Roche and As­traZeneca set­tle years­long patent bat­tle over Ul­tomiris — re­port

Roche’s Chugai unit and As­traZeneca’s Alex­ion have set­tled a years­long patent bat­tle over the lat­ter’s Ul­tomiris — a rare blood dis­or­der treat­ment de­signed to suc­ceed Alex­ion’s block­buster Soliris, ac­cord­ing to re­ports.

The set­tle­ment was filed un­der seal on Mon­day, Bloomberg Law and Law 360 re­port­ed, and the terms are cur­rent­ly un­known. Alex­ion de­clined to com­ment on the case, while Chugai wasn’t avail­able as of press time.

The trou­ble dates back to 2018 (be­fore Ul­tomiris was ap­proved) when Chugai filed a com­plaint against Alex­ion al­leg­ing that the com­pa­ny used its patent­ed an­ti­body re­cy­cling tech­nol­o­gy to cre­ate the drug. The tech­nol­o­gy, Chugai says, could be used to ex­tend the half-life of an an­ti­body in the blood, and “im­prove the func­tion of C5 in­hibit­ing an­ti­bod­ies, in­clud­ing those used to treat rare blood dis­eases like PNH and aHUS.”

Like its pre­de­ces­sor Soliris, Ul­tomiris is a C5 in­hibitor — but while Soliris is dosed every two weeks dur­ing the main­te­nance pe­ri­od, Ul­tomiris can be tak­en every eight weeks. It snagged its first ap­proval in parox­ys­mal noc­tur­nal he­mo­glo­bin­uria (PNH), a rare but life-threat­en­ing blood dis­ease, in De­cem­ber 2018. Less than a year lat­er, it picked up a sec­ond ap­proval for atyp­i­cal he­molyt­ic ure­mic syn­drome (aHUS), a dis­ease that can cause pro­gres­sive in­jury to vi­tal or­gans via dam­age to the walls of blood ves­sels and blood clots.

Soliris and Ul­tomiris were key el­e­ments in As­traZeneca’s $39 bil­lion Alex­ion buy­out last sum­mer. The lat­ter raked in $688 mil­lion in 2021, ac­cord­ing to re­cent­ly re­leased Q4 re­sults.

In its 2018 com­plaint, Chugai ar­gued that Alex­ion knew of the al­leged patent in­fringe­ment be­cause the com­pa­ny made “mul­ti­ple in­quiries re­gard­ing ob­tain­ing a li­cense to Chugai’s an­ti­body tech­nol­o­gy patents” in 2012 and 2013.

“De­spite know­ing that Chugai did not give Alex­ion per­mis­sion to use Chugai’s re­cy­cling tech­nol­o­gy, and de­spite know­ing that Chugai patent­ed its re­cy­cling tech­nol­o­gy, Alex­ion know­ing­ly in­cor­po­rat­ed Chugai’s tech­nol­o­gy in­to its ALXN1210 prod­uct any­way. Alex­ion’s con­duct amounts to a will­ful dis­re­gard of Chugai’s patent rights,” the com­plaint states.

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