II 

118TH CONGRESS 

2D SESSION S. 5573 

To amend title 35, United States Code, to provide for a safe harbor from 

infringement of a method of use patent relating to drugs or biological 

products. 

IN THE SENATE OF THE UNITED STATES 

DECEMBER 17 (legislative day, DECEMBER 16), 2024 

Mr. HICKENLOOPER (for himself, Mr. WELCH, Mr. COTTON, and Ms. COLLINS) introduced the following bill; which was read twice and referred to 

the Committee on the Judiciary 

A BILL 

To amend title 35, United States Code, to provide for a 

safe harbor from infringement of a method of use patent 

relating to drugs or biological products. 

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 ‘‘Skinny Labels, Big 

5 Savings Act’’. 

6 SEC. 2. SAFE HARBOR FROM INFRINGEMENT OF A METHOD 

7 OF USE PATENT. 

8 (a) IN GENERAL.—Section 271 of title 35, United 

9 States Code, is amended— 


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•S 5573 IS

1 (1) by redesignating subsections (h) and (i) as 

2 subsections (k) and (l), respectively; and 

3 (2) by inserting after subsection (g) the fol4 lowing: 

5 ‘‘(h)(1) The following shall not be acts of direct, in6 duced, or contributory infringement of a method of use 

7 claim in a patent included in the list described in section 

8 505(j)(7) or section 512(n)(4) of the Federal Food, Drug, 

9 and Cosmetic Act (21 U.S.C. 355(j)(7), 360b(n)(4)) in an 

10 action or counterclaim under this section: 

11 ‘‘(A) Submitting or seeking approval of an ap12 plication under section 505(j) or section 512(b)(2) of 

13 the Federal Food, Drug, and Cosmetic Act (21 

14 U.S.C. 355(j), 360b(b)(2)), or submitting or seeking 

15 approval of an application described in section 

16 505(b)(2) of such Act (21 U.S.C. 355(b)(2)), pro17 vided that such application includes a statement 

18 under, as applicable, section 505(j)(2)(A)(viii), sec19 tion 512(n)(1)(I), or section 505(b)(2)(B) of such 

20 Act (21 U.S.C. 355(j)(2)(A)(viii), 360b(n)(1)(I), 

21 355(b)(2)(B)) for the method of use claims in the 

22 patent with the labeling proposed in such applica23 tion. 


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1 ‘‘(B) Promoting or commercially marketing a 

2 drug product with the labeling approved in an appli3 cation described in subparagraph (A). 

4 ‘‘(C) Describing a drug product approved in an 

5 application submitted under section 505(j) or section 

6 512(b)(2) of such Act (21 U.S.C. 355(j), 

7 360b(b)(2)) or approved in an application described 

8 in section 505(b)(2) of such Act (21 U.S.C. 

9 355(b)(2)) as a generic of, or therapeutically equiva10 lent to, the listed drug referenced in such applica11 tion, as applicable. 

12 ‘‘(2) Subparagraphs (A) through (C) of paragraph 

13 (1) shall apply only if the labeling, promotion, or commer14 cial marketing does not reference the condition or condi15 tions of use claimed in the patent that was identified by 

16 the patent owner or assignee to the Secretary under sec17 tion 314.53 of title 21, Code of Federal Regulations (or 

18 a successor regulation) and that was subject to the state19 ment under section 505(j)(2)(A)(viii), section 

20 512(n)(1)(I), or section 505(b)(2)(B) of the Federal Food, 

21 Drug, and Cosmetic Act (21 U.S.C. 355(j)(2)(A)(viii), 

22 360b(n)(1)(I), 355(b)(2)(B)), as applicable. 

23 ‘‘(i)(1) The following shall not be acts of direct, in24 duced, or contributory infringement of a patent claim covVerDate Sep 11 2014 05:06 Jan 21, 2025 Jkt 059200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S5573.IS S5573

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1 ering a method of using the reference product in an action 

2 or counterclaim under this section: 

3 ‘‘(A) Submitting or seeking approval of an ap4 plication under section 351(k) of the Public Health 

5 Service Act (42 U.S.C. 262(k)). 

6 ‘‘(B) Describing a biological product approved 

7 in an application described in subparagraph (A) as 

8 biosimilar to, or interchangeable with, the reference 

9 product, as applicable, with the labeling approved in 

10 such application, when the biological product has not 

11 been approved for the patented condition or condi12 tions of use. 

13 ‘‘(C) Promoting or commercially marketing a 

14 biological product with the labeling approved in an 

15 application described in subparagraph (A). 

16 ‘‘(2) Subparagraphs (A) through (C) of paragraph 

17 (1) shall apply only if the labeling, promotion, or commer18 cial marketing does not reference the condition or condi19 tions of use claimed in the patent and specifically reflected 

20 in the prescribing information. 

21 ‘‘(j) As used in this section: 

22 ‘‘(1) The terms ‘biological product’, ‘biosimilar’, 

23 ‘interchangeable’, and ‘reference product’ have the 

24 meanings given such terms in section 351(i) of the 

25 Public Health Service Act (42 U.S.C. 262(i)). 


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1 ‘‘(2) The term ‘commercial marketing’ has the 

2 meaning given such term in section 314.3 of title 21, 

3 Code of Federal Regulations (or a successor regula4 tion). 

5 ‘‘(3) The term ‘labeling’ has the meaning given 

6 such term in section 201(m) of the Federal Food, 

7 Drug, and Cosmetic Act (21 U.S.C. 321(m)). 

8 ‘‘(4) The term ‘promoting’— 

9 ‘‘(A) is within the meaning of the term 

10 used in section 202.1 of title 21, Code of Fed11 eral Regulations (or a successor regulation); 

12 and 

13 ‘‘(B) includes the use of promotional label14 ing and advertising, as described in paragraphs 

15 (1) and (2) of section 202.1(l) of title 21, Code 

16 of Federal Regulations (or successor regula17 tions).’’. 

18 (b) APPLICATION.—This Act and the amendments 

19 made by this Act shall apply to— 

20 (1) conduct that occurs before, on, or after the 

21 date of enactment of this Act; and 

22 (2) all judicial or other proceedings pending as 

23 of such date of enactment. 

Æ 


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