英國生物發(fā)明專利申請審查指南（英文）

Intellectualpropertyoffice

ExaminationGuidelinesforPatent

ApplicationsrelatingtoBiotechnological

InventionsintheIntellectualPropertyOffice

?Crowncopyright2013

IntellectualPropertyOfficeisanoperatingnameofthePatentOffice

ExaminationGuidelinesforPatentApplicationsrelatingtoBiotechnologicalInventionsintheIntellectualPropertyOffice3

Contents

Introduction Paragraphs1-3

Background Paragraphs4-6

Basicconsiderations Paragraphs7-8

Novelty Paragraphs9-24

Inventivestep Paragraphs25-54

Industrialapplication Paragraphs55-61

Methodsoftreatment,etc Paragraph62

Sufficiency/support Paragraphs63-81

Pluralityofinvention Paragraphs82-85

Publicationofsequencelistings Paragraph86

Patentsforplants Paragraphs87-90

Patentsforanimals Paragraphs91-94

Essentiallybiologicalprocesses Paragraphs95-96

Exclusionsundersection1(2)oftheAct Paragraphs99-105

Morality Paragraphs106-119

Depositofbiologicalmaterial Paragraphs120-124

Claimstomicro-organisms Paragraphs125-127

Claimconstruction AnnexA

RelevantUKcaselaw AnnexB

RelevantdecisionsundertheEPC AnnexC

Trilateralprojectreports AnnexD

4ExaminationGuidelinesforPatentApplicationsrelatingtoBiotechnologicalInventionsintheIntellectualPropertyOffice

USPTOguidelinesonutilityAnnexE

StemcellpracticenoticeAnnexF

AmicuscuriaebriefAnnexG

ExaminationGuidelinesforPatentApplicationsrelatingtoBiotechnologicalInventionsintheIntellectualPropertyOffice5

Introduction

1.TheseGuidelinessetoutthepracticewithintheIntellectualPropertyOfficeasitrelates

topatentapplicationsforbiotechnologicalinventions.Therelevantlegislationisthe

PatentsAct1977,asamendedbythePatentsRegulations2000(SI2000/2037),and

thePatentsRules1995,particularlyasamendedbythePatents(Amendment)Rules

2001(SI2001/1412).The2000Regulationscameintoforceon28July2000and

implementedtheprovisionsofArticles1to11oftheEuropeanDirective98/44/ECon

thelegalprotectionofbiotechnologicalinventions(“theBiotechDirective”).These

provisionsrelatetothepatentabilityrequirementsforbiotechnologicalinventionsand

soarearguablythemostimportantprovisionsoftheDirective.The2001(Amendment)Rulescameintoforceon6July2001andimplementedArticles13and14oftheBiotechDirective,whichrelatetothedeposit,accessandre-depositofbiologicalmaterial.

TheGuidelinesdonotaddressthepracticeinTheOfficestemmingfromthePatentsandPlantVarietyRights(CompulsoryLicensing)Regulations2002(SI2002/247),

whichimplementedArticle12oftheBiotechDirectiveon1March2002.These2002Regulationsconcerncompulsorycrosslicensingbetweenpatentsandplantbreeders’rightsanddonothaveadirectbearingonpre-grantmatters.

2.ThiseditionoftheGuidelinesisanupdateoftheGuidelinespublishedinJuly2012.Allsignificantamendmentsareindicatedbysidelines.

3.AnycommentsorquestionsarisingfromtheseGuidelinesshouldbeaddressedtoRowenaDinham,Room2.Y35,ConceptHouse,CardiffRoad,Newport,SouthWales,NP108QQ(Telephone:01633814995).

