NoC44/36 16.2.93 OfficialJournaloftheEuropeanCommunities
AmendedproposalforaCouncilDirectiveonthelegalprotectionofbiotechnological
inventions(*)
(93/C44/03
COM(92)589final—SYN159
(SubmittedbytheCommissionon16December1992pursuanttoArticle149(3)oftheEEC
Treaty)
(')OJNoC10,13.1.1989,p.3.
ORIGINALPROPOSAL AMENDED PROPOSAI
THECOUNCILOFTHEEUROPEAN COMMUNITIES ,
Unchanged
HavingregardtotheproposalfromtheCommission('),
Unchanged
HavingregardtotheopinionoftheEconomicandSocial
Committee (2),
UnchangedTHECOUNCILOFTHEEUROPEAN COMMUNITIES ,
HavingregardtotheTreatyestablishingtheEuropean
EconomicCommunity ,andinparticularArticle100a
thereof,
HavingregardtotheproposalfromtheCommission ,
IncooperationwiththeEuropeanParliament,
HavingregardtotheopinionoftheEconomicandSocial
Committee,
Whereasdifferencesexistinthelegalprotectionof
biotechnological inventionsofferedbythelawsand
practicesoftheMemberStatesandsuchdifferencescould
createbarrierstotradeandtotheinternalmarket;
Whereassuchdifferencesinlegalprotectioncouldwell
becomegreaterasMemberStatesadoptnewanddifferent
legislationandadministrative practicesorasnational
jurisprudence interpretingsuchlegislationandpractices
developsdifferently;
Whereasbiotechnology andgeneticengineeringareplaying
anincreasinglyimportantroleinabroadrangeof
industriesandtheprotectionofbiotechnological
inventionscanbeconsideredoffundamentalimportance
fortheCommunity'sindustrialdevelopment ;
Whereasthepatentsystemmustadapttonew
technological developments whichmayinvolveliving
matterbutwhichalsofulfiltherequirements for
patentability ;Unchanged
Unchanged
Whereasthelegalprotectionofbiotechnological
inventionsdoesnotnecessitatethecreationofaseparate
bodyoflawinplaceoftherulesofnationalpatentlaw;
Whereastherulesofnationalpatentlawremainthe
essentialbasisasfarasthelegalprotectionof
biotechnological inventionsisconcerned;whereas,
however,theymustbeadaptedorsupplemented incertain
specificrespectsinordertotakefullyintoaccountnew
technological developments whichmayinvolvebiological
materialbutwhichalsofulfiltherequirements for
patentability ;
(')OJNoC10,13.1.1989,p.3.
(2)OJNoC151,26.6.1989,p.10.

16.2.93 OfficialJournaloftheEuropeanCommunities NoC44/37
ORIGINAL PROPOSAL AMENDED PROPOSAL
WherasnoprohibitionorexclusionexistsinnationalorUnchanged
internationalpatentlawswhichprecludesthepatentability
oflivingmatterassuch;
WhereasinimplementingtheDirectiveregardshouldbe
hadtoexistingnationalpatentlaws,asamendedbythe
Directive;whereasthoselawscontainprovisionsonthe
criteriaforpatentabilityorexclusionfrompatentability ,
includingprovisionstotheeffectthatapatentmaynotbe
grantedinrespectofinventionsthepublicationor
exploitationofwhichwouldbecontrarytopublicpolicy
('ordrepublic')ormorality;
Whereasitisdesirabletoincludeinthebodyofthe
Directivesuchareferencetopublicpolicyandmoralityin
ordertohighlightthefactthatsomeapplicationsof
biotechnological inventions,bydintoftheirconsequences
oreffects,arecapableofoffendingagainstthem;
Whereasitisimportantalsotosetoutinthebodyofthe
Directivealistofinventionsexcludedfrompatentability
soastoprovidenationalcourtsandpatentofficeswithan
essentialguidetointerpretingthereferencetopublicpolicy
ormorality;
Whereas,inthelightofthegeneralprinciplethatthe
ownershipofhumanbeingsisprohibited,thehumanbody
orpartsofthehumanbodypersemustbeexcludedfrom
patentability ;
Whereasprocessesformodifyingthegeneticidentityof
humanbeingsforanon-therapeutic purposewhichis
contrarytothedignityofmanmustalsobeexcludedfrom
patentability ;
Whereasprocessesformodifyingthegeneticidentityof
animalswhicharelikelytoinflictsufferingorphysical
handicapswithoutanybenefittomanoranimalmust
likewisebeexcludedfrompatentabilityinsofarasthe
sufferingorphysicalhandicapsinflictedontheanimals
concernedareoutofallproportiontotheobjective
pursued;
WhereasthisDirectiveiswithoutprejudicetonationaland
Communitylawsonthemonitoringoftheapplicationsof
researchandoftheuseorcommercialization ofitsresults,
notablyfromthepointofviewoftherequirementsof
publichealth,safety,theprotectionoftheenvironment ,
theprotectionofanimals,thepreservationofgenetic
diversityandcompliancewithcertainethicalstandards;
WhereasnationalpatentsystemshaveinthepastUnchanged
successfullyadaptedtotechnicaldevelopments and
scientificbreakthroughs inaccordingpatentprotectionto
