RESTRICTED
WORLD TRADE IP/Q3/ROM/1
13November 1997
ORGANIZATION(97-4971)
Original: English/French Council forTrade-Related Aspects
ofIntellectual Property Rights
REVIEW OFTHE LEGISLATION INTHE FIELDS OFPATENTS, LAYOUT DESIGNS
(TOPOGRAPHIES) OFINTEGRATED CIRCUITS, PROTECTION OF
UNDISCLOSED INFORMATION AND CONTROL OF
ANTI-COMPETITIVE PRACTICES IN
CONTRACTUAL LICENCES
Romania
Thepresent document reproduces theintroductory statement bythedelegation ofRomania,
thequestions puttoitandtheresponses given inthereview oflegislation onpatents, layout designs
(topographies)ofintegratedcircuits,protectionofundisclosedinformationandcontrolofanti-competitive
practices incontractual licences attheCouncil 'smeeting of26-30 May1997.1
_______________
I. INTRODUCTORY STATEMENT
1. Romania hasalongtradition ofregulation intheareaofintellectual property. Thefirstlaw
ontrademarks wasadopted in1879 andthefirstlawonpatents in1906.
On6October 1920, Romania acceded totheParis Convention anditsnational legislation on
thesubject isinconformity withthesubstantive provisions ofthatConvention.
Without prejudice totheprovisions ofArticle 65.2and65.3oftheTRIPS Agreement, Romania
hasnotified under Article 63.2oftheAgreement itslawsandregulations concerning patents and
topographies ofintegrated circuits totheTRIPS Council, which havebeencirculated indocuments
IP/N/ROM/1, IP/N/ROM/P/1-3 andIP/N/1/ROM/L/1-2.2
Inrecent years, some significant modifications havebeenmade totheexisting legislation and
newregulations havebeenadopted withaviewtoestablishing amodern legalframework inthearea
ofintellectual property which isadapted tothenewtechnologies andtotheprocess ofliberalizing trade.
Thisprocess iscontinuing intensively withdueregard, interalia,fortheneedtoensure the
integral reflection oftheTRIPS Agreement. Itgoeswithout saying thatanymodification oramendment
ofthelegislation under consideration willbenotified totheTRIPS Council inthesame circumstances
astheinitial notification.
1Theminutes ofthemeeting have been circulated indocument IP/C/M/13.
2Asregards lawsandregulations relevant totheareas under review asnotified byRomania under Article 63.2
oftheAgreement, reference isalsomade todocument IP/N/1/ROM/1.IP/Q3/ROM/1
Page2
2. Patent legislation consists ofLawNo.64of1991, LawNo.120of1992onfeesandGovernment
Decision No.152of1992 ontheimplementation ofLawNo.64.
Law No.64wasadopted inthecourse oftheprocess ofharmonizing patent lawand,
consequently, offers anadequate levelofprotection.
Themain characteristics ofthePatent Lawcanbesummarized asfollows:
(a) Subject matter ofprotection
Apatentable invention mayrelate toaproduct, aprocess oramethod without anyrestriction.
Inthesense ofArticles 70.8and70.9oftheTRIPS Agreement, pharmaceutical andagricultural chemical
products areimplicity covered bytheLaw.
Aninvention ispatentable ifitisnew, involves aninventive stepandissusceptible ofindustrial
application.
(b) Scope ofprotection
Thetitleofprotection foraninvention isthepatent, which confers onitsowner anexclusive
rightofexploitation fortheduration ofitsvalidity.
Thepatent confers onitsowner therighttoprohibit thirdparties fromperforming thefollowing
actswithout hisconsent:
- inrelation toproducts: manufacturing, marketing, offering forsale,using, importing
orstoring forthepurposes ofselling, offering forsaleoruse;
- inrelation toprocesses ormethods: use.
TheLawprovides alsotherighttoremuneration fortheinventor inthecaseofaninvention
made byanemployee under acontract ofemployment thatprovides forinventive activities orinthe
caseofaninvention resulting from aresearch contract.
(c) Duration oftheprotection
Thetermofvalidity ofpatents is20years, starting onthedateonwhich aregular national
filing waseffected.
(d) Enforcement ofrights ininventions
TheLawprovides administrative, civilandcriminal means ofensuring thatpatent rights are
respected.
Although Romanian patent legislation wasadopted before theentry intoforce ofthe
WTO Agreement, itresponds inmany respects tothemajor requirements oftheTRIPS Agreement.
