HR 6485 — Skinny Labels, Big Savings Act

Summary

Skinny Labels, Big Savings ActThis 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; ordescribing 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.

Bill Text

• Introduced Introduced in House Current html December 05, 2025

Compared against current U.S. Code AI-generated reading aid — verify against the official bill.

The bill creates a safe harbor from infringement for certain method of use patents related to drugs and biological products.

• 35 U.S.C. § 271

  (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.

  This provision establishes that specific actions related to drug approval and marketing will not be infringing a method of use patent.

• 35 U.S.C. § 271

  (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.

  This provision similarly ensures certain actions regarding biological products are not considered infringement of associated method of use patents.

• 35 U.S.C. § 271

  subsections (h) and (i) → subsections (k) and (l)

  This change reorganizes the subsections, moving existing subsections (h) and (i) to (k) and (l) respectively to accommodate the newly inserted provisions.

Action History

1. December 05, 2025

   Introduced in House

2. December 05, 2025

   Introduced in House

3. December 05, 2025

   Referred to the House Committee on the Judiciary.

Sponsors

• Ben Cline · Primary
• Zoe Lofgren · Cosponsor
• Jennifer A. Kiggans · Cosponsor
• Thomas R. Suozzi · Cosponsor
• August Pfluger · Cosponsor
• Glenn Grothman · Cosponsor
• Angie Craig · Cosponsor

Subjects