FAIR Generics Act

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 Com- mittee 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 juris- diction 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. 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 ‘‘Fair And Immediate 4 Release of Generic Drugs Act’’ or the ‘‘FAIR Generics 5 Act’’. 6 VerDate Sep 11 2014 00:08 Mar 16, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H1506.IH H1506 kjohnson on DSK79L0C42 with BILLS 2 •HR 1506 IH SEC. 2. 180-DAY EXCLUSIVITY PERIOD AMENDMENTS RE- 1 GARDING FIRST APPLICANT STATUS. 2 (a) AMENDMENTS TO FEDERAL FOOD, DRUG, AND 3 COSMETIC ACT.— 4 (1) IN GENERAL.—Section 505(j)(5)(B) of the 5 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 6 355(j)(5)(B)) is amended— 7 (A) in clause (iv)(II)— 8 (i) by striking item (bb); and 9 (ii) by redesignating items (cc) and 10 (dd) as items (bb) and (cc), respectively; 11 and 12 (B) by adding at the end the following: 13 ‘‘(v) FIRST APPLICANT DEFINED.—As used in 14 this subsection, the term ‘first applicant’ means an 15 applicant— 16 ‘‘(I)(aa) that, on the first day on which a 17 substantially complete application containing a 18 certification described in paragraph 19 (2)(A)(vii)(IV) is submitted for approval of a 20 drug, submits a substantially complete applica- 21 tion that contains and lawfully maintains a cer- 22 tification described in paragraph (2)(A)(vii)(IV) 23 for the drug; and 24 VerDate Sep 11 2014 00:08 Mar 16, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H1506.IH H1506 kjohnson on DSK79L0C42 with BILLS 3 •HR 1506 IH ‘‘(bb) that has not entered into a disquali- 1 fying agreement described under clause 2 (vii)(II); or 3 ‘‘(II)(aa) for the drug that is not described 4 in subclause (I) and that, with respect to the 5 applicant and drug, each requirement described 6 in clause (vi) is satisfied; and 7 ‘‘(bb) that has not entered into a disquali- 8 fying agreement described under clause 9 (vii)(II). 10 ‘‘(vi) REQUIREMENT.—The requirements de- 11 scribed in this clause are the following: 12 ‘‘(I) The applicant described in clause 13 (v)(II) submitted and lawfully maintains a cer- 14 tification described in paragraph (2)(A)(vii)(IV) 15 or a statement described in paragraph 16 (2)(A)(viii) for each unexpired patent for which 17 a first applicant described in clause (v)(I) had 18 submitted a certification described in paragraph 19 (2)(A)(vii)(IV) on the first day on which a sub- 20 stantially complete application containing such 21 a certification was submitted. 22 ‘‘(II) With regard to each such unexpired 23 patent for which the applicant described in 24 clause (v)(II) submitted a certification de- 25 VerDate Sep 11 2014 00:08 Mar 16, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H1506.IH H1506 kjohnson on DSK79L0C42 with BILLS 4 •HR 1506 IH scribed in paragraph (2)(A)(vii)(IV), no action 1 for patent infringement was brought against 2 such applicant within the 45-day period speci- 3 fied in paragraph (5)(B)(iii); or if an action 4 was brought within such time period, such an 5 action was withdrawn or dismissed by a court 6 (including a district court) without a decision 7 that the patent was valid and infringed; or if an 8 action was brought within such time period and 9 was not withdrawn or so dismissed, such appli- 10 cant has obtained the decision of a court (in- 11 cluding a district court) that the patent is in- 12 valid or not infringed (including any substantive 13 determination that there is no cause of action 14 for patent infringement or invalidity, and in- 15 cluding a settlement order or consent decree 16 signed and entered by the court stating that the 17 patent is invalid or not infringed). 18 ‘‘(III) If an applicant described in clause 19 (v)(I) has begun commercial marketing of such 20 drug, the applicant described in clause (v)(II) 21 does not begin commercial marketing of such 22 drug until the date that is 30 days after the 23 date on which the applicant described in clause 24 (v)(I) began such commercial marketing.’’. 25 VerDate Sep 11 2014 00:08 Mar 16, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H1506.IH H1506 kjohnson on DSK79L0C42 with BILLS 5 •HR 1506 IH (2) CONFORMING AMENDMENT.—Section 1 505(j)(5)(D)(i)(IV) of such Act (21 U.S.C. 2 355(j)(5)(D)(i)(IV)) is amended by striking ‘‘The 3 first applicant’’ and inserting ‘‘The first applicant, 4 as defined in subparagraph (B)(v)(I),’’. 