人类基因序列的可专利性及相关法律问题

华中科技大学硕士学位论文人类基因序列的可专利性及相关法律问题姓名：陈建志申请学位级别：硕士专业：民商法指导教师：郑平安20080601IProblemSubmarinePatentsIIAbstractTherapiddevelopmentofgenetechnologyinevitablyimpactsthePatentLaw,Whetherthehumangenomesequencecanbepatentedbecomesthefocusofattentionofscholars.Becausethisissuehasbeguntotouchtheintellectualpropertysysteminsomeofthebasicconceptsandfundamentalprinciples,suchasdifferencesbetweentheinventionanddiscovery,theprincipleoftheinterestsofpatentrightsandrelatedethicalissues.Thispaperwillbetheoreticalbasisofpatentlaw,ethics,theprotectionofinternationaltrendstoconsiderthepatentabilityofhumangenesequence,andonthisbasistoinvestigatetherelatedissueswhatwehavetofaceafterprivilegingthepatentrightstothehumangenesequence.Atlast,authorofferssomefeasiblestrategiesandadvicestoperfecttherelatedlaw.Chapter1:Mainlyfromthetheoreticalbasisofpatentlaw,ethics,theprotectionofinternationaltrendstoconsiderthepatentabilityofhumangenesequence.Weneedtochangethepatentlawforthepatentabilityofhumangenesequence.Ifwecanprovethatsuchachangetothepatentlawinlinewiththeobjectivesofthedevelopmentandchangesinlaw,wewillbeabletoprovethepatentabilityofhumangenesequence.Ofcourse,thischangemustnotruncountertoethicalbottomline,andinlinewiththetrendofinternationalprotection.Chapter2:Focusedontheproblemsencounteredinpracticewhentheyusethepatentlawtoprotectthehumangenesequence.Thepatentabilityofhumangenesequencedosenotmeanthatthepracticeofpatentlawprotectionhaven’tanyproblem,howtosolvepracticeproblemhasbecamethecentralissue.Themainproblemsinclude:effectofupstreamresearchondownstreamdevelopment,exclusiveownershipofdiagnostictools,problemofsubmarinepatents,overmuchrightsclaiminapplicationofgenesequencepatent.Chapter3:Givesomesuggestionforthepatentlegalprotectionofgenesequence:Improvethegenesequencepatentsutilityexaminationcriterion,stricttheimplementingcriterionofthehumangenesequencepatent,usegenesequencepatentpooltopromotethedisseminationanduseofpatents,useresearchexemptiontoencouragethecommercialR&Dwhatisconducivetothepublicinterest.Tosumup,fromethics,thetheoreticalbasisofpatentlawandinternationaldevelopmenttrendsconsiderations,thehumangenesequencehasthepatentabilitycompletely.Butthelawisalwaysintheprocessofcontinuousimprovement,thehumanIIIgenesequenceofthepatentlawisintheinitialstageofthisprocess,therearestillmanyissuestoberesolved.Tothehumangenesequenceofthecontinuousinnovationanddevelopmentofscienceandtechnology,Chinamustacceleratetheimprovementofthehumangenomesequencepatentsrelatedlawsandregulations,forprotectingdevelopmentofscienceandtechnologyofthehumangenomesequence.Keywords:HumanGenesequencePatent_____11501953JAMESWASONCRICKDNADNADNA22DNA3132ProblemSubmarinePatents411.11.1.1DNADNADNARNADNADNARNADNAAdenineGuanineGThyminTCytosineCAGTCDNAAGTCDNADNARNAmRNAAGTCDNADNAmRNAmRNArRNArRNA:[1]·.——.1.,,.,2000:1-39[2]AndrewChin.RearchintheShadowofDNAPatents,thePatentandTrademarkOfficeSociety,November,20055DNADNAGeneDNAHGPDNADu1becco19901011524ONA302000626Work1ngdraft1.1.212[1]..,2000:2466345671.1.3500003[1],19989,.:“,,,,,.”[2],..,1999(5):13819801014Genetech1003520893600[1]·200010%26470%10.1%100045402000“”1.4[2]199621200321821[1]..——.,,.2000(1):45[2].,.,2000:6-23[3]..,2000:220[4]..,2004:191.21.2.1[1],.,.,.[2]..,1993:21410ELSI35ELSI5l71TRIPS2721.2.2amodernformofslavery[1]..,2001:39-4011DNADNA[1],..,2005:45-46[2].:.,2006(5):17[3]BrianGargano.theQuagmireofDNAPatents:AreDNASequencesMoreThanChemicalCompositionsofMatter?.SyracuseScience&TechnologyLawReporter.Spring,2005[4]ChristopherM.Holman.TheImpactofHumanGenePatentsonInnovationandAccess:ASurveyofHumanGenePatentLitigation.UMKCLawReview.Winter,200712[1],“,,,.131998l231.31.3.12512121011841DNADNA[1],..,2005,11:45-46[2]..,1996:49141123USPTOSpecificSubstantialCredible[1]UlrichSchatz..PatentabilityofGeneticEngineeringInventionsinEuropeanPatentOfficePractice.1998,28(1):6[2]...1.,2001(3):261[3]DR.VolkerVossius.PatentingInventionsintheBiologyandChemistryCaseLaw[J].BSLR,1997,(1):7152DiamondvChakrabartyDNADNADNA60[1]HalGibson.IntheWakeofEnzo:TheImpactoftheFederalCircuit'sDecisionontheU.S.LifeScienceIndustry.SanDiegoLawReview,Spring,2004[2]Diamondv.Chakrabarty,447U.S.303,309,206U.S.P.Q.193,197(1980)[3]StephanieArcuri.TheyCallThatNatural?AnAnalysisoftheTermNaturallyOccurringAndtheApplicationofGenestothePatenAct.ValparaisoUniversityLawReview.Summer,200616DNA201.3.2[1]2000626,,,,,97%,85%,3017116231718[1][](Badenaimer,E.).:.,1999:325-326[2],,,..1.,2003:7118[1]..,2002:1-2[2]..,2002:4-71918041896[1][]..,1982,43[2]..,2002:4-72017130013010130[1]..,2002:4-7[2]..,2000:139[3]·.——.,,.,2000:16[4]..,2000:191212[1]DianaA.Villamil:RedefiningUtilityinDeterminingthePatentabilityofDNASequences,TheJohnMarshallLawSchoolReviewofIntellectualPropertyLaw,Winter,2006[2]DianaA.Villamil,RedefiningUtilityinDeterminingthePatentabilityofDNASequences:TheJohnMarshallLawSchoolReviewofIntellectualPropertyLaw,Winter,2006[3]DianaA.Villamil:RedefiningUtilityinDeterminingthePatentabilityofDNASequences,TheJohnMarshallLawSchoolReviewofIntellectualPropertyLaw,Winter,2006221817