Am­gen files brief to Supreme Court ahead of oral ar­gu­ments — with in­dus­try am­i­cus sup­port

Am­gen is com­ing out swing­ing against Sanofi and Re­gen­eron in a Supreme Court case with sub­stan­tial im­pli­ca­tions.

In its brief filed Dec. 27, the Big Phar­ma laid out its case, say­ing among oth­er things that the Fed­er­al Cir­cuit’s stan­dard harms in­no­va­tion and al­ters the “ba­sic patent bar­gain” — deny­ing an in­ven­tor a patent based sheer­ly on the num­ber of pos­si­ble em­bod­i­ments, even if the patent’s dis­clo­sures teach the world how to “make and use” the claimed in­ven­tion. The crux of the case is around en­able­ment, which is es­sen­tial­ly if some­one “rea­son­ably skilled in the art could make or use the in­ven­tion from the dis­clo­sures in the patent cou­pled with in­for­ma­tion known in the art with­out un­due ex­per­i­men­ta­tion,” per the US Patent and Trade­mark Of­fice.

The Court will con­sid­er Am­gen’s re­quest to re­vive patents on its block­buster bi­o­log­ic Repatha and block the sale of Pralu­ent, Sanofi and Re­gen­eron’s in­de­pen­dent­ly de­vel­oped but sim­i­lar PC­SK9 in­hibitor an­ti­body drug. Both drugs, which are an­ti­bod­ies that dif­fer in amino acid se­quence and bind to PC­SK9, re­duce low-den­si­ty lipopro­tein cho­les­terol.

Am­gen scored a win in 2019 in an ini­tial tri­al, but a Delaware fed­er­al judge over­turned that rul­ing and ruled in fa­vor of Sanofi and Re­gen­eron. That de­ci­sion was then up­held in the Court of Ap­peals for the Fed­er­al Cir­cuit, deny­ing a re­hear­ing in 2021 and lead­ing Am­gen to file an ini­tial pe­ti­tion to SCO­TUS in No­vem­ber that year. Am­gen claimed that the Fed­er­al Cir­cuit de­ci­sion in­cor­rect­ly re­quires patent own­ers to iden­ti­fy and make all or near­ly all pos­si­ble vari­a­tions of the in­ven­tion — with­out “sub­stan­tial time and ef­fort.”

Sanofi had pre­vi­ous­ly said that Am­gen’s patents sur­round­ing Repatha were over­ly broad, which the fed­er­al judge had con­curred with.

GSK filed an am­i­cus brief to the Supreme Court Tues­day in sup­port of Am­gen, say­ing that genus claims — a type of patent that cov­ers not just one spe­cif­ic en­ti­ty, but a group of re­lat­ed en­ti­ties — are nec­es­sary to pro­tect “ground­break­ing dis­cov­er­ies in the life sci­ences,” and en­cour­age down­stream in­no­va­tion. In­stil Bio al­so filed a brief sup­port­ing Am­gen, not­ing that us­ing a re­quire­ment called the “full-scope re­quire­ment” to de­ter­mine en­able­ment is in­con­sis­tent with the statute, and ask­ing for the court to re­vert the stan­dard to an “un­due ex­per­i­men­ta­tion” re­quire­ment.

Am­gen’s writ of cer­tio­rari — which was ac­cept­ed two months ago — faced set­backs start­ing out, one of which oc­curred when So­lic­i­tor Gen­er­al Eliz­a­beth Prel­og­ar wrote in a 27-page brief in Sep­tem­ber that Am­gen’s ar­gu­ments “lack mer­it and fur­ther re­view is not war­rant­ed.”

“Pe­ti­tion­ers con­tend that the court of ap­peals erred by treat­ing en­able­ment as a ques­tion of law and by ex­am­in­ing the full scope of the claims in as­sess­ing whether they are ful­ly en­abled,” she wrote at the time.

Sanofi has un­til Feb. 3 to file its brief to the case, af­ter which oral ar­gu­ments will be made be­fore the bench.

Illustration: Assistant Editor Kathy Wong for Endpoints News

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