RESTRICTED
WORLD TRADE IP/C/W/70
23May1997
ORGANIZATION(97-2158)
Original: English Council forTrade-Related Aspects
ofIntellectual Property Rights
REVIEW OFLEGISLATION INTHE FIELDS OFPATENTS, LAYOUT-DESIGNS
(TOPOGRAPHIES) OFINTEGRATED CIRCUITS, PROTECTION OF
UNDISCLOSED INFORMATION AND CONTROL OF
ANTI-COMPETITIVE PRACTICES IN
CONTRACTUAL LICENCES
Replies from Japan toquestions posed by
theEuropean Communities andtheirMember States andtheUnited States
Thefollowing communications, dated 14May1997, hasbeenreceived from thePermanent
Mission ofJapan.
_______________
I. REPLY TOTHE GENERAL QUESTION CONCERNING PRIORITY RIGHTS1
Does yourcountry recognize arightofpriority onthebasis ofanearlier patent application
filedinanyother WTO Member byanational ofaWTO Member?
Article 43bisoftheJapanese Patent Lawstipulates thatanational ofaWTO Member who
filedanearlier patent application inanyother WTO Member country mayclaim arightofpriority
asprovided forinArticle 4oftheParis Convention.
II. REPLIESTOQUESTIONSPOSEDBYTHEEUROPEANCOMMUNITIESANDTHEIR
MEMBER STATES
Patents
1. Isathirdparty product brought ontothemarket inJapan between priority dateasprovided
byArticle 4oftheParis Convention (1967) anddateoffiling ofthepatent application inJapan exempt
frominfringement pursuant toSection 69,§2(ii) oftheJapanese Patent Law? (Article 2.1TRIPS)
Thesaidproduct isnotexempt frominfringement pursuant tosubparagraph 2ofparagraph 2
ofArticle 69oftheJapanese Patent Law. Article 4BoftheParis Convention provides that"[any]
acts[accomplished intheinterval] cannot giverisetoanythird-party right oranyrightofpersonal
possession", andArticle 43bisoftheJapanese Patent Lawprovides thataperson whofiledapatent
application inaWTO Member country mayclaim priority asprovided forinArticle 4oftheParis
1Atthemeeting oftheTRIPS Council of27February 1997, Members agreed torespond tothisquestion inthecontext
thepresent review (document IP/C/M/12, paragraph 18).IP/C/W/70
Page2
Convention. Consequently, forthepurpose ofsubparagraph 2ofparagraph 2ofArticle 69ofthe
Japanese Patent Law, the"patent application" isinterpreted tomean, when thepriority isclaimed,
thefirstapplication filedinanother country.
2. Would theperson referred toinSection 79ofthePatent Law,byvirtue ofprior use,beentitled
toanon-exclusive licence onthepatent rightunder thepatent application therereferred toifthatperson
hadbeencommercially working theinvention, ormaking preparations therefor, atthetimeofaprior
filingofthatpatentapplicationinanotherWTOcountry?(Article2.1TRIPS,Article4ParisConvention
(1967))
Pursuant toArticle 79oftheJapanese Patent Law, theperson (prior user) would beentitled
toanon-exclusive license onthepatent right under thepatent application ifthatperson hadbeen
commercially working theinvention ormaking preparations therefor atthetimeofaprior filing of
thatpatent application inanother WTO country. Article 4BoftheParisConvention provides that"[any]
acts[accomplished intheinterval] cannot giverisetoanythird-party rightoranyrightofpersonal
possession", andArticle 43bisoftheJapanese Patent Lawprovides thataperson whofiledapatent
application inaWTO Member country mayclaim priority asprovided forinArticle 4oftheParis
Convention. Consequently, forthepurpose ofArticle 79oftheJapanese Patent Law, the"patent
application" isinterpreted tomean, when thepriority isclaimed, thefirstapplication filedinanother
country.
