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PatentingRecentBiotechnologicalInventions
LegalServiceIndiaPatentingRecentBiotechnologicalInventions
PatentingRecentBiotechnologicalInventions
Writtenby:ReshmaAbrahamIama5thyearlawstudentatSymbiosdisLawSchool.Iamkeenonpursuing
IPRasPgsubjectandhavecompleted3diploma'sinthesame,IamcurrentlypursuingthePatentslawdiploma
Chatwithus(2PM9PMIST)

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IssuesandcontroversiesinPatentingRecentBiotechnologicalInventionsIsthepatentingoflifeequivalenttoowningit?
BackgroundtobiotechnologyandIntellectualProperty
SincethediscoveryofRecombinantDNAtechnologyintheearly1970s,Biotechnologyhasbecomeanimportanttoolformanyresearchersandindustries.
Biotechnologyandtheinventionsarisingoutofithavespurredthecreativegeniusesofmanyinventorsandhaveplayedanimportantroleinimprovingthe
nationshealth,foodsupplyandenvironment.TurningBiotechnologyinventionsintoprotectedIntellectualProperty,withconcomitantIntellectualProperty
Rightshavebeentakingplaceforoveracentury.Forexample,LouisPasteurwasgrantedaFrenchpatentin1865foryeastclonesthatheisolatedfrom
mixturesofyeastspecies.Theapplicationoftechnologytoagriculturehashelpedcontributeenormousincreasesinyieldandquality.Theisolationofadrenalin
overacenturyagofromthehumansuprarenalglandwasanimportantadvanceinthefieldofmedicine.
Legalprotectiongiventobiotechnology
Patentsareviewedasvitaltoprotectingthecommercialinterestsandintellectualpropertyrightsinbiotechnology.Patentsarelimitedrightsbasedonaclaim
thatanewtechnologicalinventionhasbeencreatedandfullycommunicatedtothepublic.Patentscancovernewproducts,processesthatcreatesthesenew
products,newprocessesforproducingexistingproductsandnewprocessesgenerally.Whilepatentingofabiotechnologicalinventionitisimportantthatit
meetsthe3criteriaslaiddownbytheTRIPstomeetpatentability,namelywhicharenewornovel,involvesaninventivestepornotobviousandcapableof
industrialapplication.TheTRIPsgivestheoptionofexcludingcertainformsofsubjectmatterfrompatentability
#Diagnostic,therapeuticandsurgicalmethodsforthetreatmentofhumansoranimals.
#Plantsandanimalsotherthanmicro0organisms,andbiologicalprocessesfortheproductionofplantsoranimalsotherthannonbiologicalandmicro
biologicalprocesses.
Howeverthepatentingofnewlifeformsraisesargumentsinfavorofandagainsttheissuanceofsuchpatents.Mostrecently,publicdebatehascenteredon
thepatentingofanimals.Discussionsregardingthepatentingofageneticallyengineeredorganismcaninvolvequestionsrelatingtotheenvironmental
applicationoftheorganism,scientificquestions,ethicalissuesandeconomicconsiderations.

ARIPO:PatentsTrademarks
ExtensiveexperiencewithARIPOLocalOfficesinSouthernAfrica
TheotherformsofIPProtectionthatcanbeofferedtobiotechnologyinvolveplantbreedersrights,trademarks,tradesecretsandgeographicalindications.
Extentoflegalprotectionofferedbypatents
Theprotectionconferredbyapatentonabiologicalmaterialextendstoanybiologicalmaterialderivedfromthatbiotechnologicallyinventedmaterialthrough
propagationormultiplicationandpossessingthesamecharacteristics.Theprotectionconferredbyapatentonaproductcontainingthegeneticinformation
extendstoallmaterialinwhichtheproductisincorporated.
Howevertheprotectiondoesnotextendtoplantpropagatingmaterialorbreedingstocksoldtoafarmerbytheholderofthepatentorwithhisconsent,provided
thatthefarmerusesthebiologicalmaterialorlivestockforhisownagriculturalpurposes.
