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US SB43
Bill
AI Summary
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Amends Section 271 of title 35, United States Code to create a safe harbor protecting generic drug and biosimilar manufacturers from patent infringement claims related to "method of use" patents when using "skinny labels" that omit patented indications
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Protects submitting drug applications, commercially marketing approved drugs, and describing generics as therapeutically equivalent to brand-name drugs from being considered direct, induced, or contributory patent infringement
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Safe harbor applies only when the labeling, promotion, or marketing does not reference the patented conditions of use identified by the patent owner to the FDA
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Extends similar protections to biosimilar biological products approved under section 351(k) of the Public Health Service Act, allowing them to be marketed without infringing method-of-use patents for indications not included in their approved labeling
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Applies retroactively to conduct occurring before, on, or after enactment and to all judicial proceedings pending at the time of enactment
Legislative Description
Skinny Labels, Big Savings Act
Commerce
Last Action
Read twice and referred to the Committee on the Judiciary.
1/9/2025