3. Inrespect ofpatents andlayout-designs (topographies), doesJapanese lawallow forthe
imposition ofcompulsory licences toremedy theabuse ofsuchrights bytherightholder orpractices
which unreasonably restrain trade oradversely affect theinternational transfer oftechnology? Ifso,
whatlimitations, ifany,would beimposed upon thegrant ofsuchlicences andonwhatlegal basis?
Areallconditions provided forinArticle 31respected? (Article 8.2TRIPS, Article 31TRIPS)
TheJapanese Patent Lawprovides forthegrant ofcompulsory licenses inthecaseof"non-
working"(Article83),"dependentpatents"(Article92)and"publicinterest"(Article93).Allconditions
providedforinArticle31shallberespectedonthesecompulsorylicenses.TheGuidelinesonArbitration
Decisions provide forclarity thatanarbitration decision shall bemade inconformity withallthe
obligations under Article 31andother relevant articles oftheTRIPS Agreement.
TheActConcerning theLayout ofaSemiconductor Integrated Circuit doesnotprovide for
anymeasures toprevent theabuse ofrights byrightholders ortheresort topractices which unreasonably
restrain trade oradversely affect theinternational transfer oftechnology.
4. Does Japanese lawapply theprinciple ofinternational exhaustion ofpatent rights?
Itisunderstood thattheprinciple ofinternational exhaustion doesnotapply topatent rights.
5. Onwhatlegalbasis dopatent owners havetherightunder Japanese lawtoassign, ortransfer
bysuccession, thepatent andtoconclude licensing contracts? (Article 28.2TRIPS)
Thepatentownershallhavetherighttoassignortransferbysuccessionthepatentaspresupposed
bysubparagraph 1ofparagraph 1ofArticle 98oftheJapanese Patent Law, andtherighttoconclude
exclusive andnon-exclusive licensing contracts asprovided forinArticles 77and78,respectively.
6. Would itbesufficient, pursuant toArticle 80ofthePatent Law,foraninventor tofileapatent
application ingoodfaithandstartworking thepatent inorder tobeentitled toanon-exclusive licence
inrespect ofapatent application filedpreviously forthesame invention? Ifso,onwhatbasis doesIP/C/W/70
Page3
theGovernment ofJapan consider thatthisdoesnotunreasonably conflict withthenormal exploitation
ofthatsecond patent? (Article 30TRIPS)
Itwould notbesufficient foraninventor (prior user) onlytofileapatent application ingood
faithandstartworking thepatent inorder tobeentitled toanon-exclusive license inrespect ofapatent
rightwithrespect towhich thepatent application wasfiledpreviously forthesameinvention. Additional
requirementsarethefactthathisinventionwasoncepatentedandtheninvalidatedpursuanttoArticle123
oftheJapanese Patent Law, andthefactthathehadstarted ormade preparations forworking hispatent
ingood faithprior tothedateofrequest fortheinvalidation ofhispatent.
Thisexception doesnotunreasonably conflict withanormal exploitation ofthepatent (second
patent), butstrikes afairbalance between theowner ofthesecond patent andabona fideuserwho
started working hisownpatent oncegranted, notknowing thathispatent fellunder anyofsubparagraphs
ofparagraph 1ofArticle 123. Itshould alsobenoted that,pursuant toparagraph 2ofArticle 80of
theJapanese Patent Law, theowner ofthesecond patent shallbeentitled toreceive remuneration from
theprior user.
7. Towhatextent andonwhich legal basis doesJapan ensure compliance withtheobligations
imposed byArticle 31(c) firsthalfsentence, (f),(g),(h)and(l)(i)TRIPS?
Theprovisions ofsubparagraphs (c),(f)and(h)ofArticle 31oftheTRIPS Agreement are
implemented byparagraph 2ofArticle 86oftheJapanese Patent Law, subparagraph (g)byArticle 90,
andsubparagraph (l)byparagraph 5ofArticle 92.TheGuidelines onArbitration Decisions provide
forclarity thatanarbitration decision shall bemade inconformity withalltheobligations under
Article 31oftheTRIPS Agreement.
