Updates in biotech practice at the patent office

UPDATESINBIOTECHPRATICEATTHEPATENTOFFICE

GABRIELLEMOISAN*
LEGERROBICRICHARD,
L.L.P.
L
AWYERS,PATENTANDTRADE-MARKSAGENTS

Followingrecentcaselawandlegislativeamendmentsrelatingtobiotechnologyin
Canada,theCanadianIntellectualPropertyOffice(“CIPO”)hasadapteditspracticeand
modifiedChapter17ofitsManualofPatentOfficePractice(the”Manual”)on
biotechnology.TheManualservesasaguideontheapplicationofthePatentActand
itsassociatedRules.

AlthoughChapter17isrelatedtobiotechnologyinventions,CIPOhasspecifiedthatthe
currentrevisionofthischapterpresentsaninterestforspecialistsinalldisciplines.

Thesummaryprovidedbelowhighlightsissuesofgeneralinterestthatareraisedinthis
newchapterwhichhasbeenineffectsinceJanuary14,2009

I.MattersthatareNon-SpecifictoBiotechnology
NoveltyandNon-ObviousnessCriteria
Thecriteriaofnoveltyandnon-obviousnessapplicabletoanypatentapplicationin
CanadahavebeenrestatedintherecentSupremeCourtdecisioninApotexInc.v.
Sanofi-SynthelaboCanadaInc.,renderedinNovember2008.TheManualreflectsthese
changesincaselaw.Formoredetailedanalysisofthequestion,consultoneofour
recentpublicationsonthissubject.
SelectionPatents
Withrespecttoselectionpatents,theManualmentionsthatwhenaninventionisrelated
totheselectionofoneorseveralspecies(thathavenotbeenpreviouslydeveloped)
belongingtoagivengenus(thelatterhavingbeendisclosed),thematteroftheselection
mustbe:(i)basedonasubstantialadvantage,(ii)thewholeoftheselectionmust
possesstheadvantage,and(iii)theadvantagemustbeinrespectofaspecialqualityor
character,tothewholeoftheselection.

©CIPS,2009.
*WithLEGERROBICRICHARD,LLP.amultidisciplinaryfirmofLawyers,andPatentandTrade-mark
Agents.PublishedintheSpring2009Newsletterofthefirm(Vol.13,No.1).Publication068.104E

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II.MattersthatareSpecifictoBiotechnology
Subject-matter
Thesubject-matterofaninventionmustrespectthedefinitionfoundwithinSection2of
thePatentAct.InCanada,whileCourtshavedeterminedthatourlifeformssuchas
animalsandplantsarenotpatentable,lowerlifeformssuchasanimalorplantcellsare
patentable.
Followingrecentcaselaw,theManualstatesthatnon-patentablelifeformsinclude
fertilizedeggsandtotipotentstemcells(exceptembryonic,multipotentandpluripotent
stemcells)whichhavetheinherentabiltiytodevelopintoananimal,aswellasorgans
andtissues.However,certainartificialorgan-likeortissue-likestructuresthatarethe
resultoftechnicalinterventioncanbedeterminedtobestatutorysubject-matterand
thereforepatentable.
TheManualalsoconsidersthatprocessesthatproducelifeformswhichoccur
essentiallyaccordingtonature,andbiomoleculesdefinedexclusivelybytheirthree-
dimensionalstructurearenotpatentable.
Medicalandsurgicalmethodswhichareusedinpreventing,curingorimprovingan
elementorpathologicalcondition(excludingnaturalconditionssuchasaging,
pregnancyorbaldness)areconsideredtobenon-patentable.However,so-calleduse
claims(forexample:useofcompoundYasanantiarrhythmicagent)canbepatentable
aslongastheydonotincludeastepcorrespondingtoamedicalorsurgicalact.

Utility
TheManual(alwaysbasedonthePatentActorcaselaw)requiresthattheobjectofan
inventioninbiotechnologymustalsobeusefulatthedateoffilingofthepatent
application.Forexample,ifaclaimedmoleculeissupposedtotreatseveraldiseases,
theutilityoftheinventionmustbedemonstratedforeachofthesediseases,particularly
throughdemonstrationofpracticalexamples.
SufficiencyoftheDescription
Ifapatentapplicationdisclosesanewnucleotideoramino-acidsequence,the
sequencemustbedescribedthroughasequencelistingwhichcomplieswiththe
InternationalPCTsequencelistingstandard.SinceJune2007inCanada,fornew
applications,thissequencelistingmustbefiledinelectronicform.

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OtherComments
Incaseswherestatementsinthechapterappeartocontradictpracticepresentedin(i)
anotherchapteroftheManualhavingapreviouspublicationdate(andwhichhasnot
beenrecentlyupdated),(ii)apriorpracticenotice,or(iii)apriorpublished
CommissionerofPatent’sdecision,thepracticesetoutintherevisedChapter17
applies.
Thisarticleissimplyasummaryofthesubject-matteroutlinedherein.Formore
informationpleasecontactoneofourprofessionalsorvisitthefollowingwebsiteofthe
CIPO.

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