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Hickenlooper, John W. [D-CO]","W.","CO","D","H000273","2025-12-18T16:16:20Z",[],"Senate",119,false,"Skinny Labels, Big Savings Act","2026-05-10T15:54:24.276Z",[],3,0,2,"s",[],[],"https:\u002F\u002Fwww.congress.gov\u002Fbill\u002F119th-congress\u002Fsenate-bill\u002F43","Commerce",{"date":6,"text":32},"Read twice and referred to the Committee on the Judiciary.",43,"in_committee",1,"A bill to amend title 35, United States Code, to provide for a safe harbor from infringement of a method of use patent relating to drugs or biological products.","2026-05-22T13:47:16.518Z","commerce",[40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,149,150,151,152,153,154,155,156,157,158,159,160,161,162,163],"skinny","sk","ski","skin","skinn","labels","la","lab","labe","label","big","savings","sa","sav","savi","savin","saving","act","bill","bi","bil","to","amend","am","ame","amen","title","ti","tit","titl","35","united","un","uni","unit","unite","states","st","sta","stat","state","code","co","cod","provide","pr","pro","prov","provi","provid","for","safe","saf","harbor","ha","har","harb","harbo","from","fr","fro","infringement","in","inf","infr","infri","infrin","infring","infringe","infringem","infringeme","infringemen","of","method","me","met","meth","metho","use","patent","pa","pat","pate","paten","relating","re","rel","rela","relat","relati","relatin","drugs","dr","dru","drug","or","biological","bio","biol","biolo","biolog","biologi","biologic","biologica","products","prod","produ","produc","product","sen","hickenlooper","hi","hic","hick","hicke","hicken","hickenl","hickenlo","hickenloo","hickenloop","hickenloope","john","jo","joh",[],true,[167],{"versionCode":168,"actionDate":6,"actionDesc":169,"text":170,"updateDate":171},"00","Introduced in Senate","\u003Cp>\u003Cstrong>Skinny Labels, Big Savings Act\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>This 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.\u003C\u002Fp>\u003Cp>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 \u003Cem>GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc.\u003C\u002Fem>, a court held that a generic manufacturer may sometimes be liable for patent infringement when it markets skinny label generics.\u003C\u002Fp>\u003Cp>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:\u003C\u002Fp>\u003Cul>\u003Cli>submitting or seeking approval of a skinny label for a generic or biosimilar drug;\u003C\u002Fli>\u003Cli>promoting or commercially marketing a drug with skinny labeling approved by the FDA; or\u003C\u002Fli>\u003Cli>describing a drug product approved by the FDA as a generic of, or therapeutically equivalent to, the branded drug.\u003C\u002Fli>\u003C\u002Ful>\u003Cp>The bill also applies the safe harbor to similar actions under the Public Health Service Act.\u003C\u002Fp>","2025-03-31T14:51:02Z",[173,178,182],{"bioguideId":174,"fullName":175,"party":176,"state":177,"sponsorshipDate":6,"isOriginalCosponsor":165,"withdrawn":19,"sponsorshipWithdrawnDate":3},"C001095","Sen. 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