8. Howandtowhatextent doesJapanese lawimplement Article 34TRIPS?
Pursuant tosubparagraph (a)ofparagraph 1ofArticle 34oftheTRIPS Agreement, Article 104
oftheJapanese Patent Lawstipulates thatincaseofapatent foraninvention ofaprocess of
manufacturing aproduct, where suchaproduct wasnotpublicly known inJapan (i.e.new) prior to
thefiling ofthepatent application concerned, anyidentical product shallbedeemed tohavebeen
manufactured bythatprocess.
There existnoprovisions inJapanese lawsinforce withrespect tomeasures toprotect the
confidentiality oftrade orbusiness secrets furnished byaparty tothecourt during legalproceedings.
TheJapanese Constitution stipulates strict requirements forexceptions totheprinciple tothe
effect thatcourt proceedings shall beopen tothepublic. Asaresult, court proceedings shall be
conducted inthecourt opentothepublic eventhough trade orbusiness secrets aredisclosed.
According toArticle 42oftheTRIPS Agreement, "theprocedure shallprovide ameans to
identify andprotect confidential information, unless thiswould becontrary toexisting constitutional
requirements ".(emphasis added)
Forreference, current situation ofrecent amendments totheCode ofCivil Procedure isas
follows:
InJapan, thethoroughly revised Code ofCivil Procedure waspromulgated inJune1996. (It
willtakeeffect within twoyears ofthedateofthepromulgation asdetermined bygovernment ordinance.
AsofApril 1997, ithasnottaken effect.) Therevised Code includes newprovisions which restrictIP/C/W/70
Page4
theinspection oflawsuit records toprevent tradesecrets recorded inlawsuit records frombeing leaked
through theinspection ofsuchrecords andtoprotect trade secrets.
Layout-designs (topographies) ofintegrated circuits
1. Does thedefinition ofsemiconductor integrated circuit assetoutinArticle 2(1)oftheAct
ConcerningtheLayoutofaSemiconductorIntegratedCircuit("theCircuitLayoutAct")includeintegrated
circuits inintermediate form? Ifnot,onwhatbasis doesJapanese lawprotect circuit layouts utilized
forthemanufacture ofintegrated circuits inintermediate form? Does thedefinition ofcircuit layout
inArticle 2(2)ofthesame Actinclude circuit layouts prepared foranintegrated circuit intended for
manufacture? Ifnot,onwhatbasisdoesJapanese lawprotect suchcircuit layouts? (Article 35TRIPS,
Article 2IPICTreaty)
Paragraph1ofArticle2oftheActConcerningtheLayoutofaSemiconductorIntegratedCircuit
("theCircuit Layout Act") defines thatasemiconductor integrated circuit shallbe"product". Therefore,
aslongastheintegrated circuits inintermediate form aredistributed inmarkets orincorporated in
goods, theyareprotected. Thedefinition ofcircuit layout inparagraph 2ofArticle 2includes circuit
layouts prepared foranintegrated circuit intended formanufacture.
2. Does Japanese lawprotect theholder ofacircuit layout rightagainst reproduction other than
byincorporation inasemiconductor integrated circuit? Ifso,onwhat basis doesitgrant such
protection? (Article 35TRIPS, Article 6(1)(a)(i) IPICTreaty)
Article 11oftheCircuit Layout Actprovide thattheholder ofacircuit layout rightshallhave
theright tousethecircuit layout forwhich heobtains registration forestablishment, andtheeffect
ofthecircuitlayoutrightshallextendtothemanufactureofasemiconductorintegratedcircuitbyutilizing
thecircuit layout according tothedefinition of"use" ofthecircuit layout assetoutinsubparagraph 1
ofparagraph 3ofArticle 2.Theeffect ofthecircuit layout right, however, shallnotextend tothe
useofacircuit layout created byanother person asstipulated under paragraph 1ofArticle 12.
