Skinny Labels, Big Savings Act

This legislation, titled the "Skinny Labels, Big Savings Act," amends title 35 of the United States Code to create a safe harbor from infringement of method of use patents for certain drug and biological products. This safe harbor applies to actions taken by generic drug and biosimilar manufacturers when their products are not approved for, and their labeling or marketing does not reference, a specific patented condition or method of use. The goal is to prevent patent holders from blocking the market entry of generic or biosimilar versions that only seek approval for non-patented uses. Specifically, the bill protects activities such as submitting applications for generic drugs (under section 505(j) or 505(b)(2) of the Federal Food, Drug, and Cosmetic Act) or biosimilar biological products (under section 351(k) of the Public Health Service Act). It also covers the promotion, commercial marketing, or description of these products as generic, therapeutically equivalent, biosimilar, or interchangeable, provided that such actions do not reference the patented conditions of use. The provisions of this Act apply retroactively to conduct occurring before, on, or after its enactment date, and to all pending judicial or other proceedings.