Whereabreedercannotacquireorexploitaplantvarietyrightwithoutinfringingapriorpatent,hecanapplyforacompulsorylicensefornonexclusiveuseof
theinventionprotectedbythispatent,subjecttopaymentofroyalty.
3.PatentingofMicroorganismsandCells
ThefirstsuccessfuldirectedinsertionofrecombinantDNAintoahostmicroorganismtookplacein1973,andsincethenscientistsrealizedthehugepotential
involvedindirectingcellularmachinerytodevelopnewandimprovedproductsandprocesses.Manyoftheseproductsweremicroorganismsorcells.Hence
withthedevelopmentoftherecombinantDNAtechnology,thepotentialofpatentingthelivingorganismresultingfromthetechnologyarose.
In1980,intheDiamondv.Chakrabartyruling,theSupremeCourtofUSruledthatalivingmicroorganismcouldbepatented.Chakrabartyhaddevelopeda
geneticallymodifiedbacteriumcapableofbreakingdownthemultiplecomponentsofcrudeoil.Sincethispropertywasnotpossessedbyanynaturally
occurringbacteria,theinventionwasthoughttohavesignificantvalue.Itwasheldthatanonnaturallyoccurringmanufacturewasaproductofhuman
ingenuity.DNAcompoundshavingnaturallyoccurringsequencesareeligibleforpatentingwhenisolatedfromtheirnaturalstateandwhenitmeetsthestatutory
criteriaforpatentability.Hencebya54rulingitwasheldthatalive,humanmademicroorganismisapatentablesubjectmatterundersection101asa
manufactureorcomposition.Thefactthatbiotechnologywasnotpredictedasabranchofsciencewhenthecongressenactedsection101doesnotarriveat
theconclusionthatmicroorganismsarenotapatentablesubjectmatteruntilthecongressexpresslyauthorizessuchprotection.

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PostChakrabartytrends
TheChakrabartydecisionsandthesubsequentactionsenactedbytheUScongressprovidedgreateconomicstimulustothepatentingofmicroorganismsand
cells,andinturnprovidedstimulustothegrowthofthebiotechnologicalindustryinthe1980s.However,increasedpatentingofbiotechnologicalinventionshas
ledtolitigationrelatedtopatentinfringementissues.Thepatentlitigationisonlylikelytoincreaseinfutureconsideringtheoverlappingofpatentclaims,the
highvalueofproducts,problemofpriorpublicationandthefactthatmanycompaniesarepursuingthesameproduct.Theincreaseinthepatentclaimsleads
totheinabilityofthepatentofficestoprocessthebiotechnologicalinventionsinatimelymanner.Turnoveramongstthepatentexaminers,luringthemtothe
privatesectorsbyofferinghigherpayetcarereasonsforthedelayinthereviewingofpatents.
PatentingofTransgenicAnimals
ThefirstanimalpatentwasissuedinApril,1988toHarvardUniversityforaparticulartypeofmammal,namelytheHarvardoncomouse,geneticallyengineered
toobtainacancercausinggene.Theoncomousehasbeengeneticallyengineeredtocarryaparticulartypeofgenecalledastheoncogenewhichmakesit
susceptibletocancerandhencemakesitidealforcancerresearch.SubsequentlytheUSPTOannouncedthatitwouldconsidernonnaturallyoccurringnon
human,multicellularorganisms,includinganimalstobepatentablesubjectmatterunderitslaws.
MostoftheanimalpatentshavebeengrantedtotransgenicanimalsproducedbyrecombinantDNAorgeneticengineering.TransgenicanimalshaveDNA
whichhasbeenmodifiedbyaddingDNAfromanothersourceotherthantheparentalgermplasm,usuallyfromdifferentanimalsorhumans.
Negativeimpactsofpatentingoftransgenicanimals
Themajorconcernthatarisesoutofpatentingoftransgenicanimalsarethattransferringgenesfromonespeciestoanothertransgressesthenaturalbarriers
betweenthemandaffectstheintegrityofspecies.Speciesbelongingtothesamegroup,thoughtheymayslightlyvaryfromoneregiontotheotherbasedon
theenvironmentalconditions,theyprimarilyhavethesamegenepool.Byallowingpatentingoftransgenicanimals,thefundamentalgeneticarchitectureis
beingtamperedwith.