Therefore, theholder ofacircuit layout right shall beprotected against reproduction, by
incorporation inasemiconductor integrated circuit orotherwise, except theuseofacircuit layout created
byanother person.
3. Does Japanese lawprotect theholder ofacircuit layout right against theactofimporting,
selling orotherwise distributing forcommercial purposes aregistered circuit layout, irrespective of
whether itisincorporated inasemiconductor integrated circuit? Ifso,onwhatbasis doesitgrant
suchprotection? (Article 35TRIPS, Article 6(1)(a)(ii) IPICTreaty)
Article 11oftheCircuit Layout Actprovides thattheholder ofacircuit layout rightshallhave
therighttousethecircuit layout forwhich heobtains registration forestablishment, andtheeffect
ofthecircuit layout rightshallextend totransfer, lease, exhibition forthepurpose oftransfer orlease
orimport ofasemiconductor integrated circuit manufactured byutilizing thecircuit layout according
tothedefinition of"use" ofthecircuit layout assetoutinsubparagraph 2ofparagraph 3ofArticle 2.
Furthermore,Article23oftheCircuitLayoutActprovidesthattheproduction,transfer,lease,exhibition
forthepurpose oftransfer orlease orimport forbusiness purposes ofobjects which aretobeused
fortheimitation ofaregistered circuit layout shallbedeemed aninfringement ofthecircuit layout
right.
Therefore, theholder ofacircuit layout rightisprotected against theactofimporting, selling
orotherwise distributing forcommercial purposes aregistered circuit layout, irrespective ofwhether
itisincorporated inasemiconductor integrated circuit.IP/C/W/70
Page5
4. DoesJapaneselawallowtheimporting,sellingorotherwisedistributingforcommercialpurposes
ofanintegrated circuit oranyarticle incorporating suchanintegrated circuit byaperson acting in
good faithafterthatperson hasreceived sufficient notice thatthelayout-design incorporated insuch
integrated circuit wasunlawfully reproduced andinreturn forareasonable royalty, irrespective of
whether suchintegrated circuits werepartofthestock onhand orhadbeenordered before thetime
thatnotice hadbeengiven? (Article 37.1TRIPS)
SuchactsareallowedinaccordancewithArticle24oftheCircuitLayoutAct("specialprovisions
foraperson acting ingood faith").
Protection ofundisclosed information
1. Inwhatmanner andonwhatlegalbasis doesJapan protect thesubmission ofundisclosed test
orother dataasacondition ofapproving themarketing ofpharmaceutical orofagricultural chemical
products which utilize newchemical entities against unfair commercial useandagainst disclosure?
(Article 39.3TRIPS)
Withrespect totheapproval ofmanufacturing pharmaceuticals orveterinary medical products
andtheregistrationforsellingagriculturalchemicals,thePharmaceuticalAffairsLawandtheAgricultural
Chemicals Regulation Lawrequire submission ofdataatthetimeofapplication fortheapproval or
registration, respectively (paragraph 3ofArticle 14ofthePharmaceutical Affairs Lawandparagraph 2
ofArticle 2oftheAgricultural Chemicals Regulation Law), andtheseLaws havenoprovisions which
allow these submitted datatothegovernment tobedisclosed tothepublic.
Inaddition, under theNational Public Service Law, anemployee whodeals withsuchdata
shallbeunder obligation nottodivulge anyconfidential information which mayhavecome tohis/her
knowledge intheperformance ofhis/her duties (paragraph 1ofArticle 100), andsuchdataarekept
undisclosed tothepublic.
Therefore, theJapanese systems under above-mentioned lawsareconsistent withparagraph 3
orArticle 39oftheTRIPS Agreement.
Reference (Provisional translation):
(1) Paragraph 3ofArticle 14ofthePharmaceutical Affairs Law
Aperson whowishes toobtain anapproval asspecified inparagraph 1shall attach data
concerning theresults ofclinical trials andother pertinent datatohisapplication...
