Biologic Patent Transparency Act

I 116TH CONGRESS 1ST SESSION H. R. 4850 To provide for certain additional requirements with respect to patent disclosures. IN THE HOUSE OF REPRESENTATIVES OCTOBER 23, 2019 Ms. SPANBERGER (for herself and Mr. REED) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subse- quently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned A BILL To provide for certain additional requirements with respect to patent disclosures. 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 ‘‘Biologic Patent Trans- 4 parency Act’’. 5 SEC. 2. PATENT DISCLOSURE REQUIREMENTS. 6 (a) IN GENERAL.—Section 351 of the Public Health 7 Service Act (42 U.S.C. 262) is amended by adding at the 8 end the following: 9 VerDate Sep 11 2014 02:36 Oct 30, 2019 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H4850.IH H4850 kjohnson on DSK79L0C42 with BILLS 2 •HR 4850 IH ‘‘(o) ADDITIONAL REQUIREMENTS WITH RESPECT 1 TO PATENTS.— 2 ‘‘(1) APPROVED APPLICATION HOLDER LISTING 3 REQUIREMENTS.— 4 ‘‘(A) IN GENERAL.—Beginning on the date 5 of enactment of the Biologic Patent Trans- 6 parency Act, within 30 days of approval of an 7 application under subsection (a) or (k), the 8 holder of such approved application shall sub- 9 mit to the Secretary a list of each patent re- 10 quired to be disclosed (as described in para- 11 graph (3)). 12 ‘‘(B) PREVIOUSLY APPROVED OR LI- 13 CENSED BIOLOGICAL PRODUCTS.— 14 ‘‘(i) PRODUCTS APPROVED UNDER 15 SECTION 351 OF THE PHSA.—Not later 16 than 30 days after the date of enactment 17 of the Biologic Patent Transparency Act, 18 the holder of a biological product license 19 that was approved under subsection (a) or 20 (k) before the date of enactment of such 21 Act shall submit to the Secretary a list of 22 each patent required to be disclosed (as de- 23 scribed in paragraph (3)). 24 VerDate Sep 11 2014 02:36 Oct 30, 2019 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H4850.IH H4850 kjohnson on DSK79L0C42 with BILLS 3 •HR 4850 IH ‘‘(ii) PRODUCTS APPROVED UNDER 1 SECTION 505 OF THE FFDCA.—Not later 2 than 30 days after March 23, 2020, the 3 holder of an approved application for a bio- 4 logical product under section 505 of the 5 Federal Food, Drug, and Cosmetic Act 6 that is deemed to be a license for the bio- 7 logical product under this section on 8 March 23, 2020, shall submit a list of each 9 patent required to be disclosed (as de- 10 scribed in paragraph (3)). 11 ‘‘(C) UPDATES.—The holder of a biological 12 product license approved under subsection (a) 13 or (k) shall submit to the Secretary a list that 14 includes— 15 ‘‘(i) any patent first required to be 16 disclosed (as described in paragraph (3)) 17 after the submission under subparagraph 18 (A) or (B), as applicable, within 30 days of 19 the earlier of— 20 ‘‘(I) the date of issuance of such 21 patent by the United States Patent 22 and Trademark Office; or 23 VerDate Sep 11 2014 02:36 Oct 30, 2019 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H4850.IH H4850 kjohnson on DSK79L0C42 with BILLS 4 •HR 4850 IH ‘‘(II) the date of approval of a 1 supplemental application for the bio- 2 logical product; and 3 ‘‘(ii) any patent, or any claim with re- 4 spect to a patent, included on the list pur- 5 suant to this paragraph with respect to the 6 biological product subsequently determined 7 to be invalid or unenforceable, within 30 8 days of a determination of patent inva- 9 lidity. 10 ‘‘(2) PUBLICATION OF INFORMATION.— 11 ‘‘(A) IN GENERAL.—Within 1 year of the 12 date of enactment of the Biologic Patent Trans- 13 parency Act, the Secretary shall publish and 14 make available to the public a single, easily 15 searchable, list that includes— 16 ‘‘(i) the official and proprietary name 17 of each biological product licensed under 18 subsection (a) or (k), and of each biological 19 product application approved under section 20 505 of the Federal Food, Drug, and Cos- 21 metic Act and deemed to be a license for 22 the biological product under this section on 23 March 23, 2020; 24 VerDate Sep 11 2014 02:36 Oct 30, 2019 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H4850.IH H4850 kjohnson on DSK79L0C42 with BILLS 5 •HR 4850 IH ‘‘(ii) with respect to each biological 1 product described in clause (i), each patent 2 submitted in accordance with paragraph 3 (1); 4 ‘‘(iii) the date of licensure and appli- 5 cation number