6ExaminationGuidelinesforPatentApplicationsrelatingtoBiotechnologicalInventionsintheIntellectualPropertyOffice

Background

4.AgreementontheEuropeanPatentConvention(EPC)inthe1970sledtoimportant

harmonisationoftherequirementsforpatentabilityamongsttheEPCContractingStates,aswellaswiththeEuropeanPatentOffice(EPO).PatentpracticeintheUKduringthe1980sand1990sgrewuponthebackofprecedentcasesfromtheUKcourtsand

theBoardsofAppealoftheEPO.However,despitetheharmonisationprovidedby

theEPCitbecameapparentduringthe1980sthatMemberStatesoftheEuropean

Union(EU)wereinterpretingthisharmonisedlawdifferently,particularlywhenappliedtobiotechnologicalinventions.ThisledtheEuropeanCommissiontoproposeaDirectiveonthelegalprotectionofsuchinventionswiththeaimofgreaterharmonisationwithin

theEU.TheBiotechDirectivewaseventuallyadoptedinJuly1998butonlyafteran

earlierDirectivehadbeenrejectedbytheEuropeanParliament.AlthoughtheUKhas

implementedtheBiotechDirectivefullyasnotedabove,thisisnotcurrentlythecaseinallMemberStatesoftheEU.However,theImplementingRegulationstotheEPC,whichregulatethegrantofEuropeanpatentsbytheEPO,havebeenbroughtintoagreementwiththeBiotechDirectiveeventhoughtheEuropeanPatentOrganisationhadno

obligationtotakeaccountofanyDirectivebecauseitisnotaCommunityinstitution.

5.IntheUKthePatentsRegulations2000confirmedandclarifiedthatinventions

concerningbiologicalmaterial,includinggenesequences,maybelegitimatelythesubjectofpatentapplications.Inotherwords,theseRegulationshaveestablishedbeyonddoubtthelegitimacyofbiotechnologypatentsintheUK.

“Aninventionshallnotbeconsideredunpatentablesolelyonthegroundsthatitconcerns-(a)aproductconsistingoforcontainingbiologicalmaterial;or

(b)aprocessbywhichbiologicalmaterialisproduced,processedorused”Paragraph1,ScheduleA2tothePatentsAct1977

6.DespitetheguidanceprovidedbytheBiotechDirective,patentofficesinEuropefaceacontinuingchallengewhenexaminingpatentapplicationsforbiotechnologicalinventions.Researchersareusingevermoreingenioustoolsandtechniquestoprobethemysteriesofbiologicalprocessesandhaveattheirdisposalvastamountsoftheinformationwhichmayprovidethekeytonewmedicaltreatments,improvedcropsandsoon.Thismeansthatthebenchmarksusedbyexaminerstoassessthepatentabilityofbiotechnologicalinventionsareforeverchangingasthetechnologyitselfmovesforwardatconsiderablepace.Forexample,withthepublicationofthehumanandothergenomesandthe

numberofbioinformaticstoolsnowavailable,patentapplicantsareseekingtoprotectpolynucleotidesandpolypeptideswhichhavebeenorcouldhavebeenidentifiedby

insilicomethodsratherthantraditional‘wetbiology’.Suchmethodsinvolvewhatissometimescalled“datamining”andatthemostbasiclevelinvolveahomologysearchforgeneslistedinadatabasesoridentifiedbyrandomsequencing,andassigninga

functiontothesegenesbasedupontheclosestmatchingproteinofknownfunction.

ExaminationGuidelinesforPatentApplicationsrelatingtoBiotechnologicalInventionsintheIntellectualPropertyOffice7

Computerprogramsforcarryingoutsuchhomologysearchesarewellknownandthe

databasescontainingtherelevantinformationarewidelyavailableontheworldwide

web.Therearealsocomputerprogramswhichrecognisecertainpatternsandprofilesinproteins,forexampletransmembraneregions,aswellasprogramswhichcanrecognisecertainmotifsinnucleotidesequences,suchastranscriptionfactorbindingsites,therebyaidingtheidentificationofregulatorysequencesofDNA.

