Skinny Labels, Big Savings Act

Summary

Creates a new patent safe-harbor that protects generic drug, certain animal drug, 505(b)(2) applications, and biosimilar applicants and marketers from being sued for infringing method‑of‑use patent claims when they seek approval, market, or describe their products as generic/biosimilar while omitting the patented uses from labeling and required FDA patent statements. The protection applies only if labeling, promotion, and statutory statements do not reference the patented conditions of use listed to FDA, and it is made retroactive to conduct and proceedings before, on, or after enactment.

• Establishes a new patent safe-harbor protecting certain generic and biosimilar regulatory filings and marketing from infringement claims on method‑of‑use patents.
• Safe-harbor applies to ANDAs (505(j)), certain animal generic filings (512(b)(2)), and 505(b)(2) applications when required patent statements are made to FDA.
• Creates a parallel safe-harbor for biosimilars under the biologics statutory framework (42 U.S.C. 262(k)).
• Protection only applies if labeling, promotion, and statutory statements do not reference the patented condition(s) of use listed to FDA.
• Adds definitions and adjusts subsection lettering in patent statute to accommodate the new provisions.
• Applies retroactively to conduct and pending proceedings before, on, or after enactment.
• Likely to shift litigation toward disputes over labeling, promotional conduct, and the content of patent-identifying statements to FDA.
• Does not appropriate funds or create new federal spending programs; relies on existing FDA and court processes.
• Could increase market entry options for generics and biosimilars for non‑patented uses, potentially lowering prices for those uses.