Non-inventive trial and error: Canada’s Federal Court of Appeal clarifies sound prediction doctrine and burden regarding sufficiency of disclosure

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NON-INVENTIVETRIALANDERROR:CANADA’SFEDERALCOURTOF
APPEALCLARIFIESSOUNDPREDICTIONDOCTRINEANDBURDEN
REGARDINGSUFFICIENCYOFDISCLOSURE

JASONMOSCOVICI*
ROBIC,LLP
LAWYERS,PATENT&TRADEMARKAGENTS

OnMarch14th2017,theCanadianFederalCourtofAppealdismissedanappealby
TEVACANADALIMITED(“TEVA”)ofadecisionunderCanada’sPMNOC
regulationsprohibitingtheMinisterofHealthfromgrantingTEVAmarketapprovalfor
anointmentcontainingcalcipotriolandbetamethasonedipropionate,untiltheexpiry
ofCanadianPatentNo2,370,565(565Patent),ownedbyLEOPHARMAINC
(“LEO”).[TEVACANADAIMITEDvLEOPHARMAINC,2017FCA50].

TheInvention

Thepatentednon-aqueousointmentisusedforthetreatmentofpsoriasisandis
preparedusing3components:ComponentA(VitaminDoraVitaminDanalogue),
ComponentB(acorticosteroid)andComponentC(asolvent).
ItwasknownthatComponentsAandBwereactivepharmaceuticalcompoundsand
thatthesecompoundswereusefulforthetreatmentofpsoriasis.Itwasalsoknown
thatthesequentialapplicationofcalcipotriol(componentA)andacorticosteroid
(componentB)providedbetterresultsthattheuseofeithercomponentalone.
However,itwasalsoknownthatcomponentAcouldnotsimplybecombinedwith
componentBtomakeoneproductbecauseoftheirpHincompatibility.Theart
neededtofindawaytosolubilizethesecomponentssothattheycouldbepresent
togetherinthesameformulationwithoutaffectingtheirefficacy.

TRIALDECISION

Teva’sattackonthevalidityofthe565Patentfocusedmainlyonthelackofutilityof
theinvention,andontheinsufficiencyofthepatent’sdisclosure.

©CIPS,2017.*OfROBIC,LLP,afirmoflawyers,patentandtrademarkagents.Publishedat(2017),31:7World
IntellectualPropertyReport.Publication064.319.

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Ontheissueofsufficiency,Tevaarguedthatthe565Patentissilentastowhichof
thecomponentsneedtobedissolvedinthesolvent(componentC),andinwhich
order.Tevaallegedthatsincethe565Patentmakesnomentionofthefactthatitis
infactcalcipotriol(ComponentA)thatneedstobedissolvedinthesolvent,thereis
notenoughinformationinthedisclosuretoenableapersonskilledintheartto
practicetheinvention.First,theCourtfoundthatthereisnoevidencetosupportthat
theorderinwhicheachcomponentisdissolvedhasanimpactontheoverall
effectiveness.Furthermore,Teva’sownexperthadtestifiedthatdissolvingor
dispersinganactiveingredientinasolvent,suchascalcipotriol,iscommonpractice.
Therefore,therewasnoneedtospecificallytellapersonskilledintheartthat
ComponentAhadtobedissolvedinthesolventofComponentC.Trialanderror
testingcouldpossiblyberequiredtodeterminetheorderthatthecomponentswould
needtobeaddedandaccordingtotheCourt,thiswouldnotpreventthedescription
frommeetingtherequirementsunderthePatentAct.PatentAct,R.S.C.,1985,c.P-4
(Act).

ConcerningTeva’sallegationsoflackofutility,sinceLeodidnottestallcombinations
ofthecomponentsfoundintherelevantclaimsofthe565Patent.Therefore,Court
hadtoconsideriftheutilityofthesubjectmatterhadbeensoundlypredicted.

