II 

116TH CONGRESS 

1ST SESSION S. 659 

To provide for certain additional requirements with respect to patent 

disclosures. 

IN THE SENATE OF THE UNITED STATES 

MARCH 5, 2019 

Ms. COLLINS (for herself, Mr. KAINE, Mr. PORTMAN, Mrs. SHAHEEN, Mr. 

BRAUN, and Ms. STABENOW) introduced the following bill; which was 

read twice and referred to the Committee on Health, Education, Labor, 

and Pensions 

A BILL 

To provide for certain additional requirements with respect 

to patent disclosures. 

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 ‘‘Biologic Patent Trans5 parency Act’’. 

6 SEC. 2. PATENT DISCLOSURE REQUIREMENTS. 

7 (a) IN GENERAL.—Section 351 of the Public Health 

8 Service Act (42 U.S.C. 262) is amended by adding at the 

9 end the following: 


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1 ‘‘(o) ADDITIONAL REQUIREMENTS WITH RESPECT

2 TO PATENTS.— 

3 ‘‘(1) APPROVED APPLICATION HOLDER LISTING

4 REQUIREMENTS.— 

5 ‘‘(A) IN GENERAL.—Beginning on the date 

6 of enactment of the Biologic Patent Trans7 parency Act, within 30 days of approval of an 

8 application under subsection (a) or (k), the 

9 holder of such approved application shall sub10 mit to the Secretary a list of each patent re11 quired to be disclosed (as described in para12 graph (3)). 

13 ‘‘(B) PREVIOUSLY APPROVED OR LI14 CENSED BIOLOGICAL PRODUCTS.— 

15 ‘‘(i) PRODUCTS APPROVED UNDER

16 SECTION 351 OF THE PHSA.—Not later 

17 than 30 days after the date of enactment 

18 of the Biologic Patent Transparency Act, 

19 the holder of a biological product license 

20 that was approved under subsection (a) or 

21 (k) before the date of enactment of such 

22 Act shall submit to the Secretary a list of 

23 each patent required to be disclosed (as de24 scribed in paragraph (3)). 


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1 ‘‘(ii) PRODUCTS APPROVED UNDER

2 SECTION 505 OF THE FFDCA.—Not later 

3 than 30 days after March 23, 2020, the 

4 holder of an approved application for a bio5 logical product under section 505 of the 

6 Federal Food, Drug, and Cosmetic Act 

7 that is deemed to be a license for the bio8 logical product under this section on 

9 March 23, 2020, shall submit a list of each 

10 patent required to be disclosed (as de11 scribed in paragraph (3)). 

12 ‘‘(C) UPDATES.—The holder of a biological 

13 product license approved under subsection (a) 

14 or (k) shall submit to the Secretary a list that 

15 includes— 

16 ‘‘(i) any patent first required to be 

17 disclosed (as described in paragraph (3)) 

18 after the submission under subparagraph 

19 (A) or (B), as applicable, within 30 days of 

20 the earlier of— 

21 ‘‘(I) the date of issuance of such 

22 patent by the United States Patent 

23 and Trademark Office; or 


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1 ‘‘(II) the date of approval of a 

2 supplemental application for the bio3 logical product; and 

4 ‘‘(ii) any patent, or any claim with re5 spect to a patent, included on the list pur6 suant to this paragraph with respect to the 

7 biological product subsequently determined 

8 to be invalid or unenforceable, within 30 

9 days of a determination of patent inva10 lidity. 

11 ‘‘(2) PUBLICATION OF INFORMATION.— 

12 ‘‘(A) IN GENERAL.—Within 1 year of the 

13 date of enactment of the Biologic Patent Trans14 parency Act, the Secretary shall publish and 

15 make available to the public a single, easily 

16 searchable, list that includes— 

17 ‘‘(i) the official and proprietary name 

18 of each biological product licensed under 

19 subsection (a) or (k), and of each biological 

20 product application approved under section 

21 505 of the Federal Food, Drug, and Cos22 metic Act and deemed to be a license for 

23 the biological product under this section on 

24 March 23, 2020; 


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1 ‘‘(ii) with respect to each biological 

