Skinny Labels, Big Savings Act

This bill protects makers of cheaper generic or biosimilar drugs from being sued for patent infringement when they use a process called "skinny labeling," where the FDA approves their drug only for uses that are no longer covered by patents. A court previously ruled that generic drug makers could sometimes still be held liable for patent infringement even when using these skinny labels, so this bill creates a clear legal protection against that. Specifically, the bill says that seeking FDA approval for a skinny label, marketing a drug with that approved label, or describing a generic drug as equivalent to the brand-name version cannot be treated as patent infringement.

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