RESTRICTED
WORLD TRADE IP/C/W/59
17April 1997
ORGANIZATION(97-1682)
Council forTrade-Related Aspects of
Intellectual Property Rights Original: English
REVIEW OFLEGISLATION INTHE FIELDS OFPATENTS, LAYOUT-DESIGNS
(TOPOGRAPHIES) OFINTEGRATED CIRCUITS, PROTECTION OF
UNDISCLOSED INFORMATION AND CONTROL OF
ANTI-COMPETITIVE PRACTICES IN
CONTRACTUAL LICENCES
Questions Posed bytheUnited States
Bymeans ofacommunication fromtheOffice oftheUnited States Trade Representative, dated
8April 1997, theSecretariat hasreceived thefollowing questions thattheUnited States had
communicated toAustralia, Bulgaria, Canada, theCzech Republic, theEuropean Communities and
their Member States, Hungary, Japan, Liechtenstein, New Zealand, Norway, Poland, theSlovak
Republic, Slovenia, South Africa andSwitzerland.
_______________
Page
Australia 2
Bulgaria 4
Canada 6
Czech Republic 8
European Communities andtheirMember States 11
Hungary 35
Japan 36
Liechtenstein 38
NewZealand 40
Norway 41
Poland 44
Slovak Republic 47
Slovenia 50
South Africa 52
Switzerland 54IP/C/W/59
Page2
AUSTRALIA
Patents
1. Pleaseexplainwhetheranyinventions,otherthanthosespecifiedinArticle18(2),arenoteligible
tobepatented under Australian law,notwithstanding thefactthattheinvention satisfies thecriteria
ofbeing novel, involving aninventive step,andbeing useful. Insodoing, please explain themeaning
ofthephrase "isamanner ofmanufacture within themeaning ofSection 6oftheStatute ofMonopolies"
andwhether under thisdefinition anyofthefollowing inventions aredeemed ineligible tobepatented
inAustralia:
(a) process inventions which, inwhole orinpart,consist ofsteps thatareperformed by
acomputer andaredirected byacomputer program;
(b) product inventions consisting ofelements ofacomputer-implemented invention,
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) methods oftreatment ordiagnosis ofhumans oranimals; or
(d) non-naturally occurring microorganisms, plants oranimals produced through some
actofhuman intervention.
2. Articles 133to140oftheAustralian Patents Actof1990, asamended byPart4ofthePatents
(World Trade Organization Amendments) Act1994, permit theissuance ofcompulsory licences under
patents within Australia under certain circumstances, notably incases where atrade orindustry in
Australia isbeing unfairly prejudiced, Australian demand forthepatented invention isnotbeing met,
orthepatented invention isnotbeing commercially worked within Australia. Theprovisions arenot
differentiated interms oftheirapplication withrespect tothetechnological fieldoftheinvention. Please
explain howthese provisions comply withArticle 31(c) oftheTRIPS Agreement, which specifies that
compulsory licences under patents concerning inventions inthefieldofsemi-conductor technology
canbegranted onlyforthepurpose ofpublic non-commercial useortoremedy apractice determined
afterjudicial oradministrative process tobeanti-competitive.
3. Chapter 17ofthePatents Actof1990, asamended byPart4ofthePatents (World Trade
Organization Amendments) Act1994, permits thegovernment ofAustralia, oritsdesignees, touse
aninvention described inanapplication orinissued patent. Notice istobeprovided assoonaspractical
aftertheusecommences, andremuneration istobeprovided. With respect totheso-called Crown
use,please explain:
(a) whether anyoftheconditions specified inArticle 31oftheTRIPS Agreement are
incorporated orapplied inthecontext ofauthorizing Crown useofapatented invention;
(b) howtheprovisions ofArticle 167,which authorize theCrown oritsdesignee under
theauthority ofCrown usetonotonlyusetheinvention buttosellproducts covered
bythepatent tothepublic atlarge, function inpractice, andhowthisauthority can
bereconciled withtheprovisions ofArticle 31;andIP/C/W/59
Page3
(c) howfrequently andunder whatcircumstances Crown useisauthorized inAustralia.
4. Please indicate howmany compulsory licences onayearly basishavebeengranted inAustralia
since 1January 1993.
5. Please explain howundisclosed information isprotected inAustralia, andthelegalbasis for
suchprotection[NOTE:nonotificationfromAustraliaconcerningprotectionofundisclosedinformation
hadbeendistributed bytheWTO Secretariat atthetimethese questions were prepared].
6. Please indicate thenature ofmeasures, ifany,thataretaken byjudicial authorities inAustralia
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.
7. Please explain themeasures, ifany,thathavebeenimplemented inAustralia toprotect against
unfair competition those parties thathave provided confidential testorother dataconcerning a
pharmaceutical oragricultural chemical product toAustralian regulatory authorities pursuant toarequest
formarketing approval. Please explain howsuchmeasures, ifany,areconsistent withArticle 39.3
oftheTRIPS Agreement.
8. Article 25oftheCircuit Layouts Actof1989 permits theGovernment ofAustralia togrant
aninvoluntary licence under acertificate ofprotection toagovernment agency orathirdpartyauthorized
bytheGovernment ofAustralia. Article 37.2oftheTRIPS Agreement requires WTO Members that
permit theinvoluntary licensing ofamask workrighttoadhere totheconditions concerning involuntary
licences forpatents found inArticle 31(a) to(k).Please explain howtheAustralian actcomplies with
therequirements ofthese Articles oftheTRIPS Agreement.IP/C/W/59
Page4
BULGARIA
Patents
1. Please explain, whether anyofthefollowing inventions areprohibited from being patented
inBulgaria iftheyotherwise satisfy theconditions ofbeing novel, involving aninventive step, and
being industrially applicable:
(a) process inventions which, inwhole orinpart,consist ofsteps thatareperformed by
acomputer andaredirected byacomputer program;
(b) product inventions consisting ofelements ofacomputer-implemented invention,
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) pharmaceutical oragricultural chemical products; or
(d) non-naturally occurring microorganisms, plants oranimals.
Ifanyofthese types ofinventions areexcluded fromeligibility tobepatented, please explain
howBulgarian patent lawcomplies withtheobligations ofArticle 27oftheTRIPS Agreement, which
mandates patent eligibility forallcategories ofinvention without discrimination.
2. Please explain whether itispossible inBulgaria toobtain acompulsory licence (alicence granted
toathirdparty without theconsent ofthepatent owner), andifso,howsuchauthority complies with
theprovisions ofArticle 31oftheTRIPS Agreement.
3. Please indicate howmany compulsory licences onayearly basishavebeengranted inBulgaria
since 1January 1993.
4. Please explain whether protection isoffered inBulgaria forplantvarieties, andifso,whether
suchprotection isbased onthestandards ofthe1978 or1991 ActsoftheInternational Convention
fortheProtection ofNewVarieties ofPlants (UPOV).
Protection ofundisclosed information
5. Please explain howundisclosed information isprotected inBulgaria, andthelegalbasis for
suchprotection [NOTE: nonotification fromBulgaria concerning protection ofundisclosed information
hadbeendistributed bytheWTO Secretariat atthetimethese questions were prepared].
6. Please indicate thenature ofmeasures, ifany,thataretaken byjudicial authorities inBulgaria
toprotect theconfidentiality ofundisclosed information furnished byaparty tothecourt during legal
proceedings, when theinformation hasbeenprovided either toenforce rights insuchinformation, or
forother purposes.IP/C/W/59
Page5
7. Please explain themeasures, ifany,thathavebeenimplemented inBulgaria toprotect against
unfair competition those parties thathave provided confidential testorother dataconcerning a
pharmaceutical oragricultural chemical product toBulgarian regulatory authorities pursuant toarequest
formarketingapprovalandhowsuchmeasuresareconsistentwithArticle39.3oftheTRIPSAgreement.
Please explain whether theinformation isprotected against disclosure indefinitely, orisonlyprotected
foraspecific period oftime.IP/C/W/59
Page6
CANADA
Patents
1. Article 55.2(1) oftheCanadian Patent Actpermits athirdparty, without theconsent ofthe
patent owner (i.e., "[i]tisnotaninfringement tomake, construct, useorsellthepatented invention
solely forusesreasonably related tothedevelopment andsubmission ofinformation required under
any…[Canadian law]..thatregulates themanufacture, construction, useorsaleofanyproduct.".
Article 55.2(2) appears toenable athird party tomanufacture andstore articles subject toapatent
without theconsent ofthepatent owner foradefined period oftimepriortotheexpiration ofapatent.
Inrelation tothese provisions, please:
(a) identify thecategories ofproducts whose manufacture, construction useorsaleare
regulated inCanada, andthussubject tothescope ofthisprovision;
(b) explain whether thisauthority would permit athird party tomanufacture andsell
commercially significant amounts ofapatented pharmaceutical product without the
consent ofthepatent owner;
(c) explain whether athirdparty isentitled tomanufacture andstore anyproduct thatis
regulated inCanada, andifso,whether anylimits apply astothescale ofthis
manufacturing andstorage activity;
(d) identify thetimelimits thathavebeensetinregulations inrelation totheright ofa
thirdparty tomanufacture andstore products inanticipation oftheexpiration ofthe
termofpatent, ascontemplated inArticle 55.2(3); and
(e) explain howthese provisions comply withtherequirements oftheTRIPS Agreement:
(i) tonotdiscriminate intheenjoyment ofpatent rights based onthefieldof
technology, orastowhether patented products areproduced locally orimported
[Article 27];
(ii) concerning theexclusive rights tobeaccorded tothepatent owner [Article 28];
and
(iii) concerning therestrictions thatmustbepresent innational lawconcerning third
party useofaninvention without consent ofthepatent owner found [Articles
30and31].
2. Article 2ofthePatent Actdefines asan"invention" "anynewanduseful art,process, machine,
manufacture orcomposition, oranynewanduseful improvement …[tosuchinventions]". This
definition apparently serves todefine thescope ofsubject matter thatcanbepatented inCanada. Please
explain whether, under thisdefinition, anyofthefollowing inventions areconsidered ineligible tobe
patented notwithstanding thefactthattheinvention isnew, useful andinvolves aninventive step:
(a) process inventions which, inwhole orinpart,consist ofsteps thatareperformed by
acomputer andaredirected byacomputer program;
(b) product inventions consisting ofelements ofacomputer-implemented invention,
including inparticular:IP/C/W/59
Page7
(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 thathavebeendeveloped
through human intervention.
3. Article 42oftheCanadian Patent Actspecifies thatthegrant ofapatent grants tothepatentee
theexclusive rightof"making, constructing andusing theinvention andselling ittoothers tobeused."
Thisprovision doesnotbestow onthepatent owner theexclusive righttoprevent others fromimporting
oroffering forsalethepatented invention. Please explain howArticle 42complies withArticle 28.1
oftheTRIPS Agreement, which requires thatthepatent bestow onthepatent holder theexclusive right
ofmaking, using, selling, offering forsaleorimporting thepatented invention.
Protection ofundisclosed information
4. Inthenotifications made bytheGovernment ofCanada, anumber oflawsconcerning regulation
ofproducts havebeenprovided. Acommon clause concerning thehandling oftestdataisinthese
lawsstates regulations shallbepromulgated thataredeemed necessary forthepurpose ofcomplying
with Canada ’sobligations under theNAFTA (Article 1711) andunder theWTO Agreement
(Article 39.3). Please explain howthese clauses havebeenimplemented bythevarious Canadian
regulatory agencies. Please alsoexplain howthepractices dictated bythese regulations relate toand
areconsistent withtherequirements ofArticle 39.3oftheTRIPS Agreement withrespect tosteps
thatmust betaken toprevent disclosure ofconfidential information provided toaregulatory agency
byprivate parties seeking marketing approval.
5. Canadian law[Food andDrug Regulation C.08.004.1] appears toenable thirdparties toobtain
access totestdataprovided byaparty totheregulatory authorities inCanada under certain conditions.
Please explain:
(a) theconditions under which athirdparty cangainaccess toconfidential information
providedtoaCanadianregulatoryagencyforpurposesofobtainingmarketingapproval;
and
(b) howthisregime complies withtherequirements ofArticle 39.3, which require WTO
Members totakesteps toprotect parties thathaveprovided suchdataagainst unfair
competition.IP/C/W/59
Page8
CZECH REPUBLIC
Patents
1. Article3-2(d)oftheCzechPatentLaw[LawonInventions,IndustrialDesignsandRationalization
Proposals] (No.527ofNovember 27,1990) provides that"programs forcomputers" arenotconsidered
tobeinventions. Please explain whether, under thisprovision, inventions within thecategories specified
below arenoteligible tobepatented intheCzech Republic, notwithstanding thefactthattheinvention
isnovel, involves aninventive step,andisuseful:
(a) process inventions which, inwhole orinpart,consist ofsteps thatareperformed by
acomputer andaredirected byacomputer program;
(b) product inventions consisting ofelements ofacomputer-implemented invention,
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.
Ifanyofthese types ofinventions areexcluded fromeligibility tobepatented, please explain
howthepatent lawoftheCzech Republic complies withtheobligations ofArticle 27oftheTRIPS
Agreement, which mandates patent eligibility forallcategories ofinvention without discrimination.
2. Article 11(1) oftheCzech Patent Lawdefines therights associated withapatent intheCzech
Republic tobethe"exclusive righttowork theinvention, toauthorize others towork theinvention
ortoassign thepatent toothers". Article 13(1) clarifies thattheperson "working" aninvention means
theperson who"manufactures, places onthemarket orusestheproduct thatisthesubject matter of
theinvention, intheframework ofhiseconomic activity". Article 13(2) clarifies thedefinition with
respect toproducts thataretheresult ofpractice ofapatented process. Article 28.1(a) oftheTRIPS
Agreement requires WTO Members togrant thefollowing exclusive rights tothepatent owner: the
righttoprevent thirdparties nothaving theowner ’sconsent frommaking, using, selling, offering for
saleorimporting forthese purposes thepatented product. Article 28.1(b) defines theexclusive right
topractise apatented process, andextends therights associated withapatented product totheproducts
obtained directly byapatented process. Please explain howCzech lawcomplies withtheobligations
ofArticles 28.1(a) and(b)oftheTRIPS Agreement.
3. Article 34oftheTRIPS Agreement requires WTO Members tomake available incivil
proceedings toenforce aprocess patent theoption ofshifting theburden ofproof regarding useof
thepatented process toanaccused infringer whohasproduced aproduct identical tothatproduced
byapatented process. Noprovision oftheCzech patent lawappears toprovide suchanoption to
apatent owner enforcing itsrights inajudicial proceeding. Please explain whether Czech courts permit
patent owners toshifttheburden ofproof sothatanaccused infringer canberequired toprove that
ithasnotusedthepatented process toproduce aproduct identical tothatwhich istheresult ofthe
patented process. Ifthisispossible inCzech courts, please explain thelegalbasis forsuchanaction
bythecourt. Ifthisisnotpossible, please explain howCzech lawcomplies withtherequirements
ofArticle 34oftheTRIPS Agreement.IP/C/W/59
Page9
4. Article 68oftheCzech Patent Lawprovides thatpatent-related appeals toacourt arepossible
onlywithrespect todecisions onthegranting ofacompulsory licence (Article 20),onanaction for
annulment (revocation) ofapatent (Article 23),oronadeclaratory action todefine thescope ofa
patent bythePatent Office (Article 67).Noprovision appears togiveapatent applicant therightto
appeal anegative decision bytheOffice onanapplication forpatent toajudicial orquasi-judicial
authority, asrequired byArticle 62.5oftheTRIPS Agreement. Please explain:
(a) whether itispossible toappeal anadverse decision ofthePatent Office onanapplication
regarding patentability toajudicial orquasi-judicial authority intheCzech Republic,
andifnot,howCzech lawcomplies withArticle 62.5oftheTRIPS Agreement; and
(b) whether thepatent owner orpatent applicant isallowed toparticipate inthe
decision-making process.
