In the Senate of the United States, 

December 10, 2020. 

Resolved, That the bill from the House of Representatives (H.R. 1520) entitled ‘‘An Act to amend the Public 

Health Service Act to provide for the publication of a list of 

licensed biological products, and for other purposes.’’, do pass 

with the following 

AMENDMENT: 

Strike all after the enacting clause and insert the 

following: 

1 SECTION 1. SHORT TITLE. 

2 The Act may be cited as the ‘‘Purple Book Continuity 

3 Act of 2020’’. 

4 SEC. 2. BIOLOGICAL PRODUCT PATENT TRANSPARENCY. 

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

6 Service Act (42 U.S.C. 262(k)) is amended by adding at 

7 the end the following: 

8 ‘‘(9) PUBLIC LISTING.— 

9 ‘‘(A) IN GENERAL.— 
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1 ‘‘(i) INITIAL PUBLICATION.—Not later 

2 than 180 days after the date of enactment 

3 of the Purple Book Continuity Act of 2020, 

4 the Secretary shall publish and make avail5 able to the public in a searchable, electronic 

6 format— 

7 ‘‘(I) a list of each biological prod8 uct, by nonproprietary name (proper 

9 name), for which, as of such date of en10 actment, a biologics license under sub11 section (a) or this subsection is in ef12 fect, or that, as of such date of enact13 ment, is deemed to be licensed under 

14 this section pursuant to section 

15 7002(e)(4) of the Biologics Price Com16 petition and Innovation Act of 2009; 

17 ‘‘(II) the date of licensure of the 

18 marketing application and the appli19 cation number; and 

20 ‘‘(III) with respect to each biologi21 cal product described in subclause (I), 

22 the licensure status, and, as available, 

23 the marketing status. 

24 ‘‘(ii) REVISIONS.—Every 30 days after 

25 the publication of the first list under clause 
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1 (i), the Secretary shall revise the list to in2 clude each biological product which has been 

3 licensed under subsection (a) or this sub4 section during the 30-day period or deemed 

5 licensed under this section pursuant to sec6 tion 7002(e)(4) of the Biologics Price Com7 petition and Innovation Act of 2009. 

8 ‘‘(iii) PATENT INFORMATION.—Not 

9 later than 30 days after a list of patents 

10 under subsection (l)(3)(A), or a supplement 

11 to such list under subsection (l)(7), has been 

12 provided by the reference product sponsor to 

13 the subsection (k) applicant respecting a bi14 ological product included on the list pub15 lished under this subparagraph, the ref16 erence product sponsor shall provide such 

17 list of patents (or supplement thereto) and 

18 their corresponding expiry dates to the Sec19 retary, and the Secretary shall, in revisions 

20 made under clause (ii), include such infor21 mation for such biological product. Within 

22 30 days of providing any subsequent or 

23 supplemental list of patents to any subse24 quent subsection (k) applicant under sub25 section (l)(3)(A) or (l)(7), the reference 
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† HR 1520 EAS 

1 product sponsor shall update the informa2 tion provided to the Secretary under this 

3 clause with any additional patents from 

4 such subsequent or supplemental list and 

5 their corresponding expiry dates. 

6 ‘‘(iv) LISTING OF EXCLUSIVITIES.—For 

7 each biological product included on the list 

8 published under this subparagraph, the Sec9 retary shall specify each exclusivity period 

10 under paragraph (6) or paragraph (7) for 

11 which the Secretary has determined such bi12 ological product to be eligible and that has 

13 not concluded. 

14 ‘‘(B) REVOCATION OR SUSPENSION OF LI15 CENSE.—If the license of a biological product is 

16 determined by the Secretary to have been revoked 

17 or suspended for safety, purity, or potency rea18 sons, it may not be published in the list under 

19 subparagraph (A). If such revocation or suspen20 sion occurred after inclusion of such biological 

21 product in the list published under subparagraph 

22 (A), the reference product sponsor shall notify the 

23 Secretary that— 

24 ‘‘(i) the biological product shall be im25 mediately removed from such list for the 
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1 same period as the revocation or suspension; 

2 and 

3 ‘‘(ii) a notice of the removal shall be 

4 published in the Federal Register.’’. 

5 (b) REVIEW AND REPORT ON TYPES OF INFORMATION

6 TO BE LISTED.—Not later than 3 years after the date of 

7 enactment of this Act, the Secretary of Health and Human 

8 Services shall— 

9 (1) solicit public comment regarding the type of 

10 information, if any, that should be added to or re11 moved from the list required by paragraph (9) of sec12 tion 351(k) of the Public Health Service Act (42 

13 U.S.C. 262(k)), as added by subsection (a); and 

14 (2) transmit to Congress an evaluation of such 

15 comments, including any recommendations about the 

16 types of information that should be added to or re17 moved from the list. 

Attest: 

Secretary. 
116TH CONGRESS 

2D SESSION H.R. 1520 

AMENDMENT