Skinny Labels, Big Savings Act

This bill protects makers of generic drugs and biosimilars when they use “skinny labels.” That means if a brand-name drug still has a patent on one use, a generic can get approved and sold for the other, non‑patented uses without being sued for patent infringement—so long as its label and marketing don’t mention the patented use. It says that applying for approval, selling or promoting the drug with the approved skinny label, and describing it as a generic or therapeutically equivalent to the brand are not infringement. The same protections apply to biosimilars described as biosimilar or interchangeable, as long as they don’t reference the patented use.

These protections only apply if the labeling and marketing avoid the patented condition of use identified to FDA and carved out of the label. The bill also says it applies to past, current, and future conduct, including ongoing court cases.

• Who is affected: Generic drug makers and biosimilar manufacturers.
• What changes: Clear safe harbor from patent infringement for submitting skinny-label applications, marketing with FDA‑approved skinny labels, and describing products as generic, therapeutically equivalent, biosimilar, or interchangeable, when the patented use is not referenced.
• When it applies: To conduct before, on, or after enactment, and to pending proceedings.