Beruflich Dokumente
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PatentAmendmentAct,2005AnOverView
LegalServiceIndiaPatentAmendmentAct,2005AnOverView
PatentAmendmentAct,2005AnOverView
Writtenby:Parikshit5thyearlawstudentSymbiosisLawcollege,Pune
Chatwithus(2PM9PMIST)
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TheintellectualpropertyinIndiaisimportantatalllevelsofstatutory,administrativeandjudiciary.Indiaratifiedtheagreementestablishingtheworldtrade
organization.Thisagreementinter_aliacontainsanagreementontraderelatedaspectsoftheintellectualpropertyrights,whichcameintoforceonthe1st
January1995.Itlaysdowntheminimumstandardsofprotectionandtheenforcementoftheintellectualpropertyrightsinthemembercountrieswithaviewto
reducethedistortionsandimpedimentsintheinternationaltrade.Tripsprovidedforthenormsandtheregulationinrespectfollowingareasoftheintellectual
propertycopyrightsandtherelatedrights,trademarks,geographicalindications,industrialdesigns,layoutdesignsoftheintegratedcircuits,protectionofthe
undisclosedinformation(tradesecrets),patentsandplantvarieties.Indiaasadevelopingcountryhadatransitionperiodoffiveyears(withtheeffectfrom1st
January1995),i.e.tilltheJanuary2000toapplytheprovisionsoftheagreement.Anadditionaltransitionperiodoffiveyears,i.e.January12005,isalso
availableforextendingtheproductpatentprotectiontotheareasofthetechnologynotprotectedsofar.Thiswouldbemainlyintheareasofpharmaceuticals
andagriculturalchemicals.
BasicProvisionsOfTheTripsLeadingIndiaToRunInConsonance
vTheTRIPSAgreementrequiredMembercountriestomakepatentsavailableforanyinventions,whetherproductsorprocesses,inallfieldsoftechnology
withoutdiscrimination,subjecttothenormaltestsofnovelty,inventivenessandindustrialapplicability.(Article27.1)Therearethreepermissibleexceptionsto
thebasicruleonpatentability.
1.Forinventionscontrarytoorderpublicormoralitythisexplicitlyincludesinventionsdangeroustohuman,animalorplantlifeorhealthorseriouslyprejudicial
totheenvironment.Theuseofthisexceptionissubjecttotheconditionthatthecommercialexploitationoftheinventionmustalsobepreventedandthis
preventionmustbenecessaryfortheprotectionofordrepublicormorality(Article27.2).
2.Membersmayexcludefrompatentabilitydiagnostic,therapeuticandsurgicalmethodsforthetreatmentofhumansoranimals(Article27.3(a)).
3.Membersmayexcludeplantsandanimalsotherthanmicroorganismsandessentiallybiologicalprocessesfortheproductionofplantsoranimalsotherthan
nonbiologicalandmicrobiologicalprocesses.Moreover,thewholeprovisionissubjecttoreviewfouryearsafterentryintoforceoftheAgreement(Article
27.3(b)).
vMembersmayprovidelimitedexceptionstotheexclusiverightsconferredbyapatent,providedthatsuchexceptionsdonotunreasonablyconflictwitha
normalexploitationofthepatentanddonotunreasonablyprejudicethelegitimateinterestsofthepatentowner,takingaccountofthelegitimateinterestsof
thirdparties(Article30).
vThetermofprotectionavailableshallnotendbeforetheexpirationofaperiodof20yearscountedfromthefilingdate(Article33).
vMembersshallrequirethatanapplicantforapatentshalldisclosetheinventioninamannersufficientlyclearandcompletefortheinventiontobecarriedout
byapersonskilledintheartandmayrequiretheapplicanttoindicatethebestmodeforcarryingouttheinventionknowntotheinventoratthefilingdateor,
wherepriorityisclaimed,attheprioritydateoftheapplication(Article29.1).
vIfthesubjectmatterofapatentisaprocessforobtainingaproduct,thejudicialauthoritiesshallhavetheauthoritytoorderthedefendanttoprovethatthe
processtoobtainanidenticalproductisdifferentfromthepatentedprocess,wherecertainconditionsindicatingalikelihoodthattheprotectedprocesswas
usedaremet(Article34).
vCompulsorylicensingandgovernmentusewithouttheauthorizationoftherightholderareallowed,butaremadesubjecttoconditionsaimedatprotectingthe
legitimateinterestsoftherightholder.TheconditionsaremainlycontainedinArticle31.
