Official Summaries

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:

• submitting or seeking approval of a skinny label for a generic or biosimilar drug;
• promoting or commercially marketing a drug with skinny labeling approved by the FDA; or
• describing a drug product approved by the FDA as a generic of, or therapeutically equivalent to, the branded drug.

The bill also applies the safe harbor to similar actions under the Public Health Service Act.

Current Full Text

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

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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.
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