for each such biological 6 product; 7 ‘‘(iv) the marketing status, dosage 8 form, route of administration, strength, 9 and, if applicable, reference product, for 10 each such biological product; 11 ‘‘(v) the licensure status for each such 12 biological product, including whether the li- 13 cense at the time of listing is approved, 14 withdrawn, or revoked; 15 ‘‘(vi) any period of any exclusivity 16 under subsection (k)(7)(A) or subsection 17 (k)(7)(B) of this section or section 527 of 18 the Federal Food, Drug, and Cosmetic 19 Act, and any extension of such period in 20 accordance with subsection (m) of this sec- 21 tion with respect to each such biological 22 product, and the date on which such exclu- 23 sivity expires; 24 VerDate Sep 11 2014 02:36 Oct 30, 2019 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H4850.IH H4850 kjohnson on DSK79L0C42 with BILLS 6 •HR 4850 IH ‘‘(vii) information regarding any de- 1 termination related to biosimilarity or 2 interchangeability for each such biological 3 product; and 4 ‘‘(viii) information regarding approved 5 indications for each such biological prod- 6 uct, in such manner as the Secretary de- 7 termines appropriate. 8 ‘‘(B) UPDATES.—Every 30 days after the 9 publication of the first list under subparagraph 10 (A), the Secretary shall revise the list to in- 11 clude— 12 ‘‘(i)(I) each biological product licensed 13 under subsection (a) or (k) during the 30- 14 day period; and 15 ‘‘(II) with respect to each biological 16 product described in subclause (I), the in- 17 formation described in clauses (i) through 18 (viii) of subparagraph (A); and 19 ‘‘(ii) any updates to information pre- 20 viously published in accordance with sub- 21 paragraph (A). 22 ‘‘(3) PATENTS REQUIRED TO BE DISCLOSED.— 23 In this section, a ‘patent required to be disclosed’ is 24 any patent for which the holder of a biological prod- 25 VerDate Sep 11 2014 02:36 Oct 30, 2019 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H4850.IH H4850 kjohnson on DSK79L0C42 with BILLS 7 •HR 4850 IH uct license approved under subsection (a) or (k), or 1 a biological product application approved under sec- 2 tion 505 of the Federal Food, Drug, and Cosmetic 3 Act and deemed to be a license for a biological prod- 4 uct under this section on March 23, 2020, believes 5 a claim of patent infringement could reasonably be 6 asserted by the holder, or by a patent owner that 7 has granted an exclusive license to the holder with 8 respect to the biological product that is the subject 9 of such license, if a person not licensed by the holder 10 engaged in the making, using, offering to sell, sell- 11 ing, or importing into the United States of the bio- 12 logical product that is the subject of such license.’’. 13 (b) DISCLOSURE OF PATENTS.—Section 14 351(l)(3)(A)(i) of the Public Health Service Act (42 15 U.S.C. 262(l)(3)(A)(i)) is amended by inserting ‘‘included 16 in the list provided by the reference product sponsor under 17 subsection (o)(1)’’ after ‘‘a list of patents’’. 18 (c) RESTRICTION ON CLAIMS OF PATENT INFRINGE- 19 MENT.—Section 271(e) of title 35, United States Code, 20 is amended by adding at the end the following: 21 ‘‘(7) The owner of a patent that should have 22 been included in the list described in section 23 351(o)(1) of the Public Health Service Act (42 24 U.S.C. 262(o)(1)), including any updates required 25 VerDate Sep 11 2014 02:36 Oct 30, 2019 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H4850.IH H4850 kjohnson on DSK79L0C42 with BILLS 8 •HR 4850 IH under subparagraph (C) of that section, but was not 1 timely included in such list, may not bring an action 2 under this section for infringement of the patent.’’. 3 (d) REGULATIONS.—The Secretary of Health and 4 Human Services may promulgate regulations to carry out 5 subsection (o) of section 351 of the Public Health Service 6 Act (42 U.S.C. 262), as added by subsection (a). 7 (e) RULE OF CONSTRUCTION.—Nothing in this Act, 8 including an amendment made by this Act, shall be con- 9 strued to require or allow the Secretary of Health and 10 Human Services to delay the licensing of a biological prod- 11 uct under section 351 of the Public Health Service Act 12 (42 U.S.C. 262). 13 Æ VerDate Sep 11 2014 02:36 Oct 30, 2019 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6301 E:\BILLS\H4850.IH H4850 kjohnson on DSK79L0C42 with BILLS