Sinceamongalltheaboveprovisionsexcepttheproductpatentwerealmostinconsonancewiththetripsagreement,theamendmentwasbasicallydoneto
bringintoforcearticle27effectively.
TheFewImportantAmendmentoftheActIncludes
1)EmphasisonIndigenousmanufacturers:Indigenousmanufacturersareallowedtomanufacturepatentedproductsevenafterapatentisgranted,inrespect
ofmailboxapplications,onpaymentofareasonableroyaltytothepatentholder,iftheyhadbeenproducingandmarketingtheconcernedproductsincepriorto
1/1/2005.Thisprovidesalevelplayingfieldfordomesticplayerswhohavealreadymadesubstantialinvestmentsandhavebeenmanufacturingtheproducts
forwhichapplicationsforpatentshavebeenreceivedinthemailbox.Thisprovisionensuresthesmoothtransitionfromprepatenteratopostpatentera.
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(2)Bothpregrantandpostgrantoppositionavenues:Thesystemprovidesforbothpregrantandpostgrantoppositionavenues,andreducesthetimeframefor
grantofpatentsinacosteffectivemanner,whiletakingcareofpublicinterest.Infact,pregrantoppositiontopatentshasbeenstrengthenedandallthe11
groundsforpregrantoppositiontopatentshavebeenspecificallylistedintheAct,inthesamewayasbeforetheOrdinanceofDecember2004.
GroundofoppositionU/S25aswellasrevocationU/S64havebeenenlargedbyaddingfollowinggrounds:
i.Nondisclosureorwronglymentioningthesourceofgeographicaloriginofbiologicalmaterialusedforinvention
ii.AnticipationhavingregardtotheknowledgeoralorotherwiseavailablewithinlocalorindigenouscommunityinIndiaorelsewhere.
Thisprovisionisaimedatestablishingamechanismbywhichsystemofpatentprotectionandprovidesavenuesforthepatentholderstochallengeviolationof
theirintellectualpropertyrightsbyunfairmeans.
(3)Prevent"evergreening"ofpatents:Inordertoprevent"evergreening"ofpatentsforpharmaceuticalsubstances,provisionslistingoutexceptionsto
patentability(orwhatcannotbepatented)havebeensuitablyamendedsoastoremoveallambiguityastothescopeofpatentability.Thisisveryimportantin
Indiancontextasitisveryrichintraditionalknowledgeandheritage.Theclearcutinstructionsregardingwhatcannotbepatentedwouldhelppublicatlargein
alongrun.ThehealingtechniquesofwellestablishedinethnicsystemofmedicinessuchasAyurveda,SiddhaandUnanisystemandformulationstherein
couldntbepatented.
(4)Conditionsforobtainingcompulsorylicense:Conditionsforobtainingcompulsorylicensehavebeenclarifiedinordertofacilitateexportofpatented
pharmaceuticalproductsbyIndiancompaniestocountriesthatdonothaveadequateproductioncapacitiessuchasleastdevelopedcountries.Thecompulsory
licensingisaninstrumentthattheTRIPsallowsbywhichgovernmentscanallowdomesticmanufacturerstomanufacturepatentedproductswithin3yearsof
theirintroduction.Theprovisionofthiswouldbeanopportunityforindigenousmanufacturerstoexportthemedicinestothirdworldcountries,whichcannot
manufacturetheirowndrugs.TherearemanycountriesinAfrica,AsiaandSouthAmerica,whichareinneedofcheapdrugsduetopooreconomic
developmentinthisarea.Itwillbeaboonforbasicandformulationmanufacturersasthemarkettothissegmentwilldefinitelypromotesopportunities.India
beingrichincosteffectiveandintellectuallycompetitivemanpowerandotherresourceswoulddefinitelyemergeasworldleaderasfarasexportofdrugis
concerned.
