Skinny Labels, Big Savings Act
This bill provides a statutory safe harbor from patent infringement claims for generic or biosimilar manufacturers that seek or obtain approval for skinny labels of their drugs.
Under current law, the Food and Drug Administration (FDA) may approve generic and biosimilar drugs through a process known as skinny labeling, which allows a generic manufacturer to seek approval only for approved uses of the drug that are no longer protected by patents. However, in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., a court held that a generic manufacturer may sometimes be liable for patent infringement when it markets skinny label generics.
The bill specifically lists the following as actions that are not considered infringement of a method of use claim in a patent under the Federal Food, Drug, and Cosmetic Act:
The bill also applies the safe harbor to similar actions under the Public Health Service Act.
[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6485 Introduced in House (IH)]
<DOC>
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 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>
Introduced in House
Introduced in House
Referred to the House Committee on the Judiciary.
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