suchdevelopments whereappropriate ;

NoC44/38 OfficialJournaloftheEuropeanCommunities 16.2.93
ORIGINAL PROPOSAL AMENDED PROPOSAL
Unchanged Whereastheinvestmentsrequiredinresearchand
developmentparticularlyforgeneticengineeringare
especiallyhighandespeciallyriskyandthepossibilityof
recoupingthatinvestmentcanonlyeffectivelybe
guaranteedthroughadequatelegalprotection;
Unchanged Whereaswithouteffectiveandapproximated protection
throughouttheMemberStatesoftheCommunitysuch
investmentsmightwellneverbemade;
Unchanged Whereassomeinventionsdevelopedthrough
biotechnology andgeneticengineeringareatpresentnot
clearlyprotectedinallMemberStatesbyexisting
legislation,administrative practiceandcourt
jurisprudence ;andsuchprotection,whereitexists,isnot
thesameorhasdifferentattributes;
Unchanged Whereastheuncoordinated development inthe
Communityofthelegalprotectionofbiotechnological
inventionsintheMemberStatescouldresultinthe
creationofnewdisincentives totradetothedetrimentof
furtherindustrialdevelopmentinsuchinventionsandof
thecompletionoftheinternalmarket;
Unchanged Whereasexistingdifferenceshavingsucheffectsneedtobe
removedandnewoneshavinganegativeimpactonthe
functioningofthecommonmarketandthedevelopment
oftradeinbiotechnological goodsandservicesprevented
fromarising;
Unchanged Whereasinternationaldevelopments inthefieldoflegal
protectionoftheresultsofbiotechnology andgenetic
engineeringdemonstratetheadvantagestobegainedfrom
approximation ofnationallegislation;
Unchanged Whereasscientificandtechnological developments are
oftenaresultofinternational collaboration onresearch
and,inconsequence ,needexiststoensurethat
biotechnological inventionsmaybenefitfromcomparable
protectiononaninternationallevel;
Unchanged Whereasalthoughinternationalinstrumentsexistorare
underconsideration toharmonizevariousaspectsofthe
legalprotectionofbiotechnological inventions,theyare
notsufficientforCommunitypurposeswhichmusttake
accountoftheneedsofCommunityscienceandindustry
andaCommunitymarket;
Unchanged Whereasthepatentlawsapplicableatpresentinthe
MemberStatescontaindisparitieswhichhinderthe
developmentoftradeinbiotechnological goodsand
services,distortcompetitionwithinthecommonmarket
andthereforedirectlyaffecttheestablishment and
functioningofthatmarket;whereasitisparticularly

16.2.93 OfficialJournaloftheEuropeanCommunities NoC44/39
ORIGINALPROPOSAL AMENDED PROPOSAL
importanttoremovethesedisparitiesbecause,atthestage
reachedatpresentinestablishingthecommonmarket,
therewouldappeartobeanurgentneedtoensurethat
undertakingswillbeofferedthepossibilityofobtaining
effectiveandequivalentlegalprotectioninallMember
Statesfortheresultsoftheirresearchactivitiesinanypart
oftheCommunity ;
Whereasanapproximation ofthelegislationoftheUnchanged
MemberStatesisalsonecessitatedbyexistinglanguagein
nationallawsoriginatingincertaininternationalpatent
andplantvarietyconventionswhichhavegivenriseto
considerableuncertaintyastothepossibilityofprotecting
biotechnological inventionsconcerningplantmatterand
microbiological inventions,languagesuchastheexclusion
frompatentabilityofplantandanimalvarietiesandof
essentiallybiologicalprocessesfortheproductionofplants
andanimals;
Whereasitisnecessarytoencouragepotentialinnovation
inthefullrangeofhumanendeavoursbyrecognizingthat
humanintervention whichconsistsofmorethanthe
selectionofbiologicalmaterialandallowingsuchmaterial
toperforminherentlybiologicalfunctionsundernatural
conditionsshouldbeconsideredpatentablesubject-matter
andshouldnotberegardedessentiallybiological;Whereasitisnecessarytoencouragepotentialinnovation
inthefullrangeofhumanendeavoursbyrecognizingthat
humaninterventionanditsimpactontheresultachieved
mustbetakenintoaccountindeterminingwhetherthe
exclusionfrompatentabilityofessentiallybiological
processesapplies,itbeingunderstoodthataprocess
which,takenasawhole,doesnotexistinnatureandis
morethanamereproductionprocessispatentable;
WhereasitisseemlythatthelegislationoftheMember Unchanged
Statesshouldbeharmonizedinsuchawaysoasnotto
conflictwiththeexistinginternationalconventionson
whichmanyMemberStates'patentandplantvarietylaws
arebased;
WhereastheCommunity'slegalframeworkonthe
protectionofbiotechnological inventionscanbelimitedto
layingdowncertainprinciplesastheyapplytothe
