I 
119TH CONGRESS 
1ST SESSION H. R. 6485 
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 HOUSE OF REPRESENTATIVES 
DECEMBER 5, 2025 
Mr. CLINE (for himself and Ms. LOFGREN) introduced the following bill; which 
was 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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Skinny Labels, Big 
Savings Act’’. 
SEC. 2. SAFE HARBOR FROM INFRINGEMENT OF A METHOD 
OF USE PATENT. 
(a) IN GENERAL.—Section 271 of title 35, United 
States Code, is amended— 
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(1) by redesignating subsections (h) and (i) as 
subsections (k) and (l), respectively; and 
(2) by inserting after subsection (g) the fol-
lowing: 
‘‘(h)(1) The following shall not be acts of direct, in-
duced, or contributory infringement of a method of use 
claim in a patent included in the list described in section 
505(j)(7) or section 512(n)(4) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355(j)(7), 360b(n)(4)) in an 
action or counterclaim under this section: 
‘‘(A) Submitting or seeking approval of an ap-
plication under section 505(j) or section 512(b)(2) of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(j), 360b(b)(2)), or submitting or seeking 
approval of an application described in section 
505(b)(2) of such Act (21 U.S.C. 355(b)(2)), pro-
vided that such application includes a statement 
under, as applicable, section 505(j)(2)(A)(viii), sec-
tion 512(n)(1)(I), or section 505(b)(2)(B) of such 
Act (21 U.S.C. 355(j)(2)(A)(viii), 360b(n)(1)(I), 
355(b)(2)(B)) for the method of use claims in the 
patent with the labeling proposed in such applica-
tion. 
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‘‘(B) Promoting or commercially marketing a 
drug product with the labeling approved in an appli-
cation described in subparagraph (A). 
‘‘(C) Describing a drug product approved in an 
application submitted under section 505(j) or section 
512(b)(2) 
of 
such 
Act 
(21 
U.S.C. 
355(j), 
360b(b)(2)) or approved in an application described 
in section 505(b)(2) of such Act (21 U.S.C. 
355(b)(2)) as a generic of, or therapeutically equiva-
lent to, the listed drug referenced in such applica-
tion, as applicable. 
‘‘(2) Subparagraphs (A) through (C) of paragraph 
(1) shall apply only if the labeling, promotion, or commer-
cial marketing does not reference the condition or condi-
tions of use claimed in the patent that was identified by 
the patent owner or assignee to the Secretary under sec-
tion 314.53 of title 21, Code of Federal Regulations (or 
a successor regulation) and that was subject to the state-
ment 
under 
section 
505(j)(2)(A)(viii), 
section 
512(n)(1)(I), or section 505(b)(2)(B) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(j)(2)(A)(viii), 
360b(n)(1)(I), 355(b)(2)(B)), as applicable. 
‘‘(i)(1) The following shall not be acts of direct, in-
duced, or contributory infringement of a patent claim cov-
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