{"bill":{"id":"119-hr-6485","congress":119,"type":"HR","number":6485,"title":"Skinny Labels, Big Savings Act","originChamber":"House","introducedDate":"2025-12-05","sponsors":[{"bioguideId":"C001118","fullName":"Rep. Cline, Ben [R-VA-6]","party":"R","state":"VA","district":6}],"cosponsorsCount":1,"latestAction":{"actionDate":"2025-12-05","text":"Referred to the House Committee on the Judiciary."},"policyArea":"Commerce","subjects":[],"actions":[{"date":"2025-12-05","text":"Referred to the House Committee on the Judiciary.","type":"IntroReferral","chamber":"House floor actions","hasVote":false},{"date":"2025-12-05","text":"Introduced in House","type":"IntroReferral","chamber":"Library of Congress","hasVote":false},{"date":"2025-12-05","text":"Introduced in House","type":"IntroReferral","chamber":"Library of Congress","hasVote":false}],"summary":"<p><strong>Skinny Labels, Big Savings Act</strong></p><p>This bill provides a statutory safe harbor from patent infringement claims for generic or&nbsp;biosimilar manufacturers that seek or obtain approval for skinny labels of their drugs.</p><p>Under current law, the Food and Drug Administration (FDA) may approve generic and&nbsp;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 <em>GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc.</em>, a court held that a generic manufacturer may sometimes be liable for patent infringement when it markets skinny label generics.</p><p>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:</p><ul><li>submitting or seeking approval of a skinny label for a generic or biosimilar drug;</li><li>promoting or commercially marketing a drug with skinny labeling approved by the FDA; or</li><li>describing a drug product approved by the FDA as a generic of, or therapeutically equivalent to, the branded drug.</li></ul><p>The bill also applies the safe harbor to similar actions under the Public Health Service Act.</p>","updateDate":"2026-02-23T16:04:45Z"},"markets":[],"stateBills":[],"meta":{"sources":["congress.gov"],"latencyMs":312,"ts":"2026-04-15T20:36:34.820Z"},"nextActions":{"inspect":[],"related":[{"description":"Search related legislation","method":"GET","url":"/api/public/query-gov?q=Skinny%20Labels%2C%20Big%20Savings%20Act"}]}}