patentabilityofbiologicalmaterialassuch;totheability
touseadepositmechanisminlieuofwrittendescriptions
tosatisfytheenablingdisclosurerequirementsforpatent
applicationprocedures;toareversaloftheburdenof
proof;andtotherighttoanon-exclusive compulsory
licenceforplantvarieties;WhereastheCommunity'slegalframeworkonthe
protectionofbiotechnological inventionscanbelimitedto
layingdowncertainprinciplesastheyapplytothe
patentabilityoflivingmatterassuch;totheabilitytouse
adepositmechanisminlieuofwrittendescriptionsto
satisfytheenablingdisclosurerequirementsforpatent
applicationprocedures;toareversaloftheburdenof
proofwherereleaseofself-replicablematterhasoccurred
andtotherighttoanon-exclusivedependencylicencefor
plantandanimalvarieties;
Whereas,inviewofthefactthatthefunctionofapatentUnchanged
istorewardtheinventorwithanexclusivebuttime-bound
rightforhiscreativeeffortsandtherebyencourage
inventiveactivities,therightholdershouldbeentitledto
prohibittheuseofpatentedself-replicable materialin
situationsanalogoustothosewhereitwouldbepermitted
toprohibitsuchuseofpatented,non-self-replicable
products,i.e.inrespectoftheproductionofthepatented
productitself;

NoG44/40 OfficialJournaloftheEuropeanCommunities 16.2.93
ORIGINAL PROPOSAL AMENDED PROPOSAL
Deleted Whereas,intheareaofagriculturalexploitationofnew
plantcharacteristics resultingfromgeneticengineering,
guaranteedremuneratedaccessintheformoflicencesof
rightmustbeprovidedforasanexceptiontothegeneral
principlesofpatentlaw,
Whereascomplementary measuresofCommunitylawcan
beadoptedlater,ifnecessary,inordertoensure
consistencybetweenpatentlawandtheplantvarieties
protectionregime,
HASADOPTEDTHISDIRECTIVE : HASADOPTED THISDIRECTIVE :
CHAPTER 1
Patentabilityoflivingmatter
Article1
MemberStatesshallensurethattheirnationalpatentlaws
complywiththeprovisionsofthisDirective.CHAPTER I
Patentabilityofbiologicalmaterial
Article1
MemberStatesshallensurethatlegalprotectionfor
biotechnological inventionsonthebasisoftheirnational
patentlawscomplieswiththeprovisionsofthis
Directive .
Article2
Asubject-matter ofaninventionshallnotbeconsidered
unpatentableforthereasononlythatitiscomposedof
livingmatter.Article2
1.Asubject-matter ofaninventionshallnotbe
consideredunpatentableforthereasononlythatitis
composedof,usesorisappliedtobiologicalmaterial.
2.'Biologicalmaterial'withinthemeaningofthis
Directivemeansanyself-replicating livingmatterandany
mattercapableofbeingreplicatedthroughabiological
systemorbyanyindirectmeans.
3.Inventionsshallbeconsideredunpatentablewhere
publicationorexploitationthereofwouldbecontraryto
publicpolicyormorality,providedthattheexploitation
shallnotbedeemedtobesocontrarymerelybecauseitis
prohibitedbylaworregulationinsomeorallofthe
MemberStates.
Onthisbasis,thefollowinginteraliashallbe
unpatentable :
(a)thehumanbodyorpartsofthehumanbody
perse;
(b)processesformodifyingthegeneticidentityofthe
humanbodyforanon-therapeutic purposewhichis
contrarytothedignityofman;
(c)processesformodifyingthegeneticidentityofanimals
whicharelikelytoinflictsufferingorphysical
handicapsuponthemwithoutanybenefittomanor
animal.

16.2.93 OfficialJournaloftheEuropeanCommunities NoC44/41
ORIGINAL PROPOSAL AMENDED PROPOSAL
4.ThisDirectiveshallnotaffectnationaland
Communitylawsonthemonitoringoftheapplicationsof
researchandoftheuseorcommercialization ofits
results.
Article3
Biologicalmaterial,includingplantsandanimals,aswell
aspartsofplantsandanimals,exceptplantandanimal
varieties,shallbepatentable.Article3
1.Micro-organisms ,biologicalclassifications other
thanplantoranimalvarietiesaswellaspartsofplantand
animalvarietiesotherthanpropagatingmaterialthereofof
thekindprotectableunderplantvarietyprotectionlaw
shallbeconsideredpatentablesubject-matter .Claimsfor
classifications higherthanvarietiesshallnotbeaffectedby
anyrightsgrantedinrespectofplantandanimal
varieties .
2.Notwithstanding theprovisionsofparagraph 1,
plantsandplantmaterialshallbeconsideredpatentable
subject-matter unlesssuchmaterialisproducedbythe
non-patentable useofapreviouslyknownbiotechnological
process.Deleted
Article4
Usesofplantoranimalvarietiesandprocessesforthe
productionthereofshallbeconsideredpatentable
subject-matter .Article4
Usesofplantoranimalvarietiesorofprocessesfortheir
production,otherthanessentiallybiologicalprocesses,
shallbepatentable.
