HR 6485 · 119th CongressIn Committeecongress.gov ↗
What this bill does
AI plain-language summaryThis bill protects generic and biosimilar drug makers from being sued for patent violations when they use "skinny labels." Skinny labels let generic companies get approval only for uses of a drug that are no longer protected by patents, but a court recently said they could still be sued for patent violations. The bill says that submitting, seeking approval for, or marketing drugs with these FDA-approved skinny labels cannot be considered patent violations.
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