(2) Paragraphs 1and2ofArticle 2oftheAgricultural Chemicals Regulation Law
(i) Anymanufacturer orimporter shallnotselltheagricultural chemicals which he/she
manufactured,processedorimportedunlesshe/sheobtaintheregistrationthereofgranted
bytheMinister ofAgriculture, Forestry andFisheries...
(ii) Anapplication fortheregistration specified inthepreceding paragraph shallbemade
bysubmittinganapplicationwhichcontainsthefollowinginformation,documentswhich
contain thetestresults concerning effectiveness, phytotoxicity, toxicity andpersistence
oftheagricultural chemicals and samples oftheagricultural chemicals:
(subparagraph (1)to(10)omitted)IP/C/W/70
Page6
(3) Paragraph 1ofArticle 100oftheNational Public Service Law
Anemployee shallnotdivulge anyconfidential information which mayhavecome tohis/her
knowledge intheperformance ofhis/her duties. Thisprovision shallalsoapply toanemployee after
he/she hasceased toassume his/her official duties.
III. REPLIES TOQUESTIONS POSED BYTHE UNITED STATES
Patents
1. Section 32oftheJapanese Patent Lawsetsforth certain exclusions from patentability for
"inventions liable tocontravene public order, morality orpublic health". Itisalsoknown that
"diagnostic,therapeuticandsurgicalmethodsforthetreatmentofhumansoranimals"arenotpatentable
inJapan because suchinventions arenotconsidered bytheJapanese Patent Office tobe"industrially
applicable", asrequired inSection 29(1) oftheJapanese law. Withregard tothisissue, please
(a) explain whether thisinterpretation isconsistent withpractice intheJapanese Patent
Office, andindicate whether theJapanese Government intends tomake legislative
changes toprovide anexplicit exclusion frompatentability intheJapanese Patent Law;
(b) indicate whether anyother subject matter isroutinely excluded ontheground thatthe
invention lacks industrial application inJapan, butwhich arenotexplicitly excluded
under theJapanese Patent Law.
Inorder togiveexamples ofinventions which lackindustrial applicability, theExamination
Guidelines oftheJapanese Patent Office setforth "diagnostic, therapeutic andsurgical methods for
thetreatment ofhumans", butmethods foranimals arenotexcluded frompatentability inJapan. The
Japanese Government doesnotintend tochange itsPatent Lawtoprovide anexplicit exclusion.
Withrespect tothesecond question (b),theGuidelines alsosetforththefollowing inventions:
(i)aninvention which cannot beutilized forcommercial purposes; and(ii)aninvention which may
work theoretically butcannot bemade towork inpractice.
2. Please indicate whether anyofthefollowing inventions aretreated inJapan asbeing
non-patentable inventions notwithstanding thefactthataninvention inthecategory isnovel, involves
aninventive stepandhasindustrial application:
(a) process inventions which, inwhole orinpart, consist ofsteps thatareperformed by
acomputer andaredirected byacomputer program;
(b) productinventionsconsistingofelementsofacomputer-implementedinvention,including
inparticular:
(i) machine-readable computer program codestored onatangible medium such
asafloppy disk,computer harddrive orcomputer memory; and
(ii) ageneral purpose computer whose novelty overtheprior artarises primarily
duetoitscombination withaspecific computer program;
(c) non-naturally occurring microorganisms, plants oranimals produced through some
actofhuman intervention.IP/C/W/70
Page7
None ofthese inventions areexcluded from patentable subject matters inJapan.
3. TheJapanese Patent Law, inSections 68and2(3)defines therights provided byapatent.
Article 28oftheTRIPS Agreement setsforth theminimum rights thatmustbeconferred, including
therighttoexclude others from, among other things, "offering forsale" and"selling". Please explain
whether therights of"assigning, leasing" or"offering forassignment orlease" aretreated asbeing
coextensive withthescope oftheterms "offering forsale" or"selling" asitappears intheTRIPS
Agreement. Ifnot,please explain howJapanese lawconforms toArticle 28oftheTRIPS Agreement.