Nevertheless, certain modifications andamendments areunder consideration oratthedrafting stage
tofillthegapswhich stillexistinrespect oftheTRIPS Agreement.
3. Romanian legislation onthetopographies ofintegrated circuits consists ofLawNo.16of1995
andGovernment Decision No.535of1996 toimplement LawNo.16of1995.IP/Q3/ROM/1
Page3
Withrespect tothescope ofLawNo.16,itmaybenoted thatitisdivided intoeightchapters.
Chapter Ionthesubject matter ofprotection, Chapter IIontherighttoprotection, Chapter IIIonthe
registration oftopographies, Chapter IVonrights, Chapter Vonthetransfer ofrights, Chapter VI
ontheexhaustion ofrights, Chapter VIIonenforcement ofrights, Chapter VIIIonfeesandChapter IX
onfinalprovisions.
Weconsider thatLawNo.16of1995isessentially inkeeping withtheprovisions oftheTRIPS
Agreement, butthere arestillcertain amendments thatneedtobemade toit.
4. Theprotectionofplantvarietiesandanimalbreedsiscoveredbytheexpressprovisionscontained
inthepatent legislation, namely, LawNo.64of1991 andGovernment Decision No.152of1992.
With respect totheprotection ofplant varieties, theadoption ofanewlawontheprotection
ofprocesses fortheproduction ofplants isunder consideration.
5. Asregards theprotection ofundisclosed information, therelevant provisions aretobefound
inthelawsconcerning intellectual property andinother regulations, suchastheCode ofPenal Law
(Articles 196and298) andLaw No.11of1991 onUnfair Competition (Articles 1,3and4
paragraph (c)). Bythese latter regulations, persons intrade areobliged toexercise theiractivities in
good faithandinaccordance withhonest practice. Criminal penalties areprescribed forrevealing
toacompetitor undisclosed information concerning theactivities ofaperson intrade, ifthisisdone
byoneofhisemployees Atthesame time, thedisclosure ofinformation byaperson whopossesses
suchinformation because ofhisemployment isalsopunishable iftheactofdisclosure islikely tocause
injury.
6. Anti-competitive practices incontractual licences arenotatpresent regulated bylegislation,
butclauses toprevent suchpractices canbeincluded inlicensing contracts.
7. Weconsider thatthisreview process isveryuseful tous,andanyadvice andtechnical assistance
which might beoffered touswould beverywellreceived byourauthorities.
TheRomanian delegation hasprepared thepreliminary replies tothequestions addressed to
it,despite thefactthatthese questions reached itrather late,evenatthebeginning oftheCouncil 's
present session. Ourdelegation willdoitsbesttorespond toanyadditional requests forclarification.
II. REPLY TOTHE GENERAL QUESTION ONPRIORITY RIGHTS3
Doesyourcountry recognize aright ofpriority onthebasis ofanearlier patent application
filedinanyother WTO Member byanational ofaWTO Member?
Yes,anational ofaWTO Member canclaim therightprovided forinArticle 20oftheLaw
inthesense ofArticle 4oftheParis Convention.
III. REPLIES TOQUESTIONS POSED BYJAPAN
1. Inyourcountry, arethefollowing subject matters protectable bypatent: (1)plants and
animals, and(2)plant andanimal varieties?
3Atthemeeting oftheTRIPS Council of27February 1997, Members agreed torespond tothisquestion
inthecontext ofthepresent review (document IP/C/M/12, paragraph 18).IP/Q3/ROM/1
Page4
Thelegislation inforce doesnotcontain provisions concerning theprotection ofplants and
animals.
AccordingtoArticle11ofLawNo.64of1991andChapterIIIofGovernmentDecisionNo.152
of1992, varieties ofplants andanimal breeds canbeprotected bypatent.
2. Inyour country, istheactofoffering forsaleincluded intheexclusive rights ofpatent?
Yes,under Article 34,firstparagraph, subparagraph (a),ofLawNo.64of1991, offering
forsaleisincluded intheexclusive rights conferred byapatent relating toaproduct inthesense of
Article 2oftheLaw. With respect toapatent relating toaprocess, seethereply toquestion 2asked
bytheEuropean Communities andtheirMember States.
3. Inyour country, what kinds ofactsarerecognized asexceptions totheexclusive rights
conferred byapatent right?
Seetherelevant partofthereply toquestion 4asked bytheEuropean Communities andtheir
Member States.
