Supreme Court okays selection patents while refining novelty and obviousness tests

S
UPREMECOURTOKAYSSELECTIONPATENTSWHILEREFININGNOVELTY
ANDOBVIOUSNESSTESTS

ADAMMIZERA,CATHERINEGECIANDDAMIENCALVET*
LEGERROBICRICHARD,
LLP
L
AWYERS,PATENTANDTRADEMARKAGENTS

Thesubjectofselectionpatentswasaddressedbyarecentunanimousdecisionof
theSupremeCourtofCanadainApotexInc.v.SanofiSynthelaboCanadaInc.
1In
thiscase,theSupremeCourtreaffirmedtherulesassociatedwiththegrantingand
validityofselectionpatentsinCanada,moreparticularlyinthepharmaceuticalfield.
Inrenderingitsdecision,theSupremeCourtalsoclarifiedimportantjudicialteststo
beappliedwhenevaluatingthenoveltyandobviousnessofinventionsingeneral.
Giventhatnoveltyandobviousnessareissuesthatareatthecoreofthevalidityof
anypatentandarethusfrequentlyaddressedinmostpatentcourtcases,thiscase
islikelytobecitedorconsideredofteninfutureCanadianpatentjurisprudence.

FactualBackground
Sanofi-SynthelaboCanadaInc.(Sanofi)istheowneroftwopatents.Thefirstpatent
‘875generallyclaimsafamilyof250000moleculeshavinganti-coagulant
properties.Thesecondpatent‘777claimedamorespecificmoleculefromthis
family,knownas“Clopidogrel”anditsbisulfatesalt.Clopidogrelbisulfatealsohas
anti-coagulantpropertiesandismarketedbySanofiunderthetradenamePlavix®.
Aproductbasedontheoriginalfamilyof250000moleculesdescribedin‘875
typicallycontainsequalpartsofmirror-imagemoleculescalledenantiomers.The
‘777patentdisclosedamethodofextractingaselectedoneofthesetwo
enantiomerswhichofferedadvantagesthatthemirror-imagecounterpartmolecule
didnot.
In2003,theCanadiangenericpharmaceuticalcompanyApotexInc.(Apotex)
notifiedtheMinisterofHealthofitsintentiontocommercializeagenericversionof
Plavix®,andthusattemptedtodulyobtainaNoticeofCompliancefor
commercializingthemedicine.Indoingso,ApotexservedaNoticeofAllegationto

©CIPS,2008*AllwithLEGERROBICRICHARD,LLP,amultidisciplinaryfirmoflawyers,andpatentandtrade-
markagents.PublishedinIntellectualProperty(FederatedPress).Publication173.20
12008SCC61(reasonsissuedNovember6,2008).

2
Sanofi,claimingthatitscommercializationofthegenericversionofPlavix®would
notaffectSanofi’srightsconferredbythe‘777patent,sinceApotexwouldnotbe
infringingthispatent.Indeed,initsNoticeofAllegation,Apotexclaimedthatthe‘777
patentwasinvalidforlackofnoveltyandobviousnessinviewofthemoregeneral
‘875patent.Additionally,Apotexsuggestedthatthe‘777patentwasinvalidonthe
groundsofdoublepatenting.
SanofithensoughtanorderfromtheFederalCourtofCanadaprohibitingthe
MinisterofHealthfromissuingaNoticeofComplianceonthegroundsthatApotex
wouldindeedinfringethe‘777patentbycommercializingagenericversionof
Plavix®.TheFederalCourtgrantedtheorderandconcludedthatthe‘777was
indeedvalid.TheFederalCourtofAppealupheldthelowercourt’sdecision,which
broughtApotextoappealitscasetotheSupremeCourtofCanada.
ThemainissueaddressedbytheSupremeCourtconsistedofdeterminingwhether
selectionpatentsarevalidinprincipleoronthefactsofthiscase.Thevalidityof
selectionpatentswasthusassessedonthegroundsofanticipation,obviousness
anddoublepatenting.

SelectionPatents
InhisreasonsrepresentingtheunanimousviewofthemajorityoftheCourt,Justice
Rothsteinfirstconfirmedthethreeconditionstobesatisfiedforaselectionpatentto
bevalid.AccordingtotheCourt,theseconditionswereestablishedintheoft-cited
andwellaccepteddecisionofMaughamJ.inInreI.G.FarbenindustrieA.G.’s
Patents(1930),47R.P.C.289(Ch.D.):
1.Theremustbeasubstantialadvantagetobesecuredordisadvantageto
beavoidedbytheuseoftheselectedmembers.
2.Thewholeoftheselectedmembers(subjectto“afewexceptionshereand
there”)possesstheadvantageinquestion.
3.Theselectionmustbeinrespectofaqualityofaspecialcharacterpeculiar
totheselectedgroup.Iffurtherresearchrevealedasmallnumberof
unselectedcompoundspossessingthesameadvantage,thatwouldnot
invalidatetheselectionpatent.However,ifresearchshowedthatalarger
numberofunselectedcompoundspossessedthesameadvantage,the
qualityofthecompoundclaimedintheselectionpatentwouldnotbeofa
specialcharacter.
2

2Ibid.atparagraphs8-11.

