Skinny Labels, Big Savings Act
Skinny Labels, Big Savings Act
Plain Language Summary
# Skinny Labels, Big Savings Act - Plain Language Summary **What the bill does:** This bill would protect generic and biosimilar drug manufacturers from patent lawsuits when they sell drugs with "skinny labels"—a FDA-approved practice where manufacturers market a drug only for uses that are no longer covered by patents, leaving off other patented uses. Currently, a court ruling allows brand-name drug companies to sometimes sue generic manufacturers for patent infringement even when using this approved labeling approach. This bill would eliminate that legal risk. **Who it affects and why it matters:** The bill primarily affects generic and biosimilar drug manufacturers and consumers who use generic medications. By removing the threat of patent lawsuits, the bill aims to make it easier and cheaper for generic drug makers to bring lower-cost versions of drugs to market faster.
This could increase competition and lower drug prices for patients. Brand-name pharmaceutical companies would be affected negatively, as they would lose a legal tool to block generic competition. **Current status:** The bill (S. 43) was introduced by Senator John Hickenlooper (D-CO) in the 119th Congress and is currently in committee, meaning it has not yet been debated or voted on by the full Senate.
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
Read twice and referred to the Committee on the Judiciary.