4. Inyourcountry,inwhichcaseisusewithouttheauthorizationoftherightholderpermitted,
including usebytheGovernment orbythird parties authorized bytheGovernment?
Seetherelevant partofthereply toquestion 4asked bytheEuropean Communities andtheir
Member States.
5. Inyourcountry, howistheobligation under Articles 34.1and34.2oftheTRIPS Agreement
regarding theshiftoftheburden ofproof incivilproceedings forpatent infringement related
toaprocess patent implemented?
Seetherelevant partofthereply toquestion 3asked bytheEuropean Communities andtheir
Member States.
IV. REPLIESTOQUESTIONSPOSEDBYTHEEUROPEANCOMMUNITIESANDTHEIR
MEMBER STATES
1. Article 33ofthePatent Lawlimits the"term ofvalidity ofpatents forinventions that
improve onother patented inventions andcannot beworked without thepreviously patented
inventions tothatofthepatent granted fortheinvention onwhich theimprovement wasmade,
butshall benoshorter thantenyears". Please explain howthiscomplies withArticle 33ofthe
TRIPS Agreement which provides foraterm ofprotection forpatents of20years counted from
thefiling date.
Asageneral rule,Romanian legislation provides thatthetermofvalidity ofpatents shallbe
20years starting onthedateonwhich aregular national filing waseffected. Inthespecial caseof
improvement patent, amodification ofthelawdesigned totakeaccount oftherelevant provisions of
theTRIPS Agreement isunder theconsideration.
[Follow-up question from theEC]IP/Q3/ROM/1
Page5
Could theGovernment ofRomania indicate thetime-frame fortheadoption ofthe
modifications toArticles 33and34ofthePatent Law?4
According totheprovisions oftheConstitution, modifications oramendments mustformthe
subject ofalawadopted byParliament.
TheGovernment institutions responsible intheareawilldotheirbesttoensure thatabillis
submitted toParliament assoonaspossible, foradoption.
2. Article 34(b) ofthePatent Lawstates thatinthecases ofprocesses thepatent holder has
theright toprohibit theuseofthepatented process byathird party. Could theGovernment
ofRomania clarify whether thisalsoincludes "using, offering forsale,selling orimporting for
these purposes atleasttheproduct obtained directly bythatprocess" asprovided inArticle 28.1(b)
oftheTRIPS Agreement.
Atthemoment, Romanian legislation doesnotinclude anyexpress provisions toreflect the
provisions ofArticle 28.1(b) oftheTRIPS Agreement. Anamendment isbeing prepared toArticle 34,
firstparagraph, subparagraph (b),oftheLawwhereby theowner ofthepatent mayrequest thatthird
parties acting without hisauthorization beprohibited from"using, offering forsale,selling orimporting
forthese purposes orstoring forthepurposes ofselling, atleasttheproduct obtained directly bya
patented process".
3. Furthermore, inthecases ofprocess patents, please explain howRomanian lawcomplies
withArticle 34oftheTRIPS Agreement which requires thatMembers make available, incivil
proceedings, theoption ofshifting theburden ofproof regarding theuseofapatented process
toanalleged infringer whohasproduced anidentical product asthatproduced byapatented
process.
Atpresent, theLawhasnoprovision concerning theshifting oftheburden ofproof inthe
situation covered byArticle 34oftheTRIPS Agreement. TheLawwillbeamended tomeet the
requirements ofArticle 34oftheTRIPS Agreement.
4. Could theGovernment ofRomania explain under what circumstances andeffects theuse
ofapatent without theauthorization ofthepatent holder would bepermitted, including useby
theGovernment.
Several provisions ofthePatent Lawareapplicable:
(i) Under Article 37oftheLaw, theuseofapatent without theauthorization oftheholder
ispermissable inthefollowing situations:
- useonboard vessels, landvehicles oraircraft which enter theterritory ofthe
country either temporarily oraccidentally (provision similar toArticle 5ter
oftheParis Convention);
- prior use,ingood faith, byaperson before thedateoftheregular national
filing bythepatent owner, confers arightonthatperson tocontinue suchuse
tothesame extent asonthedateofthefiling;
4Thisfollow-up question alsoapplies toquestions 2and3.IP/Q3/ROM/1
Page6
- useexclusively forexperimental purposes; and
- marketingorofferingforsale,withorwithouttheexpressconsentoftheowner,
ofspecimens oftheproduct constituting thesubject matter oftheinvention
thathadpreviously beensoldbythepatent owner.