3
Thisrepresentedastartingpointfromwhichthevalidityofthe‘777patentwastobe
evaluatedwithrespecttoanticipation,obviousnessanddoublepatenting.

ClarificationoftheLawonAnticipation
Inrecentyears,thecourtshaveestablishedthatthetestforanticipationinCanada
isdescribedinBeloitCanadaLtd.v.ValmetOY(1986),8C.P.R.(3d)289(F.C.A.),
atp.297:
Onemust,ineffect,beabletolookataprior,singlepublicationandfindinit
alltheinformationwhichforpracticalpurposes,isneededtoproducethe
claimedinventionwithouttheexerciseofanyinventiveskill.Theprior
publicationmustcontainsoclearadirectionthataskilledpersonreadingand
followingitwouldineverycaseandwithoutpossibilityoferrorbeleadtothe
claimedinvention.
3
Inthecaseathand,JusticeRothsteinaffirmedthevalidityofthistest,butstatedthat
itcouldleadtostringentinterpretationsasthe“exactinvention”wouldhavetobe
alreadymadeorpubliclydisclosed.TheCourtthenreferredtoadecisionofthe
HouseofLords(UnitedKingdom)toprovidearefinementoftheapproachsetoutin
Beloit.
InSynthonB.V.v.SmithKlineBeechamplc
4,theHouseofLordssetouttwo
requirementsforanticipation,priordisclosureandenablement.Theenablement
requirementisnotexpressedintheBeloittest.
ThepriordisclosurerequirementisexpressedinSynthonasfollows:
IfImaysummarisetheeffectofthesetwowell-knownstatements[from
GeneralTireandHillsv.Evans],thematterrelieduponaspriorartmust
disclosesubjectmatterwhich,ifperformed,wouldnecessarilyresultinan
infringementofthepatent…Itfollowsthat,whetherornotitwouldbe
apparenttoanyoneatthetime,wheneversubjectmatterdescribedinthe
priordisclosureiscapableofbeingperformedandissuchthat,ifperformed,
itmustresultinthepatentbeinginfringed,thedisclosureconditionis
satisfied.
5
TheCourtthenwentontostatethatoncethepriordisclosurerequirementis
satisfied,thepersonskilledintheartisassumedtobewillingtomaketrialanderror
3Ibid.atparagraph20.4[2006]1AllE.R.685,[2005]UKHL595Supranote1atparagraph25

4
experimentstogetittowork.AccordingtoJusticeRothstein,“Forpurposesof
enablement,thequestionisnolongerwhattheskilledpersonwouldthinkthe
disclosureofthepriorpatentmeant,butwhetherheorshewouldbeabletowork
theinvention.”
6
TheCourtthenhadtoaddresstwoissues:(1)whatconstitutesdisclosureatthefirst
stageofthetestforanticipation,and(2)howmuchtrialanderrororexperimentation
ispermittedattheenablementstage?
7
TheCourtassessedthedisclosurerequirementwithrespecttogenusandselection
patentsbystatingthatthegenuspatentdoesnotanticipatetheselectionpatentif
thereisanabsenceofadiscoveryofspecialadvantagesassociatedwiththe
selectionpatentatthestageofdevelopmentofthegenuspatent.Notrialanderror
experimentationisallowedatthispoint.
Fortheenablementrequirement,JusticeRothsteinconsideredrecentUK
jurisprudenceandsetoutfourfactorstobeapplied:
1.Enablementistobeassessedhavingregardtothepriorpatentasawhole
includingthespecificationandtheclaims.[…]
2.Theskilledpersonmayusehisorhercommongeneralknowledgeto
supplementinformationcontainedinthepriorpatent.[…]
3.Thepriorpatentmustprovideenoughinformationtoallowthe
subsequentlyclaimedinventiontobeperformedwithoutundueburden.[…]
4.Obviouserrorsoromissionsinthepriorpatentwillnotpreventenablement
ifreasonableskillandknowledgeintheartcouldreadilycorrecttheerroror
findwhatwasomitted.
8
Inviewofthesefactors,theCourtconcludedthatthe‘777patentwasnot
anticipated.

ClarificationoftheLawonObviousness
Inrecentyears,courtshavealsoestablishedthatthetestforobviousnessin
CanadaisalsosetoutinBeloit:

6Ibid.atparagraph27.7Ibid.atparagraph30.8Ibid.atparagraph37.