Basicconsiderations

7.Itiseasytofocusonthecontentiousissuessurroundingbiotechnologypatenting,suchasthecriteriaforpatentingplantsandanimals,thepatentingofgenesequencesand

moralityissuesandforgetthatthemajorityofbiotechnologypatentapplicationswillbe

decidedonthebasicissuesofnovelty,inventivestepandindustrialapplication,aswellasontherequirementsthatthedescriptionshouldbesufficientandshouldsupport

theclaims.TheManualofPatentPracticeistheexaminer’smainsourceofinformationregardingcurrentpracticeintheIntellectualPropertyOfficeunderthePatentsAct1977,andtheseGuidelinesareintendedtosupplementtheguidancegivenintheManualof

PatentPractice.Biotechinventionsareconsideredinthesamelightasothertechnicalinventions.However,oftentheapplicationofeventhebasicissuestobiotechnology

patentapplicationscanplaceconsiderabledemandsonthejudgementoftheexaminer.Therefore,theseGuidelinesseektohelpbylookingnotonlyathowthebasicissuesof

protectingbiotechnologicalinventionshavebeenappliedinthepastbutalsoathowtheyshouldbeapplied,subjecttoguidancefromthecourtsandtheEPOBoardsofAppeal,inthecontextofrecentdevelopmentsinthetechnology,suchasthosedescribedin

thepreviousparagraph.TheresultsoftheTrilateralProjects(seeAnnexD)oftheEPO,theJapanesePatentOfficeandtheUnitedStatesPatentandTrademarkOfficeon

biotechnologypracticesalsoprovideausefulinsightintohowtheEPOaddressessomeofthesebasicissues.

8.Beforeyoucandeterminewhetheraclaimedinventionisnovel,inventiveorhas

industrialapplication,itisimportanttodecideexactlywhatisbeingclaimed.AnnexAprovidesguidanceonhowtoconstrueclaimscommonlyencounteredinapplicationsforbiotechnologicalinventions.

8ExaminationGuidelinesforPatentApplicationsrelatingtoBiotechnologicalInventionsintheIntellectualPropertyOffice

Novelty

9.Section2oftheManualofPatentPracticesetsoutthepracticeintheUKconcerning

thenoveltyrequirementunderthePatentsAct1977.However,theapplicationofthe

noveltytesttobiotechnologicalinventionsdeservesspecialconsideration,nottheleastbecausemanybiotechnologicalinventionsarebasedonnaturalmaterial.Inthisrespectitisimportantnottoconfusetheobjectionthate.g.apolynucleotidesequencelacks

noveltywiththeobjectionthatthepolynucleotideisunpatentablebecauseitismerelyadiscovery.Basically,itisestablishedpracticethatanaturalsubstancewhichhasbeenisolatedforthefirsttimeandwhichhadnopreviouslyrecognisedexistence,doesnotlacknoveltybecauseithasalwaysbeenpresentinnature1.

“ItiscommongroundamongstthepartiesthatuntilacDNAencodinghumanH2-relaxinanditsprecursorswasisolatedbytheproprietor,theexistenceofthisformofrelaxinwasunknown.Itisestablishedpatentpracticetorecognisethenoveltyforanaturalsubstancewhichhasbeenisolatedforthefirsttimeandwhichhadnopreviouslyrecognisedexistence.”

HowardFloreyInstitute’sApplication/RelaxinOJEPO1995,388(V0008/94)

Discoveryisdealtwithinparagraphs102-104below.

Enablingdisclosure

10.Itisnowwellestablishedthatanoveltydestroyingdisclosuremustbe“enabling”ifwhatitdisclosesistoberegardedasbeing“madeavailabletothepublic”.

“Idonotseehowaninventioncanbesaidtohavebeenmadeavailabletothepublicmerelybyapublishedstatementofitsexistence,unlessthemethodofworkingissoself-evidentastorequirenoexplanation.”

AsahiKaseiKogyoKK’sApplication[1991]RPC485(atpage539)(HouseofLords)

11.Thisprinciplehasbeenestablishedinthecontextofanumberofbiotechnologycases2,3,4andonthisbasisadisclosureonlydestroysthenoveltyofalaterinventionifthe

informationitcontains,whenunderstoodbyapersonskilledintheart,issufficienttoallowreproductionofthelaterinvention.

