No­var­tis pe­ti­tions Supreme Court in ef­fort to 'vig­or­ous­ly de­fend' Gilenya patent

No­var­tis has of­fi­cial­ly pe­ti­tioned the Supreme Court in an on­go­ing ef­fort to pro­tect Gilenya from gener­ic ri­vals for at least an­oth­er sev­er­al years.

The Swiss phar­ma gi­ant filed the 55-page doc­u­ment Wednes­day, af­ter an­nounc­ing its in­tent to pe­ti­tion the court in Sep­tem­ber. The case dates back to 2016, when HEC Pharm filed for gener­ic ap­proval of its own ver­sion of Gilenya, No­var­tis’s block­buster mul­ti­ple scle­ro­sis drug. The gener­ic won ap­proval in 2019, but No­var­tis fought back with law­suits as­sert­ing that var­i­ous patents don’t ex­pire un­til 2027.

A fed­er­al court in Delaware pre­vi­ous­ly grant­ed a per­ma­nent in­junc­tion against HEC’s gener­ic un­til a patent cov­er­ing a 0.5 mg dos­ing reg­i­men of Gilenya ex­pires in 2027, and a three-judge ap­peals pan­el up­held the de­ci­sion last Jan­u­ary. How­ev­er, a new judge — who joined the pan­el af­ter a pri­or mem­ber re­tired — agreed to grant a re­hear­ing and the pan­el re­versed the rul­ing in June, in­val­i­dat­ing No­var­tis’s ‘405 patent.

No­var­tis ar­gued in its Supreme Court pe­ti­tion last week that the high court should “bring the Fed­er­al and Ninth Cir­cuits in line with the law and sound ju­di­cial prac­tice.”

“Al­low­ing pan­el changes to over­turn al­ready-en­tered de­ci­sions un­der­mines con­fi­dence in the ju­di­cia­ry. It cre­ates an im­pres­sion that cir­cuit courts ad­min­is­ter judge-spe­cif­ic jus­tice, with out­comes de­pend­ing not on the mer­its but on which judges are as­signed to the pan­el,” the pe­ti­tion reads.

No­var­tis had re­quest­ed a stay on the low­er court’s man­date while it pre­pared its pe­ti­tion, which the Supreme Court de­nied in Oc­to­ber. HEC’s ver­sion launched in Oc­to­ber, ac­cord­ing to court doc­u­ments. Last year, No­var­tis said it ex­pect­ed to lose about a quar­ter bil­lion dol­lars in 2022 sales if gener­ics were to hit the mar­ket.

On Jan. 11, No­var­tis filed yet an­oth­er com­plaint against HEC in Delaware fed­er­al court, al­leg­ing that the gener­ic drug’s la­bel­ing — in­clud­ing in­struc­tions to first test pa­tients for the virus that caus­es chick­en­pox — in­fringes on its patent ‘179, which al­so ex­pires in 2027.

“If De­fen­dants’ in­fringe­ment of the ’179 patent is not per­ma­nent­ly en­joined, No­var­tis will suf­fer sub­stan­tial and ir­repara­ble harm for which there is no rem­e­dy at law,” the com­pa­ny said.

Gilenya earned near­ly $2.8 bil­lion in 2021, mak­ing it No­var­tis’ third-high­est sell­er in its In­no­v­a­tive Med­i­cines seg­ment. HEC has pre­vi­ous­ly ac­cused No­var­tis of mak­ing $3.8 mil­lion per day on Gilenya in the US, “charg­ing at least 10 to 20 times what its gener­ic com­peti­tors would.”

“No­var­tis con­tin­ues to vig­or­ous­ly de­fend the va­lid­i­ty of US Patent No. 9,187,405, cov­er­ing a dos­ing reg­i­men for 0.5mg,” No­var­tis said in an email to End­points News on Tues­day. “The process may take sev­er­al months to de­ter­mine if the pe­ti­tion will be grant­ed.”

HEC Pharm was not im­me­di­ate­ly avail­able for com­ment.

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