5. Article 20oftheCzech Patent Lawpermits thePatent Office togrant acompulsory licence
iftheowner ofapatent "does notwork thepatent atallorworks itinsufficiently andcannot give
legitimate reasons forhisfailure toact". Thisprovision thenspecifies thatthegrant ofthecompulsory
licence "shall notaffect therightoftheowner toobtain compensation inrespect ofthevalue ofthe
licence". Nootherprovision oftheCzech lawappears toaddress theterms orconditions forthegranting
ofacompulsory licence toathirdparty. Inrelation tothisauthority:
(a) please explain whether theworking requirements specified canbesatisfied by
importation ofproducts subject toapatent intotheCzech Republic, orwhether the
patented invention must bephysically worked intheCzech Republic;
(b) iftheinvention mustbephysically worked within theCzech Republic, please explain
howtheCzech lawcomplies withArticle 27.1, which prohibits discrimination inthe
enjoyment ofpatent rights based onwhether products areproduced locally orimported;
and
(c) please explain howtheCzech lawcomplies withlimitations andconditions governing
theissuance ofcompulsory licences found inArticle 31(a) to(l).
6. Please indicate howmany compulsory licences onayearly basishavebeengranted intheCzech
Republic since 1January 1993.
7. Please explain howArticles 14(2) and15theCzech Republic LawonInventions, Industrial
Designs andRationalization Proposals, which imposes alimitation ontherightofapatent owner to
assign orconclude licensing contracts bymaking anassignment orauthorization effective onlyafter
ithasbeenentered intothePatent Register, complies withArticle 28.2oftheTRIPS Agreement.
8. Article 23(3) oftheCzech Republic LawonInventions, Industrial Designs andRationalization
Proposals states thatannulment ofapatent isretroactive tothedateonwhich thepatent became valid.
Under thisprovision, please explain whether, under thisprovision, apatent owner must reimburse
licensees fortheconsiderations made tothepatent owner prior tothedateofannulment ofthepatent
(i.e., royalty orlicence fees).IP/C/W/59
Page10
Protection ofundisclosed information
9. Thenotification bytheCzech Republic identifies thelegalbasisfortheprotection ofundisclosed
information within theCzech Republic. Thelawsreferred toapparently establish thelegalframework
fortheenjoyment ofrights insuchinformation. Itisunclear, however, from thisnotification asto
thespecific nature ofthese rights, andhowtheycanbeenforced. Inviewofthis,please explain:
(a) thebasic standard thatgoverns thedetermination ofwhether aparty isentitled to
protection(i.e.,whetherthestandardsreflecttheprovisionsofArticle39.2oftheTRIPS
Agreement); and
(b) thenature ofmeasures, ifany, thataretaken byjudicial authorities inthe
Czech Republic toprotect theconfidentiality ofundisclosed information furnished by
aparty toacourt during legalproceedings, when theinformation hasbeenprovided
either toenforce rights insuchinformation, orforother purposes.
10. Please explain themeasures, ifany,thathavebeenimplemented intheCzech Republic toprotect
against unfair competition those parties thathaveprovided confidential testorother dataconcerning
apharmaceutical oragricultural chemical product toCzech regulatory authorities pursuant toarequest
formarketing approval. Please explain howsuchmeasures, ifany,areconsistent withArticle 39.3
oftheTRIPS Agreement.IP/C/W/59
Page11
EUROPEAN COMMUNITIES AND THEIR MEMBER STATES
Patents
1. Please identify theissues within thefieldofpatent laworpatent enforcement thatliewithin
thecompetence oftheEuropean Community, rather thanwithin thecompetence oftheMember States.
Inyouranswer, please indicate thelegalbasis forsuchcompetence, anddescribe themeasures that
havebeensuccessfully implemented andthatareineffect inauniform fashion throughout theMember
States oftheEuropean Community.
2. Please indicate thelegal status oftheCommunity Patent Convention within theEuropean
Community. Please alsoexplain whether anydevelopments haveoccurred thatarelikely toleadto
anychange inthatstatus, orwithregard tospecific provisions orobligations oftheCommunity Patent
Convention.
3. Please indicate whether theEuropean Community hascompetence inthefieldofprotection
fornewvarieties ofplants, andthebasis ofsuchcompetence. Inthisregard, please clarify whether
theCouncil Regulations concerning plant variety rights hasbeenimplemented inauniform manner
throughout theEuropean Community Member States. Please indicate whether anysteps arebeing
taken tocoordinate within theECMember States
(a) ratification ofthe1991 ActoftheUPOV Convention by;and
(b) amendment ofMember Stateplantvariety protection systems torender themcompliant
withthe1991 ActofUPOV.
AUSTRIA
1. Article 1oftheAustrian Patent Lawprovides that"programs forcomputers" arenotconsidered
tobeinventions. Please explain whether, under thisprovision, inventions within thecategories specified
below arenoteligible tobepatented under Austrian law,notwithstanding thefactthattheinvention
isnovel, involves aninventive step,andisuseful:
(a) process inventions which, inwhole orinpart,consist ofsteps thatareperformed by
acomputer andaredirected byacomputer program;
(b) product inventions consisting ofelements ofacomputer-implemented invention,
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.
Ifanyofthese types ofinventions areexcluded fromeligibility tobepatented, please explain
howAustrian patent lawcomplies withtheobligations ofArticle 27oftheTRIPS Agreement, which
mandates patent eligibility forallcategories ofinvention without discrimination.IP/C/W/59
Page12
2. Article 28oftheTRIPS Agreement enumerates therights thateachMember country mustconfer
toapatent owner. Included among these rights aretherights toprevent thirdparties from making,
using, offering forsale,selling andimporting thepatented product without theauthorization ofthe
rightholder. Article 22(1) oftheAustrian Patent Lawprovides the"patent shallentitle thepatent holder
toexclude others from thelatter, toproduce thesubject matter oftheinvention commercially, putit
onthemarket, offer oruseitorimport orpossess itforthepurposes asstated". Please explain:
(a) howArticle 22(1) oftheAustrian Patent Lawcomplies withtheobligations inArticle 28
oftheTRIPS Agreement totheextent thatitpermits anyformof"non-commercial"
production ofaninvention without theconsent ofarightholder; and
(b) whether thelimitation thatreads "forthepurposes asstated" refers tothelimitations
found inthepatent claims, orwhether itrefers toother limitations unrelated tothe
patent claims.
3. Article 32oftheTRIPS Agreement requires eachMember country toprovide thepatent owner
withanopportunity forjudicial review ofanydecision torevoke orforfeit hispatent. IntheAustrian
Patent Law, apatent owner isgranted anopportunity forreview ofaforfeiture orrevocation ofhis
patent bytheSupreme Patent Chamber. Please explain whether theSupreme Patent Chamber isa
judicial body; and, ifnot,what authority under Austrian lawprovides judicial review ofan
administrative decision torevoke orforfeit apatent.
4. Article 31(c) oftheTRIPS Agreement specifies thatnocompulsory licence shallbegranted
byaMember under apatent concerning aninvention inthefieldofsemi-conductor technology except
forpublic non-commercial useortoremedy apractice determined afterjudicial oradministrative process
tobeanti-competitive. Articles 36(1) to(3)oftherevised Austrian Patent Lawprovide threegrounds
forathirdparty toseekacompulsory licence, namely, where theutilization ofapatented invention
isdependent onthegrant ofalicence under anearlier patent, where there isinsufficient working of
apatented invention inAustria, orwhere thegranting ofalicence liesinthepublic interest. No
provision under Austrian lawappears tolimittheavailability ofcompulsory licences withrespect to
patented inventions inthefieldofsemi-conductor technology. Please explain howAustrian lawcomplies
withtheobligations ofArticle 31(c) oftheTRIPS Agreement.
5. Please indicate howmany compulsory licences onayearly basishavebeengranted inAustria
since 1January 1993.
6. Under Austrian Patent Lawpreceding Federal Law181/1996, thetermofapatent inAustria
was18years measured from thedateofpublication inthePatent Gazette oftheapplication leading
tothepatent, andcould notexceed 20years from thedateoffiling oftheapplication. Theclause
concerning publication wasdeleted inthe1996revision totheAustrian patent act,withtheeffect that
patents inAustria canenjoy atermupto20years measured from thefiling dateoftheapplication.
The1996 legislation, however, doesnotcontain provisions thatmandate thatanypatent stillinforce
on1January 1996, orwhich derives fromanapplication filedonorbefore 1January 1996, shallenjoy
atermofnotlessthan20years measured from thefiling dateoftheapplication, consistent with
Article 70.2oftheTRIPS Agreement, which requires every WTO Member toapply thetermprovisions
ofArticle 33oftheTRIPS Agreement tosubject matter existing onthedateofapplication oftheTRIPS
Agreement tothatMember (i.e., 1January 1996). Recognizing thatmany patents granted inAustria
prior tothechange inthelawweregiven atermoflessthan20years fromtheireffective filing date,
please explain howAustrian lawcomplies withArticles 70.2and33oftheTRIPS Agreement.IP/C/W/59
Page13
Protection ofundisclosed information
7. Please explain howundisclosed information isprotected inAustria, andthelegalbasisforsuch
protection [NOTE: nonotification fromAustria concerning protection ofundisclosed information had
beendistributed bytheWTO Secretariat atthetimethese questions were prepared].
8. Please indicate thenature ofmeasures, ifany,thataretaken byjudicial authorities inAustria
toprotect theconfidentiality ofundisclosed information furnished byaparty tothecourt during legal
proceedings, when theinformation hasbeenprovided either toenforce rights insuchinformation, or
forother purposes.
9. Please explain themeasures, ifany,thathavebeenimplemented inAustria toprotect against
unfair competition those parties thathave provided confidential testorother dataconcerning a
pharmaceutical oragricultural chemical product toAustrian regulatory authorities pursuant toarequest
formarketingapprovalandhowsuchmeasuresareconsistentwithArticle39.3oftheTRIPSAgreement.
Please explain whether theinformation isprotected against disclosure indefinitely, orisonlyprotected
foraspecific period oftime.
BELGIUM
Patents
1. Article 3-1(3) oftheBelgian Patent Lawprovides that"programs forcomputers" arenot
considered tobeinventions. Please explain whether, under thisprovision, inventions within the
categories specified below arenoteligible tobepatented under Belgian law,notwithstanding thefact
thattheinvention isnovel, involves aninventive step,andisuseful:
(a) process inventions which, inwhole orinpart,consist ofsteps thatareperformed by
acomputer andaredirected byacomputer program;
(b) product inventions consisting ofelements ofacomputer-implemented invention,
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.
Ifanyofthese types ofinventions areexcluded fromeligibility tobepatented, please explain
howBelgian patent lawcomplies withtheobligations ofArticle 27oftheTRIPS Agreement, which
mandates patent eligibility forallcategories ofinvention without discrimination.
2. Article 27.1(c) oftheBelgian Patent Lawdefines certain actsrelating theproduct ofapatented
process asbeing actsofinfringement, consistent withtherequirements ofArticle 28.1(b) oftheTRIPS
Agreement. Please explain howBelgian lawcomplies withtheobligations ofArticle 34oftheTRIPS
Agreement, which requires Members tomake available incivilproceedings toenforce apatent the
option ofshifting theburden ofproof regarding useofapatented process toanalleged infringer who
hasproduced theidentical product asthatwhich isproduced byapatented process.IP/C/W/59
Page14
3. Articles 31to38oftheBelgian patent lawestablish acompulsory licensing system forpatents.
Concerning thissystem, please explain:
(a) whetherthepatentownersatisfiestherequirementfor"effectiveandcontinuousworking
within Belgium" under Article 31.1(1) bydemonstrating thatproducts subject tothe
patent havebeenimported byhimintoBelgium, andifnot,howthisprovision complies
withArticle27oftheTRIPSAgreementwhichprohibitsdiscriminationintheenjoyment
ofrights based onthelocation ofmanufacture ofproducts;
(b) whether acompulsory licence canbegranted within Belgium under apatent covering
aninvention inthefieldofsemiconductor technology forfailure towork theinvention,
orduetothepresence ofadominant patent, andifso,howthissystem complies with
Article 31(c); and
(c) whether thephrase "particular technical importance" inArticle 31.1(2) oftheBelgian
patent lawisconsidered tobeequivalent tothephrase "important technical advance
ofconsiderable economic significance" asitisusedtoevaluate thesignificance ofa
dependent patented invention inrelation tothedominant patent, andifnot,howthis
provision complies withArticle 31(l)(i) oftheTRIPS Agreement.
4. Please indicate howmany compulsory licences onayearly basishavebeengranted inBelgium
since 1January 1993.
Protection ofundisclosed information
5. Please explain howundisclosed information isprotected inBelgium, andthelegalbasis for
suchprotection [NOTE: nonotification fromBelgium concerning protection ofundisclosed information
hadbeendistributed bytheWTO Secretariat atthetimethese questions were prepared].
6. Please indicate thenature ofmeasures, ifany,thataretaken byjudicial authorities inBelgium
toprotect theconfidentiality ofundisclosed information furnished byaparty tothecourt during legal
proceedings, when theinformation hasbeenprovided either toenforce rights insuchinformation, or
forother purposes.
7. Please explain themeasures, ifany,thathavebeenimplemented inBelgium toprotect against
unfair competition those parties thathave provided confidential testorother dataconcerning a
pharmaceutical oragricultural chemical product toBelgian regulatory authorities pursuant toarequest
formarketingapprovalandhowsuchmeasuresareconsistentwithArticle39.3oftheTRIPSAgreement.
DENMARK
Patents
1. Section2(iii)oftheDanishPatentsActprovidesthat"computerprograms"arenottoberegarded
as"inventions." Please explain whether, under thisprovision, inventions within thecategories specified
below arenoteligible tobepatented under Danish law,notwithstanding thefactthattheinvention
isnovel, involves aninventive step,andisuseful:
(a) process inventions which, inwhole orinpart,consist ofsteps thatareperformed by
acomputer andaredirected byacomputer program;IP/C/W/59
Page15
(b) product inventions consisting ofelements ofacomputer-implemented invention,
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.
Ifanyofthese types ofinventions areexcluded fromeligibility tobepatented, please explain
howDanish patent lawcomplies withtheobligations ofArticle 27oftheTRIPS Agreement, which
mandates patent eligibility forallcategories ofinvention without discrimination.
2. Section 45oftheDanish Patents Actpermits theissuance ofacompulsory licence under a
patent thathasnotbeenworked orbrought intousetoareasonable extent inDenmark. Theprovision
further provides thattheevaluation ofwhether these standards aremetwillpermit consideration of
whether there hasbeenasufficient working oftheinvention inaforeign state, provided thatforeign
statereciprocates insuchanevaluation. With regard tothese provisions, please explain:
(a) whether importation ofapatented product atalevel which satisfies Danish market
demands willsatisfy therequirement ofapatent owner tobring theinvention intouse
toareasonable extent inDenmark, andifnot,please explain howthisprovision
complies withArticle 27.1oftheTRIPS Agreement, which precludes discrimination
intheenjoyment ofpatent rights withregard tolocalmanufacture orimportation of
thepatented invention; and
(b) explain howDenmark evaluates reciprocity ifaforeign statedoesnotpermit the
possibility ofissuance ofcompulsory licences.