1HowardFloreyInstitute’sApplication/RelaxinOJEPO1995,388(V0008/94)

2Asahi’sApplication[1991]RPC485(HouseofLords)

3Collaborative/PreprorenninOJEPO1990,250(T0081/87)

4Genentech’s(HumanGrowthHormone)Patent[1989]RPC613(PatentsCourt)

ExaminationGuidelinesforPatentApplicationsrelatingtoBiotechnologicalInventionsintheIntellectualPropertyOffice9

“Whilstitmaytheoreticallynotbeabsolutelyimpossibletoproceedonthebasisofthecitation,anoveltydestroyingdocumentmustaccordingtostandardpractice,beenablingwithoutundueburdentoapersonskilledintheart.Insuchcircumstances,inventionsmightrequireanactualdemonstrationofreductiontopracticeandcorrespondingdetailedinstructionstothepublicinadocument,tobecomeavailableforthepurposesofArticle54EPCaspartofthestateoftheart.”

Collaborative/PreprorenninOJEPO1990,250(T0081/87)

12.However,anearlierenablingdisclosurecoulddestroythenoveltyofalaterinventionevenifthisearlierdisclosurehasnotactuallybeen“enabled”or“reducedtopractice”

5.Actualprioridentificationofaprocessorproductclaimedisnotinitselfnecessary

tofindalackofnovelty,merelyinstructionswhich,iffollowed,wouldinevitablyresult

intheuseoftheclaimedprocessorproduct.InSmithKlineBeechamPlc’s(Paroxetine

Methanesulfonate)patent6,theHouseofLordsconsideredthatapersonskilledintheartmustbeabletoperformtheinvention,evenifitwasnotpreciselydescribedintheearlierdisclosure.Inthiscase,theearlierdisclosureusedasolventthatwasunsuitableforthecrystallisationofparoxetinemethanesulfonate,butapersonskilledintheartwouldknowtochangethesolventinordertogeneratethecrystals.(“Personskilledintheart”isdealtwithinparagraph29).

“Ifaninventorthroughcleverforesightorluckyguessworkdescribessomethingwhichworksandhowtodoit,hisdisclosureisenabling.Itisnihiladremthathenevercarriedouttheexperimentsthemselvesorfakedtheresults.Themorecomplextheareaoftechnology,thelesslikelyitisthattheinventorwillbeabletopredicttheresultsofexperimentshenevercarriedoutorthathewillstrikelucky,butwhatisimportantiswhatthedocumentteaches,nothowthecontentsgotthere.”

EvansMedicalLtd’sPatent[1998]RPC517(atpage550)(PatentsCourt)

13.TheOfficepracticeinrelationtoadocumentthatoutlinesthestepstoobtainadesired

endproduct,istoassumethatthedisclosureisanenablingdisclosureofthatend

product.Anapplicantagainstwhoseapplicationsuchadocumentiscitedcanchallengethisassumptionbyargumentand/orevidence.Iftheydo,theOfficewilldecide,onthebalanceofprobabilities,whetherthedisclosureisenablingornot.

5EvansMedicalLtd’sPatent[1998]RPC517(PatentsCourt)

6SmithKlineBeechamPlc’s(Paroxetinemethanesulfonate)Patent[2006]RPC10(HouseofLords)

10ExaminationGuidelinesforPatentApplicationsrelatingtoBiotechnologicalInventionsintheIntellectualPropertyOffice

Productbyprocessclaims

14.InKirin-AmgenvHoechstMarionRousseltheHouseofLords7disagreedwiththeviewoftheCourtofAppeal8thataclaimtoanyproductcanbecharacterisedbyamethod

ofproducingtheproduct,andthattheproductofaclaimedmethodwillbenovelifthatmethoditselfisnovel.TheEPOdoesnotrecognisethatnoveltycanbeconferreduponaknownsubstancebyanovelprocessforproducingthatsubstance9,andtherulingbytheHouseofLordsledtheIntellectualPropertyOfficetochangeitspracticeandfollowthatoftheEPO,thusrejectingproductbyprocessclaimswheretheproductisknown,onthebasisthatitisnotnovel.Inlightofthis,theIntellectualPropertyOfficenowtakestheviewthataclaimtoaproductobtainedorproducedbyaprocessisanticipated

byanypriordisclosureofthatparticularproductperse,regardlessofitsmethodofproduction.