Article 68andparagraph 3ofArticle 2oftheJapanese Patent Lawstipulate thatthepatent
rightcovers theactsof"assigning (inJapanese "joto")" and"offering forassignment (inJapanese "joto
nomohside")". Theactof"assigning (joto)" includes theactofselling. Theactofselling isconsidered
inJapan tomean anonerous assigning act.Bythesame token, theactof"offering forassignment"
includes theactof"offering forsale".
4. Article 30oftheTRIPS Agreement provides limited exceptions totheexclusive rights conferred
byapatent, which exceptions aresubject totheproviso that"such exceptions donotunreasonable
conflictwithanormalexploitationofthepatentanddonotunreasonableprejudicethelegitimateinterests
ofthepatent owner, taking intoaccount thelegitimate interests ofthirdparties." Please explain how
theexceptions provided inSections oftheJapanese patent lawlisted below comply withArticle 30,
andwhether suchprovisions arelimited soastoensure thatanyauthorized usedoesnotunreasonably
conflict withthenormal exploitation ofthepatent orunreasonably prejudice thelegitimate interests
ofthepatent owner:
(a) Section 69(1) concerning useforresearch orexperimental purposes;
(b) Sections 81and82concerning grants ofanon-exclusive licences under patents that
cover adesign previously subject toadesign right thathasexpired; and
(c) Articles 175and176concerning situations ofintervening useofapatented invention
when apatent hasbeendeclared inacourt offirstinstance invalid butwhose validity
islaterrestored through "retrial".
(a) Theexception asprovided inparagraph 1ofArticle 69oftheJapanese Patent Lawcomplies
withArticle 30oftheTRIPS Agreement because theexception islimited totheworking ofthepatented
inventionsolelyforthepurposeofscientificresearchandexperimentandnotforthecommercialpurpose.
While intended topromote further inventive activities among thepublic, theexception doesneither
unreasonably conflict withanormal exploitation ofthepatent norunreasonably prejudice thelegitimate
interests ofthepatent owner.
(b) Thenon-exclusive licenses assetforth inArticles 81and82oftheJapanese Patent Laware
alsoconsistent withArticle 30oftheTRIPS Agreement. These aredesigned tostrike afairbalance
between therightofthepatent owner andtherightoftheowner oftheexpired design rightwithrespect
towhich thedesign application wasfiledprior tooronthefiling dateofthepatent application with
respect tothesame product. Iftheowner ofthedesign rightwereprohibited fromcontinuing touse
hisdesign afterthedateoftheexpiration ofthedesign right, thenthelegitimate interests ofthedesign
right owner, whofirstfiledthedesign application andcontinued towork thedesign rightforyears
could notbeprotected. Asthescope ofthenon-exclusive license onthepatent under Articles 81or
82isstrictly limited tothepreviously existing design right, itdoesnotunreasonably conflict witha
normal exploitation ofthepatent.IP/C/W/70
Page8
(c) Therestriction ofthepatent rightasprovided forinArticles 175and176oftheJapanese Patent
Lawisalsoconsistent withArticle 30oftheTRIPS Agreement. Asitisveryrarethataretrial may
berequested forrestoring theinvalidated patents andmuch lesspossible thattheinvalidated patent
isrestored through theretrial procedure, thethirdparties haveagood reason tobelieve thattheyare
notprohibited fromworking theinvalidated patents priortotheregistration oftheretrial. Therestriction
shallbeapplied onlytoproducts imported into,ormanufactured oracquired inJapan ingood faith
afterthedecision ontheinvalidation wasfinalized andbefore therequest foraretrial wasregistered.
Thisexception doesnotunreasonably conflict withanormal exploitation ofthepatent.
5. Please explain whether, under Japanese law,specific measures existthatprotect thelegitimate
interests ofdefendants intheirmanufacturing andbusiness secrets consistent withArticle 34.3ofthe
TRIPS Agreement, andifso,whatisthespecific authority thatprovides suchprotection.
