Skinny Labels, Big Savings Act

Under current law, the Food and Drug Administration (FDA) may approve generic and biosimilar drugs through a process known as skinny labeling, which allows a generic manufacturer to seek approval only for approved uses of the drug that are no longer protected by patents. However, in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., a court held that a generic manufacturer may sometimes be liable for patent infringement when it markets skinny label generics.

The bill specifically lists the following as actions that are not considered infringement of a method of use claim in a patent under the Federal Food, Drug, and Cosmetic Act:

submitting or seeking approval of a skinny label for a generic or biosimilar drug;

promoting or commercially marketing a drug with skinny labeling approved by the FDA; or

describing a drug product approved by the FDA as a generic of, or therapeutically equivalent to, the branded drug.

The bill also applies the safe harbor to similar actions under the Public Health Service Act.