Skinny Labels, Big Savings Act
Sponsored By: Representative Cline, Ben [R-VA-6]
Introduced
Summary
Safe harbors for method-of-use patents. This bill would protect certain generic and biosimilar approval, labeling, and marketing steps from method-of-use patent infringement claims when the labeling and promotion do not reference the patented use.
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- Generic drug makers: Would shield companies that submit applications under FDA pathways like 505(j) or 505(b)(2) from direct, induced, or contributory infringement claims for method-of-use patents when their application includes the required statement and their labeling and promotion avoid the patented condition.
- Biosimilar developers: Would allow applicants under Public Health Service Act section 351(k) to describe or market a product as biosimilar or interchangeable without triggering method-of-use infringement claims, provided labeling and promotion do not reference the patented condition and match approved prescribing information.
- Patent owners: Would narrow enforcement by preventing suits for method-of-use claims when the patent-listed use is not included or referenced in the generic or biosimilar labeling, promotion, or descriptions that comply with the bill's rules.
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Bill Overview
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
Safer rules for generics and biosimilars
If enacted, this bill would create a legal safe harbor for many generic and biosimilar drug makers. It would make filing ANDAs, certain animal drug filings, 505(b)(2) filings, and 351(k) biosimilar applications non‑infringing in specified cases. Protection would apply only if the application includes the required statement and the approved label, promotion, or marketing does not reference the patented use. It would also shield calling an approved product a generic, therapeutically equivalent, biosimilar, or interchangeable when using the approved label and not mentioning the patented condition. The safe harbor would cover conduct before, on, or after enactment and apply to pending cases.
Sponsors & CoSponsors
Sponsor
Cline, Ben [R-VA-6]
VA • R
Cosponsors
Lofgren
CA • D
Sponsored 12/5/2025
Rep. Kiggans, Jennifer A. [R-VA-2]
VA • R
Sponsored 4/20/2026
Rep. Suozzi, Thomas R. [D-NY-3]
NY • D
Sponsored 4/20/2026
Roll Call Votes
No roll call votes available for this bill.
View on Congress.gov