3. Sections 45to50oftheDanish Lawpermit theissuance ofinvoluntary (compulsory) licences
under apatent foravariety ofreasons. Please explain howthisregime complies withtherequirements
ofArticle 31oftheTRIPS Agreement, andinparticular:
(a) howSection 46oftheDanish Patent Lawconcerning dependent patent compulsory
licences complies withtherequirement ofArticle 31(l)(i) thatthedependent patent
concern aninvention thatinvolves "animportant technical advance ofconsiderable
economic significance inrelation totheinvention claimed inthe"dominant patent;
(b) howSections 45to50comply withtherequirement ofArticle 31(c) oftheTRIPS
Agreement, which specifies thatlicences forinventions inthefieldofsemiconductor
technology mayonlybejustified forpublic non-commercial useortoremedy ajudicial
oradministrative finding ofanti-competitive practices; and
(c) whatfactors areusedbyDanish courts todetermine compensation under acompulsory
licence, andwhether courts arerequired toensure thatremuneration takesintoaccount
theeconomic value oftheauthorization.
4. Please indicate howmany compulsory licences onayearly basishavebeengranted inDenmark
since 1January 1993.IP/C/W/59
Page16
Protection ofundisclosed information
5. Please explain howundisclosed information isprotected inDenmark, andthelegalbasis for
suchprotection.
6. Please indicate thenature ofmeasures, ifany,thataretaken byjudicial authorities inDenmark
toprotect theconfidentiality ofundisclosed information furnished byaparty tothecourt during legal
proceedings, when theinformation hasbeenprovided either toenforce rights insuchinformation, or
forother purposes.
7. Please explain themeasures, ifany,thathavebeenimplemented inDenmark toprotect against
unfair competition those parties thathave provided confidential testorother dataconcerning a
pharmaceutical oragricultural chemical product toDanish regulatory authorities pursuant toarequest
formarketingapprovalandhowsuchmeasuresareconsistentwithArticle39.3oftheTRIPSAgreement.
Please explain whether theinformation isprotected against disclosure indefinitely, orisonlyprotected
foraspecific period oftime.
FINLAND
Patents
1. Article 1(3)oftheFinnish Patents Actof1967 (lastmodified 22December 1995) provides
that"programs forcomputers" arenottoberegarded as"inventions". Please explain whether, under
thisprovision, inventions within thecategories specified below arenoteligible tobepatented under
Finland law,notwithstanding thefactthattheinvention isnovel, involves aninventive step, andis
useful:
(a) process inventions which, inwhole orinpart,consist ofsteps thatareperformed by
acomputer andaredirected byacomputer program;
(b) product inventions consisting ofelements ofacomputer-implemented invention,
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.
Ifanyofthese types ofinventions areexcluded fromeligibility tobepatented, please explain
howFinnish patent lawcomplies withtheobligations ofArticle 27oftheTRIPS Agreement, which
mandates patent eligibility forallcategories ofinvention without discrimination.IP/C/W/59
Page17
2. Under Article 2oftheFinnish Patent Law,pharmaceutical products maybepatented inFinland.
Itisourunderstanding thatsuchprotection wasextended in1987. Please explain whether anapplication
filedpriorto1January1996,whichcontainedclaimsonlytoamethodofmanufacturingapharmaceutical
product maybeamended toinclude aclaim tothepharmaceutical product perse.Ifnot,please explain
howtheFinnish patent lawcomplies withArticle 70.7oftheTRIPS Agreement, which mandates that
incases where protection issubject toregistration (e.g. forpatents), WTO Members must permit
applicants whose applications werepending onthedatetheAgreement became applicable totheMember
toamend theirapplications toclaim anyenhanced protection under theprovisions oftheAgreement.
3. Article 3(1)exempts from thescope oftheexclusive rights ofapatent a"usewhich isnot
commercial." Please explain howthisprovision hasbeeninterpreted byFinnish courts bygiving
examples, ifany,ofthetypes ofactivities thathavebeenfound tobe"non-commercial" andpermissible
without theconsent ofthepatent owner. Please alsoexplain whether Finnish courts consider the
economic effect ofthenon-commercial activities being conducted byapartyotherthanthepatent owner.
Ifthecourts donotconsider thisvariable, please explain howthisprovision ofFinnish lawcomplies
withArticles 28and30oftheTRIPS Agreement, which collectively require thattheeconomic effect
oftheactivities onthepatent owner beconsidered.
4. Article 45permits theissuance ofacompulsory licence under apatent thathasnotbeenworked
orbrought intousetoareasonable extent inFinland. Theprovision further provides thattheevaluation
ofwhether these standards aremetwillpermit consideration ofwhether there hasbeenasufficient
working oftheinvention inaforeign state, provided thatforeign statereciprocates insuchanevaluation.
With regard tothese provisions, please explain:
(a) whether importation ofapatented product atalevel which satisfies Finnish market
demands willsatisfy therequirement ofapatent owner tobring theinvention intouse
toareasonable extent inFinland, andifnot,please explain howthisprovision complies
withArticle 27.1oftheTRIPS Agreement, which precludes discrimination inthe
enjoyment ofpatent rights withregard tolocal manufacture orimportation ofthe
patented invention; and
(b) explain howFinland evaluates reciprocity ifaforeign state does notpermit the
possibility ofissuance ofcompulsory licences.
5. Articles 45to50oftheFinnish lawpermit theissuance ofinvoluntary (compulsory) licences
under apatent foravariety ofreasons. Please explain howthisregime complies withtherequirements
ofArticle 31oftheTRIPS Agreement, andinparticular:
(a) howArticle 46oftheFinnish patent lawconcerning dependent patent compulsory
licences complies withtherequirement ofArticle 31(l)(i) thatthedependent patent
concern aninvention thatinvolves "animportant technical advance ofconsiderable
economic significance inrelation totheinvention claimed inthe"dominant patent;
(b) howArticles 45to50comply withtherequirement ofArticle 31(c) oftheTRIPS
Agreement, which specifies thatlicences forinventions inthefieldofsemiconductor
technology mayonlybejustified forpublic non-commercial useortoremedy ajudicial
oradministrative finding ofanti-competitive practices; and
(c) whatfactors areusedbyFinnish courts todetermine compensation under acompulsory
licence, andwhether courts arerequired toensure thatremuneration takesintoaccount
theeconomic value oftheauthorization.IP/C/W/59
Page18
6. Please indicate howmany compulsory licences onayearly basishavebeengranted inFinland
since 1January 1993.
Protection ofundisclosed information
7. Please explain themeasures, ifany,thathavebeenimplemented inFinland toprotect against
unfair competition those parties thathave provided confidential testorother dataconcerning a
pharmaceutical oragricultural chemical product toFinnish regulatory authorities pursuant toarequest
formarketing approval.
8. Please explain whether Finnish lawconditions theenjoyment ofprotection intestdataprovided
toaFinnish regulatory agency onthecoexistence ofpatent rights intheregulated product. Ifsuch
acondition isimposed (i.e.,thedataisprotected against disclosure tothirdparties onlywhile apatent
remains inforce covering theproduct), please explain howtheFinnish lawcomplies with the
requirements ofArticle 39.3oftheTRIPS Agreement, which requires WTO Members toprevent use
ofsuchdatainsuchafashion astorepresent unfair competition totheparty supplying thedataand
doesnotcondition enjoyment ofthisprotection ontheexistence ofconcurrent patent protection.
FRANCE
Patents
1. Section L.611-10(2) oftheFrench Patent Lawprovides that"programs forcomputers" are
notconsidered tobeinventions. Please explain whether, under thisprovision, inventions within the
categories specified below arenoteligible tobepatented under French law,notwithstanding thefact
thattheinvention isnovel, involves aninventive step,andisuseful:
(a) process inventions which, inwhole orinpart,consist ofsteps thatareperformed by
acomputer andaredirected byacomputer program;
(b) product inventions consisting ofelements ofacomputer-implemented invention,
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.
Ifanyofthese inventions arenoteligible tobepatented, please explain howthisprovision
oftheFrench patent lawcomplies withtheobligations ofArticle 27oftheTRIPS Agreement, which
mandates patent eligibility forallcategories ofinvention without discrimination.
2. Please indicate whether inventions consisting ofnucleic acidsequences thatcorrespond toor
arederived fromhuman genetic material canbepatented inFrance iftheyarenew,involve aninventive
stepandarecapable ofindustrial application. Ifthisisnotthecase, please identify theprovisions
ofFrench lawthatpreclude thepatenting ofsuchinventions, andexplain howsuchprovisions are
consistent withArticle 27oftheTRIPS Agreement. Please identify anddescribe anyother restrictions
thatareplaced onthepatenting oforenjoyment ofpatent rights inrespect ofinventions inthefield
ofbiotechnology.IP/C/W/59
Page19
3. Sections L613-11 toL.613-14 oftheFrench Patent Lawestablish asystem forthegrant of
compulsory licences. Please explain howthese provisions areconsistent withtherequirements of:
(a) Article 31(b) thatanycompulsory licence granted bytheFrench Government contain
"reasonable commercial terms andconditions" forthecompulsory licence andinclude
thelimitation of"areasonable period oftime" fortheduration oflicence;
(b) Article 31(f)thatthelicence permit use"predominately forthesupply ofthedomestic
market oftheMember authorizing suchuse";
(c) Article 31(g) thattheFrench Government terminate acompulsory licence "ifandwhen
thecircumstances which ledtoitcease toexistandareunlikely torecur"; and
(d) Article 31(h) thataright holder shall bepaid "adequate remuneration inthe
circumstancesofeachcase,takingintoaccounttheeconomicvalueoftheauthorization".
4. SectionsL.613-16andL.613-17oftheFrenchPatentLawestablishasystemofexofficiolicences
inthecaseofpatents granted formedicines andforprocesses forproducing medicines, forproducts
necessary inobtaining suchmedicines orforprocesses formanufacturing suchproducts. Please explain
howthisauthority concerning exofficio licences complies withArticle 31(b), (c),(d),(f),(g),(h),
(i),and(j)oftheTRIPS Agreement.
5. Section L.613-18 oftheFrench Patent Lawestablishes asystem ofexofficio licences inthe
caseofpatents thatarenotworked soastosatisfy therequirements ofthenational economy. With
respect tothisprovision oftheFrench Patent Law:
(a) Please indicate whether theGovernment ofFrance considers theimportation ofproducts
covered byapatent1tosatisfy therequirement of"working" apatent within themeaning
ofSection L.613-18 oftheFrench Law.
(b) Iftheanswer toquestion 4(a)is"no", please explain howSection L.613-18 ofthe
French patent lawcomplies withtherequirement inArticle 27oftheTRIPS Agreement
which prohibits discrimination intheenjoyment ofpatent rights based ontheplace
ofmanufacture oftheinvention.
(c) Inaddition, regardless oftheanswer toquestion 4(a), please explain howSection
L.613-18 oftheFrench patent lawcomplies withtheprovisions ofArticle 31(b), (c),
(f),(g),(h),(i),and(j)oftheTRIPS Agreement.
6. Section L.613-19 oftheFrench Lawestablishes asystem ofexofficio licences toallow the
working ofapatented invention inorder tomeet defense requirements irrespective ofwhether the
working istobedone bytheState itself oronitsbehalf. Please explain howthisprovision ofthe
French patent lawcomplies withArticles 31(b), (c),(d),(f),(g),(h),(i),and(j)oftheTRIPS
Agreement.
1Theterm "covered byapatent" asused here means thattheproduct iscovered directly byaproduct
patent claim orindirectly asaproduct produced byapatented process.IP/C/W/59
Page20
7. Article 31(c) oftheTRIPS Agreement specifies thatnocompulsory licence shallbegranted
byaMember under apatent concerning aninvention inthefieldofsemi-conductor technology except
forpublic non-commercial useortoremedy apractice determined afterjudicial oradministrative process
tobeanti-competitive. Noprovision intheFrench patent lawappears tolimit theavailability of
compulsory licences withrespect topatented inventions inthefieldofsemi-conductor technology.
Please explain howFrench lawcomplies withtheobligations ofArticle 31(c) oftheTRIPS Agreement.
8. Please indicate howmany compulsory licences onayearly basishavebeengranted inFrance
since 1January 1993.
9. Section L.613-3 oftheFrench Patent Lawdefines certain actsrelating toaproduct ofapatented
process tobeactsofinfringement, consistent withtherequirements ofArticle 28.1(b) oftheTRIPS
Agreement. Please explain howFrench lawcomplies withtheobligations ofArticle 34oftheTRIPS
Agreement, which requires Members tomake available incivilproceedings toenforce apatent the
option ofshifting theburden ofproof regarding useofapatented process toanalleged infringer who
hasproduced theidentical product asthatwhich isproduced byapatented process.
Protection ofundisclosed information
10. Please describe howFrench authorities responsible forthegranting ofmarketing approval for
regulated products (e.g. pharmaceuticals, agricultural orother chemical products) handle testdata
provided totheauthority forthepurpose ofobtaining marketing approval. Inparticular, please explain
thelegaloradministrative measures, ifany,thatserve toprotect suchdatafromdisclosure tothepublic
andfromunfair commercial usebythirdparties. Please explain alsohowthesemeasures areconsistent
withtheobligations ofArticle 39.3oftheTRIPS Agreement.
GERMANY
Patents
1. Article 1oftheGerman Patent Lawprovides that"programs forcomputers" arenotconsidered
tobeinventions. Please explain whether, under thisprovision, inventions within thecategories specified
below arenoteligible tobepatented under German law,notwithstanding thefactthattheinvention
isnovel, involves aninventive step,andisuseful:
(a) process inventions which, inwhole orinpart,consist ofsteps thatareperformed by
acomputer andaredirected byacomputer program,
(b) product inventions consisting ofelements ofacomputer-implemented invention,
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.
Ifanyofthese types ofinvention areexcluded fromeligibility tobepatented, please explain
howtheGerman patent lawcomplies withtheobligations ofArticle 27oftheTRIPS Agreement, which
mandates patent eligibility forallcategories ofinvention without discrimination.IP/C/W/59
Page21
2. Article 9oftheGerman Patent Lawgrants apatent owner ,interalia,theright toprevent
thirdparties fromoffering forsale,stocking, orputting apatented product onthemarket. Article 28
oftheTRIPS Agreement enumerates therights thateachMember country mustconfer toapatent owner.
Included among these rights aretherights toprevent thirdparties from selling thepatented product.
Please explain whether thephrase "putting onthemarket" isinterpreted under German lawtoallow
thepatent owner toprevent thirdparties from selling thepatented invention. Ifnot,please explain
howGerman lawcomplies withtheobligations ofArticle 28oftheTRIPS Agreement.
3. Article 13oftheGerman Patent Lawpermits theFederal Government todeclare thatapatent
"shall havenoeffect" ifitorders theinvention subject tothepatent tobeexploited intheinterest of
public welfare. Article 13(2) provides anavenue forthepatent owner toappeal suchadeclaration,
andArticle 13(3) enables thepatent owner topursue aclaim forreasonable compensation against the
Federal Republic. With regard tothisauthority, please provide answers tothefollowing questions.
(a) Please indicate whether thepatent subject toanorder under Article 13(1) remains in
effect astoparties other thantheFederal Government, orifthepatent isconsidered
nullified orrevoked. Ifthelatter, please explain thebasis intheTRIPS Agreement
under which theGerman Government would bejustified intaking these actions which
materially impair thelegitimate interests ofthepatent owner.
(b) Please indicate howtheauthority specified inArticle 13(1) isconsidered tobeconsistent
withArticles 30and31oftheTRIPS Agreement. Inparticular, please explain how
German lawcomplies withtheconditions concerning usewithout authorization ofthe
patent owner specified inparagraphs (a)to(l)ofArticle 31oftheTRIPS Agreement.
4. Article 24(1) oftheGerman Patent Lawallows forthegranting ofcompulsory licences tothird
parties if"theapplicant orpatentee refuses topermit theexploitation oftheinvention byanother person
offering topayreasonable compensation andtofurnish security therefor". Thelastsentence ofthis
provision specifies that"acompulsory licence maybegranted subject torestrictions andmade dependent
onconditions". Please answer thefollowing questions concerning thisprovision ofGerman law:
(a) Article 5(A)(4) oftheParisConvention, asmade applicable toWTO Members through
Article 2.1oftheTRIPS Agreement, specifies that"nocompulsory licence maybe
applied forontheground offailure towork orinsufficient working prior tothe
expiration ofaperiod offouryears from thedateoffiling ofthepatent application
orthreeyears fromthedateofthegrantofthepatent, whichever period expires last...".
