)(A)(vii)(IV), information about the patent is in- 25 VerDate Sep 11 2014 03:51 May 31, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S1617.IS S1617 kjohnson on DSK79L0C42 with BILLS 6 •S 1617 IS cluded on the list or is included on the list on a pro- 1 visional basis.’’. 2 (b) EFFECTIVE DATE.—The amendments made by 3 subsection (a) shall apply only with respect to patents 4 issued after the date of enactment of this Act. 5 Æ VerDate Sep 11 2014 03:51 May 31, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6301 E:\BILLS\S1617.IS S1617 kjohnson on DSK79L0C42 with BILLS