(5)Reasonableperiodfornegotiationsbetweenthepatentholderandcompaniesseekingcompulsorylicense:Reasonableperiod'fornegotiationsbetweenthe
patentholderandcompaniesseekingcompulsorylicensehasbeenfixedatsixmonths.ThisprovisionoftheActwouldensurepositivedialoguesand
negationstohappenbetweenindigenousmanufacturerstoarriveatdealsleadingtowinsituations.Induecourseoftimeabetterunderstandingofthe
situationsandconditionsintheneedypoornationswouldresolvetheconflictsasthepatentholderswouldalsoappreciatetheeffortsoftheindigenous
manufacturerseffortstoselldrugsatacheaperprice.Thepatentholderwillnotbeinterestedtosellthedrugstothepoornationsashewouldfindpractically
obstaclesandconsiderationsarenotcosteffectiveforhim.
(6)Exemptionofresearchanddevelopmentfromtheambitofpatents:Exemptionofresearchanddevelopmentfromtheambitofpatents,including
experimentalandeducationalpurposes.Thebasicresearchandeducationarethepillarsofappliedresearch.Theeducationandresearchmethodologiesare
thetollsfordevelopingscienceandtechnology.Barringthisareafromthepatent,governmentwantstoensureavailabilityoftrainedmanpowerforsustained
growth.
(7).Productpatent:Productpatenthasbeenincludedinallfieldsofthetechnology(thatisdrugs,foodandchemicals).
(8).Appellateboard:Appellateboardsjurisdictionhasbeenenhancedanditnowincludesthejurisdictiontorevokepatentsalso.
SomeoftheeffectiveamendmentsintheActandRulesare:
Termofeverypatentwhichisinforceincludingapatentrestorable,U/S.60ason20.5.2003hasnowbecome20yearsfromdateoffiling.Timeforrestoration
ofaceasedpatent,U/S60hasnowincreasedfrom12monthsto18monthsassuchanapplicationforrestorationofapatentceasedonorafter20th
May,2003canbefiledwithin18monthsfromthedateofceasession.Anewdefinitionof"Invention"meansanewproductorprocessinvolvinginventivestep
andcapableofindustrialapplicationhasnowcomeinforce.Amethodorprocessoftestingduringtheprocessofmanufacturewillnowbepatentable.Process
defined,U/S3(i)incaseofplants,arenowpatentablewhileaprocessfordiagnosticandtherapeutichasnowbeenconsideredasnonpatentable.
AlistofAuthorizedDepositoryInstitutionshavebeennotified(annexedhereto)intheGazetteOfIndia,PartII,Section3subsection(ii)dated20.5.2003for
depositingthebiologicalmaterialsmentionedinthespecificationatthetimeoffilingapatentapplication.18monthspublicationhasbeenintroduced,therefore,
everypatent(exceptingwhichasecrecydirectionisgivenU/S35)willnowbepublishedjustafter18monthsfromthedateoffiling/priorityandwillbeopenfor
publiconpayment.AssuchthefilingintimationbeingpublishedintheGazetteimmediatelyafterfilinghasbeenstopped.Arequestforexaminationsystem
hasbeenintroducedandthereforeallthepatentapplicationsinwhichFirstExaminationReporthasnotbeenissuedonorbefore19thMay,2003willnowbe
examinedU/S12onlyafterfilingarequestforexaminationonForm19withprescribedfee.Theapplicationsforpatentwillnowbeexaminedinserialorderin
whichtherequestforexaminationisfiled.IncasetheapplicationhasbeenfiledbeforethecommencementofthisAct,therequestshallbemadewithina
periodoftwelvemonthsfromthedateofcommencementoftheActi.e.20thMay2003or48monthsfromthedateofapplication,whicheverislater.
