legislation: 119-hr-6485

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bill_id congress bill_type bill_number title policy_area introduced_date latest_action_date latest_action_text origin_chamber sponsor_name sponsor_state sponsor_party sponsor_bioguide_id cosponsor_count summary_text update_date url
119-hr-6485 119 hr 6485 Skinny Labels, Big Savings Act Commerce 2025-12-05 2025-12-05 Referred to the House Committee on the Judiciary. House Rep. Cline, Ben [R-VA-6] VA R C001118 1 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. 2026-02-23T16:04:45Z  

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