Article5
1.Microbiological processesshallbepatentable .For
thepurposesofthisDirective,'microbiological process'
meansaprocessinvolvingorperformeduponorresulting
inmicrobiological material.Article5
Microbiological processesshallbeconsideredpatentable
subject-matter .ForpurposesofthisDirective,thisterm
shallbetakentomeanandtoincludeaprocess(or
processes)carriedoutwiththeuseoforperformedupon
orresultinginamicro-organism .
2.Aprocessconsistingofasuccessionofstepsshallbe
treatedasamicrobiological processifatleastoneessential
stepoftheprocessismicrobiological .
Deleted Article6
Aprocessconsistingofasuccessionofstepsshallbe
regardedamicrobiological process,iftheessenceofthe
inventionisincorporated inoneormoremicrobiological
stepsoftheprocess.
Article7
Aprocessinwhichhumaninterventionconsistsinmore
thanselectinganavailablebiologicalmaterialandlettingit
performaninherentbiologicalfunctionundernatural
conditionsshallbeconsideredpatentablesubject-matter .Article6
Essentiallybiologicalprocessesshallnotbepatentable .In
determiningwhetherthisexclusionapplies,human
interventionanditsimpactontheresultachievedshallbe
takenintoaccount.Aprocesswhich,takenasawhole,
doesnotexistinnatureandismorethanamere
productionprocessshallbepatentable .

NoC44/42 OfficialJournaloftheEuropeanCommunities 16.2.93
ORIGINAL PROPOSAL AMENDED PROPOSAL
Article8
Asubject-matter ofaninvention,includingamixture,
whichformedanunseparatedpartofapre-existing
material,shallnotbeconsideredunpatentable forthe
reasononlythatitformedpartofsaidnaturalmaterial.Article7
Aninventionconcerningabiologicalmaterialshallnotbe
consideredadiscoveryorlackinginnoveltyforthereason
onlythat,althoughnotknown,itformedpartofan
existingmaterial.
Article9 Deleted
Asubject-matter ofaninvention,includingamixture,
whichformedanunseparatedpartofapre-existing
material,shallnotbeconsideredasanunpatentable
discoveryoraslackingnoveltyforthereasononlythatit
formedpartofsaidnaturalmaterial.
CHAPTER 2
Scopeofprotection
Article10 Deleted
Theuseofaproductprotectedbyapatentcomprisingor
consistingofgeneticinformationtodevelopanothersuch
productortheuseofapatentedprocesstoobtainsucha
productshallnotberegardedasexperimentalforpurposes
ofestablishingpatentinfringement ,ifthedeveloped
productobtainedfromtheexperimentsoritsprogenyin
identicalordifferentiated form,isusedforotherthan
privateorexperimentalpurposes.
Article11 Deleted
Ifaproductenjoyingpatentprotectionandputonthe
marketbythepatenteeorwithhisconsentis
self-replicable ,therightsconferredbythenationalpatent
shallnotextendtoactsofmultiplication andpropagation
onlywheresuchactsareunavoidableforcommercialuses
otherthanmultiplication andpropagation .
Article8
Methodsfortreatmentofthehumanoranimalbodyby
surgeryortherapyanddiagnosticmethodspractisedon
thehumanoranimalbodyshallnotbepatentable .This
provisionshallnotapplytoproducts,inparticular
substancesorcompositions ,foruseinanyofthese
methods.

16.2.93 OfficialJournaloftheEuropeanCommunities NoC44/43
ORIGINAL PROPOSAL AMENDED PROPOSAL
Article9
Aprocesscomprisingasuccessionofstepsshallnotbe
excludedfrompatentabilityforthereasononlythatoneor
moreofthestepsinvolveasurgical,therapeuticor
diagnosticmethodpractisedontheanimalbody.The
treatmentordiagnosticmethodshallnot,however,be
protectedperse.
CHAPTER II
Scopeofprotection
Article10
1.Theprotectionconferredbyapatentonabiological
materialpossessing,asaresultoftheinvention,specific
characteristics shallextendtoallbiologicalmaterials
derivedfromthatbiologicalmaterialthrough
multiplication orpropagationandpossessingthesame
characteristics .Article12
1.Ifthesubject-matter ofapatentisaprocessforthe
productionoflivingmatterorothermattercontaining
geneticinformationpermittingitsmultiplication in
identicalordifferentiatedform,therightsconferredbythe
patentshallnotonlyextendtotheproductinitially
obtainedbythepatentedprocessbutalsotheidenticalor
differentiated productsofthefirstorsubsequent
generationsobtainedtherefrom,saidproductsbeing
deemedalsodirectlyobtainedbythepatentedprocess.
2.Anyextensionoftheprotectionconferredbythe
patenttoaprocessasindicatedunderparagraph1toa
productobtainedtherebyshallnotbeaffectedbyan
exclusionofplantoranimalvarietiesfrompatentability .2.Theprotectionconferredbyapatentonaprocess
thatenablestheproductionofabiologicalmaterial
possessing,asaresultoftheinvention,specific
characteristics shallextendtobiologicalmaterialdirectly
obtainedusingthatprocessandtoanyotherbiological
materialderivedfromsuchbiologicalmaterialthrough
multiplication orpropagationandpossessingthesame
characteristics .Thisextensionofprotectionshallnotbe
affectedbytheexclusionfrompatentabilityofplantand
animalvarietiesprovidedforinArticle3ofthis
Directive.
