119-s43

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 43 Introduced in Senate

    (IS) ]

<DOC>

119th CONGRESS
 1st Session
 S. 43

 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

 January 9, 2025

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.

 Be it enacted by the Senate and House of Representatives 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--

    (1) by redesignating subsections

    (h) and
            (i) as subsections

    (k) and
            (l) , respectively; and

    (2) by inserting after subsection

    (g) the following:
 ``

    (h)

    (1) The following shall not be acts of direct, induced, 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 application 
 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) ), provided 
 that such application includes a statement under, as 
 applicable, 

section 505

    (j)

    (2)
        (A)
            (viii) , 

section 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 
 application.
 ``
        (B) Promoting or commercially marketing a drug product 
 with the labeling approved in an application 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 equivalent to, 
 the listed drug referenced in such application, as applicable.
 ``

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

    (1) shall apply 
only if the labeling, promotion, or commercial marketing does not 
reference the condition or conditions of use claimed in the patent that 
was identified by the patent owner or assignee to the Secretary under 

section 314.53 of title 21, Code of Federal Regulations (or a successor 
regulation) and that was subject to the statement 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, induced, or 
contributory infringement of a patent claim covering a method of using 
the reference product in an action or counterclaim under this section:
 ``
        (A) Submitting or seeking approval of an application 
 under 

section 351

    (k) of the Public Health Service Act (42 
 U.S.C. 262

    (k) ).
 ``
        (B) Describing a biological product approved in an 
 application described in subparagraph
        (A) as biosimilar to, or 
 interchangeable with, the reference product, as applicable, 
 with the labeling approved in such application, when the 
 biological product has not been approved for the patented 
 condition or conditions of use.
 ``
            (C) Promoting or commercially marketing a biological 
 product with the labeling approved in an application described 
 in subparagraph
        (A) .
 ``

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

    (1) shall apply 
only if the labeling, promotion, or commercial marketing does not 
reference the condition or conditions of use claimed in the patent and 
specifically reflected in the prescribing information.
 ``

    (j) As used in this section:
 ``

    (1) The terms `biological product', `biosimilar', 
 `interchangeable', and `reference product' have the meanings 
 given such terms in 

section 351
            (i) of the Public Health Service 
 Act (42 U.S.C. 262
            (i) ).
 ``

    (2) The term `commercial marketing' has the meaning given 
 such term in 

section 314.3 of title 21, Code of Federal 
 Regulations (or a successor regulation).
 ``

    (3) The term `labeling' has the meaning given such term 
 in 

section 201
            (m) of the Federal Food, Drug, and Cosmetic Act 
 (21 U.S.C. 321
            (m) ).
 ``

    (4) The term `promoting'--
 ``
        (A) is within the meaning of the term used in 
 

section 202.1 of title 21, Code of Federal Regulations 
 (or a successor regulation); and
 ``
        (B) includes the use of promotional labeling and 
 advertising, as described in paragraphs

    (1) and

    (2) of 
 

section 202.1
            (l) of title 21, Code of Federal 
 Regulations (or successor regulations).''.

    (b) Application.--This Act and the amendments made by this Act 
shall apply to--

    (1) conduct that occurs before, on, or after the date of 
 enactment of this Act; and

    (2) all judicial or other proceedings pending as of such 
 date of enactment.
 <all>