There existnoprovisions inJapanese lawsinforce withrespect tomeasures toprotect the
confidentiality oftrade orbusiness secrets furnished byaparty tothecourt during legalproceedings.
TheJapanese Constitution stipulates strict requirements forexceptions totheprinciple tothe
effect thatcourt proceedings shall beopen tothepublic. Asaresult, court proceedings shall be
conducted inthecourt opentothepublic eventhough trade orbusiness secrets aredisclosed.
According toArticle 42oftheTRIPS Agreement, "theprocedure shallprovide ameans to
identify andprotect confidential information, unless thiswould becontrary toexisting constitutional
requirements ."(emphasis added)
Forreference, current situation ofrecent amendments totheCode ofCivil Procedure isas
follows:
InJapan, thethoroughly revised Code ofCivil Procedure waspromulgated inJune1996. (It
willtakeeffect within twoyears ofthedateofthepromulgation asdetermined bygovernment ordinance.
AsofApril 1997, ithasnottaken effect). Therevised Code includes newprovisions which restrict
theinspection oflawsuit records toprevent tradesecrets recorded inlawsuit records frombeing leaked
through theinspection ofsuchrecords andtoprotect trade secrets.
6. Please indicate howmany compulsory licences onayearly basis havebeengranted inJapan
since 1January 1993.
Nocompulsory licenses havebeengranted since 1January 1993.
Protection ofundisclosed information
7. Please explain howundisclosed information isprotected inJapan, andthelegalbasis forsuch
protection.
TheJapanese Unfair Competition Prevention Lawprovides thatthespecific actsconcerning
atrade secret come under theunfair competition (subparagraphs 4to9ofparagraph 1ofArticle 2).
According toArticle 2,theactofimproper acquisition ofatradesecret, ortheactofusing ordisclosing
atrade secret which hasbeendisclosed bytheperson holding itforthepurpose ofacquiring anunfair
benefit orinflicting injury ontheholder ofthesecret, isconsidered tobe"unfair competition". The
holder isentitled torequest aninjunction preventing orsuspending suchunfair competition (Article 3).
Furthermore, theinfringer shallbeliable tocompensate damages which result therefrom (Article 4).IP/C/W/70
Page9
8. Please indicate thenature ofmeasures, ifany,thataretaken byjudicial authorities inJapan
toprotect theconfidentiality ofundisclosed information (e.g.trade orbusiness secrets) furnished by
aparty tothecourt during legalproceedings, when theinformation hasbeenprovided either toenforce
trade secret rights insuchinformation, orpursuant toother proceedings.
There existnoprovisions inJapanese lawsinforce withrespect tomeasures toprotect the
confidentiality oftrade orbusiness secrets furnished byaparty tothecourt during legalproceedings.
TheJapanese Constitution stipulates strict requirements forexceptions totheprinciple tothe
effect thatcourt proceedings shall beopen tothepublic. Asaresult, court proceedings shall be
conducted inthecourt opentothepublic eventhough trade orbusiness secrets aredisclosed.
According toArticle 42oftheTRIPS Agreement, "theprocedure shallprovide ameans to
identify andprotect confidential information, unless thiswould becontrary toexisting constitutional
requirements ".(emphasis added)
Forreference, current situation ofrecent amendments totheCode ofCivil Procedure isas
follows:
InJapan, thethoroughly revised Code ofCivil Procedure waspromulgated inJune1996. (It
willtakeeffect within twoyears ofthedateofthepromulgation asdetermined bygovernment ordinance.
AsofApril 1997, ithasnottaken effect.) Therevised Code includes newprovisions which restrict
theinspection oflawsuit records toprevent tradesecrets recorded inlawsuit records frombeing leaked
through theinspection ofsuchrecords andtoprotect trade secrets.
