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AssociationforMolecularPathologyvMyriadGeneticsIncETAL.pdf

IanMarcellinoAssociationforMolecularPathologyETAL.v.MyriadGenetics,INC.,ETAL. FactsRespondentMyriadGenetics,Inc.(Myriad),discoveredthepreciselocationandsequenceoftwohumangenes(BRCA1&BRCA2),mutationsofwhichcansubstantiallyincreasetherisksofbreastandovariancancer.MyriaddidnotcreateoralteranyofthegeneticinformationencodedintheBRCA1andBRCA2geneshoweverMyriaddidisolatethesegenesorsequencesofnucleotidesfromtherestofthechromosome,whichininsolation,donotoccurnaturally.Uponisolationoftheseparticulargenes,MyriadwasabletoalterthesesequencesofnucleotidesandcreatecomplimentaryDNA(cDNA).OnceitfoundthelocationandsequenceoftheBRCA1andBRCA2genes,Myriadsoughtandobtainedseveralpatentsbasedonthisdiscovery,threeofwhichareinquestioninthiscase.Myriad'spatentswould,ifvalid,giveitboththeexclusiverighttoisolateanindividual'sBRCA1andBRCA2genesandsyntheticallycreateBRCAcDNA.IssueIsanaturallyoccurringsegmentofdeoxyribonucleicacid(DNA)patenteligibleunder35U.S.C.101byvirtueofitsisolationfromtherestofthehumangenome?Furthermore,isasyntheticallycreateddeoxyribonucleicacid(DNA)knownascomplimentaryDNA(cDNA),whichcontainsthesameprotein-codinginformationfoundinasegmentofnaturalDNAbutomitsportionswithintheDNAsegmentthatdonotcodeforproteins,patenteligible?HoldingTheCourtheldthatMyriad'sdiscoveriesoftheBRCA1andBRCA2genesarenotpatenteligibleunder35U.S.C.101.HowevertheirsynthesisoftheBRCAcDNAarepatenteligibleandprotectedunder35U.S.C.101.ReasoningAnaturallyoccurringDNAsegmentisaproductofnatureandnotpatenteligiblemerelybecauseithasbeenisolated.SyntheticcomplimentaryDNA(cDNA)ispatenteligiblebecauseitisnota"productofnature."PhilosophicalQuestions

1. AlthoughcDNAdoesnotnecessarilyoccurnaturally("onitsown"),shouldthefactthatitisastillrepresentativeofnaturallifemakeitanymorepatenteligiblethannaturallyoccurringDNA?

2. IsitethicallysoundtopatentandlicenseDNAforprofit?

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