“IthinkitisimportantthattheUnitedKingdomshouldapplythesamelawastheEPOandtheotherMemberStateswhendecidingwhatcountsasnewforthepurposesoftheEPC…Itistruethatthismeansachangeinpracticewhichhasexistedformanyyears.Butthedifferenceisunlikelytobeofgreatpracticalimportancebecauseapatenteecanrelyinsteadontheprocessclaimandarticle64(2).ItwouldbemostunfortunateifweweretoupholdthevalidityofapatentwhichwouldonidenticalfactshavebeenrevokedinoppositionproceedingsintheEPO”

Kirin-AmgenInc.andothersvHoechstMarionRousselLtdandothers[2004]UKHL46(HouseofLords)

Section60(1)(c)oftheAct,whichcorrespondstoArticle64(2)oftheEPC,statesthattheprotectionprovidedbyaclaimforaprocessextendstotheproductofthatprocess.Therefore,thepatenteewillstillhavesomeprotectionfortheproductsofhisnovelprocessunderthissectionoftheAct.

15.TheEPOdoesallowproduct-by-processclaimsincertaincircumstances,andthe

IntellectualPropertyOfficenowfollowsthispractice.Therefore,aclaimtoanovelandinventiveproductdefinedbyitsmethodofproductionisacceptableprovidedthatthereisnophysical,chemicalorbiologicalmeansfordistinguishingthatproductfromthe

priorart.However,aclaimtoanovelandinventiveproductdefinedbyitsmethodofproductionisconsideredtolackclarityifthereisanalternativechemical,physicalorbiologicalwayofdefiningthatproduct.

7Kirin-AmgenInc.andothersvHoechstMarionRousselLtdandothers[2005]RPC9(HouseofLords)

8Kirin-AmgenInc.andothersv.TranskaryoticTherapiesIncandothers[2003]RPC3(CourtofAppeal)

9InternationalFlavours&FragrancesInc[1984]OJEPO309(T0150/82)

ExaminationGuidelinesforPatentApplicationsrelatingtoBiotechnologicalInventionsintheIntellectualPropertyOffice11

“Aproduct-byprocessclaimisinterpretedaccordingtothejurisprudenceoftheBoardsofAppealasaclaimdirectedtotheproductperse,sincethereferencetoaprocessservesonlythepurposeofdefiningthesubjectmatterforwhichprotectionissought,whichisaproduct.Whetherornottheterm‘directlyobtained’oranyotherterm,suchas‘obtained’or‘obtainable’isusedinaproduct-by-processclaim,thecategoryofthatclaimdoesnotchangeasitisdirectedtoaphysicalentityandthesubjectmatterofthatclaims,forwhichprotectionissought,remainstheproductperse……Therefore,irrespectiveofhowaproduct-by-processclaimisworded,itisstilldirectedtotheproductperseandconfersabsoluteprotectionupontheproduct,preciselyasanyotherclaimtoaproductperse.Thatproductclaim,hence,confersprotectionupontheproductregardlessoftheprocessbywhichitisprepared”

AmorphousTPM/Enichem(notreported)(T0020/94)

16.Asproduct-by-processclaimsareconsideredtorelatetotheproductperse,aclaimtoaproduct‘obtainable’byaprocessisalsoacceptable,providedtheproductisnewandinventiveandcannotbeotherwisedefined.Whilsttheterm‘obtainable’doesnotlimittheclaimtoaproductwhenmadebyaparticularprocess,thisisnotnecessaryastheclaimistreatedasaperseclaim.ThisisconsistentwithPartC,ChapterII,para4.7bofthe

EPOExaminationGuidelines.