9. Please explain themeasures, ifany,thathavebeenimplemented inJapan toprotect against
unfair competition those parties thathave provided confidential testorother dataconcerning a
pharmaceuticaloragriculturalchemicalproducttoJapaneseregulatoryauthoritiespursuanttoarequest
formarketing approval. Please explain howsuchmeasures, ifany,areconsistent withArticle 39.3
oftheTRIPS Agreement.
Withrespect totheapproval ofmanufacturing pharmaceuticals ofveterinary medical products
andtheregistrationforsellingagriculturalchemicals,thePharmaceuticalAffairsLawandtheAgricultural
Chemicals Regulation Lawrequire submission ofdataatthetimeofapplication fortheapproval or
registration, respectively (paragraph 3ofArticle 14ofthePharmaceutical Affairs Lawandparagraph 2
ofArticle 2oftheAgricultural Chemicals Regulation Law), andthese Laws havenoprovisions which
allow these submitted datatothegovernment tobedisclosed tothepublic.
Inaddition, under theNational Public Service Law, anemployee whodeals withsuchdata
shallbeunder obligation nottodivulge anyconfidential information which mayhavecome tohis/her
knowledge intheperformance ofhis/her duties (paragraph 1ofArticle 100), andsuchdataarekept
undisclosed tothepublic.
Therefore, theJapanese systems under above-mentioned lawsareconsistent withparagraph 3
ofArticle 39oftheTRIPS Agreement.IP/C/W/70
Page10
Reference (Provisional translation):
(1) Paragraph 3ofArticle 14ofthePharmaceutical Affairs Law
Aperson whowishes toobtain anapproval asspecified inparagraph 1shallattach
dataconcerning theresults ofclinical trials andother pertinent datatohisapplication...
(2) Paragraphs 1and2ofArticle 2oftheAgricultural Chemicals Regulation Law
(a) Anymanufacturer orimporter shallnotselltheagricultural chemicals which he/she
manufactured,processedorimportedunlesshe/sheobtaintheregistrationthereofgranted
bytheMinister ofAgriculture, Forestry andFisheries...
(b) Anapplication fortheregistration specified inthepreceding paragraph shallbemade
bysubmittinganapplicationwhichcontainsthefollowinginformation,documentswhich
contain thetestresults concerning effectiveness, phytotoxicity, toxicity andpersistence
oftheagricultural chemicals andsamples oftheagricultural chemicals:
- (subparagraphs (1)to(10)omitted)
(3) Paragraph 1ofArticle 100oftheNational Public Service Law
Anemployee shallnotdivulge anyconfidential information which mayhavecome
tohis/her knowledge intheperformance ofhis/her duties. Thisprovision shallalsoapply
toanemployee afterhe/she hasceased toassume his/her official duties.
10. Anotice issued bytheDirector oftheMinistry ofHealth [Directors Notice No.698,dated
30May1980], appears torequire apartyseeking marketing approval foranewdruginJapan topublish
anydatathatistobesubmitted totheMinistry ofHealth inamedical orscientific journal issued in
Japan. Publication ofconfidential dataeliminates theability ofaparty toenjoy trade secret rights
insuchdataandpermits third parties tounfairly compete withtheparty thathasdeveloped anew
drug. Please indicate whether parties seeking tosubmit testdatatotheMinistry ofHealth pursuant
toarequest formarketing approval ofanewdrugmustpreviously publish theinformation inamedical
orscientific journal inorder tohavethedataconsidered bytheMinistry ofHealth. Ifso,please indicate
howthispractice conforms totherequirements ofArticle 39.3oftheTRIPS Agreement.
Paragraph 1-4oftheDirector 'snotice doesnotrequire thatalldatawhich are,under paragraph
3ofArticle 14ofthePharmaceutical Affairs Law, required toattach toanapplication forthemarketing
approval bepublished. Data thataredifficult topublish forsome reasons maybeaccepted after
consultation. Suchdataarekeptundisclosed tothepublic. Therefore, thisscheme isconsistent with
paragraph 3ofArticle 39oftheTRIPS Agreement.