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16THISpastAugustMonsantox19soriginalpatentonRoundupReadysoybeansexpiredinCanada.Thesechangeswillculminatein2013whichrepresentsthefrstopportunityorCanadianarmerstoplantoriginalRoundupReadysoybeansromsavedseed.IntheUnitedStatesthissametraittechnologyremainsunderU.S.patentprotectionuntil2014.DuringthetermothesepatentsMonsantohashadtheexclusiverighttoexcludeothersrommakingusingoeringorsaleorsellingtheprotectedtechnology.OncethesepatentshaveexpiredintheoryMonsantowillnolongerhavetherighttoexcludeothersromtheprotectedtechnology.HowevertheregulatorymechanismsthatmustbemaintainedorthecommercializationotheRoundupReadytraitsmaymakeitdifcultorotherstomakeuseorsellproductsincorporatingtheprotectedtechnologyaterthepatentshaveexpired.TheagriculturalindustryhastackledavarietyoissuesovertheyearsbutnoissuehasproducedasmuchdiscussionandconusionastheexpirationoMonsantox19svarioustrait-basedpatentsinthenextcoupleoyears.TheexpirationoMonsantox19sRoundupReadyorglyphosatepatentscreatesinterestingnewquestionsortheindustry.Whathappensbetween2011and2013WhataretheopportunitiesandobligationsWhatdoesthefutureholdforsoybeanproductioninCanadawithRoundupReadyandotherproductiontechnologiesWilltheexpirationoftheRoundupReadypatentsleadtogenericRoundupReadyseedintheCanadianandU.S.marketsWhowillpayforthemaintenanceoftheregulatoryapprovalinCanadatheUnitedStatesandworldwideHowwilltheexpirationoftheRoundupReadyandothertrait-basedpatentsaecttheimportandexportoseedintotheNorthAmericanmarketplaceRegulatoryBackgroundCanadaandtheUnitedStateshavesolidregulatorysystemsx14mostothetraitsthatareincorporatedintoEXPIRATIONDATETheexpirationofMonsantox19sRoundupReadypatentsiscreatingawaveofdiscussionandconfusionintheseedindustryandisraisingnewquestionsfortheentiresector.GMcropsarerequiredtoberegulatedbytheCanadianFoodInspectionAgencyandtheHealthCanadaPestManagementRegulatoryAgencyinCanadaandbytheUnitedStatesDepartmentoAgriculturetheEnvironmentalProtectionAgencyandtheFoodandDrugAdministrationintheUnitedStates.Theseregulatorybodiesregulatethedevelopmenttransportationtestinganddisposaloplantmaterialasanagricultureproduct.ThePMRAandEPAwillthenregulateaGMproductithereisapesticidesubstanceincorporatedintotheplantsuchastheBtgene.DuringthelieotheRoundupReadypatentsMonsantohasmaintainedtheregulatoryrequirementsoeachagencyortheintroductionandcommercializationotheRoundupReadytraitsincludingallothedatainordertousethesetraitsinCanadatheUnitedStatesandinternationalmarkets.Accordingtothearticleentitledx1cRoundupReadySoybeanPost-PatentRegulatoryCommitmentExtendedthrough2021x1donthecompanyx19swebsiteMonsantoestimatesthatitspendsapproximately1-1.5millionperyearorthemaintenanceoregulatoryapprovalsoraproduct.WiththeexpirationothelastotheMonsantoRoundupReadypatentsMonsantohasstatedthatitwillmaintaintheRoundupReadyregulatoryapprovalgloballythrough2021.SystemNeededforMaintainingRegulatoryExpensesBasedonthisstatementitappearsthatRoundupReadyseedwillstillbeavailableuntil2021.Neverthelessitisstillunclearwhetherotherseedcompanieswillbeabletoproduceandsellgenericversionsaterthispoint.Inadditionwhowillmaintaintheregulatoryapprovalater2021WillsmallerseedcompaniesbeabletoaordthecostsothemaintenanceoregulatoryapprovalandwilltheybeabletoproducethedatanecessaryorregulatorycompliancebasedonthecurrentsystemTheissueopatentexpirationandthemaintenanceotheregulatoryapprovalorGMseedisveryconusingandleadstothequestionisnx19tthereasimplemechanismorGMseedtobemadeavailableorcompaniestouseonceapatentexpireswithouttheneedorlargeregulatorymaintenanceexpenses