Provisionforfilingrequestforexaminationbyanyotherinterestedperson(otherthanapplicant)alsohasbeenintroduced.
Provisionforthewithdrawalofapplicationbyapplicantanytimebeforegranthasbeenintroduced.TimeforputtingtheapplicationinorderforacceptanceU/S
21hasnowbeenreducedfrom15/18monthsto12months.Section39inmodifiedformprohibitingfilingpatentapplicationoutsideIndia,inventionslimitedto
thefieldsofdefencepurposesoratomicenergyhasbeenreintroduced.
OppositionProceedingsU/S25havebeensimplifiedandshortened,fixinghearingisnotcompulsory,iftheapplicantdoesnotfilereplystatementand
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evidence,applicationwillbedeemedtohavebeenabandoned.Provisionforextensionoftimeupto6monthsforpayingtheoverduerenewalfeesinitiallyi.e.
renewalfees,whichhavebecomedue,duetothelategrantofpatentcannowbepaidwithin9monthsfromthedateofrecorderbytakinganextensionon
Form4.ChargesforsupplyingthephotocopiesofthedocumentsavailableinthePatentOfficehavenowbeenreducedfromRs.10/toRs.4/perpage.
Chargesforamendmentsinname,address,nationality,andaddressforservice,payableonForm13havebeendrasticallyreducedfromRs.1000/6000to
Rs.200/500.PatentApplicationsandotherdocuments(exceptPCTInternationalapplication)arenowrequiredtobefiledonlyinduplicate.Documentscannow
befiled1copyinelectronicformwithonehardcopy(paperform).
Feesrequiredtobepaidondocumentscannowbepaidwithin1monthfromitsdateoffiling.ProvisionforallowingParisConventionPriorityhasbeen
extendedtogrouporunionofcountriesorintergovernmentalorganizations,therefore,12monthprioritywillalsobeavailabletoapplicationsfiledinEPO,
AIRPO,OAPIandEAPO.
TheScopeofPatentabilityCriticalAnalysis
Someofthekeyissuesrelatingtothescopeofpatentabilityaregivenbelow
.InventiveStep:Theactprovidesthefollowingdefinitionofwhatisrequiredofapatentapplicationtomeettheinventivestepcriteriaafeatureofaninvention
thatinvolvestechnicaladvanceascomparedtotheexistingknowledgeorhavingeconomicsignificanceorboththatmakestheinventionnotobvioustoa
personskilledintheart.Theaboveprovisionarguablybroadenstheexistingprovisiontothebenefitofpatentholdersandisambiguoustotheextentthatit
allowsfortwocriteriaformeetinganinventivestep.Asitstands,tomeetinventivestepcriteriathepatenteewilleitherhavetoshowthattheinventionincludes
atechnicaladvanceorhaseconomicsignificance,orboth.
Theprovisionshouldhaverequiredtheapplicanttocomplywithbothrequirementsforaninventivestep,namelyexistingknowledgeandhavingeconomic
significanceanddeletethetermorboth.Otherwise,therequirementoftechnicaladvanceiscompromisedanddilutedbythefactthatapatentcouldbesimply
grantedoneconomicsignificancealone.Economicsignificancealone,cannotdeterminetheinventivestepofapatentableinvention.
Pharmaceuticalsubstance
TheamendmentcurrentlydescribesPharmaceuticalsubstanceasanynewentityinvolvingoneormoreinventivesteps.
Asitstands,theprovisionistoobroadasitallowsalltypesofpharmaceuticalsubstances.Thetermchemicaloughttohavebeeninsertedsoastoreadany
newchemicalentity.