5
Thetestforobviousnessisnottoaskwhatcompetentinventorsdidorwould
havedonetosolvetheproblem.Inventorsarebydefinitioninventive.The
classicaltouchstoneforobviousnessisthetechnicianskilledintheartbut
havingnoscintillaofinventivenessorimagination;aparagonofdeduction
anddexterity,whollydevoidofintuition;atriumphofthelefthemisphereover
theright.Thequestiontobeaskediswhetherthismythicalcreature(the
manintheClaphamomnibusofpatentlaw)would,inthelightofthestateof
theartandofcommongeneralknowledgeasattheclaimeddateof
invention,havecomedirectlyandwithoutdifficultytothesolutiontaughtby
thepatent.Itisaverydifficulttesttosatisfy.
9
TheCourtstatedthatthistestprecludesthepossibilityofusingan“obvioustotry”
conceptwhenevaluatingobviousness.Thisconcepthasbeengenerallyacceptedin
recentAmericanandUKcaselaw.JusticeRothsteinthusadoptedafour-step
approachtoobviousnessdescribedinPozzoliSPAv.BDMOSA
10,whichrestates
anobviousnesstestoriginallystatedinWindsurfingInternationalInc.v.Tabur
Marine(GreatBritain)Ltd.
11:
(1)(a)Identifythenotional“personskilledintheart”;(b)Identifythe
relevantcommongeneralknowledgeofthatperson;
(2)Identifytheinventiveconceptoftheclaiminquestionorifthatcannot
readilybedone,construeit;
(3)Identifywhat,ifany,differencesexistbetweenthemattercitedas
formingpartofthe“stateoftheart”andtheinventiveconceptofthe
claimortheclaimasconstrued;
(4)Viewedwithoutanyknowledgeoftheallegedinventionasclaimed,
dothosedifferencesconstitutestepswhichwouldhavebeenobvious
tothepersonskilledintheartordotheyrequireanydegreeof
invention?
12

TheCourtthenproposedthatthe“obvioustotry”issuecouldarisewhenassessing
thefourthstep,especiallyforinventionsthatrequiredevelopmentthrough
experimentation.TheCourtthusofferedanon-exhaustivelistfactorstoconsider
whendeterminingwhetheraninventionwasobvioustotry:
1)Isitmoreorlessself-evidentthatwhatisbeingtriedoughttowork?[…]
(2)Whatistheextent,natureandamountofeffortrequiredtoachievethe
invention?[…]
(3)Isthereamotiveprovidedinthepriorarttofindthesolutionthepatent
addresses?
13

9Ibid.atparagraph52.10[2007]F.S.R.37,[2007]EWCACiv588.11[1985]R.P.C.59(C.A.)12Supra,note1atparagraph67.13Ibid.atparagraph69.

6
Usingthesedifferentapproachestoaddressthefactsofthecase,theCourt
concludedthatthe‘777patentwasnotobviousinviewofpatent‘875.

DoublePatenting
Inthiscase,Apotexalsoclaimedthatselectionpatentsshouldbechallengedonthe
basisofdoublepatentingasthepatentholdercan“evergreen”afirstinventionby
extendingtheoriginalperiodofmonopolyaccordedbyanoriginalgenuspatent
throughfilingofasubsequentselectionpatents.TheCourtrejectedthisclaimbased
ontwoarguments.Firstly,aselectionpatentmaybeobtainedbyapartywhoisnot
theownerororiginalinventorofthegenuspatent.Consequently,theevergreening
concerndoesnotariseinallcases.Secondly,thepossibilityofobtainingselection
patentsencouragesinnovationasresearcherscanbemotivatedtosearchfor
improvementsoverthesubjectmatterdisclosedintheoriginalgenuspatent.
Conclusion
Inthisdecision,theSupremeCourtofCanadahasconfirmedthevalidityof
selectionpatents,aslongastheyrespecttherequirementsofnoveltyandnon-
obviousness.Thisconfirmationshouldfavourpatenteesinthepharmaceuticalfield
andmotivatethemtosearchforfurtherimprovementswithrespecttoexistinggenus
patents.TheSupremeCourtalsousedthisoccasiontorefinethemoregeneraltests
forevaluatingthenoveltyandobviousnessofinventionsandthusbetteralign
CanadiancaselawwithAmericanandUKjurisprudence.However,asthisjudgment
wasbasedonpatentsgovernedbythepre-1989versionoftheCanadianPatent
Act,itremainstobeseenifanyoftheconceptsintroducedinthisdecisionwillbe
followed,distinguishedorrejectedinfutureCanadianpatentcourtcases.

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