(ii) Article 40oftheLawprovides thatuseoftheinvention bythirdparties during the
timebetween theforfeiture oftheowner 'srights andthereinstatement ofthepatent
shallnotbeaninfringement oftheowners 'rights.
(iii) Article 49oftheLawprovides thatacompulsory licence maybegranted bythecourt
inthefollowing cumulative circumstances:
- afterfouryears haveelapsed fromthedateofregistration ofapatent application
orthree years from thegrant ofthepatent, whichever period expires later;
- theinvention hasnotbeenexploited orhasbeeninsufficiently exploited inthe
territory ofRomania during theperiod mentioned above; and
- theowner cannot justify hisinaction andithasnotbeenpossible toreach any
agreement withhim.
Thecompulsory licence isnon-exclusive andisgranted oncertain specific conditions
regarding duration, royalties andtheeconomic rights accruing totheinventor.
Where thelicensee isfound tobenotcomplying withhisobligation toexploit the
invention under theagreed conditions, thecompulsory licence mayberevoked bythe
court attherequest ofthepatent owner.
(iv) Under Article 50oftheLaw, anexofficio licence maybegranted bythecourt for
inventions intheareaofhealth, when theinterests ofpublic health dictate, thatare
notbeing exploited orarebeing insufficiently exploited, where thepatent owner is
unable tojustify hisinaction.
(v) TheGovernment grants exofficio licences ontheconditions provided forinArticles 51
and52oftheLaw.
Under Article 51,thecompetent ministry fortheareacovered bythepatented invention
mayserve notice onthepatent owner, incaseofnon-exploitation orinsufficient exploitation
ofthepatented invention, ifthisisneeded bythenational economy.
Ifthenotice thusserved hasnoeffect within oneyearandthelackofexploitation or
insufficient exploitation, interms ofquality orquantity, isseriously prejudicial tothenational
economy orthepublic interest, thepatent concerning which thenotice wasserved may, at
therequest ofthecompetent ministry, bemade subject toexofficio licensing byorder ofthe
Government.
After publication ofthedecision, anyinterested party mayapply tothecompetent
ministry foranon-exclusive licence toexploit theinvention.IP/Q3/ROM/1
Page7
Under Article 52,theGovernment maygrant, attherequest ofthecompetent ministry,
anexofficio licence fortheexploitation ofaninvention thatisintheinterest ofnational defence
orState security.
Thelicence granted bytheGovernment produces itseffects asfrom thedateofthe
Government decision andisnottransferable.
Under Article 54oftheLaw, royalties fortheexploitation licences provided forin
Article 50,51and52aredetermined bycontract between theparties or,intheevent of
disagreement, bythecourt.
Areview process isincourse, withaviewtodeciding onpossible modifications to
theLawsoastoreflect more adequately theprovisions ofArticle 31oftheTRIPS Agreement.
5. Article 49ofthePatent Lawdescribes theconditions under which acompulsory licence
canbeissued incases ofinsufficient working ofapatent.
(a) Article 31oftheTRIPS Agreement setsoutdetailed criteria under which such
alicence should begranted butwhich thisArticle doesnotreflect initsentirety.
Please explain.
(b) Please alsoexplain whether thepatent owner cansatisfy thisrequirement by
demonstrating thatproducts subject tothepatent havebeenimported byhiminto
Romania and,ifnot,howthisprovision complies withArticle 27.1oftheTRIPS
Agreement which prohibits discrimination intheenjoyment ofrights based on
thelocation ofmanufacture ofproducts.
(a) Seetherelevant partofthereply toquestion 4.
Forthepurpose offullyreflecting theprovisions ofArticle 31oftheTRIPS Agreement,
amendments toArticle 49oftheLawareunder consideration.
(b) Under Article 34,firstparagraph, subparagraph (a),theimportation intoRomania of
products resulting from thepatent constitutes anactofworking thepatent.
Ifthepatent owner candemonstrate thatproducts resulting fromthepatent havebeen
imported intoRomania inquantities sufficient forthemarket, nocompulsory licence
canbegranted.
[Follow-up question from theEC]
Could theGovernment ofRomania indicate thetime-frame fortheadaptation ofArticle 49
ofthePatent Lawtotherequirements ofArticle 31oftheTRIPS Agreement.
Reply similar tothatgiven tothefollow-up question toquestion No.1.