Inventionsnotpatentable
Section3(d)hasbeenamendedtoread:themerediscoveryofanewformofaknownsubstancewhichdoesnotresultintheenhancementoftheknown
efficacyofthatsubstanceorthemerediscoveryofanynewpropertyornewuseforaknownsubstanceorthemereuseofaknownprocess,machineor
apparatusunlesssuchknownprocessresultsinanewproductoremploysatleastemploysonenewreactant.
Theuseofthephrasewhichdoesnotresultintheenhancementoftheknownefficacyisambiguous,toobroadandpotentiallyallowsfornewformsofexisting
substancestobecomepatented.Forexample,resultinenhancementofefficacycouldbeaminoramendmenttoanexistinginventiontoinordertogetaround
theprovisionasitstands.Also,theexplanationsupportingtheaboveprovisionsprovides:Salts,esters,ethers,polymorphs,metabolites,pureform,particle
size,isomers,mixturesofisomers,complexes,combinationsandotherderivativesofknownsubstanceshallbeconsideredtobethesamesubstance,unless
theydiffersignificantlyinpropertieswithregardtoefficacy.
Thephraseunlesstheydiffersignificantlyinpropertieswithregardtoefficacyisnotnecessaryandoffersanentrypointinfavourofthepatentee,thusleading
toexcessivelitigation.Forexample,certainpropertiesareneverknownorareclearatthetimeofapplicationintheclaimsoonewouldnotknowhowthey
differ,thusleavinganyrecoursetoopposition.
Thedefinitionofpharmaceuticalsubstanceisnotlinkedtotheprovisionsrelationtotheexclusionforpatentsand,therefore,standsalone.Furthermore,the
inventivesteprequirementhasbeenseverelydiluted.Asaresult,section3(d)allowsevergreening.
Immunitytoongoinggenericproduction:
Theactpermitsgenericmanufacturerstocontinueproducinggenericversionofnewdrugs,whichareinthemailbox.However,thisonlyapplieswherethe
genericproducerhasmadeasignificantinvestmentprovidedtheywereproducingandmarketingthegenericversionpriorto1stJanuary2005.However,the
genericcompaniesarerequiredtopaythepatentholderareasonableroyalty.
Thequestionofsignificantinvestmentposesathreatofpotentialinfringementsuitsasthegenericproducerwouldhavetoclearlyshowthatishasmadewhat
wouldbeconsideredasignificantinvestmentinproducingandmarketingthegenericdrugs.Withrespecttothereasonableroyaltyitcreatestheproblemo
excessivedemandsfromthepatentholderandlitigation.Thereasonableroyaltyrateshouldhavebeenfixedasaparticularpercentage,thenormbeing4%.
ForexampleinthatinSouthAfrica,GlaxoSmithKlinedemandedaroyaltyof25%beforethecourtsintervened.
Publication:
TheactamendsSection11AofthePatentsActwhichprescribestheinitialpublicationrequirement.Afterthepublicationtheapplicantshallhavetherightsas
ifpatentfortheinventionhadbeengrantednthedateofpublicationoftheapplication.However,noinfringementproceedingsarepermissibleuntilthegrantof
patent.Thismeansthatonecangettheprivilegeofpatentfromthedateofpublicationi.e.evenbeforefilingtherequestfortheexaminationofapplication.