Nolimitation appears intheGerman patent lawconcerning theearliest dateonwhich
athirdparty isabletoapply fororobtain acompulsory licence. Please explain how
German lawcomplies withArticle 2.1oftheTRIPS Agreement totheextent it
incorporates theobligations ofArticle 5(A)(4) oftheParis Convention.
(b) Noprovisions intheGerman Patent Lawappear toaddress thenumerous specific
conditions found inArticle 31oftheTRIPS Agreement. Accordingly, please explain
howGerman lawcomplies witheachoftherequirements ofArticles 31(a) to(l)of
theTRIPS Agreement.
(c) Please identify thespecific legal orregulatory provisions thatgovern thesetting of
conditions ofacompulsory licence under German law.
(d) Please explain theprocedures thatgovern theevaluation andgrant ofanapplication
foracompulsory licence inGermany.IP/C/W/59
Page22
5. Please indicate howmany compulsory licences onayearly basishavebeengranted inGermany
since 1January 1993.
6. Article 24(2) oftheGerman Patent Lawstates that"forfeiture ofapatent shallbepronounced
iftheinventionisexclusivelyormainlyexploitedoutsideGermany".Pleaseexplainwhetherimportation
cansatisfy thestandard specified in24(2) oftheGerman Patent Law, andifnot,please explain how
thisprovision complies withArticle 27.1oftheTRIPS Agreement, which precludes discrimination
intheenjoyment ofpatent rights withregard tolocal manufacture orimportation ofthepatented
invention.
7. Article 30oftheTRIPS Agreement allows Member countries toprovide limited exceptions
totheexclusive rights granted bythepatent provided these exceptions donot"unreasonably conflict
withanormal exploitation ofthepatent anddonotunreasonably prejudice thelegitimate interests of
thepatent owner". Articles 11and13oftheGerman Patent Lawprovide forexceptions toapatent
owner ’sexclusive rights for"private andnon-commercial purposes" (Article 11(1)) andforpublic
welfare andsecurity (Article 13(1)). Please explain howeachofthese exceptions complies with
Article 30.
Protection ofundisclosed information
8. Please indicate thenature ofmeasures, ifany,thataretaken byjudicial authorities inGermany
toprotect theconfidentiality ofundisclosed information furnished byaparty tothecourt during legal
proceedings, when theinformation hasbeenprovided either toenforce rights insuchinformation, or
forother purposes.
9. Please explain themeasures, ifany,thathavebeenimplemented inGermany toprotect against
unfair competition those parties thathave provided confidential testorother dataconcerning a
pharmaceutical oragricultural chemical product toGerman regulatory authorities pursuant toarequest
formarketing approval. Please explain howsuchmeasures, ifany,areconsistent withArticle 39.3
oftheTRIPS Agreement.
GREECE
Patents
1. Subsection 2(c)ofArticle 5oftheGreek Lawon"Technology transfer, inventions, and
technological innovation", makes computer programs unpatentable. Please explain whether, under
thisprovision, inventions within thecategories specified below arenoteligible tobepatented under
Greek law,notwithstanding thefactthattheinvention isnovel, involves aninventive step,andisuseful:
(a) process inventions which, inwhole orinpart,consist ofsteps thatareperformed by
acomputer andaredirected byacomputer program;
(b) product inventions consisting ofelements ofacomputer-implemented invention,
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.IP/C/W/59
Page23
Ifanyofthese types ofinvention areexcluded from eligibility tobepatented, please explain
howtheGreek Patent Lawcomplies withtheobligations ofArticle 27oftheTRIPS Agreement, which
mandates patent eligibility forallcategories ofinvention without discrimination.
2. Please explain howArticle 12ofGreece ’sLawon"Technology transfer, inventions, and
technological innovation", which imposes alimitation ontherightofapatent owner toassign rights
ortoconclude licensing contracts bymaking themeffective onlyaftertheyareentered intothepatent
register, complies withArticle 28.2oftheTRIPS Agreement.
3. Article 13ofGreece ’sLawon"Technology transfer, inventions, andtechnological innovation"
doesnotappear torequire thattheapplicant foracompulsory licence demonstrate thathehasmade
efforts toobtain authorization fromthepatentee onreasonable commercial terms andconditions. The
applicant apparently needonlynotify thepatentee onemonth prior toinitiating judicial proceedings
foracompulsory licence. Please explain howtheconditions forcompulsory licensing setoutin
Article 31oftheTRIPS Agreement aremetinconnection withArticle 13.
4. Please indicate howmany compulsory licences onayearly basishavebeengranted inGreece
since 1January 1993.
Protection ofundisclosed information
5. Please explain howundisclosed information isprotected inGreece, andthelegalbasisforsuch
protection [NOTE: nonotification fromGreece concerning protection ofundisclosed information had
beendistributed bytheWTO Secretariat atthetimethese questions were prepared].
6. Please indicate thenature ofmeasures, ifany,thataretaken byjudicial authorities inGreece
toprotect theconfidentiality ofundisclosed information furnished byaparty tothecourt during legal
proceedings, when theinformation hasbeenprovided either toenforce rights insuchinformation, or
forother purposes.
7. Please explain themeasures, ifany,thathavebeenimplemented inGreece toprotect against
unfair competition those parties thathave provided confidential testorother dataconcerning a
pharmaceutical oragricultural chemical product toGreek regulatory authorities pursuant toarequest
formarketingapprovalandhowsuchmeasuresareconsistentwithArticle39.3oftheTRIPSAgreement.
8. Under theGreek Ministerial Decree 9392/91, protection ofdataprovided toGreek regulatory
agency pursuant toparty’sefforts toobtain marketing approval isconditioned ontheco-existence of
apatent covering theregulated product. Please explain howthispractice complies withArticle 39.3
oftheTRIPS Agreement, which does notcondition theavailability ofprotection against unfair
competition withregard totestdataontheco-existence ofpatent protection.
IRELAND
Patents
1. Subsection 9(2)oftheIrishPatents Act,1992, provides thatcomputer programs arenotto
beregarded asaninvention within themeaning ofthePatent Act. Please explain whether, under this
provision, inventions within thecategories specified below arenoteligible tobepatented inIreland,
notwithstanding thefactthattheinvention isnovel, involves aninventive step,andisuseful:IP/C/W/59
Page24
(a) process inventions which, inwhole orinpart,consist ofsteps thatareperformed by
acomputer andaredirected byacomputer program;
(b) product inventions consisting ofelements ofacomputer-implemented invention,
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.
Ifanyofthese types ofinvention areexcluded fromeligibility tobepatented, please explain
howtheIrishpatent lawcomplies withtheobligations ofArticle 27oftheTRIPS Agreement, which
mandates patent eligibility forallcategories ofinvention without discrimination.
2. Paragraph 13oftheFirstSchedule concerning transitional measures ofthe1992IrishPatents
Actspecifies thatanyapplication foracompulsory licence under Article 42ofthe1964Actthatwas
pending atthecommencement ofthisAct(27February 1992) shallbedecided under theprovisions
oftheActof1964. Article 42ofthe1964Patents Actdiscriminates initsapplication between patents
covering pharmaceuticals andpatents covering inventions inother areas oftechnology. Article 70.6
oftheTRIPS Agreement specifies thatMembers arenotobliged toapply therequirements ofArticle 31
concerning compulsory licences orArticle 27.1concerning non-discrimination intheavailability or
enjoyment ofpatent rights where usebyathirdparty hasbeenauthorized bytheMember before the
datethisAgreement became known. With regard tothese provisions:
(a) Please indicate whether theIrishGovernment hasgranted anycompulsory licences
onthebasis ofanapplication filedunder the1964 Act,where thedecision togrant
thelicence wasmade onorafter20December 1992. Iftheanswer is"yes", please
explain howsuchanaction complies withArticle 70.6oftheTRIPS Agreement.
(b) Please indicate whether itisthepolicy oftheIrishGovernment todenyapproval of
anyapplication thatissubject tothistransitional provision where suchapplications
remained pending onorafter20December 1992.
(c) Please explain howparagraph 13ofthetransitional measure, totheextent itpermits
theissuance ofacompulsory licence ontheterms ofthe1964 Act,complies with
Articles 27and70.6oftheTRIPS Agreement.
3. Articles 70(2)(a), (b)and(c)oftheIrishPatents Actof1992 provide fortheavailability of
compulsory licences insituations involving inadequate working ofaninvention within Ireland. Ineach
ofthese provisions, importation iscastasacondition thatjustifies thegrant ofaninvoluntary licence.
Please explain howthese provisions comply withtherequirement ofArticle 27.1oftheTRIPS
Agreement, which precludes discrimination intheenjoyment ofpatent rights withregard tolocal
manufacture orimportation ofthepatented invention.
4. Article 72(1) oftheIrishPatents Actspecifies thatanyMinister oftheGovernment may, after
aspecified period, request theController ofPatents tospecify that,ononeofthegrounds forissuance
ofacompulsory licence, thepatent bedesignated ashaving alicence ofrightthatpermits anyinterested
party torequest andobtain acompulsory licence under thepatent. Please explain howthisprovision
complieswiththerequirementofArticle31(a)oftheTRIPSAgreement,whichspecifiesthatapplications
forcompulsory licences aretobeconsidered ontheirindividual merits.IP/C/W/59
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5. Article 75(1) oftheIrishPatents Actspecifies thatacompulsory licence granted under the
Actshall"have effect asifitwereadeed". Please explain whether thisprovision enables therecipient
ofacompulsory licence toassign thecompulsory licence toathirdparty without having toassign along
withthelicence thatpartoftheenterprise orgoodwill which istoenjoy thebenefits ofthelicence.
Ifthisisthecase,please explain howthisprovision oftheIrishPatents Actcomplies withArticle 31(d)
oftheTRIPS Agreement.
6. Under Article 31oftheTRIPS Agreement, numerous conditions mustbeadhered tobyWTO
Members should suchMembers provide forthepossibility ofgranting involuntary licences under a
patent. Articles 70to75oftheIrishPatents Actestablishes asystem whereby suchlicences maybe
granted. These provisions aresilent onanumber oftheelements required byArticle 31.Inview
ofthis,please explain howIrishpatent lawcomplies withthefollowing requirements ofArticle 31
oftheTRIPS Agreement, andinparticular thatthefollowing conditions beassociated withthegrant
ofanycompulsory licence:
(a) thatthelicence begranted onlyif,prior totheauthorization, theparty seeking the
licence hassought unsuccessfully toobtain avoluntary licence fromthepatent owner
onreasonable commercial terms andconditions andwithin areasonable period
[Article 31(b)];
(b) thescope andduration ofthelicence belimited tothepurpose forwhich itwas
authorized [Article 31(c)];
(c) thatthelicence benon-exclusive [Article 31(d)];
(d) thatthelicence benon-assignable, except withthatpartoftheenterprise orgoodwill
which enjoys theuseofthepatented invention [Article 31(e)];
(e) thatthelicence authorize useofthepatented invention predominantly forthesupply
ofthedomestic market oftheMember [Article 31(f)];
(f) thatthelicence besubject totermination iftheconditions thatledtoitsissuance cease
toexistandareunlikely torecur [Article 31(g)];
(g) thatthepatent owner bepaidadequate remuneration thatreflects, inter alia,the
economic value ofthelicence [Article 31(h)]; and
(h) thatwithrespect todependent patents, theinvention claimed inthedependent patent
beanimportant technical advance ofconsiderable economic significance overthe
original patented invention, thattheowner ofthedominant patent beissued a
cross-licence forthedependent patent, andthatthelicence ofthedependent patent
notbeassignable except withtheassignment ofthesecond patent [Article 31(l)].
7. Please explain howtheIrishlawcomplies withtheobligations ofArticle 31(c) oftheTRIPS
Agreement, which specifies thatcompulsory licences under apatent notbeissued withregard to
inventions inthefieldofsemiconductor technology other thanforpublic non-commercial useorto
remedy adjudicated findings ofanti-competitive practices bythepatent owner.
8. Please indicate howmany compulsory licences onayearly basishavebeengranted inIreland
since 1January 1993.IP/C/W/59
Page26
9. Paragraph 4ofthetransitional provisions oftheFirstSchedule tothe1992 IrishPatents Act
specifies thatapatent owner maynotinstitute actions forinfringement against athird party during
thefinaltwoyears ofthe20yearpatent termifthethirdparty hasmade certain preparations forputting
theinvention intoeffect commercially aftertheexpiration ofthepatent term. Article 70.4oftheTRIPS
Agreement specifies thatWTO Members maylimittherights given topatent owners vis-à-vis parties
thathavecommenced useoforwhohavemade substantial investments prior tothedateofacceptance
oftheAgreement bytheMember. Should suchalimitation beimposed, theWTO Member must at
leastprovide forequitable remuneration tothepatent owner. Noconditions concerning thedateon
which athirdparty hasengaged inthequalifying activities oronequitable remuneration canbefound
inparagraph 4ofthetransitional procedures. Please explain howIrishlawcomplies withArticle 70.4
oftheTRIPS Agreement.
LUXEMBOURG
Patents
1. Article 5(3)ofthePatent LawofLuxembourg permits theprovides thatapatent thatthepatent
willcease tohaveeffect byaroyal Grand-Ducal order, under theadvice oftheCounsel ofState, where
itisdeemed inthepublic interest. Withregard tothisauthority, please provide answers tothefollowing
questions.
(a) Please indicate whether thepatent subject tosuchanorder remains ineffect astoparties
other thanthegovernment, orifthepatent isconsidered nullified orrevoked. Ifthe
latter, please explain thebasisintheTRIPS Agreement under which theGovernment
ofLuxembourg would bejustified intaking these actions which materially impair the
legitimate interests ofthepatent owner.
(b) Please indicate howtheauthority specified inArticle 13(1) isconsidered tobeconsistent
withArticles 30and31oftheTRIPS Agreement. Inparticular, please explain how
thelawofLuxembourg complies with theconditions concerning usewithout
authorization ofthepatent owner specified inparagraphs (a)to(l)ofArticle 31of
theTRIPS Agreement.
2. Thefirstparagraph ofArticle 18ofthePatent LawofLuxembourg provides thatthepatent
maybewithdrawn ("retiré") byroyal Grand-Duchy order ifthepatent holder doesnotexploit his
invention intheGrand-Duchy inasuitable amount ordoeslessthanisnecessary toassure this
exploitation. With regard tothisprovision, please explain:
(a) howthePatent LawofLuxembourg complies withtheobligations Article 33ofthe
TRIPS Agreement withrespect toactions towithdraw thepatent priorto20years from
thedateoffiling ofthepatent application;
(b) howtheprovision complies withtheobligations ofArticle 30and31oftheTRIPS
Agreement; and
(c) iftheprovision isinterpreted soasbeapplicable based onafailure toadequately work
theinventionwithintheterritorialconfinesofLuxembourg,howthisprovisioncomplies
withArticle 27.1oftheTRIPS Agreement, which specifies thatpatent rights shallbe
enjoyable whether products areimported orlocally produced.IP/C/W/59
Page27
3. Thesecond paragraph ofArticle allows athirdparty without theconsent ofthepatent owner
toexploit aninvention ifsogranted byroyal Grand-Ducal order upon demand andifitisdeemed in
thepublic interest. Noprovisions intheLuxembourg patent lawappear toaddress thenumerous specific
conditions found inArticle 31oftheTRIPS Agreement. Accordingly, please explain howthelaw
ofLuxembourg complies witheachoftherequirements ofArticles 31(a)to(l)oftheTRIPS Agreement.
4. Please indicate howmany compulsory licences onayearly basis have been granted in
Luxembourg since 1January 1993.