Article11
TheprotectionreferredtoinArticle10shallnotextendto
biologicalmaterialderivedfrombiologicalmaterialthat
hasbeenmarketedbythepatentholderorwithhis
consentifthemultiplication orpropagationresultfrom
theapplicationforwhichthematerialwasmarketed.
Article12
Theprotectionconferredbyapatentonaproduct
containingorconsistingofgeneticinformationshall
extendtoallmaterialinwhichtheproductisincorporated
andinwhichthegeneticinformationiscontainedand
expressed.Article13
Theprotectionforaproductconsistingoforcontaining
particulargeneticinformationasanessentialcharacteristic
oftheinventionshallextendtoanyproductsinwhichsaid
geneticinformationhasbeenincorporated andisof
essentialimportanceforitsindustrialapplicabilityor
utility.

16.2.93 NoC44/44 OfficialJournaloftheEuropeanCommunities
ORIGINAL PROPOSAL AMENDED PROPOSAL
Article13
1.BywayofderogationfromChapterIIofthis
Directive,farmersmayuseforpurposesofmultiplication
orpropagationontheirownfarmstheseedsobtained
fromcropscultivatedontheirownfarmsusingseeds
protectedbypatent.Onlymultiplication orpropagation
withaviewtoproducingcropsforthefarmersconcerned
canbeauthorized .
2.BywayofderogationfromChapterIIofthis
Directive,farmersrearinglivestockprotectedbypatent
mayuseitformultiplication purposesontheirownfarms
torenewtheirstock.
CHAPTER 3
DependencylicenceforplantvarietiesCHAPTER III
Compulsorylicence
Article14 Article14
1.Iftheholderofapatentonabiotechnological
inventionrefusestoallowanotherpartywhoistheholder
ofaplantvarietyrighttousetheinventioninreturnforan
appropriateroyalty,anon-exclusive compulsorylicence
maybesoughtfromthecompetentauthorityanditshall
begranteduponpaymentofanappropriateroyaltyifthis
isinthepublicinterest.1.Iftheholderofaplantbreeders'rightoravariety
certificatecanexploitorexercisehisexclusiverightsonly
byinfringementoftherightsattachedtoapriornational
patent,anon-exclusive licenceofrightshallbeaccorded
tothebreeders'rightholdertotheextentnecessaryforthe
exploitationofsuchbreeders'rightwherethevariety
protectedrepresentssignificanttechnicalprogress,upon
paymentofreasonableroyaltieshavingregardtothe
natureofthepatentedinventionandconsistentwithgiving
theproprietorofsuchpatentduerewardforthe
investmentleadingtoanddevelopingtheinvention.
2.EachMemberStateshalldesignatetheauthority
competenttograntlicencesandshallinformthe
Commissionofeachlicencegranted.2.Alicenceunderparagraph 1shallnotbeavailable
priortotheexpirationofthreeyearsfromthedateofthe
grantofthepatentorfouryearsfromthedateonwhich
theapplicationforapatentwasfiled,whicheverperiod
lastexpires.
3.Iftheholderofaplantvarietyrightrefusestoallow
anotherpartywhoistheholderofapatenttoengagein
activitiesrequiringhisconsentonreasonableterms,a
non-exclusivecompulsorylicencemaybesoughtfromthe
competentauthorityanditshallbegranteduponpayment
ofanappropriateroyaltyifthisisinthepublicinterest.3.Ifalicenceaccordingtoparagraph 1hasbeen
granted,andifavarietyprotectedbyaplantbreeders'
rightorvarietycertificatecanbeexploitedbythepatentee
onlybyinfringementoftherightsattachedtosuchvariety,
anon-exclusive licenceshallbeaccordedtotheoriginal
patenteetotheextentnecessaryfortheexploitationofthe
breeders'rightorvarietycertificate,uponpaymentof
reasonableroyaltieshavingregardtothenatureofthe
improvementandconsistentwithgivingtheproprietorof
thebreeders'rightduerewardfortheinvestmentleading
toanddevelopingthenewvariety.
4.Anappealshallliefromdecisionsofthecompetent
authoritytothecourts.4.Wheredisagreements arisewithregardtothe
significanceofthetechnicalprogressandastothelevelof
royalties,MemberStatesshallprovideforacourtof
competentjurisdictiontoresolvethedispute.