5 (b) APPLICABILITY.—The amendments made by sub- 6 section (a) shall apply only with respect to an application 7 filed under section 505(j) of the Federal Food, Drug, and 8 Cosmetic Act (21 U.S.C. 355(j)) to which the amendments 9 made by section 1102(a) of the Medicare Prescription 10 Drug, Improvement, and Modernization Act of 2003 (Pub- 11 lic Law 108–173) apply. 12 SEC. 3. 180-DAY EXCLUSIVITY PERIOD AMENDMENTS RE- 13 GARDING AGREEMENTS TO DEFER COMMER- 14 CIAL MARKETING. 15 (a) AMENDMENTS TO FEDERAL FOOD, DRUG, AND 16 COSMETIC ACT.— 17 (1) LIMITATIONS ON AGREEMENTS TO DEFER 18 COMMERCIAL MARKETING DATE.—Section 19 505(j)(5)(B) of the Federal Food, Drug, and Cos- 20 metic Act (21 U.S.C. 355(j)(5)(B)), as amended by 21 section 2, is further amended by adding at the end 22 the following: 23 ‘‘(vii) AGREEMENT BY FIRST APPLICANT TO 24 DEFER COMMERCIAL MARKETING; LIMITATION ON 25 VerDate Sep 11 2014 00:08 Mar 16, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H1506.IH H1506 kjohnson on DSK79L0C42 with BILLS 6 •HR 1506 IH ACCELERATION OF DEFERRED COMMERCIAL MAR- 1 KETING DATE.— 2 ‘‘(I) AGREEMENT TO DEFER APPROVAL OR 3 COMMERCIAL MARKETING DATE.—An agree- 4 ment described in this subclause is an agree- 5 ment between a first applicant and the holder 6 of the application for the listed drug or an 7 owner of one or more of the patents as to which 8 any applicant submitted a certification quali- 9 fying such applicant for the 180-day exclusivity 10 period whereby that applicant agrees, directly 11 or indirectly, (aa) not to seek an approval of its 12 application that is made effective on the earliest 13 possible date under this subparagraph, subpara- 14 graph (F) of this paragraph, section 505A, or 15 section 527, (bb) not to begin the commercial 16 marketing of its drug on the earliest possible 17 date after receiving an approval of its applica- 18 tion that is made effective under this subpara- 19 graph, subparagraph (F) of this paragraph, sec- 20 tion 505A, or section 527, or (cc) to both items 21 (aa) and (bb). 22 ‘‘(II) AGREEMENT THAT DISQUALIFIES AP- 23 PLICANT FROM FIRST APPLICANT STATUS.—An 24 agreement described in this subclause is an 25 VerDate Sep 11 2014 00:08 Mar 16, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H1506.IH H1506 kjohnson on DSK79L0C42 with BILLS 7 •HR 1506 IH agreement between an applicant and the holder 1 of the application for the listed drug or an 2 owner of one or more of the patents as to which 3 any applicant submitted a certification quali- 4 fying such applicant for the 180-day exclusivity 5 period whereby that applicant agrees, directly 6 or indirectly, not to seek an approval of its ap- 7 plication or not to begin the commercial mar- 8 keting of its drug until a date that is after the 9 expiration of the 180-day exclusivity period 10 awarded to another applicant with respect to 11 such drug (without regard to whether such 180- 12 day exclusivity period is awarded before or after 13 the date of the agreement). 14 ‘‘(viii) LIMITATION ON ACCELERATION.—If an 15 agreement described in clause (vii)(I) includes more 16 than 1 possible date when an applicant may seek an 17 approval of its application or begin the commercial 18 marketing of its drug— 19 ‘‘(I) the applicant may seek an approval of 20 its application or begin such commercial mar- 21 keting on the date that is the earlier of— 22 ‘‘(aa) the latest date set forth in the 23 agreement on which that applicant can re- 24 ceive an approval that is made effective 25 VerDate Sep 11 2014 00:08 Mar 16, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H1506.IH H1506 kjohnson on DSK79L0C42 with BILLS 8 •HR 1506 IH under this subparagraph, subparagraph 1 (F) of this paragraph, section 505A, or 2 section 527, or begin the commercial mar- 3 keting of such drug, without regard to any 4 other provision of such agreement pursu- 5 ant to which the commercial marketing 6 could begin on an earlier date; or 7 ‘‘(bb) 180 days after another first ap- 8 plicant begins commercial marketing of 9 such drug; and 10 ‘‘(II) the latest date set forth in the agree- 11 ment on which that applicant can receive an ap- 12 proval that is made effective under this sub- 13 paragraph, subparagraph (F) of this paragraph, 14 section 505A, or section 527, or begin the com- 15 mercial marketing of such drug, without regard 16 to any other provision of such agreement pursu- 17 ant to which commercial marketing could begin 18 on an earlier date, shall be the date used to de- 19 termine whether an applicant is disqualified 20 from first applicant status pursuant to clause 21 (vii)(II).’’