5. Please explain howtheLawofLuxembourg complies withtheobligations ofArticle 34of
theTRIPS Agreement, which requires Members tomake available incivilproceedings toenforce a
patent theoption ofshifting theburden ofproof regarding useofapatented process toanalleged
infringer whohasproduced theidentical product asthatwhich isproduced byapatented process.
NETHERLANDS
Patents
1. Article 2.2(c) oftheNetherlands Patents Actof1995 specifies thatcomputer programs are
nottoberegarded asinventions. Please explain whether, under thisprovision, inventions within the
categories specified below arenoteligible tobepatented intheNetherlands, notwithstanding thefact
thattheinvention isnovel, involves aninventive step,andisuseful:
(a) process inventions which, inwhole orinpart,consist ofsteps thatareperformed by
acomputer andaredirected byacomputer program;
(b) product inventions consisting ofelements ofacomputer-implemented invention,
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.
Ifanyofthese types ofinventions areexcluded fromeligibility tobepatented, please explain
howtheDutch patent lawcomplies withtheobligations ofArticle 27oftheTRIPS Agreement, which
mandates patent eligibility forallcategories ofinvention without discrimination.
2. Please explain howArticles 56.2and65.3oftheNetherlands ’sPatents Actof1995, which
impose alimitation ontherightofapatent owner toconclude licensing contracts ortoassign rights,
respectively bymaking themeffective onlyaftertheyareentered intothepatent register, areconsistent
withArticle 28.2oftheTRIPS Agreement.
3. Articles 57and58oftheNetherlands ’sPatents Actof1995establish asystem forthegranting
ofinvoluntary (compulsory) licences ofDutch patents. Article 58(a) imposes certain conditions that
govern theexercise oravailability ofsuchlicences. Please answer thefollowing questions regarding
thissystem.IP/C/W/59
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(a) Paragraph 2ofArticle 57provides thatacompulsory licence shallbegranted ifneither
thepatent owner noralicensee "operates anindustrial establishment intheKingdom
orinanother State tobedesignated byadministrative order inwhich theproduct
concerned orwhere theprocess concerned isbeing applied ingood faithandona
sufficient scale…".Paragraph 3extends thisprovision tocertain contiguous territories
oftheNetherlands ortheNetherlands Antilles. Please explain whether theDutch
Government hasdecreed through anadministrative order thatactivities inanyWTO
Member shallbeconsidered sufficient tosatisfy theconditions specified forissuance
ofacompulsory licence. Ifthisisnotthecase, please explain howthiscondition
complies withArticle 27.1oftheTRIPS Agreement, which specifies thatpatent rights
shallbeenjoyable whether products areimported orlocally produced.
(b) Article 31(f) imposes anobligation onWTO Members toensure thatthegrant ofa
compulsory licence istobelimited forthepurpose ofsupply ofthedomestic market
oftheMember, rather thanauthorizing unrestricted useoftheinvention (i.e.,topermit
export ofthepatented products toother countries). Therequirement ofcommercial
working oftheinvention within theNetherlands isspecified asacondition tojustify
thegrant ofacompulsory licence inArticle 57.Noprovisions areincluded inthe
Dutch patent law,evenasamended in1995, concerning thescope ofauthorization
tobeprovided under acompulsory licence intheNetherlands. Please explain how
Dutch laworpractice complies withtherequirements ofArticle 31(f) oftheTRIPS
Agreement.
(c) Article 58(6) oftheDutch Patent Lawspecifies thatthecourtshallfixtheremuneration
thatthelicensee hastopaytothepatent owner. Please indicate whether anyother
legal authority governs thesetting oftheamount ofremuneration foracompulsory
licence intheNetherlands, andhowthisprovision isapplied inpractice. Please also
explain how Dutch practice inthisregard complies with therequirements of
Article 31(h), which specifies notonlythatthere isarightofremuneration butthat
theamount oftheremuneration shalltake"into account theeconomic value ofthe
authorization" ofthelicence.
4. Please indicate howmany compulsory licences onayearly basis havebeengranted inthe
Netherlands since 1January 1993.
5. Itisnotclearfrom Part4oftheNetherlands ’sPatents Actof1995 whether injunctions are
available topatent owners against those whoinfringe theirexclusive rights. Please explain ifandhow
apatentee canstoptheactivities ofaninfringer aswellasobtain damages.
Protection ofundisclosed information
6. Please explain howundisclosed information isprotected intheNetherlands, andthelegalbasis
forsuchprotection.
7. Please indicate thenature ofmeasures, ifany,thataretaken byjudicial authorities inthe
Netherlands toprotect theconfidentiality ofundisclosed information furnished byaparty tothecourt
during legal proceedings, when theinformation hasbeenprovided either toenforce rights insuch
information, orforother purposes.IP/C/W/59
Page29
8. Please explain themeasures, ifany,thathavebeenimplemented intheNetherlands toprotect
against unfair competition those parties thathaveprovided confidential testorother dataconcerning
apharmaceutical oragricultural chemical product toDutch regulatory authorities pursuant toarequest
formarketingapprovalandhowsuchmeasuresareconsistentwithArticle39.3oftheTRIPSAgreement.
Please explain whether theinformation isprotected against disclosure indefinitely, orisonlyprotected
foraspecific period oftime.
PORTUGAL
Patents
1. Please explain howPortugal hasimplemented theobligations ofArticle 70.2and70.7, asthey
pertain toArticle 33oftheTRIPS Agreement, given thattheprevious termofprotection under apatent
inPortugal was15years from thedateofgrant, rather than20years from thedateoffiling ofthe
patent application.
2. ThePortuguese patent lawprovides that"programs forcomputers" arenotconsidered tobe
inventions. Please explain whether, under thisprovision, inventions within thecategories specified
below arenoteligible tobepatented under Portuguese law,notwithstanding thefactthattheinvention
isnovel, involves aninventive step,andisuseful:
(a) process inventions which, inwhole orinpart,consist ofsteps thatareperformed by
acomputer andaredirected byacomputer program;
(b) product inventions consisting ofelements ofacomputer-implemented invention,
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.
Ifanyofthese inventions arenoteligible tobepatented, please explain howthePortuguese
patent lawcomplies withtheobligations ofArticle 27oftheTRIPS Agreement, which mandates patent
eligibility forallcategories ofinvention without discrimination.
3. Please explain whether Portuguese lawpermits importation tosatisfy thecondition ofworking
ofapatented invention inconsiderations relating toissuance ofacompulsory licence forinadequate
working oftheinvention inPortugal. Ifnot,please explain howPortuguese lawcomplies with
Article 27.1oftheTRIPS Agreement, which prohibits discrimination intheenjoyment ofpatent rights
based onwhether products areproduced locally orimported.
4. Articles 103,105and106ofthePortuguese Patent Lawappear topermit theissuance ofa
compulsory licence insituations where local manufacture ofapatented invention failtosatisfy the
export market demands forthepatented invention. Please explain howtheseprovisions ofthePortuguese
patent lawcomply withArticle 27.1oftheTRIPS Agreement, andArticle 31(f), which specifies that
theuseauthorized under acompulsory licence bepredominantly forthesupply ofthedomestic market
oftheMember.IP/C/W/59
Page30
5. Please explain howthePortuguese patent lawincorporates theobligations ofparagraphs (a)
to(l)ofArticle 31oftheTRIPS Agreement concerning theconditions andavailability ofcompulsory
licences.
6. Please indicate howmany compulsory licences onayearly basishavebeengranted inPortugal
since 1January 1993.
Protection ofundisclosed information
7. Please explain themeasures, ifany,thathavebeenimplemented inPortugal toprotect against
unfair competition those parties thathave provided confidential testorother dataconcerning a
pharmaceuticaloragriculturalchemicalproducttoPortugueseregulatoryauthoritiespursuanttoarequest
formarketing approval.
8. Please explain whether Portuguese lawconditions theenjoyment ofprotection intestdata
provided toaPortuguese regulatory agency onthecoexistence ofpatent rights intheregulated product.
Ifsuchacondition isimposed (i.e., thedataisprotected against disclosure tothirdparties onlywhile
apatent remains inforce covering theproduct), please explain howthePortuguese lawcomplies with
therequirements ofArticle 39.3oftheTRIPS Agreement, which requires WTO Members toprevent
useofsuchdatainsuchafashion astorepresent unfair competition totheparty supplying thedata
anddoesnotcondition enjoyment ofthisprotection ontheexistence ofconcurrent patent protection.
SPAIN
Patents
1. Article 133oftheSpanish Patent Lawappears torequire thatthepatent owner adequately work
theinvention inSpain inorder togivethepatent owner theability toobtain injunctive relief against
infringing parties. Please explain howthisprovision complies with:
(a) Article 27.1oftheTRIPS Agreement, which prohibits discrimination intheenjoyment
ofpatent rights based onwhether products areproduced locally orimported; and
(b) Article 28oftheTRIPS Agreement, which requires thatthepatent owner begiven
exclusive rights which arenotconditioned inanyform.
Protection ofundisclosed information
2. Article 11ofRoyal Decree 767/1993 linkstheavailability ofprotection forconfidential test
orother datasubmitted toaSpanish regulatory agency totheexistence ofapatent inforce thatcovers
theproduct subject totheregulatory review. Please explain howthisprovision oftheSpanish law
complies withArticle 39.3oftheTRIPS Agreement, which requires protection beprovided against
unfair competition arising fromuseofconfidential information submitted pursuant totheparty seeking
marketing approval, andwhich doesnotcondition theenjoyment ofthisprotection ontheexistence
ofpatent rights.IP/C/W/59
Page31
SWEDEN
Patents
1. Article 1(3)oftheSwedish Patents Actspecifies that"aprogram forcomputers" shallnever
beregardedasaninvention.Pleaseexplainwhether,underthisprovision,inventionswithinthecategories
specified below arenoteligible tobepatented under Swedish law,notwithstanding thefactthatthe
invention isnovel, involves aninventive step,andisuseful:
(a) process inventions which, inwhole orinpart,consist ofsteps thatareperformed by
acomputer andaredirected byacomputer program;
(b) product inventions consisting ofelements ofacomputer-implemented invention,
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.
Ifanyofthese types ofinventions areexcluded fromeligibility tobepatented, please explain
howtheSwedish patent lawcomplies withtheobligations ofArticle 27oftheTRIPS Agreement, which
mandates patent eligibility forallcategories ofinvention without discrimination.
2. Section 3oftheSwedish Patents Actexcludes from thedefinition oftheexclusive rights of
apatent useswhich are"notcommercial". Some non-commercial exploitation ofapatented invention
could "unreasonably prejudice thelegitimate rights ofpatent owners" byhaving theeffect ofcausing
economic harm tothepatent owner ’sinterests. Please explain howthisprovision hasbeeninterpreted
bySwedish courts bygiving examples, ifany,ofthetypes ofactivities thathavebeenfound tobe
"non-commercial" andpermissible without theconsent ofthepatent owner. Please alsoexplain whether
Swedish courts consider theeconomic effect ofthenon-commercial activities being conducted bya
party other thanthepatent owner. Ifthecourts donotconsider thisvariable, please explain howthis
provision ofSwedish lawcomplies withArticles 28and30oftheTRIPS Agreement, which collectively
require thattheeconomic effect oftheactivities onthepatent owner beconsidered.
3. Section 5oftheSwedish Patents Actprovides thattemporary presence offoreign vessels does
notconstitute patent infringement. It,however, further provides thattheimportation ofpartsforsuch
vessels donotinfringe apatent ifreciprocal exemptions fromliability areavailable inthecountry of
origin. Please explain howthisArticle complies withArticle 4oftheTRIPS Agreement, which requires
most-favoured treatment forallWTO Members.
4. Section 6oftheSwedish Patents Actprovides therightofpriority toMember States ofthe
ParisConvention fortheProtection ofIndustrial Property andtoentities thatprovide reciprocity. Please
explain howthisprovision complies withArticles 3and4oftheTRIPS Agreement concerning national
treatment andmost-favoured nation treatment forallWTO Members.IP/C/W/59
Page32
5. Sections 45to48oftheSwedish Patents Actprovide forthepossibility ofissuing compulsory
licences onfourdistinct grounds. Sections 49and50oftheActenumerate specific principles governing
thegrant ofcompulsory licences. Please answer thefollowing questions regarding thecompulsory
licensing system established bythese provisions:
(a) Article 50specifies thatcompulsory licences shallbegranted bythecourt, andthat
thecourt shalldecide theconditions andterms ofthelicence. Noother provision of
theSwedish lawappears toaddress thequestion ofspecific terms orconditions that
mustbeassociated withthegrant ofanycompulsory licence. Please explain whether
SwedishcourtsimposeconditionsconsistentwiththosespecifiedinArticle31paragraphs
(a)to(k)oftheTRIPS Agreement, andifnot,howSwedish lawcomplies witheach
ofthese specifically enumerated requirements oftheTRIPS Agreement.
(b) Article 45permits theissuance ofacompulsory licence onthegrounds thatthepatented
invention wasnotworked toareasonable extent inSweden. Thisprovision also
provides thattheSwedish Government mayconsider working inaforeign country if
there isreciprocal treatment extended bythatcountry. Please indicate whether the
Swedish Government hasdecreed thatworking ofainvention inanyWTO Member
shallbeconsidered tobeequivalent toworking oftheinvention within Sweden. Also,
please explain howSwedish lawcomplies withArticle 27.1oftheTRIPS Agreement,
which prohibits discrimination intheenjoyment ofpatent rights based onwhether
products areproduced locally orimported.
(c) Section 46ofthePatents Actsregulates thegrant ofcompulsory licences todependent
patentownersbypermittingacompulsorylicenceifthedependentinventionisimportant
orforother special reasons. Article 31(l)ofTRIPS Article 31permits thegrant of
acompulsory licence onlyifthedependent invention involves animportant technical
advance ofconsiderable economic significance inrelation tothedominant patented
invention. Article 31(l)alsorequires inevery instance ofissuance ofsuchcompulsory
licence thattheowner ofthedominant patent receive across-licence under thedependent
patent. Please explain whether Section 46isinterpreted soastoimpose these
requirements inallinstances ofdependent patent compulsory licences, andifnot,how
Swedish lawcomplies withArticle 31(l)oftheTRIPS Agreement.
6. Please indicate howmany compulsory licences onayearly basishavebeengranted inSweden
since 1January 1993.
7. Section 79ofthePatents Actprovides thatinventions thatareimportant tothedefense ofthe
countryaregovernedbyseparateprovisions.Pleaseexplainthenatureandlegalbasisoftheseprovisions
andhowtheycomply withArticles 30and31oftheTRIPS Agreement.
8. Please explain howSwedish lawcomplies withtheobligations ofArticle 34oftheTRIPS
Agreement, which requires Members tomake available incivilproceedings toenforce apatent the
option ofshifting theburden ofproof regarding useofapatented process toanalleged infringer who
hasproduced theidentical product asthatwhich isproduced byapatented process.IP/C/W/59
Page33
UNITED KINGDOM
Patents
1. Section1(2)(c)oftheUnitedKingdomPatentsAct(1977)specifiesthataprogramforacomputer
isnotaninvention forthepurposes ofthatAct.Please explain whether, under thisprovision, inventions
within thecategories specified below arenoteligible tobepatented under UKlaw,notwithstanding
thefactthattheinvention isnovel, involves aninventive step,andisuseful:
(a) process inventions which, inwhole orinpart,consist ofsteps thatareperformed by
acomputer andaredirected byacomputer program;
(b) product inventions consisting ofelements ofacomputer-implemented invention,
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.
Ifanyofthese types ofinventions areexcluded fromeligibility tobepatented, please explain
howtheUKpatent lawcomplies withtheobligations ofArticle 27oftheTRIPS Agreement, which
mandates patent eligibility forallcategories ofinvention without discrimination.