SoundPrediction

Briefly,thedoctrineofsoundpredictionsallowsforutilitytobedeterminedonthe
basisofathreeprongedtest:whethertheinventorhadi)afactualbasis,ii)asound
lineofreasoningfromwhichthedesiredresultcanbeinferredfromthefactualbasis,
andiii)properdisclosure.

LEOdidnottestallthecombinationsitclaimed.However,theCourtnotedthatwhile
thetestofsoundpredictionfocusesontheinventor’spointofview(ie:didthe
inventorhaveasoundlineofreasoningtoinfertheintendedresult),thisdoesnot
inherentlyexcludetakingintoaccounttheperspectiveoftheskilledperson,someone
outsideoftheinvention.Inotherwords,thefactsreliedontoputintopracticethe
soundpredictiontestdonotneedtobedisclosedexplicitlyinthespecification,norbe
factuallyattachedtotheinventor.Ifthesefactswouldbeselfevidenttoaperson
skilledintheart,inviewofthecommongeneralknowledge,theycanbeappliedto
thetest.

Assuch,theCourtfoundthat,whilenooneatLeounderstoodwhythecombinations
coveredbytherelevantclaimsworked,itneverthelesshadafactualbasisanda
soundlineofreasoningtopredicttheutilityofthesubjectmattercoveredbythe
claim.TheCourtfoundthataskilledpersonintheartwouldhaveunderstoodfroma
reviewofthedisclosurethatComponentsAandBsharea“chemicalscaffold”and
thattheythereforebehavesimilarly.Noexpressmentionofthisinthedisclosurewas
necessarytomakethisreasoningsoundandtheinventorsdidnotneedtorelaytheir
factualawarenessofthiscommongeneralknowledgeeither.

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Appeal

Onappeal,TevacontestedtheFederalCourt’sdecisionandalleged:
-thatiterredinlawinitsfindingsthattheutilityofthecompositionsofthe565Patent
(claim17specifically)couldbesoundlypredicted.Leocouldn’texplainwhythe
combinationsworkedandthelineofreasoningtheCourtreliedonwasbasedon
expertevidenceandwasnotspecificallysetoutinthedisclosure.
-ThatiterredinlawbyfailingtoallowTevatoadvanceitsallegationthatthepatent’s
disclosurewasinsufficientandthatthe565Patentfailstofullydisclosetheinvention
ascontemplated.

Onappeal,thenoveltyandnon-obviousnessofthepatentwasnotindispute.The
FederalCourtofAppealreiteratedthatquestionsoffactarereviewedonlyfor
palpableandoverridingerrorsandthaterrorsinlawarereviewedunderthe
correctnessstandard.

Onthequestionofsoundprediction,TevaarguedthattheCourthadnoevidenceof
thefactualbasisthatwasreliedonbytheinventors.Withoutthisfactualbasis,the
Courtcouldnotdeterminetheinventor’sactuallineofreasoningandcouldnothave
appliedthetestcorrectly.TheFederalCourtofAppealdidnotagree.

Sinceapplyingthesoundpredictiontestisaquestionoffact,thestandardisthatof
palpableandoverridingerror.TheFederalCourtofAppealfoundthatTevadidnot
establishapalpableandoverridingerrorinthisregard.TEVA’sargumentthat“one
cannotmakeasoundpredictionwhenonedoesnotknowexactlywhyaparticular
combinationworks”wasrejectedsincetheapplicationofthedoctrineofsound
predictiondependsonthenatureoftheinvention,andanyparticularitiesofitsfieldof
use,ordiscipline.Thereisnorequirementthattheinventorsknowexactlywhytheir
inventionworks.Ifthatwerethecase,theutilitywouldnotneedtobesoundly
predicted.

UseofComponentsAorBinointmentsforthetreatmentofpsoriasiswasknown.
Therewasexpertevidencethatestablishedthattherewasahighprobabilitythatifa
solventwasusedwiththespecificcombinationofcomponentsAandBthatwas
testedbyLEO,thattheresultswouldlikelybereproducibleforothercombinationsof
thesamecategories.