. 22 (2) NOTIFICATION OF FDA.—Section 505(j) of 23 such Act (21 U.S.C. 355(j)) is amended by adding 24 at the end the following: 25 VerDate Sep 11 2014 00:08 Mar 16, 2019 Jkt 089200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H1506.IH H1506 kjohnson on DSK79L0C42 with BILLS 9 •HR 1506 IH ‘‘(11)(A) The holder of an abbreviated application 1 under this subsection shall submit to the Secretary a noti- 2 fication that includes— 3 ‘‘(i)(I) the text of any agreement entered into 4 by such holder described under paragraph 5 (5)(B)(vii)(I); or 6 ‘‘(II) if such an agreement has not been re- 7 duced to text, a written detailed description of such 8 agreement that is sufficient to disclose all the terms 9 and conditions of the agreement; and 10 ‘‘(ii) the text, or a written detailed description 11 in the event of an agreement that has not been re- 12 duced to text, of any other agreements that are con- 13 tingent upon, provide a contingent condition for, or 14 are otherwise related to an agreement described in 15 clause (i). 16 ‘‘(B) The notification described under subparagraph 17 (A) shall be submitted not later than 10 business days 18 after execution of the agreement described in subpara- 19 graph (A)(i). Such notification is in addition to any notifi- 20 cation required under section 1112 of the Medicare Pre- 21 scription Drug, Improvement, and Modernization Act of 22 2003. 23 ‘‘(C) Any information or documentary material filed 24 with the Secretary pursuant to this paragraph shall be ex- 25 VerDate Sep 11 2014 00:08 Mar 16, 2019 Jkt 089200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H1506.IH H1506 kjohnson on DSK79L0C42 with BILLS 10 •HR 1506 IH empt from disclosure under section 552 of title 5, United 1 States Code, and no such information or documentary ma- 2 terial may be made public, except as may be relevant to 3 any administrative or judicial action or proceeding. Noth- 4 ing in this paragraph is intended to prevent disclosure to 5 either body of the Congress or to any duly authorized com- 6 mittee or subcommittee of the Congress.’’. 7 (3) PROHIBITED ACTS.—Section 301(e) of such 8 Act (21 U.S.C. 331(e)) is amended by striking ‘‘505 9 (i) or (k)’’ and inserting ‘‘505 (i), (j)(11), or (k)’’. 10 (b) INFRINGEMENT OF PATENT.—Section 271(e) of 11 title 35, United States Code, is amended by adding at the 12 end the following: 13 ‘‘(7) The exclusive remedy under this section for an 14 infringement of a patent for which the Secretary of Health 15 and Human Services has published information pursuant 16 to subsection (b)(1) or (c)(2) of section 505 of the Federal 17 Food, Drug, and Cosmetic Act shall be an action brought 18 under this subsection within the 45-day period described 19 in subsection (j)(5)(B)(iii) or (c)(3)(C) of section 505 of 20 the Federal Food, Drug, and Cosmetic Act.’’. 21 (c) APPLICABILITY.— 22 (1) LIMITATIONS ON ACCELERATION OF DE- 23 FERRED COMMERCIAL MARKETING DATE.—The 24 VerDate Sep 11 2014 00:08 Mar 16, 2019 Jkt 089200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H1506.IH H1506 kjohnson on DSK79L0C42 with BILLS 11 •HR 1506 IH amendment made by subsection (a)(1) shall apply 1 only with respect to— 2 (A) an application filed under section 3 505(j) of the Federal Food, Drug, and Cos- 4 metic Act (21 U.S.C. 355(j)) to which the 5 amendments made by section 1102(a) of the 6 Medicare Prescription Drug, Improvement, and 7 Modernization Act of 2003 (Public Law 108– 8 173) apply; and 9 (B) an agreement described under section 10 505(j)(5)(B)(vii)(I) of the Federal Food, Drug, 11 and Cosmetic Act (as added by subsection 12 (a)(1)) executed after the date of enactment of 13 this Act. 14 (2) NOTIFICATION OF FDA.—The amendments 15 made by paragraphs (2) and (3) of subsection (a) 16 shall apply only with respect to an agreement de- 17 scribed under section 505(j)(5)(B)(vii)(I) of the 18 Federal Food, Drug, and Cosmetic Act (as added by 19 subsection (a)(1)) executed after the date of enact- 20 ment of this Act. 21 Æ VerDate Sep 11 2014 00:08 Mar 16, 2019 Jkt 089200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6301 E:\BILLS\H1506.IH H1506 kjohnson on DSK79L0C42 with BILLS