6. Articles 50,51and54ofthePatent Lawprovide foranexofficio licence inthecaseof
interests ofpublic health andwhere thegranted patent isnotbeing (sufficiently) exploited. This
Article doesnotincorporate thecriteria forthegranting ofcompulsory licences asprovided in
Article 31oftheTRIPS Agreement. Please explain howthevarious provisions provided forin
Article 31oftheTRIPS Agreement aretaken intoaccount inthePatent Law.IP/Q3/ROM/1
Page8
Asstated inthereplies toquestions 4and5,theLawreflects inpartthecriteria setforth in
Article 31oftheTRIPS Agreement.
Toensure afullreflection oftheprovisions ofArticle 31oftheTRIPS Agreement, Articles 50,
51and54oftheLawwillbeamended.
[Follow-up question from theEC]
Could theGovernment ofRomania indicate thetime-frame fortheadoption ofthe
modifications toArticles 50,52and54announced intheanswer toquestion 6?
Reply similar tothatgiven tothefollow-up question toquestion No.1.
7. Article 19oftheLawontheProtection ofTopographies ofIntegrated Circuits defines
theterm ofprotection. Could theGovernment ofRomania clarify whether "first commercial
exploitation" would include "thefirstcommercial exploitation wherever intheworld itoccurs"
asprovided inArticle 38oftheTRIPS Agreement?
Article 19oftheLawandRule7,item2,paragraph (g)ofGovernment Decision No.535
fortheapproval oftheRegulations fortheRegistration ofTopographies ofIntegrated Circuits, as
currently worded, donotexpressly provide thatthefirstcommercial exploitation includes "thefirst
commercial exploitation wherever intheworld itoccurs".
Anamendment toArticle 19oftheLaw, withaviewtobringing itintolinewithArticle 38
oftheTRIPS Agreement, isunder consideration.
8. Article 37.2oftheTRIPS Agreement refers totheconditions assetoutinArticle 31(a)
through (k)intheevent ofanynon-voluntary licensing ofalayout design orofitsusebyorfor
thegovernment without theauthorization oftheright holder. However, Chapter VoftheLaw
ontheProtection ofTopographies ofIntegrated Circuits, which describes theconditions under
whichnon-voluntarylicencescanbegrantedunderRomanianlaw,onlyincludessomeofthecriteria
foreseen bytheTRIPS Agreement. Please explain.
Article 33,firstparagraph, subparagraphs (a)and(b),oftheLawsetsouttheconditions on
which thecourt cangrant anon-voluntary licence forexploitation topersons who,despite theirefforts,
havenotbeenabletoobtain from theowner theauthorization touseaprotected topography.
Such alicence canbegranted when itisnecessary, instates ofemergency affecting defence
andnational security, fortheprevention orelimination oftheeffects ofnatural disasters orwhen
infringement ofcompetition legislation ornon-observance ofthenational standards concerning
environmental pollution haveoccurred.
Thelicence isgranted ifaperiod ofatleastfouryears haselapsed since thebeginning ofthe
period ofprotection andthetopography hasstillnotbeenthesubject ofcommercial exploitation in
theterritory ofRomania.
Thenon-voluntary licence isnon-exclusive andcanbetransferred onlywiththeassets needed
foritsapplication.
TheLawprovides thatthenon-voluntary licence canberevoked bythecourt attherequest
oftheowner, when theconditions onwhich thelicence wasgranted haveceased toexist.IP/Q3/ROM/1
Page9
Forthepurpose offullyreflecting theprovisions ofArticle 31(a)to(k)oftheTRIPS Agreement,
Chapter VoftheLawwillbeamended. Anamendment along these linesisunder consideration.
9. Please explain howundisclosed information isprotected andthelegal basis forsuch
protection (Articles 39.1and39.2oftheTRIPS Agreement).
Atpresent, undisclosed information isprotected byprovisions included intheCode ofPenal
LawandLawNo.11/1991 ontheRepression ofUnfair Competition.
Theactspunishable bytheCode ofPenal Lawareasfollows:
- theunlawful disclosure ofinformation byaperson towhom ithadbeenconfided or
whohadbecome aware ofitinthecourse ofhisprofession orduties, iftheactislikely
tocause injury toaperson, thepenalty being atermofimprisonment offrom three
months totwoyears orafine(Code ofPenal Law, Article 196);
- thedisclosure ofinformation notintended forpublicity byaperson whopossesses such
information because ofhisemployment, iftheactislikely tocause injury, thepenalty
being aterm ofimprisonment offrom twotoseven years (Code ofPenal Law,
Article 298).
