Skinny Labels, Big Savings Act

Summary

Creates a legal safe harbor that shields generic drug and biosimilar applicants, and certain labeling/marketing tied to those approvals, from claims of patent infringement based on method-of-use (treatment-use) patents so long as the application, labeling, and promotion stay within the approved statements submitted to FDA. The protection covers filing ANDAs, certain 505(b)(2) and NADA applications, and biosimilar (BLA 262(k)) filings, and applies both to past and future conduct once enacted.

• Creates a statutory safe harbor that shields certain generic and biosimilar approval filings from method-of-use patent infringement claims.
• Protects filing ANDAs, certain 505(b)(2) applications, certain NADAs, and 262(k) biosimilar applications when statutorily required patent statements are included.
• Permits promotion and commercial marketing consistent with approved labeling without triggering method-of-use infringement liability.
• Safe harbor is lost if labeling, promotion, or marketing explicitly references patented uses disclosed to FDA.
• Key terms are defined by reference to existing FDA/PHSA statutory definitions.
• Applies retroactively and prospectively to conduct and proceedings before, on, or after enactment.
• Does not affect patent claims unrelated to method-of-use (e.g., composition or manufacturing patents).
• Likely to encourage 'skinny labeling' strategies that avoid patented indications to preserve immunity.