2. Acompulsory licensing system forpatents isestablished bySections 46to54oftheUnited
Kingdom Patents Act. Under proposed legislation, these provisions would nolonger beapplicable
tonationals ofWTO Members, andintheplace ofthissystem anewsystem thatappears tobebased
onArticle 31oftheTRIPS Agreement would apply. Please respond tothefollowing questions
concerning thissituation:
(a) Please explain howthecurrent UKlawcomplies withtheobligations specified in
Article 27.1, which prohibits discrimination intheenjoyment ofpatent rights based
onwhether products areproduced locally orimported.
(b) Please explain howthecurrent UKlawcomplies witheachoftheprovisions concerning
compulsory licences thatarecontained inparagraphs (a)to(l)ofArticle 31oftheTRIPS
Agreement.
(c) Please indicate when thenewlegislation isanticipated tocome intoforce within the
United Kingdom, andexplain theschedule ofactivity thatmusttobetaken incident
toitsenactment.
(d) Please explain whether thenewlegislation willgovern anycompulsory licences that
were(i)granted onorafter20December 1993, or(ii)wereinforceon1January 1996.IP/C/W/59
Page34
(e) Please indicate whether, inproposed Article 47B(3) ofthenewlegislation, importation
ofaproduct willbeconsidered tobeasatisfactory basis formeeting demand fora
patented product intheUnited Kingdom, andthatimportation shallnotbeviewed as
being abasis forasserting thatcommercial orindustrial activities arebeing unfairly
prejudiced within theUnited Kingdom. Ifthisisnottheintent ofthelegislation, please
explain howthese provisions comply withArticle 27.1oftheTRIPS Agreement.
3. Article 55to59ofthe1977 Patents Actauthorizes theGovernment oftheUnited Kingdom
tousewithout aconsequence ofinfringement apatented invention without theconsent ofthepatent
owner. Article 57Aofthe1988 Actclarifies thatthepatent owner incases ofsuch"Crown use"is
entitled tocompensation foruseofthepatented invention. Withrespect totheseprovisions concerning
Crown use,please:
(a) clarify whether theapplication ofArticle 56(2) results indistinct treatment ofpatent
rights forinventions inthefields oftechnology specified insubparagraphs (a)to(c)
(i.e., supply ofanything forforeign defense purposes, forproduction orsupply of
pharmaceuticals, andrelated toatomic energy), and,ifso,howthisprovision complies
with Article 27oftheTRIPS Agreement, which prohibits discrimination inthe
availability ofpatents andenjoyment ofpatent rights based onthetechnological field
oftheinvention; and
(b) explain howtheprovisions concerning Crown useareapplied inpractice, andin
particular whether authorizations provided under theauthority ofCrown usecomply
withtheprovisions ofparagraphs (b),(c),(d),(e),and(g)ofArticle 31oftheTRIPS
Agreement.
4. Please indicate howmany compulsory licences onayearly basis havebeengranted inthe
United Kingdom, andhowmany times Crown usehasbeeninvoked tobytheGovernment ofthe
United Kingdom toenable useofapatented invention without theconsent ofthepatent owner since
1January 1993.IP/C/W/59
Page35
HUNGARY
Patents
1. Article 27ofHungary ’sLawNo.XXXIII ontheProtection ofInventions byPatents makes
nullandvoidanypatent licensing Agreement thatrestricts economic competition orhasapurpose
incompatible withthesocial functions ofpatent rights. Please explain howthisSection isinterpreted
inHungary, giving examples ifpossible, andexplain howsuchprovisions comply withtherequirement
ofArticle 30oftheTRIPS Agreement, which specifies thatlimited exceptions totheexclusive rights
conferred byapatent donotunreasonably conflict withanormal exploitation ofthepatent anddonot
unreasonably prejudice thelegitimate interests ofthepatent owner.
2. Please explain whether apatentee cansatisfy theobligation to"exploit" theinvention inHungary
asusedinArticle 21ofHungary ’sLawontheProtection ofInventions byPatents through importation
ofthepatented product. Ifnot,please explain howthisprovision complies withtherequirements of
Article 27.1oftheTRIPS Agreement, which precludes discrimination intheenjoyment ofpatent rights
withregard tolocalmanufacture orimportation ofthepatented invention.
3. Article 33(4) ofHungary ’sLawontheProtection ofInventions byPatents states thattheholder
ofacompulsory licence hasthesame rights asthepatentee inregard tothemaintenance ofthepatent
andtheexercise oftherights deriving from protection. Please explain howthisprovision isapplied
inpractice, providing examples where possible.
4. Please indicate howmany compulsory licences onayearly basishavebeengranted inHungary
since 1January 1993.
5. Article 37ofHungary ’sLawontheProtection ofInventions byPatents provides foraruling
onlackofinfringement ifaperson believes thatpatent infringement proceedings maybeinstituted
against him. Itisnotclear from thelawwhether theruling made bythePatent Office under
Articles 44(d), 46,47,82,and83would bemade afteraproceeding inwhich thepatentee would have
anopportunity toparticipate. Please describe indetail howthisArticle isimplemented.IP/C/W/59
Page36
JAPAN
Patents
1. Section 32oftheJapanese Patent Lawsetsforth certain exclusions from patentability for
"inventions liable tocontravene public order, morality orpublic health". Itisalsoknown that
"diagnostic, therapeutic andsurgical methods forthetreatment ofhumans oranimals" arenotpatentable
inJapan because suchinventions arenotconsidered bytheJapanese Patent Office tobe"industrially
applicable", asrequired inSection 29(1) oftheJapanese law. With regard 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.
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) product inventions consisting ofelements ofacomputer-implemented invention,
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.
3. TheJapanese Patent Law, inSections 68and2(3)defines therights provided byapatent.
Article 28oftheTRIPS Agreement setsforththeminimum 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.IP/C/W/59
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4. Article 30oftheTRIPS Agreement provides limited exceptions totheexclusive rights conferred
byapatent, which exceptions aresubject totheproviso that"such exceptions donotunreasonable
conflict withanormal exploitation ofthepatent anddonotunreasonable prejudice thelegitimate interests
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 rightthathasexpired; and
(c) Articles 175and176concerning situations ofintervening useofapatented invention
when apatent hasbeendeclared inacourt offirstinstance invalid butwhose validity
islaterrestored through "retrial".
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..
6. Please indicate howmany compulsory licences onayearly basis havebeengranted inJapan
since 1January 1993.
Protection ofundisclosed information
7. Please explain howundisclosed information isprotected inJapan, andthelegalbasisforsuch
protection.
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.
9. Please explain themeasures, ifany,thathavebeenimplemented inJapan toprotect against
unfair competition those parties thathave provided confidential testorother dataconcerning a
pharmaceutical oragricultural chemical product toJapanese regulatory authorities pursuant toarequest
formarketing approval. Please explain howsuchmeasures, ifany,areconsistent withArticle 39.3
oftheTRIPS Agreement.
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 thirdparties tounfairly compete withtheparty thathasdeveloped anewdrug.
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 howthis
practice conforms totherequirements ofArticle 39.3oftheTRIPS Agreement.IP/C/W/59
Page38
LIECHTENSTEIN
Itisourunderstanding that, under theterms oftheTreaty between thePrincipality of
Liechtenstein andtheSwiss Confederation ontheProtection Conferred byPatents ofInvention that
(1)theterritories ofSwitzerland andLiechtenstein andconsidered unified forthepurposes ofpatent
protection and(2)theapplicable lawforthatunified territory isthePatent LawofSwitzerland.
1. Article 32oftheSwiss Patent Lawprovides that"ifthepublic interest sorequires, theFederal
Council maywholly orpartially expropriate thepatent". Withregard tothisprovision, please explain:
whether thepatent owner isabletopractise theinvention orenjoy patent rights vis-à-vis thirdparties
afterapartial ortotalexpropriation ofthepatent hasoccurred. Please indicate whether anyactof
expropriation isconditioned upon theprovision ofcompensation ornotice tothepatent owner, and
thesituation inwhich suchanauthority might beexercised bytheSwiss Government. Please explain
howSwiss lawcomplies withArticle 30oftheTRIPS Agreement, andparagraphs (a)to(l)ofArticle 31
oftheTRIPS Agreement.
2. Articles 37to40oftheSwiss Patent Lawestablishes asystem ofcompulsory licences. Please
explain howthefollowing specific obligations ofArticle 31oftheTRIPS areimplemented inSwiss
law:
(a) therequirements concerning "reasonable commercial terms andconditions" and"a
reasonable period oftime" [Article 31(b)];
(b) therequirement thatacompulsory licence belimited tothescope andduration forwhich
thelicence isauthorized, andthatnocompulsory licences beissued onpatents
concerning inventions inthefieldofsemiconductor technology except toremedy
anti-competitive practices orpursuant topublic non-commercial use[Article 31(c)];
(c) therestriction thatacompulsory licence benon-exclusive andnon-assignable except
withthethatpartoftheenterprise orgoodwill thatenjoys theuseauthorized bythe
licence [Articles 31(d) and(e)];
(d) thelimitation thattheauthorized usebelimited "predominately forthesupply ofthe
domestic market oftheMember authorizing suchuse"[Article 31(f)];
(e) therequirement thatthepatent owner begiven theright toterminate acompulsory
licence "ifandwhen thecircumstances which ledtoitcease toexistandareunlikely
torecur [Article 31(g)];
(f) therequirement thataright holder shall bepaid"adequate remuneration inthe
circumstances ofeachcase,taking intoaccount theeconomic value oftheauthorization"
[Article 31(h)];
(g) therequirement thatdecisions concerning thegrant ofalicence andthelevel of
remuneration besubject toreview byacourt orindependent higher butseparate body
[Articles 31(i)and(j)].IP/C/W/59
Page39
3. Article36oftheSwissPatentLawprovidesforthegrantofcompulsorylicenceswhereapatented
invention cannot beusedwithout violating anearlier dominant, or"first" patent. Article 31(l)ofthe
TRIPS Agreement requires, inthecaseofsuchcompulsory licences, thatthesecond patented invention
beanimportant technical advance ofconsiderable economic significance inrelation totheinvention
inthedominant patent, andthattheuseauthorized inrespect ofthefirstpatent shallbenon-assignable
except withtheassignment ofthesecond patent. Please explain howSwiss lawimplements this
obligation.
4. PleaseindicatehowmanycompulsorylicencesonayearlybasishavebeengrantedinSwitzerland
since 1January 1993.
Protection ofundisclosed information
5. Please explain themeasures, ifany,thathavebeenimplemented inSwitzerland toprotect against
unfair competition those parties thathave provided confidential testorother dataconcerning a
pharmaceutical oragricultural chemical product toSwiss regulatory authorities pursuant toarequest
formarketing approval. Please explain howsuchmeasures, ifany,areconsistent withArticle 39.3
oftheTRIPS Agreement.IP/C/W/59
Page40
NEW ZEALAND
Patents
1. Please explain whether anyinventions arenoteligible tobepatented under NewZealand law,
notwithstanding thefactthattheinvention satisfies thecriteria ofbeing novel, involving aninventive
step,andbeing useful. Insodoing, please explain themeaning ofthephrase "means anymanner of
newmanufacture thesubject ofletters patent andgrant ofprivilege within Section 6oftheStatute of
Monopolies andanynewmethod orprocess oftesting applicable totheimprovement orcontrol of
manufacture" andwhether under thisdefinition anyofthefollowing inventions ifotherwise patentable
aredeemed ineligible tobepatented inNewZealand:
(a) process inventions which, inwhole orinpart,consist ofsteps thatareperformed by
acomputer andaredirected byacomputer program;
(b) product inventions consisting ofelements ofacomputer-implemented invention,
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) methods oftreatment ordiagnosis ofhumans oranimals; or
(d) non-naturally occurring microorganisms, plants oranimals produced through some
actofhuman intervention.
2. Article 30(3) oftheNewZealand Patents Actstates that"thetermofevery patent shallbe
20years from thedateofthepatent". Please clarify whether the"date ofthepatent" refers tothe
dateonwhich thepatent isgranted, ortheeffective filing dateoftheapplication leading tothepatent.
3. Section 18ofthe1994 Patents Amendment Actspecifies thatthetermofpatents thatwere
ineffect onthedateofenactment oftheActshallbeextended from 16to20years from thedateof
thepatent. Under Section 17oftheAct,itappears thatsome, butnotall,applications thatwerepending
onthisdate,should theymature intoapatent, canobtain atermof20years fromthedateofthepatent.
Please explain (a)theprocedures thatmust becomplied withbyanapplicant whose application was
pending onthedateofenactment ofthe1994 Actinorder toobtain apatent withatermof20years
fromthedateofthepatent, and(b)whether, under anyconditions, a20yeartermwillnotbeaccorded
toapatent thatderives fromanapplication pending onthedateonwhich theTRIPS Agreement became
applicable toNewZealand.
4. TheNewZealand Patents Actdoesnotappear tocontain aprovision which specifically defines
thespecific exclusive rights tobeenjoyed byapatent owner. Please identify thelegalbasisuponwhich
apatent owner canenforce therights tobeprovided withthegrant ofapatent asspecified inArticle 28
oftheTRIPS Agreement.IP/C/W/59
Page41
NORWAY
Patents
1. Article 1(3)oftheNorwegian Patent Lawprovides that"programs forcomputers" arenot
considered tobeinventions. Please explain whether, under thisprovision, inventions within the
categories specified below arenoteligible tobepatented under Norwegian law,notwithstanding the
factthattheinvention isnovel, involves aninventive step,andisuseful:
(a) process inventions which, inwhole orinpart,consist ofsteps thatareperformed by
acomputer andaredirected byacomputer program;
(b) product inventions consisting ofelements ofacomputer-implemented invention,
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.
Ifanyofthese types ofinventions areexcluded fromeligibility tobepatented, please explain
howtheNorwegian patent lawcomplies withtheobligations ofArticle 27oftheTRIPS Agreement,
which mandates patent eligibility forallcategories ofinvention without discrimination.
2. Section 3ofthePatents Lawexcludes from theexclusive rights ofapatent the"exploitation
fornon-commercial purposes." Please explain howthisprovision hasbeeninterpreted byNorwegian
courts bygiving examples, ifany,ofthetypes ofactivities thathavebeenfound tobe"non-commercial"
andpermissible without theconsent ofthepatent owner. Please alsoexplain whether Norwegian courts
consider theeconomic effect ofthenon-commercial activities being conducted byaparty other than
thepatent owner. Ifthecourts donotconsider thisvariable, please explain howthisprovision of
Norwegian lawcomplies withArticles 28and30oftheTRIPS Agreement, which collectively require
thattheeconomic effect oftheactivities onthepatent owner beconsidered.
3. Section5ofthePatentsLawprovidesthattemporarypresentofforeignvesselsdoesnotconstitute
patent infringement. It,however, further provides thatpartstheimportation ofwhich would infringe
apatent ispermitted ifreciprocal rights areavailable inthecountry oforigin. Please explain how
thisArticle complies withTRIPS Article 3,which requires most-favoured treatment forallTRIPS
Members.
4. Section 45ofthePatents Actspecifies thatathirdpartywhowishes toworkapatented invention
inNorway without theconsent ofthepatent owner canobtain acompulsory licence ifthepatent owner
hasnotworked intheinvention toareasonable extent within Norway. Thisprovisions further provides
thattheKingmayconsider working inothercountries toconstitute working inNorway, onthecondition
ofreciprocal treatment intheother country. With regard tothisprovision, please explain:
(a) whether theKingofNorway hasdeclared thatworking oftheinvention inanyWTO
Member shallbeconsidered inevaluation ofthequestion ofwhether theinvention is
being worked toareasonable extent inNorway;
(b) whether theKingofNorway hasdeclared thatworking oftheinvention inanyspecific
WTO Member istobeconsidered inevaluation ofapplication ofthisprovision;IP/C/W/59
Page42
(c) whether theNorwegian Patent Office orNorwegian courts willconsider importation
tosatisfy therequirement ofworking toareasonable extent within Norway; and
(d) howthisprovision complies withArticle 27.1oftheTRIPS Agreement, which prohibits
discrimination intheenjoyment ofpatent rights based onwhether products areproduced
locally orimported.