Sequenceclaims

17.Thecontextinwhichapolynucleotidesequenceispublishedcanhaveabearingon

whethersuchanearlierpublicationwilldestroythenoveltyofalaterclaimforthat

sequence.Forexample,thepriorpublicationmaybeofthepolynucleotidesequenceasitoccurs,i.e.asitisembedded,withinthehumangenome.Thispriorpublication

wouldnotimpugnthenoveltyofthesequencewhenitisclaimedinanisolatedstate.Similarly,acDNAwhichcorrespondstoanaturallyoccurringpolynucleotide,wouldnotbeanticipatedbythepriordisclosureofthenaturalpolynucleotidesbecausecDNAsdonotoccurinnature.

“,theclaimedDNAfragmentsencodingrelaxinanditsprecursors(prepro-andpro-forms)

arecDNAs,ieDNAcopiesofhumanmRNAencodingrelaxin.cDNAsdonotoccurinthehumanbody.Thesequencesofclaims1-7arehencenovelforthisreasonalone.”

HowardFloreyInstitute’sApplicationOJEPO1995,388(V0008/94)

18.Ontheotherhand,aclaimtoapolynucleotidesequencethatwasavailablee.g.as

partofalibrary,beforetherelevantdate,lacksnovelty,evenifthesequenceofthe

polynucleotidehasnotbeenpreviouslydetermined10.However,aclaimtoasequence

doesnotlacknoveltyifthecompletefulllengthsequenceisnotpresentinalibrary,evenifitisrepresentedbyoverlappingfragmentsofagenomewithinseverallibraryclones11.

10F-Hoffmann-LaRocheAGBLO/192/04(notreported)

11Ajinomoto/Aminoacidproduction(notreported)(T2352/09)

12ExaminationGuidelinesforPatentApplicationsrelatingtoBiotechnologicalInventionsintheIntellectualPropertyOffice

19.Ifaclaimforanisolatedpolynucleotideembracesthepolynucleotideaspartofan

unrestrictedlargersequence(seeExamples3and4inAnnexA),itmightbeanticipatedbyalargerisolatedpolynucleotide,possiblyeventheassociatedchromosomeifthis

hasbeenisolated.Ontheotherhand,aclaimgenerallytoanyisolatedfragmentofanidentifiedsequence(seeExample5inAnnexA)wouldlacknoveltybecauseitwould

beanticipatedbyasingle,isolatednucleotide.However,aclaimtoaspecificfragmentmightbeallowableasa“selectioninvention”whereitcanbeshownthatthefragmenthassomeadvantageorusefulqualitynotpreviouslyrecognised,suchasaspecific

polymorphism.

Implicitdisclosure

20.Itisnormallyrequiredthatthefeaturesoftheclaimunderconsiderationareexplicitlydisclosed,forexampleinanearlierpublication.However,theteachingimplicitinadocumentcanbetakenintoaccount,asguidedbyparagraph2.07oftheManualofPatentPractice.

21.Sometimes,claimedsequencesarequalifiedbytheiractivity.Anearlierdisclosureofthesamesequencebutwithoutanyindicationofitsactivitywouldprimafacieconstituteanoveltyanticipationoftheclaimedsequence.Theassumptionmustbethattheearliersequenceinherentlypossessestheactivityofthelatersequence.Hereitshouldbe

notedthatalthoughthereisarequirementthatanearlierdescriptionmustbeenabling,thereisnorequirementthattheskilledworkershouldbeabletodeterminetheactivityoftheearliersequencefromtheearlierdisclosureiftheclaimmerelyseekstoprotectthesequence.

22.Thesameassumptioncanbeappliedtopolypeptideswhenclaimedbytheirtertiary

structureifthesamepolypeptidepreviouslyhasbeenisolatedfromthesamesource,withthesamefunction,andwithapproximatelythesamemolecularweight;itcanbe

assumedthattheearlierpolypeptidehasthesametertiarystructureastheclaimed

polypeptide.However,aclaimtoacrystallisedformofaknownpolypeptidemaybe

novelifthepriorartdoesnotdisclosecrystalsofthepolypeptideormethodsofmakingthecrystals.

