On December 5, 2025, the Skinny Labels, Big Savings Act (H.R. 6485) was introduced in the House of Representatives. The bill, if enacted, would shield certain drug manufacturers who have submitted drug applications to the Food and Drug Administration (“FDA”) from patent infringement liability, including induced and contributory infringement, based on those submissions and commercial marketing of the approved drug.[1] The safe harbor for drugs in the proposed legislation is limited to infringement claims based on method-of-use patents listed in the FDA’s Orange Book, which relates to drugs for human use, or the Agency’s Green Book, which relates to drugs for animal use. If the bill is enacted, the safe harbor would extend to three types of acts.
The first is the act of “[s]ubmitting or seeking approval” of Abbreviated New Drug Applications (ANDAs), Abbreviated New Animal Drug Applications (ANADAs), or 505(b)(2) New Drug Applications (NDAs).[2] To be afforded the proposed bill’s safe harbor protection, the application would need to include the applicable “carve-out” statement confirming that the proposed labeling excludes the patented method-of-use claims. For example, an ANDA would need to include a Section VIII Statement.[3]
The second is the act of “[p]romoting or commercially marketing a drug product with the labeling approved” in an ANDA, ANADA, or 505(b)(2) NDA.
The third is the act of “[d]escribing a drug product approved” under an ANDA, ANADA, or 505(b)(2) NDA “as a generic of, or therapeutically equivalent to, the listed drug referenced in such application, as applicable.”
The bill’s safe harbor would “apply only if the labeling, promotion, or commercial marketing does not reference the condition or conditions of use” claimed in the patent and excluded in the carve-out statement.
The bill would provide analogous protections for biosimilars under a 351(k) application.[4]
An essentially identical bill (S.43) was introduced in the Senate on December 9, 2025.[5] Each bill has been referred to the Judiciary Committee of its respective chamber for review. Next, each Judiciary Committee will review its respective bill, hold hearings if needed, consider amendments, and then vote on whether to send the bill to the full chamber for debate and a vote. Even if enacted, it remains uncertain whether the Skinny Label, Big Savings Act would increase certainty surrounding drug label carve-outs or invite new legal challenges.
Editor: Brenden S. Gingrich, Ph.D.
[1] https://www.congress.gov/bill/119th-congress/house-bill/6485
[2] ANDA application under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 355(j)); ANADA application under section 512(b)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 360b(b)(2)); NDA application under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 355(b)(2))
[3] 21 U.S.C. § 355(j)(2)(A)(viii)
[4] Application under section 351(k) of the Public Health Service Act (42 U.S.C. § 262(k))
[5] https://www.congress.gov/bill/119th-congress/senate-bill/43
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