‘Skin­ny la­bels’ on gener­ics can save pa­tients mon­ey, re­search shows, but re­cent court de­ci­sions cloud fu­ture

New re­search shows how gener­ic drug com­pa­nies can suc­cess­ful­ly mar­ket a lim­it­ed num­ber of ap­proved in­di­ca­tions for a brand name drug, pri­or to com­ing to mar­ket for all of the in­di­ca­tions. But sev­er­al re­cent court de­ci­sions have cre­at­ed a lay­er of un­cer­tain­ty around these so-called “skin­ny” la­bels.

While courts have gen­er­al­ly al­lowed gener­ic man­u­fac­tur­ers to use their statu­to­ri­ly per­mit­ted skin­ny-la­bel ap­provals, last sum­mer, a fed­er­al cir­cuit court found that Te­va Phar­ma­ceu­ti­cals was li­able for in­duc­ing pre­scribers and pa­tients to in­fringe Glax­o­SmithK­line’s patents through ad­ver­tis­ing and mar­ket­ing prac­tices that sug­gest­ed Te­va’s gener­ic, with its skin­ny la­bel, could be em­ployed for the patent­ed us­es.

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