5. Section 46ofthePatents Actspermits theholder ofadependent patent toobtain acompulsory
licence fromtheowner ofthedominant patent "ifthisisfound tobejustified inviewoftheimportance
oftheformer invention orforother special reasons". Thesecond clause inthisArticle specifies that
thedominant patent owner canobtain acompulsory licence fromthedependent patent owner "unless
special reasons make itundesirable". With regard tothisauthority, please explain:
(a) whatcircumstanceshavebeenfoundbytheNorwegiancourtstoconstitute"otherspecial
reasons"; and
(b) howthisprovision complies withArticle 31(l)(1) oftheTRIPS Agreement, particularly
therequirements that:
(i) dependent patent compulsory licences beavailable onlywhere thedependent
patented invention involves atechnical advance ofconsiderable economic
significant andfornoother reasons; and
(ii) anysuch compulsory licence granted tothedependent patent owner be
non-transferable.
6. Section 47ofthePatents Lawpermits thegrantofacompulsory licence toanyone when required
bythepublic interest. Please explain theconditions thatwilljustify agrant ofacompulsory licence
under thisprovision, andhowthisprovision complies withtherequirement inclause (a)ofTRIPS
Article 31thateachcompulsory licence must beconsidered on"itsindividual merits".
7. Section 48ofthePatents Lawpermits thegrant ofacompulsory licence toanyone whoused
thepatented invention atthetimethepatent application waslaidopen. Howthiscomplies withthe
requirement inclause (a)ofTRIPS Article 31thateachcompulsory licence must beconsidered on
"itsindividual merits"?
8. Sections 45through 48ofthePatents Law provide fourtypes ofcompulsory licences.
Sections 49and50enumerate specific principles forgranting thesefourtypes ofcompulsory licences.
Noprovisions intheNorwegian patent lawappear toimpose specific limitations orconditions oneither
theterms ofacompulsory licence oronthedecision togrant orrevoke suchlicences. Please explain
howtheNorwegian lawcomplies withthefollowing provisions ofArticle 31oftheTRIPS Agreement:
(a) paragraph (a),which requires anydecision togrant acompulsory licence tobe
considered onitsownindividual merits;
(b) paragraph (b),which requires anyprospective licensee torequest avoluntary licence
onreasonable commercial terms from thepatent owner;
(c) thefirstclause ofparagraph (c),which requires thatthescope ofanylicence belimited
tothepurpose forwhich itwasauthorized;IP/C/W/59
Page43
(d) thesecond clause ofparagraph (c),which specifies thatlicences forinventions inthe
fieldofsemiconductor technology mayonlybejustified forpublic non-commercial
useortoremedy ajudicial oradministrative finding ofanti-competitive practices;
(e) paragraph (f),which restricts theauthorization provided byacompulsory licence to
useofthepatented invention forsupplying thedomestic market oftheMember;
(f) paragraph (g),which specifies thatthepatent owner beabletoseektermination of
thelicence when theconditions leading toitsgrant cease toexistandareunlikely to
recur;
(g) paragraph (h),which requires theremuneration totakeintoaccount theeconomic
value oftheauthorization provided bythecompulsory licence; and
(h) paragraphs (i)and(j),which require thatthepatent owner beabletoappeal decisions
relating tomatters relating tothecompulsory licence toacourt orother independent
anddistinct reviewing authority.
9. Section 71ofthePatents Actprovides thatinventions thatareimportant tothedefense ofthe
country aregoverned byaseparate act.Please identify thisAct,explain itsprovisions andhowthey
relate totheexisting patent lawsofNorway.
10. Please indicate howmany compulsory licences onayearly basishavebeengranted inNorway
since 1January 1993.
11. Please explain howNorwegian lawcomplies withtheobligations ofArticle 34oftheTRIPS
Agreement, which requires Members tomake available incivilproceedings toenforce apatent the
option ofshifting theburden ofproof regarding useofapatented process toanalleged infringer who
hasproduced theidentical product asthatwhich isproduced byapatented process.
Protection ofundisclosed information
12. Please explain themeasures, ifany,thathavebeenimplemented inNorway toprotect against
unfair competition those parties thathave provided confidential testorother dataconcerning a
pharmaceuticaloragriculturalchemicalproducttoNorwegianregulatoryauthoritiespursuanttoarequest
formarketing approval.
13. Please explain whether Norwegian lawconditions theenjoyment ofprotection intestdata
provided toaNorwegian regulatory agency onthecoexistence ofpatent rights intheregulated product.
Ifsuchacondition isimposed (i.e., thedataisprotected against disclosure tothirdparties onlywhile
apatent remains inforce covering theproduct), please explain howtheNorwegian lawcomplies with
therequirements ofArticle 39.3oftheTRIPS Agreement, which requires WTO Members toprevent
useofsuchdatainsuchafashion astorepresent unfair competition totheparty supplying thedata
anddoesnotcondition enjoyment ofthisprotection ontheexistence ofconcurrent patent protection.IP/C/W/59
Page44
POLAND
Patents
1. Article 12(4) ofthePolish LawonInventive Activity specifies thatpatents shallnotbegranted
for"computer programs". Please explain whether, under thisprovision, inventions within thecategories
specified below arenoteligible tobepatented under Polish law,notwithstanding thefactthatthe
invention isnovel, involves aninventive step,andisuseful:
(a) process inventions which, inwhole orinpart,consist ofsteps thatareperformed by
acomputer andaredirected byacomputer program;
(b) product inventions consisting ofelements ofacomputer-implemented invention,
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.
Ifanyofthese inventions arenoteligible tobepatented, please explain howthePolish patent
lawcomplies withtheobligations ofArticle 27oftheTRIPS Agreement, which mandates patent
eligibility forallcategories ofinvention without discrimination.
2. Section 16(1) ofthePolish lawonInventive Activity provides thattherights granted incident
toaPolish patent shall consist of"theexclusive right toexploit theinvention forderiving profits
therefrom orforprofessional purposes throughout theterritory oftheState". Please explain howthis
definition complies withArticle 28oftheTRIPS Agreement, which specifies thatthegrant ofapatent
inaWTO Member shallgivethepatent owner theexclusive rightofpreventing thirdparties without
theirconsent from making, using, selling, offering forsaleorimporting thepatented invention.
3. Section 16(6) ofthePolish LawonInventive Activity states thatexploitation ofaninvention
fornational purposes when itisindispensable toprevent oreliminate astateofemergency relating
tosecurity orpublic order shallnottobeconsidered aninfringement ofthepatent. Article 31ofthe
TRIPS Agreement requires, among other things, thatwhen thesubject matter ofapatent isusedwithout
theauthorization ofaright holder, even when usedbygovernments orbythird parties withthe
authorization ofthegovernment, incaseofanational emergency orother circumstances ofextreme
urgency, therightholder istobenotified assoonasreasonably practicable oftheuseandtheright
holder istobepaidadequate remuneration fortheuse. Please explain howSection 16(6) conforms
totheobligations ofArticle 31oftheTRIPS Agreement.
4. Section 49(1)(2)(ii) ofthePolish LawonInventive Activity permits thePolish Patent Office
togrant acompulsory licence toexploit apatented invention thatissubject toadominant patent.
Article 31(l)oftheTRIPS Agreement concerns compulsory licences granted toallow exploitation of
apatent which cannot beexploited without infringing anearlier granted patent. Under Article 31(l),
aWTO Member mayallow acompulsory licence tobegranted onlywhere theinvention claimed in
thesecond patent involves animportant technical advance ofconsiderable economic significance in
relation totheinvention claimed inthefirstordominant patent. Please explain howSection 49(1)(2)(ii)
complies withArticle 31(l)oftheTRIPS Agreement.IP/C/W/59
Page45
5. Article 31(c) oftheTRIPS Agreement (b)provides thatcompulsory licences forinventions
inthefieldofsemiconductor technology mayonlybejustified forpublic non-commercial useorto
remedy ajudicial oradministrative finding ofanti-competitive practices. Noprovisions inthePolish
LawonInventive Activity concerning thegranting ofacompulsory licence distinguish inventions in
thefieldofsemiconductor technology fromother fields oftechnology. Please explain howthePolish
patent lawcomplies withtheobligations ofArticle 31(c) oftheTRIPS Agreement.
6. Please indicate howmany compulsory licences onayearly basishavebeengranted inPoland
since 1January 1993.
7. Sections 68to70ofthePolish LawonInventive Activity provide thatapatent canbedeclared
nullandvoid, inwhole orinpart,ifitfailstomeettherequirements forpatentability, andthat,in
theevent apatent isdeclared nullandvoid, licensees, purchasers andothers would beentitled to
compensation forpayments made inconnection withsuchpurchases orlicences. Itwould appear that
suchdecisions areappealable toaBoard ofAppeals ofthePatent Office. Article 32oftheTRIPS
Agreement requires thatanopportunity forjudicial appeal beavailable regarding anydecision torevoke
orforfeit apatent. Please explain ifanappeal toacourt isavailable from anydecision oftheBoard
ofAppeals and,ifnot,howtheLawonInventions complies withArticle 32oftheTRIPS Agreement.
8. Sections 10to12ofthePolish LawonInventive Activity make product patent protection
available forpharmaceuticals. Thislawwasimplemented in1993, andrepresents achange fromthe
previous lawwithregard totheavailability ofsuchprotection. Please explain whether thePolish Patent
Office permits patent applicants whose applications werefiledprior totheenactment ofthenewlaw,
butwhich were pending onorafterthedateoftheapplication oftheTRIPS Agreement toPoland,
canamend theirapplications toaddproduct claims totheirpending applications. Ifnot,please explain
howthePolish lawcomplies withtherequirements ofArticle 70.7oftheTRIPS Agreement.
9. Section 16(2) ofthePolish LawonInventive Activity provides thatthetermofapatent in
Poland shallbe20years starting from thedateatwhich theapplication ofinvention wasfiledwith
thePatent Office. Thepatent terminPoland prior tothischange in1993waslessthan20years from
filing date. Please explain whether anypatents granted under theprevious lawthatwereinforce in
Poland on1January 1996, havehadtheirterms extended tonotlessthan20years fromthefiling date
oftheapplication leading tothepatent, andifnot,please explain howPolish lawcomplies withthe
obligations ofArticle 70.2asitapplies toArticle 33oftheTRIPS Agreement.
Control ofanti-competitive practices
10. Section 42(2) ofPoland ’sLawonInventive Activity authorizes thePatent Office torequest
explanations fromthepatentee oralicensee regarding exploitation oftheinvention, inorder todetermine
howtheexclusive rights ofthepatent arebeing used. Article 40oftheTRIPS Agreement authorizes
Members tospecify intheirlegislation licensing practices orconditions thatwould constitute anabuse
ofexclusive rights, Section 42(2) doesnotappear tobelimited tolicensing practices. Please explain
indetail anyregulations governing themanner inwhich Section 42(2) hasbeenimplemented and,if
information hasbeenrequested ofpatentees orlicensees under thisSection, please explain thenature
oftheinformation requested andthecircumstances thatledtotherequest.
Protection ofundisclosed information
11. Please explain howundisclosed information isprotected inPoland, andthelegalbasisforsuch
protection.IP/C/W/59
Page46
12. Please indicate thenature ofmeasures, ifany,thataretaken byjudicial authorities inPoland
toprotect theconfidentiality ofundisclosed information furnished byaparty tothecourt during legal
proceedings, when theinformation hasbeenprovided either toenforce rights insuchinformation, or
forother purposes.
13. Please explain themeasures, ifany,thathavebeenimplemented inPoland toprotect against
unfair competition those parties thathave provided confidential testorother dataconcerning a
pharmaceutical oragricultural chemical product toPolish regulatory authorities pursuant toarequest
formarketing approval. Please explain howsuchmeasures, ifany,areconsistent withArticle 39.3
oftheTRIPS Agreement.IP/C/W/59
Page47
SLOVAK REPUBLIC
Patents
1. Article 3-2(d) oftheSlovak Patent Law [Law onInventions, Industrial Designs and
Rationalization Proposals (No.527ofNovember 27,1990) provides that"programs forcomputers"
arenotconsidered tobeinventions. Please explain whether, under thisprovision, inventions within
thecategories specified below arenoteligible tobepatented intheSlovak Republic, notwithstanding
thefactthattheinvention isnovel, involves aninventive step,andisuseful:
(a) process inventions which, inwhole orinpart,consist ofsteps thatareperformed by
acomputer andaredirected byacomputer program;
(b) product inventions consisting ofelements ofacomputer-implemented invention,
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.
Ifanyofthese types ofinventions areexcluded fromeligibility tobepatented, please explain
howthepatent lawoftheSlovak Republic complies withtheobligations ofArticle 27oftheTRIPS
Agreement, which mandates patent eligibility forallcategories ofinvention without discrimination.
2. Article 11(1) oftheSlovak Lawdefines therights associated withapatent intheSlovak Republic
tobethe"exclusive righttowork theinvention, toauthorize others towork theinvention ortoassign
thepatent toothers". Article 13(1) clarifies thattheperson "working" aninvention means theperson
who"manufactures, places onthemarket orusestheproduct thatisthesubject matter oftheinvention,
intheframework ofhiseconomic activity". Article 13(2) clarifies thedefinition withrespect toproducts
thataretheresult ofpractice ofapatented process. Article 28.1(a) oftheTRIPS Agreement requires
WTO Members togrant thefollowing exclusive rights tothepatent owner: therighttoprevent third
parties nothaving theowner ’sconsent frommaking, using, selling, offering forsaleorimporting for
these purposes thepatented product. Article 28.1(b) defines theexclusive righttopractise apatented
process, andextends therights associated withapatented product totheproducts obtained directly
byapatented process. Please explain howSlovak lawcomplies withtheobligations ofArticles 28.1(a)
and(b)oftheTRIPS Agreement.
3. Article 34oftheTRIPS Agreement requires WTO Members tomake available incivil
proceedings toenforce aprocess patent theoption ofshifting theburden ofproof regarding useof
thepatented process toanaccused infringer whohasproduced aproduct identical tothatproduced
byapatented process. Noprovision oftheSlovak patent lawappears toprovide suchanoption to
apatent owner enforcing itsrights inajudicial proceeding. Please explain whether Slovak courts permit
patent owners toshifttheburden ofproof sothatanaccused infringer canberequired toprove that
ithasnotusedthepatented process toproduce aproduct identical tothatwhich istheresult ofthe
patented process. Ifthisispossible inSlovak courts, please explain thelegalbasisforsuchanaction
bythecourt. Ifthisisnotpossible, please explain howSlovak lawcomplies withtherequirements
ofArticle 34oftheTRIPS Agreement.IP/C/W/59
Page48
4. Article 68oftheSlovak Patent Lawprovides thatpatent-related appeals toacourt arepossible
onlywithrespect todecisions onthegranting ofacompulsory licence (Article 20),onanaction for
annulment (revocation) ofapatent (Article 23),oronadeclaratory action todefine thescope ofa
patent bythePatent Office (Article 67).Noprovision appears togiveapatent applicant therightto
appeal anegative decision bytheOffice onanapplication forpatent toajudicial orquasi-judicial
authority, asrequired byArticle 62.5oftheTRIPS Agreement. Please explain
(a) whether itispossible toappeal anadverse decision ofthePatent Office onanapplication
regarding patentability toajudicial orquasi-judicial authority intheSlovak Republic,
andifnot,howSlovak lawcomplies withArticle 62(5) oftheTRIPS Agreement; and
(b) whether thepatent owner orpatent applicant isallowed toparticipate inthe
decision-making process.