NoC44/45 16.2.93 OfficialJournaloftheEuropeanCommunities
ORIGINAL PROPOSAL AMENDED PROPOSAL
CHAPTER IV
Deposit,accessandre-deposit
Article15
1.Whereaninventioninvolvestheuseoforconcernsa
biologicalmaterialwhichisnotavailabletothepublicand
whichcannotbedescribedinapatentapplicationinsuch
amannerastoenabletheinventiontobecarriedoutbya
personskilledintheart,thedescriptionshallbeconsiderd
inadequateforthepurposesofpatentlawunless:CHAPTER 4
Deposit,accessandre-deposit
Article15
1.Ifaninventioninvolvestheuseofamicro-organism
orotherself-replicablematterwhichisnotavailabletothe
publicandwhichcannotbedescribedinapatent
applicationinsuchamannerastoenabletheinventionto
becarriedoutbyapersonskilledintheart,orifit
concernssuchmatterperse,theinventionshallonlybe
regardedasbeingdisclosedforpurposesofnationalpatent
lawif:
(a)themicro-organism orotherself-replicablematterhas
beendepositedwitharecognizeddepositary
institutionnotlaterthanthedateoffilingofthe
application;(a)thebiologicalmaterialhasbeendeposited,nolater
thanthedateonwhichthepatentapplicationwas
filed,atleastwithanauthorizedinstitutionin
accordancewiththeprovisionsoftheBudapest
Treatyontheinternationalrecognitionofthedeposit
ofmicro-organisms forthepurposesofpatent
procedureof28April1977;
(b)theapplicationasfiledcontainssuchrelevant
informationasisavailabletothedepositoronthe
characteristics ofthebiologicalmaterialdeposited;
(c)thepatentapplicationstatesthenameofthe
authorizeddepositaryinstitutionandtheaccession
numberidentifyingthedepositedbiologicalmaterial.
Deleted(b)theapplicationasfiledgivessuchrelevant
informationasisavailabletotheapplicantonthe
characteristics ofthemicro-organism orother
self-replicable matter;
(c)thedepositaryinstitutionandthefilenumberofthe
depositarestatedintheapplication .
2.Theinformationreferredtoinparagraph1(c)may
besubmitted :
(a)withinaperiodof16monthsafterthedateoffiling
oftheapplicationor,ifpriorityisclaimed,afterthe
prioritydate;
(b)uptothedateofsubmissionofarequestforearly
publicationoftheapplication;
(c)withinonemonthafterthenationalpatentofficehas
communicated totheapplicantthatarightto
inspectionofthefilesexistspursuanttoparagraph3
(a)(ii)below.
Therulingperiodshallbetheonewhichisthefirstto
expire.Thecommunication ofthisinformationshallbe
consideredasconstitutingtheunreservedandirrevocable
consentoftheapplicanttothedepositedmatterbeing
availabletothepublicinaccordancewiththisArticle.
3.(a)Unlesstheapplicationhasbeenrefusedor
withdrawnorisdeemedtobewithdrawn,the
depositedmattershallbeavailableuponrequest:
(i)toanypersonfromthedateofpublicationof
thepatentapplication;and2.Accesstothedepositedbiologicalmaterialshallbe
providedthroughthesupplyofasample:
(a)uptothefirstpublicationofthepatentapplication,to
onlythosepersonswhoareauthorizedundernational
patentlaw;

NoC44/46 OfficialJournaloftheEuropeanCommunities 16.2.93
ORIGINAL PROPOSAL AMENDED PROPOSAL
(b)betweenthefirstpublicationoftheapplicationand
thegrantingofthepatent,toanyonerequestingitor,
ifthedepositorsorequests,onlytoanindependent
expert;
(c)afterthepatenthasbeengranted,toanyone
requestingit.(ii)toanypersonhavingarighttoinspectthe
filesundertheprovisionsofnationalpatent
lawrelatingtoapplicationsunderwhich
rightsareinvokedagainstsuchaparty,prior
tothedateofpublication .
3.Unlessthepatentholderorapplicant,asapplicable,
abandonshisrights,thesamplecanbesuppliedonlyifthe
personrequestingitundertakes,forthedurationofthe
validityofthepatent:
(a)nottomakeitoranymatterderivedtherefrom
availabletothirdparties;
(b)nottouseitoranymatterderivedtherefrominany
countryexceptforexperimentalpurposes.(b)Subjecttotheprovisionsofparagraph4,such
availabilityshallbeeffectedbytheissueofa
sampleofthedepositedmattertotheperson
makingtherequest(hereinafterreferredtoasthe
'requester').Saidissueshallbemadeonlyifthe
requesterhasundertakenvis-a-vistheapplicantfor
orproprietorofthepatent:
(i)nottomakethedepositedmatterorany
matterderivedtherefromavailabletoany
thirdparty;
(ii)tousethedepositedmatteroranymatter
derivedtherefrominanycountryonlyfor
experimental purposesconcerning the
invention,withtheprovisothatthis
restrictionwillcease,inthecountryofthe
patentrightonthebasisofwhichthesample
ofthedepositedmatterwasobtained,with
thegrantofapatentorotherenforceable
rightintheinventioninvolved.Thisprovision
shallnotapplyinthecountryofthepatent
rightonthebasisofwhichthesampleofthe
depositedmatterwasobtainedinsofarasthe
requesterisusingthematterundera
compulsorylicence.Theterm'compulsory
licence'shallbeconstruedasincludingex
officiolicencesandtherighttousepatented
inventionsinthepublicinterest.
Deleted 4.Untilthedateonwhichthetechnicalpreparations
forpublicationoftheapplicationaredeemedtohavebeen
completed,theapplicantmayinformthenationalpatent
officethat,untilthepublicationofthementionofthe
grantofthepatent,theavailabilityreferredtoin
paragraph3shallbeeffectedonlybytheissueofasample
toanexpertnominatedbytherequester.