Tevaarguedthatthisexpertevidencecannotbeusedtodeterminefactsthatare
normallyintimatetotheinventorsinordertoestablishtheirlineofreasoning.
However,theFederalCourtofAppealfoundthatthislimitationdoesnotexist.The
caselawinsupportofthesoundpredictiondoctrinedoesnotlimithowthefacts
necessarytoapplythisdoctrinecanbeestablished.Inotherwords,howsomeone
provesafactthatleadstothislineofreasoningdependsoneachcase.TEVAalso

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arguedthat,attheveryleast,thelineofreasoningshouldbeinferredfroma
statementfoundinthedisclosureofthepatent.TheFederalCourtofAppealheld
thatthereisnosuchcriteriaandthatthereisnoneedtospelloutwhatisself-evident
orwhatisgenerallyknowntoapersonskilledintheart.Therefore,sincethe
applicationofthedoctrineofsoundpredictionisamatteroffact,factscanbe
establishedinmanyways,suchasbywayofexpertevidence.Withthisinmind,the
FederalCourtofAppealfoundthattheCourtappliedtopropertest.Allclaimed
alternativesforComponentsAandBhavethesamechemicalscaffoldastheones
testedforthe565Patentandtherefore,thesealternativeswouldbeexpectedtobe
asuseful.TheCourtwasentitledtousethisexpertevidenceinitsapplicationofthe
soundpredictiondoctrine.

Onthematterregardinginsufficiencyofthedisclosure,TEVA’sfirsthurdlewas
convincingtheFederalCourtofAppealtohearitsargumentssincethisallegation
wasnotproperlyraisedattrial.TEVAarguedthatinportionsofthecross
examinationofLEO’sexpert,ithadbeenestablished,andthatitwasofrecord,that
theorderinwhichacomponentisaddedtothenon-aqueousointmentisanessential
elementtotheinventionthatshouldhavebeendisclosed.TEVAallegedthat
consequently,theCourterredinlawbynotconsideringthislimitationanddespite
this,acknowledgedthatonemayhavetodosometrialanderrorexperimentsto
establishhowacomponentmustbedissolvedordispersedinsolvent,andinwhich
order,beforemakingthepetroleumbasedointment.

ConsideringtheexcerptofthecrossexaminationofLeo’sexpertattrial,wasthe
Courtrequiredtoconcludethattheorderinwhichthecomponentsaremixedwasan
essentialelementoftheinventionthathadtobedisclosed?TheFederalCourtof
AppealfoundthattheCourtmadenoerrorinthisregardandthat“askilledperson
wouldbeabletomaketheclaimedformulationbasedonhisorherownknowledge,
possiblythroughsomenon-inventivetrialanderror”.Orputanotherway,the“trial
anderrorrequiredtodeterminethemosteffectivewaytomakeagoodpancakemix
withnolumps”.Theneedforthistypeoftrialanderrortoenableaskilledpersonto
usetheinventiondoesnotmakethedisclosureautomaticallyinsufficient.TEVA’s
argumentwasthereforedismissed.

Conclusion

WhileitmaybesurprisingontheonsettoseethattheFederalCourtofAppeal
acceptedtheCourt’sdecisionthatexternalelementsasfactualevidencetoestablish
theinventor’sdesiredresultwheretheinventor’sthemselvesdidnotknowwhytheir
inventionworked,thisdecisionisinlinewithCanadiancaselawontheissueofsound
prediction.Furthermore,itwasinterestingtoseetheFederalCourtofAppealalso
clarifythatcertainnon-inventivetrialanderrorcouldberequiredtoputinpracticean
invention(likefindingagoodpancakemix)anditneedstobekeptinmindthatthese
findingsareverymuchfactbasedanddependonthefieldoftheinvention.Assuch,

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notalltrialanderrorisenabling,andnotallgeneralknowledgeisusefultoestablish
aninventor’ssoundlineofreasoning.

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