EthicalIssues
Anumberofethicalissuesstemfromthepatentingofanimals.Mostofthemdealwiththeconsequencesthatcouldarisesubsequenttopatentingofanimals
whiletheotherargumentsfocusonthereligious,philosophicalandspiritualgrounds.Theargumentswhichgoagainstthepatentingofanimalsaredifficultto
proveasmanyofthemarefactualassertionswhicharestilltooccurortobeproven.TheDNAisconsideredtobeintimatelyrelatedtothespeciesidentityand
hencenopartofitshouldbecontrolledforcommercialinterest.Incaseofhumanbeings,humanDNAisuniqueandhencepossessesintrinsicvalueofa
sacredkind.ItcanalsobeputasHumanDNAbearstheimageofGodandtotamperwiththemandownthemforcommercialandeconomicinterestswould
hurtthesentimentsofthemany.Theviewthatplants,animalsandmicroorganismscomprisinglifeoneartharepartofthenaturalworldintowhichweareborn
andhencetheconversionofthesespecies,theirmolecules,orpartsintocorporatepropertythroughpatentmonopoliesiscountertotheinterestofthepeople
ofthecountryandworld,hasbeentakenbymany.
Howevermostofthereligiousandethicalissuesariseoutofproductpatentswhichhavebeengiventoorgans,cells,genesandproteins.Henceonepossibility
thatcouldbeacceptedbysuchreligiousleaderscouldbetheissuanceofprocesspatents,wherebyonlytheprocessinvolvedinthemanipulationofparticular
genesarepatentedratherthanthegenesinitself.
5.PatentingofGenes
OurGenesdefineus,asaspeciesaswellasindividuals,andhenceforhumangenestherearestrongoppositionsbothonthereligiousandsecularfront.
Patentsarebeinggrantedtogenesdespitetherebeingmanyargumentsforkeepingthegenesinthepublicdomain.Apatentcannotbegrantedonageneasit
naturallyoccurs.Isolationofthegeneisrequiredforittobepatentable.Thepatentofficeshavetreatedgenesasanewchemicalcompoundandhavegranted
compositionofmatterpatents.ThusapatentgrantedonanisolatedandpurifiedDNAcompositionconferstherighttoexcludeothersfromanymethodof
usingthatDNAcompositionforupto20yearsfromthedateoffiling.HoweverHumanBeingsarenotpatentableashumanmulticellularlivingorganismsarenot
apatentablesubjectmatterundersection101.
Whyaregenesbeingpatented?
#Geneshavebeenusedforgenetherapythoughitisstillintheearlydevelopmentalstages.Thetechnologyusedineachgenetherapywillhavehuge
commercialvalueinthecomingfuturemakingpatentingcrucial.HowevergenetherapyisnotapatentablesubjectmatterinIndia.
#Someofthegenesencodeproteinsthatcanactastherapeuticagents.(e.g.thehumangrowthhormone).Hencebyofferingpatentprotectiontosuchgenes,
theinterestsofthepharmaceuticalindustrieswillbemaintained.However,thepharmaceuticalindustriesshouldbegrantedaccesstothegenesandnotthe
ownership.Monopoliesongenesarenotinpublicinterest.
#ForBiotechnologicalcompanies,genepatentsareconsideredasvaluegeneratorsandenhancethevalueofthecompanyintheeyesoftheinvestors.Most
oftheBiotechnologicalcompaniesandresearchinstituteshavecreatedTechnologyTransferOffices(TTO)sothatthepatentsgeneratedbytheirresearchwill
generatehugefinancialrewards.
#Sequencesofgenesandgenomicsprovidedataforfurtherresearch.Thepatentingofgenesforcesthedisclosureofinformationinsteadofitbeingkeptasa
tradesecret.Fullandfreeaccesstogenomicsdataisessentialforacademicresearchandowninggenepatentsarethebestwaytoensurehindrancefree
accesstosuchdata.