23.Whilstitcouldbearguedthatitisimplicitthatthesequenceofaprotein,whichbynameandfunctionisidenticaltothepolypeptideclaimed,wouldalsobeidenticalinsequence,itcouldalsobearguedthatduetotheextentofvariationbetweenpeptidesequences

ofthesamefamilythesequencemaydiffersignificantly.Therefore,adocumentshouldnotbecitedundernoveltyunlessitiscertainthatonlyoneuniqueformofaparticular

polypeptideexists.Ifthiscertainlydoesnotexist,thenadocumentshouldonlybecitedundernoveltyifthepeptidesequenceisexplicitlydisclosed.

24.Aclaimtoanisolatedandpurifiedmoleculewhichcomprisesthebindingpocketofa

knownprotein,whichisdefinedbystructuralcoordinates,isnotconsideredtobenovelastheisolatedknownproteinwouldinherentlycomprisethisbindingpocket.However,anisolatedpolypeptideconsistingofthebindingpocket,andwhichisdemonstratedtoretainthebindingandsignallingactivityoftheproteinmaybenovelifnosuchisolatedpolypeptidefragmentisknowninthepriorart.

ExaminationGuidelinesforPatentApplicationsrelatingtoBiotechnologicalInventionsintheIntellectualPropertyOffice13

Inventivestep

“Wheneveranythinginventiveisdoneforthefirsttimeitistheresultoftheadditionofanewideatotheexistingstockofknowledge.Sometimes,itistheideaofusingestablishedtechniquestodosomethingwhichnoonehadpreviouslythoughtofdoing.Inthatcasetheinventiveideawillbedoingthenewthing.Sometimesitisfindingawayofdoingsomethingwhichpeoplehadwantedtodobutcouldnotthinkhow.Theinventiveideawouldbethewayofachievingthegoal.Inyetothercases,manypeoplemayhaveageneralideaofhowtheymightachieveagoalbutnotknowhowtosolveaparticularproblemwhichstandsintheirway.Ifsomeonedevisesawayofsolvingtheproblem,hisinventivestepwillbethatsolution,butnotthegoalitselforthegeneralmethodofachievingit.”

BiogenIncvMedevaplc[1997]RPC1(atpage34)(HouseofLords)

25.Section3oftheManualofPatentPracticeoutlinesthepracticeintheUKconcerning

therequirementforaninventivestepunderthePatentsAct1977.Whendetermining

inventivestepthefourstepsof“Windsurfing”12,asreformulatedinPozzoliSPAv

BDMOSA13areused.ThefourstepapproachofWindsurfing/Pozzoliisintendedto

addresstheconceptofinventivestepwithoutthebenefitofhindsight,byensuring

thattheexaminerassessestheinventionthroughtheeyesofthepersonskilledinthe

art,withthebenefitofhiscommongeneralknowledge.Theinventiveconceptofthe

claiminquestionisthenconstrued,andthedifferencesbetweenthestateoftheart

andtheinventiveconceptoftheclaimareidentified.Thisthenenablestheexaminertoapproachthefinalstepandask“isitobvious”.Section3oftheManualdiscussesthesestepsindetail,andthereforeeachstepofthistestwillnotbediscussedindetailhere.

InsteadtheseGuidelineswillreviewtherequirementforaninventivestepinthelightof

judgmentsoftheUKcourtsanddecisionsoftheEPOBoardsofAppealastheyrelatetobiotechnologyinparticular,andbytheirrelevancetoaspecificstepoftheWindsurfing/Pozzolitest.

26.Ingeneraltermswhethere.g.asequencecomprisesaninventivestepisdetermined

inasimilarfashiontothatwhichappliestochemicalcompounds,i.e.whilstidentityof

structurewillbeenoughtoprovelackofnovelty,similarityofstructurewillnotbeenoughtoprovelackofinventivestepunlesstheactivityisidenticalinatleastqualitativeterms.Thereisanotherwayinwhichasequencemaybeshowntolackinventivestepandthatiswhereanearlierdisclosurepointstotheinevitablyofarrivingataparticularsequenceeventhoughtheactualstructureofthesequenceisnotdetermineduntilsometimelater.

27.Inthecasewhereanapplicanthaspreparedaknownproteinbyr