2 product described in clause (i), each patent 

3 submitted in accordance with paragraph 

4 (1); 

5 ‘‘(iii) the date of licensure and appli6 cation number for each such biological 

7 product; 

8 ‘‘(iv) the marketing status, dosage 

9 form, route of administration, strength, 

10 and, if applicable, reference product, for 

11 each such biological product; 

12 ‘‘(v) the licensure status for each such 

13 biological product, including whether the li14 cense at the time of listing is approved, 

15 withdrawn, or revoked; 

16 ‘‘(vi) any period of any exclusivity 

17 under subsection (k)(7)(A) or subsection 

18 (k)(7)(B) of this section or section 527 of 

19 the Federal Food, Drug, and Cosmetic 

20 Act, and any extension of such period in 

21 accordance with subsection (m) of this sec22 tion with respect to each such biological 

23 product, and the date on which such exclu24 sivity expires; 


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1 ‘‘(vii) information regarding any de2 termination related to biosimilarity or 

3 interchangeability for each such biological 

4 product; and 

5 ‘‘(viii) information regarding approved 

6 indications for each such biological prod7 uct, in such manner as the Secretary de8 termines appropriate. 

9 ‘‘(B) UPDATES.—Every 30 days after the 

10 publication of the first list under subparagraph 

11 (A), the Secretary shall revise the list to in12 clude— 

13 ‘‘(i)(I) each biological product licensed 

14 under subsection (a) or (k) during the 30- 

15 day period; and 

16 ‘‘(II) with respect to each biological 

17 product described in subclause (I), the in18 formation described in clauses (i) through 

19 (viii) of subparagraph (A); and 

20 ‘‘(ii) any updates to information pre21 viously published in accordance with sub22 paragraph (A). 

23 ‘‘(3) PATENTS REQUIRED TO BE DISCLOSED.— 

24 In this section, a ‘patent required to be disclosed’ is 

25 any patent for which the holder of a biological prodVerDate Sep 11 2014 22:49 Mar 21, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S659.IS S659

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1 uct license approved under subsection (a) or (k), or 

2 a biological product application approved under sec3 tion 505 of the Federal Food, Drug, and Cosmetic 

4 Act and deemed to be a license for a biological prod5 uct under this section on March 23, 2020, believes 

6 a claim of patent infringement could reasonably be 

7 asserted by the holder, or by a patent owner that 

8 has granted an exclusive license to the holder with 

9 respect to the biological product that is the subject 

10 of such license, if a person not licensed by the holder 

11 engaged in the making, using, offering to sell, sell12 ing, or importing into the United States of the bio13 logical product that is the subject of such license.’’. 

14 (b) DISCLOSURE OF PATENTS.—Section 

15 351(l)(3)(A)(i) of the Public Health Service Act (42 

16 U.S.C. 262(l)(3)(A)(i)) is amended by inserting ‘‘included 

17 in the list provided by the reference product sponsor under 

18 subsection (o)(1)’’ after ‘‘a list of patents’’. 

19 (c) RESTRICTION ON CLAIMS OF PATENT INFRINGE20 MENT.—Section 271(e) of title 35, United States Code, 

21 is amended by adding at the end the following: 

22 ‘‘(7) The owner of a patent that should have 

23 been included in the list described in section 

24 351(o)(1) of the Public Health Service Act (42 

25 U.S.C. 262(o)(1)), including any updates required 


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1 under subparagraph (C) of that section, but was not 

2 timely included in such list, may not bring an action 

3 under this section for infringement of the patent.’’. 

4 (d) REGULATIONS.—The Secretary of Health and 

5 Human Services may promulgate regulations to carry out 

6 subsection (o) of section 351 of the Public Health Service 

7 Act (42 U.S.C. 262), as added by subsection (a). 

8 (e) RULE OF CONSTRUCTION.—Nothing in this Act, 

9 including an amendment made by this Act, shall be con10 strued to require or allow the Secretary of Health and 

11 Human Services to delay the licensing of a biological prod12 uct under section 351 of the Public Health Service Act 

13 (42 U.S.C. 262). 

Æ 


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