Skinny Labels, Big Savings Act

New safe harbor for drug makers

This bill would protect certain generic, 505(b)(2), animal drug, and biosimilar applicants and sellers from method-of-use patent lawsuits tied to FDA approvals. For generics and similar applicants, it would block infringement claims for filing the required method-of-use statement, selling or promoting the product with the approved label, and calling it a generic or equivalent — only if the label or promotion does not reference the patented use reported to FDA. For biosimilars, it would block infringement claims for filing a 351(k) application, describing the product as biosimilar or interchangeable, and marketing it with approved labeling — only if labeling and promotion do not reference the patented condition in the prescribing information. The bill would also adopt specific definitions for terms like "biosimilar," "labeling," and "promoting," and it would apply to conduct before, on, and after enactment and to pending cases.