5. Article 20oftheSlovak Patent Lawpermits thePatent Office togrant acompulsory licence
iftheowner ofapatent "does notwork thepatent atallorworks itinsufficiently andcannot give
legitimate reasons forhisfailure toact". Thisprovision thenspecifies thatthegrant ofthecompulsory
licence "shall notaffect therightoftheowner toobtain compensation inrespect ofthevalue ofthe
licence". Noother provision oftheSlovak Lawappears toaddress theterms orconditions forthe
granting ofacompulsory licence toathirdparty. Inrelation tothisauthority:
(a) please explain whether theworking requirements specified canbesatisfied by
importationofproductssubjecttoapatentintoSlovak,orwhetherthepatentedinvention
must bephysically worked intheSlovak Republic;
(b) iftheinvention mustbephysically worked within theSlovak Republic, please explain
howtheSlovak Lawcomplies withArticle 27.1, which prohibits discrimination in
theenjoyment ofpatent rights based onwhether products areproduced locally or
imported; and
(c) please explain howtheSlovak Lawcomplies withlimitations andconditions governing
theissuance ofcompulsory licences found inArticle 31(a) to(l).
6. Please indicate howmany compulsory licences onayearly basishavebeengranted intheSlovak
Republic since 1January 1993.
7. Please explain howArticles 14(2) and15theSlovak Republic LawonInventions, Industrial
Designs andRationalization Proposals, which impose alimitation ontheright ofapatent owner to
assign orconclude licensing contracts bymaking anassignment orauthorization effective onlyafter
ithasbeenentered intothePatent Register, comply withArticle 28.2oftheTRIPS Agreement.
8. Article 23(3) oftheSlovak Republic LawonInventions, Industrial Designs andRationalization
Proposals states thatannulment ofapatent isretroactive tothedateonwhich thepatent became valid.
Under thisprovision, please explain whether apatent owner must reimburse licensees forthe
considerations made tothepatent owner prior tothedateofannulment ofthepatent (i.e., royalty or
licence fees).IP/C/W/59
Page49
Protection ofundisclosed information
9. ThenotificationbytheSlovakRepublicidentifiesthelegalbasisfortheprotectionofundisclosed
information within theSlovak Republic. Thelawsreferred toapparently establish thelegalframework
fortheenjoyment ofrights insuchinformation. Itisunclear, however, from thisnotification asto
thespecific nature ofthese rights, andhowtheycanbeenforced. Inviewofthis,please explain:
(a) thebasic standard thatgoverns thedetermination ofwhether aparty isentitled to
protection(i.e.,whetherthestandardsreflecttheprovisionsofArticle39.2oftheTRIPS
Agreement); and
(b) thenature ofmeasures, ifany,thataretaken byjudicial authorities intheSlovak
Republic toprotect theconfidentiality ofundisclosed information furnished byaparty
toacourt during legalproceedings, when theinformation hasbeenprovided either
toenforce rights insuchinformation, orforother purposes.
10. Please explain themeasures, ifany,thathavebeenimplemented intheSlovak Republic to
protect against unfair competition those parties thathave provided confidential testorother data
concerning apharmaceutical oragricultural chemical product toSlovak regulatory authorities pursuant
toarequest formarketing approval. Please explain howsuchmeasures, ifany,areconsistent with
Article 39.3oftheTRIPS Agreement.IP/C/W/59
Page50
SLOVENIA
Patents
1. Article 47oftheLawonIndustrial Property implements Article 11oftheParis Convention
regardingprotectionforinventionsdisplayedatrecognizedexhibitions.Itrestrictsacceptableexhibitions
tothose heldinSlovenia orthecountries oftheParisUnion. Please explain howthisprovision complies
withtherequirement toprovide national treatment andmost-favoured nation treatment toallWTO
Members pursuant toArticles 3and4oftheTRIPS Agreement.
2. Article 48oftheSlovenian LawonIndustrial Property implements Article 4oftheParis
Convention regarding therightofpriority. Thisprovision islimited tonationals ofcountries ofthe
Paris Union. Please explain howthisprovision complies withtherequirements ofArticle 4ofthe
TRIPS Agreement toprovide most-favoured nation treatment toallTRIPS Members.
3. Article 94oftheLawonIndustrial Property defines infringement ofapatent asanyunauthorized
use.Nospecific actsofinfringement areenumerated inthisoranyother provision ofSlovenian law.
Please explain howtheSlovenian patent lawcomplies withArticle 28oftheTRIPS Agreement, in
particular withrespect tothespecifically enumerated rights thataretobeassociated withthegrant
ofapatent.
4. Articles 113through 118oftheIndustrial Property Lawprovides forthegrant ofcompulsory
licences. These Sections, however, donotimpose address thespecific terms ofcompulsory licences
thataregranted inSlovenia, northesituations where suchlicences aretobeterminated. Inlightof
this,please explain howSlovenian lawcomplies withthefollowing provisions ofArticle 31ofthe
TRIPS Agreement:
(a) thefirstclause ofparagraph (c),which requires thatthescope ofanylicence belimited
tothepurpose forwhich itwasauthorized;
(b) thesecond clause ofparagraph (c),which specifies thatlicences forinventions inthe
fieldofsemiconductor technology mayonlybejustified forpublic non-commercial
useortoremedy ajudicial oradministrative finding ofanti-competitive practices;
(c) paragraph (e),which precludes assignability ofacompulsory licence except withthe
transfer ofthatpartoftheenterprise orgoodwill which enjoys theuseofthepatented
invention authorized bythelicence;
(d) paragraph (f),which restricts theauthorization provided byacompulsory licence to
useofthepatented invention forsupplying thedomestic market oftheMember;
(e) paragraph (g),which specifies thatthepatent owner beabletoseektermination of
thelicence when theconditions leading toitsgrant cease toexistandareunlikely to
recur; and
(f) paragraph (h),which requires theremuneration totakeintoaccount theeconomic
value oftheauthorization provided bythecompulsory licence.IP/C/W/59
Page51
5. Article 114oftheIndustrial Property lawpermits theissuance ofcompulsory licences tothe
holders ofdependent patents ifthesubject matter ofthedependent patent is"ofspecial importance
fortheeconomy orisinthepublic interest". Clause (l)ofArticle 31permits compulsory licences
onlyifthesubject matter ofthedependent patent isan"important technical advance ofconsiderable
economic significance". Please explain howArticle 114complies withArticle 31(l) oftheTRIPS
Agreement. Please alsoexplain howtherequirement thatthelicence benon-assignable hasbeen
implemented inSlovenia.
6. Article 121oftheIndustrial Property Lawexcludes from liability forinfringement theuse
ofcertain patented substances asmedicines ifthepatent applications werefiledbefore acertain date.
Please explain howthiscomplies withtherequirements of:
(a) Article 70.2,which requires allWTO Members toapply theAgreement toallsubject
matter inexistence atthedateofapplication;
(b) Article 27.1,which prohibits discrimination among different fields oftechnology; and
(c) Article 30,which places limitations onthetypes ofexceptions totheexclusive rights
associated withthegrant ofapatent.
7. Please explain whether allpatents inforce inSlovenia asof1January 1996 haveatermof
protection oftwenty years fromthefiling date. Ifnot,please explain which patents arenotgiven this
term, andhowSlovenian lawcomplies withtheobligations ofArticle 70.2oftheTRIPS Agreement.
8. Please indicate howmany compulsory licences onayearly basishavebeengranted inSlovenia
since 1January 1993.IP/C/W/59
Page52
SOUTH AFRICA
Patents
1. Article 25oftheSouth African Patent Lawstates that"computer programs" shallnotbean
inventionsforthepurposesoftheSouthAfricanPatentAct.Pleaseexplainwhether,underthisprovision,
inventions within thecategories specified below arenoteligible tobepatented under South African
law,notwithstanding thefactthattheinvention isnovel, involves aninventive step,andisuseful:
(a) process inventions which, inwhole orinpart,consist ofsteps thatareperformed by
acomputer andaredirected byacomputer program;
(b) product inventions consisting ofelements ofacomputer-implemented invention,
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.
Ifanyofthese types ofinventions areexcluded fromeligibility tobepatented, please explain
howtheSouth African patent lawcomplies withtheobligations ofArticle 27oftheTRIPS Agreement,
which mandates patent eligibility forallcategories ofinvention without discrimination.
2. Article 28oftheTRIPS Agreement enumerates therights thateachMember country mustconfer
toapatent owner. Included among these rights aretherights toprevent thirdparties from making,
using, offering forsale,selling andimporting thepatented product. Article 45oftheSouth African
patent lawvestspatent owners ’withtheright"toexclude other persons frommaking, using, exercising
ordisposing oftheinvention sothatheshallhaveandenjoy thewhole profit andadvantage accruing
byreason oftheinvention". Itisnotclear whether thepatent owner isgranted therighttocontrol
theimportation, offering forsale,andsalethepatented product. Also, itisnotclearwhether thephrase
-"sothatheshallhaveandenjoy thewhole profit andadvantage accruing byreason oftheinvention"
-operates inamanner thatrestricts enforcement oftherights. Please explain howtheSouth African
patent lawgrants apatent owner therights ofimporting, selling andoffering forsaleandwhether
Article 45imposes andlimitations onthepatent owner ’sexclusive rights.
3. Articles55and56oftheSouthAfricanPatentLawestablishasystemforthegrantofcompulsory
licences. Please answer thefollowing questions inrelation tothissystem.
(a) Article 56(5) specifies that,other thancompulsory licences granted forfailure to
adequately work aninvention, acompulsory licence maybeanexclusive licence to
practise thepatented invention. Please explain howthisprovision complies with
Article 31(d) oftheTRIPS Agreement, which specifies thatanycompulsory licence
granted bytheGovernment shallbenon-exclusive innature.IP/C/W/59
Page53
(b) Article 56(4)(a) and(b)authorize theCommissioner tosettheterms ofacompulsory
licence asheseesfit.Noprovisions oftheSouth African patent lawappear toconstrain
thediscretion oftheCommissioner toastorequire specific conditions forevery
compulsory licence granted. Please explain whether theterms andconditions specified
inArticles 31(a) to(l)areimposed withrespect toevery compulsory licences granted
inSouth Africa. Ifnot,please explain howSouth African lawcomplies withthe
requirements ofeachoftheparagraphs ofArticle 31oftheTRIPS Agreement.
(c) Article 56(2)(a) specifies thatfailure towork thepatented invention onacommercial
scale ortoanadequate extent within theRepublic ofSouth Africa canbeagrounds
forissuance ofacompulsory licence. Article 56(2)(b) specifies thatifimportation
results inahindrance ofworking ofthepatented invention intheRepublic ofSouth
Africa, italsocanserve asabasisforissuing acompulsory licence. Article 56(2)(e)
specifies thatacompulsory licence canbegranted ifimportation issatisfying market
demand buttheprice ofpatented products isexcessive. Each ofthese provisions
represents adiscrimination intheenjoyment onpatent rights based onthefactthat
thepatented product isbeing imported rather thanproduced within South Africa. Please
explain howtheseprovisions comply withtherequirements ofArticle 27.1oftheTRIPS
Agreement, which prohibits discrimination intheenjoyment ofpatent rights based on
whether products areproduced locally orimported.
(d) Article 55oftheSouth African Patent Lawpermits theissuance ofacompulsory licence
toenable thepractice ofadependent patented invention. Theprovision provides
discretion totheCommissioner tosettheterms ofthelicence. Itisnotclear from
thisprovision whether dependent patent compulsory licences areavailable onlyin
situations where thedependent patented invention represents animportant technical
advance ofconsiderable economic significance inrelation tothedominant patented
invention, orwhether theCommissioner isrequired togrant tothedominant patent
holder across-licence under thedependent patent. Please clarify ifthese conditions
areimposed inallsituations where adependent patent compulsory licence isgranted,
andifnot,howSouth African lawcomplies withtherequirements ofArticle 31(l)of
theTRIPS Agreement.
4. Please indicate howmany compulsory licences onayearly basis have been granted in
South Africa since 1January 1993.
5. Article 30ofTRIPS allows Member countries toprovide limited exceptions totheexclusive
rights granted bythepatent provided these exceptions donot"unreasonably conflict withanormal
exploitation ofthepatent anddonotunreasonably prejudice thelegitimate interests ofthepatent owner".
Article 4oftheSouth African patent lawprovides foranexception toapatent owner ’srights for"public
purposes". Please explain howthisprovision isinterpreted andapplied inpractice, andhowitcomplies
withArticle 30.IP/C/W/59
Page54
SWITZERLAND
Patents
1. Article 32oftheSwiss Patent Lawprovides that"ifthepublic interest sorequires, theFederal
Council maywholly orpartially expropriate thepatent". Withregard tothisprovision, please explain:
whether thepatent owner isabletopractise theinvention orenjoy patent rights vis-à-vis thirdparties
afterapartial ortotalexpropriation ofthepatent hasoccurred. Please indicate whether anyactof
expropriation isconditioned upon theprovision ofcompensation ornotice tothepatent owner, and
thesituation inwhich suchanauthority might beexercised bytheSwiss Government. Please explain
howSwiss lawcomplies withArticle 30oftheTRIPS Agreement, andparagraphs (a)to(l)ofArticle 31
oftheTRIPS Agreement.
2. Articles 37to40oftheSwiss Patent Lawestablishes asystem ofcompulsory licences. Please
explain howthefollowing specific obligations ofArticle 31oftheTRIPS areimplemented inSwiss
law:
(a) therequirements concerning "reasonable commercial terms andconditions" and"a
reasonable period oftime" [Article 31(b)];
(b) therequirement thatacompulsory licence belimited tothescope andduration forwhich
thelicence isauthorized, andthatnocompulsory licences beissued onpatents
concerning inventions inthefieldofsemiconductor technology except toremedy anti-
competitive practices orpursuant topublic non-commercial use[Article 31(c)];
(c) therestriction thatacompulsory licence benon-exclusive andnon-assignable except
withthethatpartoftheenterprise orgoodwill thatenjoys theuseauthorized bythe
licence [Articles 31(d) and(e)];
(d) thelimitation thattheauthorized usebelimited "predominately forthesupply ofthe
domestic market oftheMember authorizing suchuse"[Article 31(f)];
(e) therequirement thatthepatent owner begiven theright toterminate acompulsory
licence "ifandwhen thecircumstances which ledtoitcease toexistandareunlikely
torecur" [Article 31(g)];
(f) therequirement thataright holder shall bepaid"adequate remuneration inthe
circumstances ofeachcase,taking intoaccount theeconomic value oftheauthorization"
[Article 31(h)];
(g) therequirement thatdecisions concerning thegrant ofalicence andthelevel of
remuneration besubject toreview byacourt orindependent higher butseparate body
[Articles 31(i)and(j)].
3. Article36oftheSwissPatentLawprovidesforthegrantofcompulsorylicenceswhereapatented
invention cannot beusedwithout violating anearlier dominant, or"first" patent. Article 31(l)ofthe
TRIPS Agreement requires, inthecaseofsuchcompulsory licences, thatthesecond patented invention
beanimportant technical advance ofconsiderable economic significance inrelation totheinvention
inthedominant patent, andthattheuseauthorized inrespect ofthefirstpatent shallbenon-assignable
except withtheassignment ofthesecond patent. Please explain howSwiss lawimplements this
obligation.IP/C/W/59
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4. PleaseindicatehowmanycompulsorylicencesonayearlybasishavebeengrantedinSwitzerland
since 1January 1993.
Protection ofundisclosed information
5. Please explain themeasures, ifany,thathavebeenimplemented inSwitzerland toprotect against
unfair competition those parties thathave provided confidential testorother dataconcerning a
pharmaceutical oragricultural chemical product toSwiss regulatory authorities pursuant toarequest
formarketing approval. Please explain howsuchmeasures, ifany,areconsistent withArticle 39.3
oftheTRIPS Agreement.