5.Thefollowingmaybenominatedasanexpert:Deleted
(a)anynaturalpersonprovidedthattherequester
furnishesevidence,whenfilingtherequest,thatthe
nominationhastheapprovaloftheapplicant;
(b)anynaturalpersonrecognizedasanexpertbythe
nationalpatentoffice.Thenominationshallbe
accompanied byanundertakingfromtheexpert
vis-a-vistheapplicant;paragraphs3(b)(i)and(ii)
shallapply,therequesterbeingregardedasathird
party.

16.2.93 OfficialJournaloftheEuropeanCommunities NoC44/47
ORIGINAL PROPOSAL AMENDED PROPOSAL
Deleted 6.Forthepurposesofparagraph3(b),anymatter
derivedfromthedepositedmattershallbedeemedtobe
anymatterderivedtherefrombyculturingorinanyother
wayofreplicationwhichmatterstillexhibitsthose
characteristics ofthedepositedmatterwhichareessential
toorforcarryingouttheinvention.Theundertaking
referredtoinparagraph3(b)shallnotimpedeadepositof
derivedmatter,necessaryforthepurposesofpatent
procedure .
Deleted 7.Therequestprovidedforinparagraph3shallbe
submittedtothenationalpatentofficeonaform
recognizedbythatoffice.Thenationalpatentofficeshall
certifyontheformthatanationalpatentapplication
referringtothedepositofthemicro-organism orother
self-replicablematterhasbeenfiled,andthattherequester
ortheexpertnominatedbyhimisentitledtotheissueofa
sampleofthemicro-organism orotherself-replicable
matter.
Deleted 8.Thenationalpatentofficeshalltransmitacopyof
therequest,withthecertificationprovidedforin
paragraph7tothedepositaryinstitutionaswellastothe
applicantfor,ortheproprietorof,thepatent.
Deleted 9.MemberStatesshalldesignaterecognizeddepositary
institutionsforpurposesofthisArticle.
Deleted 10.Ifamicro-organism orotherself-replicablematerial
hasbeendepositedinaccordancewithparagraphs 1and2
andhasbecomeavailabletoanypersonoranexpertin
accordancewithparagraphs3or4,itshallhenceforthbe
regardedavailabletothepublicinaccordancewith
paragraph 1.
4.Atthedepositor'srequest,whereanapplicationis
refusedorwithdrawnorapatentisrevokedorcancelled,
accesstothedepositedmaterialshallbelimitedtoan
independentexpertfor20yearsfromthedateonwhich
thepatentapplicationwasfiled.Intheabovementioned
case,theprovisionsofparagraph3shallapply.
Article16 Article16
Ifthebiologicalmaterialdepositedinaccordancewith
Article15ceasestobeavailablefromtheauthorized
depositaryinstitution,anewdepositofthematerialshall
bepermittedinaccordancewiththeprovisionsofthe
BudapestTreatyontheinternationalrecognitionofthe
depositofmicro-organisms forthepurposesofpatent
procedureof28April1977.1.Ifamicro-organism orotherself-replicablematter
depositedinaccordancewithArticle15ceasestobe
availablefromtheinstitutionwithwhichitwasdeposited
because:
(a)themicro-organism orotherself-replicablematteris
nolongerviable;or
(b)foranyotherreasonthedepositaryinstitutionis
unabletosupplysamples,
andifthemicro-organism orotherself-replicablematter
hasnotbeentransferredtoanotherdepositaryinstitution
recognizedforthepurposesofArticle15,fromwhichit
continuestobeavailable,aninterruptioninavailability

NoC44/48 OfficialJournaloftheEuropeanCommunities 16.2.93
ORIGINAL PROPOSAL AMENDED PROPOSAL
shallbedeemednottohaveoccurredifanewdepositof
themicro-organism orotherself-replicable matter
originallydepositedismadewithinaperiodofthree
monthsfromthedateonwhichthedepositorwasnotified
oftheinterruptionbythedepositaryinstitutionandifa
copyofthereceiptofthedepositissuedbytheinstitution
isforwardedtothenationalpatentofficewithinfour
monthsfromthedateofthenewdepositstatingthe
numberoftheapplicationorofthenationalpatent.
2.Inthecaseprovidedforinparagraph1(a),thenewDeleted
depositshallbemadewiththedepositaryinstitutionwith
whichtheoriginaldepositwasmade;inthecasesprovided
forinparagraph 1(b),itmaybemadewithanother
depositaryinstitutionrecognizedforthepurposesof
Article15(9).
3.WheretheinstitutionwithwhichtheoriginaldepositDeleted
wasmadeceasestoberecognizedforthepurposesofthe
applicationofArticle15,whetherentirelyorforthekind
ofmicro-organism orotherself-replicablemattertowhich
thedepositedmicro-organism orotherself-replicable
matterbelongs,orwherethatinstitutiondiscontinues ,
temporarilyordefinitively,theperformance ofits
functionsasregardsdepositedmicro-organisms orother
self-replicable matter,andthenotificationreferredtoin
paragraph1fromthedepositaryinstitutionisnotreceived
withinsixmonthsfromthedateofsuchevent,the
three-monthperiodreferredtoinparagraph1shallbegin
onthedateonwhichthiseventisannouncedintheofficial
publicationofthenationalpatentoffice.