LastlytheBillreferstothepublicationofanapplication,butfailsmakethepublicationofthecompletespecificationavailabletothepublic.Thiswillgreatly
hamperoppositionproceedings
CompulsoryLicenses
Theeffectiveandefficientissuanceofcompulsorylicensesisimperativetocurbtheabuseofpatentrightsbythepatentee.Theamendmenthasonlymade
cosmeticchangestoquickentheprocessofdealingwithanapplicationforacompulsorylicenseinsection84(6)totheextentthatwheretheapplicanthas
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madeeffortstoobtainalicensefromthepatenteeonreasonabletermsandconditionsandsucheffortshavenotbeensuccessfulwithinareasonableperiod,
theControllercannowinterpretreasonableperiodtomeanaperiodnotordinarilyexceeding6months.However,theamendmentdoesnotremovetheexisting
requirementthatonlyafterthreeyearsafterthegrantofapatent,(unlessthereisanationalemergency,whichhasneverbeenused)canapersonmakean
applicationtotheControllerforthegrantofacompulsorylicense.Therefore,intotaltherequestforacompulsorylicensedoesnothavetobeconsideredforat
least3yearsand6monthsfromthedateofthegrantofthepatent.Furthermore,onealsohastotakeintotheaccountthattheBillfailstoprovideatimeline
withinwhichtheControllermustdealwithcompulsorylicenseapplicationoncemade.Therefore,thiscouldleadtoafurtherdelaybeforeanylicensecanbe
issued,asitiswellknownthatMNCpharmaceuticalsoftenrefusetodealwithrequestsforcompulsorylicensesordemandhighroyalties.
Withrespecttoexportingdrugstoacountry,whichmakesarequestforagenericdrug,theamendmentnolongerrequirestheimportingcountrytoissuea
compulsorylicense.However,onequestionthatarisesiswhethertheprocedureforthegrantofthecompulsorylicenseforthedomesticmarket(undersection
84(6)discussedabove)willalsobethesameforcompulsorylicensesforexport.Itisquitepossibletoarguetheprocedurebothways,therefore,potentially
delayingurgentnewdrugsthatadevelopingorleastdevelopingcountrymayrequire.
Discretionarypowersofthepatentoffice:
TheActtookawaythelimitationsimposedbytheAct,andmadeitdiscretionaryofthePatentOfficebyvirtueoftheRules.Asaresult,thepatentofficecan
nowtamperwiththevarioustimelinesbyamendingtheRulesasandwhentheychoose.Undertheamendedordinance,7typesoftimelimitswillbe
determinedbytheofficethroughtheRulesandnotbythestatute.TheexcessiveandunbridleddelegationtothePatentOfficeisfurtherincreasedbythe
followingprovision:thecentralgovernmentway,ifitissatisfiedthatcircumstancesexist,whichrenderitpracticallynotpossibletocomplywithsuchcondition
ofpreviouspublication,dispenseswithsuchcompliance.Asaresult,thepublicwillnotbegivenanopportunitytoofferitscommentstotheRulesbeforeit
beingamended.
QuickExamination.
AspertheactthetimeframeformakingtheexaminationreportislefttotheRules.ThenewRulesprovideaperiod1monthfortheexaminationreporttobe
issuedfollowingtheapplication.Thisperiodwaspreviously18monthsperiod.ThisislikelytocreateimmensepressureontheIndianPatentOfficeasthere
willnotbeenoughexaminertodealwithitthoroughly.
NecessaryImplicationsoftheActDominanceoftheMultinationals
OveraperiodoftimeIndiandrugcompanieswilllosetheopportunitytodevelopprocessesforpatentprotecteddrugsinthecountry.Indiandrugcompanies
mightbecomedependantonMNCsfortechnologytoproducenewdrugs.However,amongexistingdrugssayabout10percentofthemarketeddrugsare
likelytobecomeexpensiveduetoamendmentsmadein
newPatentsAct.However,theexisting90percentoftheolddrugswillnotbeaffectedbythisAct.Whilethisistrue,itmustbeunderstoodthattherateof
obsolescenceofolddrugsisextremelyfasttoday.
Itwasfearedmostthat,technologicaldependenceonMNCswillleadtoestablishtheirdominanceovertheIndiandrugmarket.MNCsonceagainmaystart
chargingexorbitantpricesfordrugsintheIndianmarket.India,whichhasmorethan70USFDAapprovedmanufacturingplants,couldbecomeaproduction
hubbecauseofitscheapandskilledlabour.''AsofnowpharmacycompaniesinIndiawerethrivingonreverseengineeringbuttheruleofthegameislikelyto
changeandmostfirmsbelongingtotheorganisedsectorarefullygearedtofacetheupcomingchallenges.ItmustbenoticedthatoutsidetheUSA,maximum
numberofUSFDAapprovedplantsareinIndia,whichinitselfisatestimonytothepreparednessontheIndianindustry.
