Teva fires back at GSK again over potential ‘skinny’ label SCOTUS case – Endpoints News

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Teva fires back at GSK again over potential ‘skinny’ label SCOTUS case – Endpoints News


Te­va on Wednes­day fired back at GSK af­ter the UK-based drug­mak­er sought to squash Te­va’s at­tempt to get its “skin­ny” la­bel case over­turned by the US Supreme Court.

Te­va filed a re­ply to GSK on Wednes­day, slam­ming the firm’s claims around these la­bel carve-outs, which gener­ic drug­mak­ers use fre­quent­ly to get com­pe­ti­tion on the mar­ket be­fore all the patent­ed in­di­ca­tions of the ref­er­ence prod­uct can be chal­lenged.

The Is­raeli gener­ic drug­mak­er notes that a pri­or fed­er­al court de­ci­sion in GSK’s fa­vor “is more than just a mis­ap­pli­ca­tion of set­tled prece­dent: it is an about-face, be­cause it adopts what was pre­vi­ous­ly a dis­sent­ing view and al­lows a ju­ry to find ac­tive in­duce­ment in vir­tu­al­ly any carve­out case.”

GSK, mean­while, pre­vi­ous­ly claimed that SCO­TUS shouldn’t hear the case, which hinges on Te­va’s “skin­ny” la­bel that was found to in­fringe on GSK’s be­ta-block­er Coreg af­ter the gener­ic firm mar­ket­ed one of the un­ap­proved in­di­ca­tions.

Te­va not­ed that while GSK says gener­ic man­u­fac­tur­ers can claim carve-outs are pro­tect­ed if they “ful­ly and tru­ly carve out” patent­ed in­di­ca­tions, that’s still a thorny is­sue.

“Un­der the Fed­er­al Cir­cuit’s de­ci­sion, the carve-out statute pro­vides no pro­tec­tion, not even to a com­pa­ny that fol­lows FDA’s di­rec­tions and carves out every­thing the brand man­u­fac­tur­er iden­ti­fies,” Te­va’s lawyers said — adding, “That is pre­cise­ly why cer­tio­rari is need­ed.”

The crux of GSK’s re­sponse, filed by at­tor­neys for the UK phar­ma cen­tered on the fol­low­ing ques­tion:

When a gener­ic drug is dou­bly in­di­cat­ed for a patent­ed use, and there is strong record ev­i­dence of in­tent and in­duc­ing con­duct, can the gener­ic man­u­fac­tur­er evade li­a­bil­i­ty for in­duced patent in­fringe­ment mere­ly be­cause it did not in­clude on its la­bel (i.e. ‘carved out’) one of the two in­di­ca­tions cor­re­spond­ing to the patent­ed use?

Te­va al­so pre­vi­ous­ly pe­ti­tioned the high court two months ago to pro­tect this long­stand­ing prece­dent be­hind “skin­ny” la­bels, which is now in lim­bo thanks to the 2021 Fed­er­al Cir­cuit court de­ci­sion.

Har­vard med­ical pro­fes­sor Aaron Kessel­heim told End­points News at the time that the rul­ing, “was a prob­lem­at­ic de­ci­sion be­cause it made it hard­er for gener­ic com­pa­nies to do what they’re legal­ly al­lowed to do.”

But GSK claims that this case does not present threats to “gener­ic com­pa­nies who op­er­ate prop­er­ly un­der the law of in­duced in­fringe­ment as ap­plied to gener­ic drug la­bels — “skin­ny” or not. And, it con­cerns cir­cum­stances high­ly un­like­ly to be re­peat­ed, as well as reg­u­la­tions and poli­cies FDA has changed mul­ti­ple times.”



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