Skinny Labels, Big Savings Act
Skinny Labels, Big Savings Act
Plain Language Summary
# Skinny Labels, Big Savings Act - Summary **What the Bill Does:** This bill would protect generic and biosimilar drug manufacturers from patent lawsuits when they use "skinny labels"—a FDA-approved process where manufacturers sell cheaper generic versions of drugs but only advertise them for uses whose patents have expired. Currently, a court ruling allows brand-name drug companies to sue generic manufacturers for patent infringement even when using skinny labels, which creates legal uncertainty for generic drugmakers. **Who It Affects:** The bill primarily benefits generic and biosimilar drug manufacturers and consumers who use generic medications.
It could indirectly help patients by making it easier and cheaper for generic companies to bring their products to market without expensive patent litigation. Brand-name pharmaceutical companies would be affected negatively, as they'd lose the ability to sue over skinny label generics. **Key Provision:** The bill creates a legal "safe harbor" stating that submitting skinny label applications to the FDA or marketing drugs with skinny labels would not be considered patent infringement under federal law. **Current Status:** HR 6485 is currently in committee and has not yet been voted on by the full House of Representatives.
CRS Official Summary
Skinny Labels, Big Savings ActThis bill provides a statutory safe harbor from patent infringement claims for generic or biosimilar manufacturers that seek or obtain approval for skinny labels of their drugs.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; ordescribing 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.
Latest Action
Referred to the House Committee on the Judiciary.