HotbedForTheClinicalResearch
Withpatentprotection,Indiacouldbeidealcenterforactivitiesofresearchanddevelopmentandclinicalstudies.Thecontractresearchorganisationsof
domesticandglobalareviewingasthehotbedforclinicalresearch.TheproficiencyinEnglishandskilledmanpower,andavailabilityofhugepatientvolunteers
withthisnewamendmentisgoingsetphaseforunprecedentedopportunitiesfordomesticmanufacturers.
ProfitForTheDomesticManufacturers
DomesticmanufacturersalongwithMNCsmayalsofinditprofitabletodiscovernoveldrugsfordiseasesofdevelopingcountries.ThediseaseslikeMalaria,
Tuberculosisneedstobeaddressedurgently.Thereseemstobestimulationinactivitiesinthisneglectedfieldofdiseases.
UnnecessaryFlexibility
TheIndiagovernmentisgoingfarbeyondwhatisrequiredunderWTOrules.Thebillproposestoextendthepatentprotectiontothenewusesoftheknown
drugsaleveloftheprotection,whichisnotrequiredbythetripsagreement.Thiswouldincreasethefrivolousinventionsjustbyincreasingtheslightefficacy.
IndifferentCompulsoryLicensingAndTheLossToTheSmallerCompaniesAndPoorerCountries
TheimportantaspectforthedevelopmentofthesmallcompanyinIndiaisapropercompulsorylicensingsystem.Inaproductpatentregime,aproper
compulsorylicensingsystemisofvitalimportanceinpromotingcompetitionwhileensuringthatpatenteesgetcompensationthroughroyalties.Infact
compulsorylicensingisoneofthewaysinwhichTRIPSattemptstostrikeabalancebetweenpromotingaccesstoexistingdrugsandpromotingR&Dintonew
drugs.ButIndiahasnotbeenabletotakefulladvantageofthecompulsorylicensingprovisions.Thewordingofthegeneralgroundsforcompulsorylicensesis
notamenabletoeasyinterpretationandisnotoperationallyuseful..TheprocessismuchmorelegalisticthanwhatTRIPSrequires.Itprovidesopportunitiesto
thepowerfulpatenteestomanipulatetheprocessbylitigationtopreventothersfromgettingsuchlicenses.Evenincasesofspecialprovisionsrelatingto
nationalemergency,extremeurgencyorpublicnoncommercialuse,adequatecarehasnotbeentakentoputinplaceaproperstructuretopreventdelaydue
tolitigation.Tomakesurethatthepoorercountriesdonotfindthewaysofusingthecompulsorylicensing,themajorcompaniesareusingthearmyoflawyers
topresstheircasehencethesmallercompaniesareunabletoaccesssuchinventions.
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NocareonExportofInventiontotheLowManufacturingCountries
Indiaasalowcostproducerofdrugshasparticularsignificancefromthepointofviewofsuppliestocountrieswithnomanufacturingcapacities.Carehasnot
beentakeninthepatentamendmentstofacilitatesuchexports.
Conclusion
PatentamendmentshouldbefavouredforthepatentprotectionIndiawhichwillinturnIndiaanidealcenterfortheresearchandthedomesticmanufacturers
willbebenefitedbuttheloopholesinitshouldberectifiedfortheallrounddevelopment.
PatentlawArticles:
PatentingofMicroOrganismsinIndia
Patentability
Patent&ItsEffectInIndia
ChallengestoIndiaPatentRegime
WhetherPatentLawProtectsBiotechnologicalInventions
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SaloniGuptaInternatKhurpi.com
Brilliantarticle.
LikeReplyMar27,201611:54am
VimalaVasuLectureratGovt.pucollegekolar
verypreciseninformativearticle
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