ARIPO:PatentsTrademarks
ExtensiveexperiencewithARIPOLocalOfficesinSouthernAfrica
MoralityandPatentsIsthereaconnection?
Lawandmoralityareinterconnectedandsomeareasoflawrequirethelegaladjudicatorstodrawonmoralityinconsideringthedecisionmakingprocess.The

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patentlawespeciallyconcerningthepatentingofbiotechnologicalinventionsdoesjustthis.ThebestexampleofthiswouldbeArticle53(a)oftheEuropean
PatentConvention1973,whichdoesnotallowthegrantofpatentsforinventionsthepublicationorexploitationofwhichwouldbeconsideredtobecontraryto
ordrepublicormorality.Mostofthenationalpatentlawsofvariouscountriesembracethemoralstandardswithinitsambit.Whenthelegislaturesenactpatent
laws,themoralstandardsofthecommunitytowhichtheybelongtoareoneofthefactorswhichaffecttheircontent.Moreover,thepatentingsystemcannotbe
consideredtobeanethicallyneutralconcept.AsystemcanbeconsideredtobeethicallyneutralwhenitdoesnotaffectAsinterestsvisvisBsinterest.
Thewholecruxofpatentsistoexcludeothersfromaccesstoinformationcontainedintheclaimsandhenceitcannotbeconsideredtobemorallyorethically
neutral.Thisactofexcludingotherstoprotectyourinterestwillinevitablyaffectsomeoneelsesrightsinsomewayortheother.
PatentingwithinthebiotechnologicalsphereandthesubsequentoppositionproceedingswhichhavebeenundertakenbyNGOssuchastheGreenpeace,
whichhavebecomeworriedbyprospectssuchasthepatentingoflife,haveledcourtstohighlighttherelationshipbetweenpatentsandmorality.Howeverit
hastobekeptinmindthattheconceptofmoralityisrelativetothevaluesprevailinginsociety.Thedecisionsbasedonmoralityshouldnotbebasedonwhat
somemembersofthepublicfindobjectionable,butshouldincludeadetailedanalysisoftheeffectonhumanhealth,economicimpact,environmentalissues
andopinionofthepopulationasawhole.Themainpoint,howeveristhatnonpatentabilitywouldonlymeanthattheinventionisnotthesubjectofanyproperty
rights,itcanstillbeusedandworkedevenifitiscontrarytopublicinterestandmoralityasitstillliesinthepublicdomain.
WhysayNOtoLifepatenting?
TheWTOhasforcedcountriestointroducelawsthatallowthepatentingoflifeformsandlivingorganisms.InIndia,thiswasdonethroughthePatentsActof
1970.Duetotheintroductionofsuchamonopolisticsetupwherebiotechnologicalinventionscanbepatented,ithasledtoanepidemicofbiopiracyandthe
patentingoftraditionalknowledge.Thefollowingaretheotherreasonswhichhavebeenlaiddownwhichobjecttolifeformpatenting:
#Farmerswouldbeobligedtopayroyaltiesoneverygenerationofplantsandlivestocktheybuyandreproduceforproductionpurposes.
#Breederswillnolongerhavefreeaccesstogermplasmfordevelopingnewvarietiesofplantsandanimals.
#Consumerswillenduppayinghighpricesforfood,medicineandotherbiotechnologicalproducts.
#Intheend,publicresearchwhichispaidforbyallwillbeprivatizedbyafew.
#Foodsupplywillbethreatenedbymonopolisticcontrolovergeneticresources
#TheconceptofHumanrightswillbethreatenedashumanbeings,andpartsoftheirbodieswillbecometheexclusivepropertyofthepatentholders.
#Animalwelfarewillbecomeathingofthepastasthepatentsystemstimulatesgeneticengineeringofanimalsforproductionoffoodandmedicinenomatter
howtheysuffer.
#ButthemainobjectiontothepatentingoflifeformsarethatDNAisaproductofnatureandnotaproductofhumaningenuity.
Theauthorcanbereachedat:reshma.abraham07@legalserviceindia.com/PrintThisArticle
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