Skinny Labels, Big Savings Act

The Skinny Labels, Big Savings Act amends U.S. patent law to create a safe harbor from infringement liability for certain activities related to method of use patents for drugs and biological products. It protects generic and biosimilar manufacturers from being sued for patent infringement when they seek approval, promote, or market their products with labeling that does not reference the patented uses.

Sec. 2, Safe harbor from infringement of a method of use patent: This section adds new subsections (h), (i), and (j) to Section 271 of title 35. Subsection (h) provides that submitting or seeking approval of an abbreviated new drug application (ANDA) or 505(b)(2) application, promoting or marketing a drug product with approved labeling, or describing a generic as therapeutically equivalent to a listed drug is not infringement of a method of use patent, provided the labeling, promotion, or marketing does not reference the patented condition of use identified by the patent owner. Subsection (i) provides similar protection for biological products approved under a 351(k) application, including describing a product as biosimilar or interchangeable, and promoting or marketing it, as long as the labeling, promotion, or marketing does not reference the patented condition of use. Subsection (j) defines key terms like 'biological product', 'biosimilar', 'commercial marketing', 'labeling', and 'promoting'. The amendments apply to conduct before, on, or after enactment and to pending proceedings.