4.Anynewdepositshallbeaccompanied byaDeleted
statementsignedbythedepositorallegingthatthenewly
depositedmicro-orgariism orotherself-replicablematteris
thesameasthatoriginallydeposited.
5.IfthenewdepositprovidedforinthepresentArticleDeleted
hasbeenmadeundertheBudapestTreatyonthe
internationalrecognitionofthedepositofmicro-organisms
forthepurposesofpatentprocedureof28April1977,the
provisionsofthatTreatyshallprevailincaseofconflict.
6.Ifadepositisnotacceptedorifthedeposited Deleted
materialisnolongeravailablefromthedepositary
institutionandare-depositaccordingtoparagraphs 1to5
doesnotorcouldnotremedytheunavailability ,such
unavailability shallnotaffectthepatentabilityofthe
inventioniftheapplicant/patenteeprovidestherequesting
partyentitledtoreceiveasamplewithsuchsamecertifying
itsidentitywiththematerialusedintheinventionor
obtainedastheinventionorwiththeoriginallydeposited
material,asthecasemaybe.

16.2.93 OfficialJournaloftheEuropeanCommunities NoC44/49
ORIGINAL PROPOSAL AMENDED PROPOSAL
Deleted 7.Ifapatentisdeemedinvalidbecausethepatentee
cannolongerprovideforasampleofthedeposited
materialinaccordancewiththisArticle,suchinvalidity
shallinnocasehaveretroactiveeffects.
CHAPTER 5
ReversaloftheburdenofproofCHAPTER V
Reversaloftheburdenofproof
Article17
1.Ifthesubject-matter ofapatentisaprocessfor
obtaininganewproduct,anyidenticalproductproduced
byanypersonotherthanthepatentholdershall,inthe
absenceofprooftothecontrary,bedeemedtohavebeen
obtainedbymeansofthepatentedprocess.Article17
1.Ifthesubject-matter ofapatentisaprocessfor
obtaininganeworknownproduct,thesameproduct
whenproducedbyanyotherpartyshall,intheabsenceof
prooftothecontrary,bedeemedtohavebeenobtainedby
thepatentedprocess,ifanecessarymeanstocarryoutthe
processhadbeendepositedinaccordancewithArticle14
andhadbeenreleasedtoathirdparty.
2.Intheadductionofprooftothecontrary,the
legitimateinterestsofthedefendantinprotectinghis
manufacturing andbusinesssecretsshallbetakeninto
account .2.Intheadductionofprooftothecontrary,the
legitimateinterestsofthedefendantinprotectinghis
manufacturing andbusinesssecretsshallbetakeninto
account .
CHAPTER 6
MiscellaneousCHAPTER VI
Finalprovisions
Deleted Article18
Anyexclusionfrompatentabilityorfromthefieldof
industrialapplicabilityofsurgicalordiagnosticmethods
practisedonananimalbodyshallapplytosuchmethods
onlyifpractisedforatherapeuticpurpose.
Article19
ForthepurposesofthisDirective: Deleted
(a)theword'micro-organism ',whereused,shallbe
interpretedinitsbroadestsenseasincludingall
microbiological entitiescapableofreplication,e.g.as
comprising,interalia,bacteria,fungi,viruses,
mycoplasmae ,rickettsiae,algae,protozoa,andcells;
and
(b)theword'self-replicable matter',whereused,shallbe
interpretedtocomprisealsomatterpossessingthe
geneticmaterialnecessarytodirectitsownreplication
viaa.hostorganismorinanyotherindirectway,e.g.
ascomprising,interalia,seeds,plasmids,DNA
sequences,protoplasts ,repliconsandtissuecultures.

NoC44/50 OfficialJournaloftheEuropeanCommunities 16.2.93
ORIGINAL PROPOSAL AMENDED PROPOSAL
Article20
1.MemberStatesshallbringintoforcethelaws
necessarytocomplywiththisDirectivenotlaterthan
31December1990.Article18
1.TheMemberStatesshalladoptthelaws,regulations
andadministrative provisionsnecessaryfortheir
compliancewiththisDirectivenotlaterthan
WhentheyadoptsuchmeasurestheMemberStatesshall
includereferencestothisDirectiveorshallmakesuch
referenceswhentheyeffectofficialpublication .The
mannerinwhichsuchreferencesaretobemadeshallbe
laiddownbytheMemberStates.
2.TheMemberStatesshallcommunicate tothe
Commissionthetextsoftheprovisionsofnationallaw
whichtheyadoptinthefieldcoveredbythisDirective.2.MemberStatesshallcommunicate tothe
Commissionthetextsofthemainprovisionsofnational
lawwhichtheyadoptinthisfieldcoveredbythis
Directive.
Article21 Article19
Unchanged ThisDirectiveisaddressedtotheMemberStates.