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# ‘Skinny Label’ Safe Harbor Bills Introduced
- URL: https://www.fdaweb.com/skinny-label-safe-harbor-bills-introduced/
- Published: 2026-01-06T12:00:00.000Z
- Updated: 2026-09-14T15:29:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160432

Bipartisan legislation has been introduced in the House and Senate to shield certain drug manufacturers who have submitted drug applications to FDA from patent infringement liability, including induced and contributory infringement, based on the submissions and marketing of the approved drug. The Skinny Labels, Big Savings Act (H.R. 6485) was introduced in the House by Rep. **Ben Cline** (R-VA). Companion legislation was introduced in the Senate by Sen. **John Hickenlooper** (D-CO).

Two Knobbe Martens attorneys say in an online [post](https://www.knobbe.com/blog/proposed-legislation-to-codify-skinny-label-safe-harbor/?ref=fdaweb.com#%5Fftn1) that the safe harbor for drugs in the proposed legislation is limited to infringement claims based on method-of-use patents listed in FDA’s *Orange Book*, covering drugs for human use, and its *Green Book*, covering drugs for animal use.

The attorneys write that if the bill is enacted, the safe harbor would extend to three types of acts:

- · submitting or seeking approval of ANDAs, ANADAs, or 505(b)(2) NDAs, including the applicable carve-out statement confirming that the proposed labeling excludes the patented method-of-use claims;
- · promoting or commercially marketing a drug product with the labeling approved in an ANDA, ANADA, or 505(b)(2) NDA; and
- · describing a drug product approved under an ANDA, ANADA, or 505(b)(2) NDA as a generic of, or therapeutically equivalent to, the reference-listed drug.

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 attorneys write. It would provide analogous protections for biosimilars under a 351(k) application.

The measures have been referred to the House and Senate Judiciary Committees for review.