Sound Prediction of the Utility of Patentable Inventions in the Life Sciences

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SOUNDPREDICTIONOFTHEUTILITYOFPATENTABLEINVENTIONSINTHE
LIFESCIENCES

BobH.SotiriadisandMoniqueSullivan*

LEGERROBICRICHARD,Lawyers,
ROBIC,Patent&TrademarkAgents
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Tel.(514)9876242–Fax(514)8457874
www.robic.ca–info@robic.com
OnDecember5th,2002theSupremeCourtofCanadaorderedtwogeneric
drugmanufacturingcompaniestopayGlaxoWellcomeFoundationInc.
damagesof$200million.GlaxoWellcomesufferedthelossesbecauseithad
tolowerthepriceofAZTtoremaincompetitivewiththegenericmadedrug.
Thedecision,knownasApotexv.WellcomeFoundationInc.,isparticularly
importantforthelifesciencesindustryinCanadaforatleasttworeasons.
First,itsetsthestandardofwhatapatenteemaylegitimatelyclaimbasedon
soundpredictionofutilityasopposedtobonafideprovenordemonstrated
utility.Second,examinersattheCanadianPatentOfficewillinvokethis
decisionagainstpatentapplicationsthatfailtomeetthestandardsetoutin
theSupremeCourtdecision.
TherearethreebasiccriteriaforpatentabilityinCanada:novelty,non-
obviousness,andutility.Whatallpotentialpatentapplicantsshouldalso
knowisthat,accordingtoCanadianlaw,intheabsenceofdemonstrated
utilitytheyareexpected,attheveryleast,tobeabletomakea«sound
prediction»oftheutilityoftheirinventionasoftheclaimdate.Butjustwhatis
itthatmakesapredictionofutilityasoundone?
Briefly,thepatentatissueclaimedthatAZTwouldbeusefulinthetreatment
andpreventionofHIVinfectionsandfullblownAIDSinhumanbeings.Itis
importanttorememberthattheperiodoftimerelevanttothecasewas
early1985.Inshort,theCourthadtodecidewhetherornotthatparticular



















































*
©LEGERROBICRICHARD,2003.
Lawyer,BobH.SotiriadisisaseniorpartnerinthelawfirmLEGERROBICRICHARD,g.p.andin
thepatentandtrademarkagencyfirmROBIC,g.p.;LawyerandBiochemist,MoniqueSulivan
isamemberofthesamefirms.PublishedintheissueofJuly2003ofMontrealBusiness
Magazine,atp.26.Publication062.002E.

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predictionofutilityofAZTwasinfactasoundpredictionatthetimeofthe
claimdate.
Itisinterestingtonotethatthedoctrineofsoundpredictionoriginatedin
EnglandwellbeforeitwasfirstadmittedintoCanadianlawbytheSupreme
CourtinitsabundantlyciteddecisionMonsantoCo.v.Commissionerof
patents.Theunderlyingprincipleofthedoctrineofsoundpredictionistheso-
calledhonestfoundation.Statedinotherwords:ifapatenteecanformulate
anhonestpredictionastotheutilityoftheinvention,heorsheshouldinall
fairnessbeentitledtobaseaclaimonit.Thedoctrineofsoundprediction
shouldnotbeabusedordiluted,theCourtwarned,forpatentsarenottobe
issuedinexchangeformisinformation,merespeculations,orluckyguesses.
However,asoundpredictionisnotacertaintyeither.
So,justwhatisit?TheSupremeCourtsaidtherecipeforasoundprediction
containsthefollowingthreeindispensibleingredients:(1)asolidfactualbasis,
(2)aclearreasoningattheclaimdatepermittingtoinferthepredictedresult
fromthefactualbasis,and(3)asufficientdescriptioninthepatent
applicationitself.Inthecaseathand,asoftheclaimdate,Glaxohadonly
testedAZTagainstmouseretrovirusesinmousecelllinesandactuallyhadto
asktwoscientistsattheNCI/NIHtoconductthenecessarytestingagainstHIV
inahumancellline.
TheresultsofthosetestsshowedthatAZTdidindeedinhibitHIVreplicationin
humancells.ThesolidfactualbasiswasthesumofGlaxo’sandtheNIH’stest
results.Therefore,withouttheNIH’stestingtherewouldhavebeennosolid
factualbasis(ingredient1)toGlaxo’spredictionthatAZTwouldbeusefulin
thetreatmentandpreventionofHIVinfectionsandfullblownAIDSinhuman
beings.BecauseGlaxounderstood,evenbeforetheclaimdate,whatthe
mechanismofactionofAZTwas(AZTisanucleosideanalogue,afakeDNA
base,thatblockstheelongationoftheDNAstrandthatisreversetranscribed
fromtheviralRNA),theCourtfoundthatithadineffectthenecessaryclear
reasoning(ingredient2)toinfertheusefulnessofAZTinthetreatmentand
preventionofHIV/AIDS.Finally,thesufficiencyofthedescription
(ingredient3)wasn’treallyatissuebecausebothelements1and2were
detailedtherein.Therefore,theCourtheldthatGlaxohadinfactformulated
asoundpredictionofutilityattheclaimdateofitspatentandwas
consequentlyentitledbylawtoframeaclaimonit.
EventhoughGlaxoshowed«preciouslittleconsideration»,inthewordsof
theCourt,tothetwoNIHscientistswhoprovideditwiththecrucialtesting,
thefactthattheseNIHscientistswerenotnamedasinventorsinthepatent
applicationdidnotinvalidateGlaxo’spatent,asthegenericcompanies
contended.TheCourtfoundthatsincetheNIHscientistshadn’tconceived

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oftheoriginalidea,buthadmerelyverifiedit,theywerenottobe
consideredasgenuineinventorsorco-inventorsasunderstoodinCanadian
law.
Themessagehereisthatinordertobeentitledbylawtoclaimtheobjectof
aprediction,thefactualinformationandexpertiseathandattheclaim
datehadbetterbeonthepatentee’sside.Therefore,especiallyinthe
absenceofclinicaltrialdata,patentapplicantsarewelladvisedtoputforth
resultsoftestsinhumanmodelsinordertohavealegitimateclaimtothe
objectofthepredictedutilityoftheirinvention.

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