Article 4,paragraph (c),ofLawNo.11/1991 provides criminal penalties forrevealing toa
competitor undisclosed information concerning theactivities ofaperson intrade, ifthisisdoneby
oneofhisemployees.
Toensure conformity withtheprovisions ofArticle 39oftheTRIPS Agreement, LawNo.11
willbeamended.
[Follow-up question from theEC]
Could theGovernment ofRomania indicate theenvisaged time-frame forputting Law
No.11intoconformity withArticles 39.2and39.3oftheTRIPS Agreement?5
According totheprovisions oftheConstitution, modifications oramendments mustformthe
subject ofalawadopted byParliament.
TheGovernment institutions responsible intheareawilldotheirbesttoensure thatabillis
submitted toParliament, assoonaspossible, foradoption.
10. Could theRomanian Government please explain howundisclosed testorother dataare
protected when, asacondition ofapproving themarketing ofpharmaceutical orofagricultural
chemical products which utilize newchemical entities, asubmission ofsuch data isrequired
(Article 39.3oftheTRIPS Agreement)?
There are,atpresent, noexpress provisions toensure conformity withArticle 39.3oftheTRIPS
Agreement, butthese provisions willbeincluded intheamendments toLawNo.11.
5Thisfollow-up question alsoapplies toquestion 10.IP/Q3/ROM/1
Page10
V. REPLIES TOQUESTIONS POSED BYTHE UNITED STATES
1. Article 2ofRomania 'sPatent Law(No.64of11October 1991) provides thatapatent
shallconfer onitsowner "anexclusive right ofexploitation fortheduration ofitsvalidity". Please
confirm that, asrequired byArticle 28oftheTRIPS Agreement, "exploitation" includes:
- where thesubject matter ofthepatent isaproduct, theactsofmaking, using,
offering forsale,selling, orimporting forthose purposes, theproduct; and
- where thesubject matter ofthepatent isaprocess, theactsofusing theprocess
andusing, offering forsale,selling, orimporting forsuchpurposes, theproduct
produced directly from theuseofthatprocess.
Under Article 2andArticle 34,firstparagraph, subparagraph (a)oftheLaw, theterm
"exploitation" covers: manufacturing, marketing, offering forsale,using, importing orstoring for
thepurposes ofselling, offering forsaleoruse.
Asregards thepatent foraprocess, seethereply toquestion No.2asked bytheEuropean
Communities andtheirMember States.
2. Article 12oftheRomanian Patent Law provides thatinventions thatarecontrary to
morality orpublic policy arenotpatentable. Please describe howthisArticle isinterpreted and
giveexamples ofcircumstances under which aninvention might befound tobecontrary tomorality
orpublic policy. What inventions have been denied patents onthebasis ofthisprovision since
theeffective dateofthePatent Law?
Theprovisions ofArticle 12oftheRomanian Patent Law, whereby inventions thatarecontrary
tomorality orpublic policy arenotpatentable, should beinterpreted inthesense oftheprovision in
Article 27.2oftheTRIPS Agreement. Since theentry intoforce ofthenewLaw, nocasewhich might
becovered bythisprovision hasarisen.
3. Article 49oftheRomanian Patent Lawprovides forcompulsory licensing if,after four
years, theinvention claimed inapatent hasnotbeenexploited orhasbeeninsufficiently exploited
intheterritory ofRomania. Please confirm thatimportation oftheproduct cansatisfy the
requirement forexploitation asrequired bythesecond sentence ofArticle 27.1oftheTRIPS
Agreement.
Yes,seetherelevant partofthereply toquestion No.5asked bytheEuropean Communities
andtheirMember States.
4. Articles 50,51and52oftheRomanian Patent Lawprovide forexofficio compulsory
licensing incertain circumstances. Please describe themanner inwhich suchdecisions canbe
appealed, asrequired under Article 31(i)oftheTRIPS Agreement.
Article 50,firstparagraph, oftheLawprovides thatanexofficio licence isgranted byacourt
decision.
Under theprovisions ofArticle 2,firstparagraph, subparagraph (d)andArticle 3,second
paragraph, oftheCode ofCivilProcedure, decisions byacourtregarding matters ofintellectual property
canbeappealed totheCourt ofAppeal.IP/Q3/ROM/1
Page11
Inthesituations covered byArticles 51and52oftheLaw, theexofficio licence isgranted
byGovernment decision. Ananalysis isinprogress oftheconformity ofArticles 51and52withthe
provisions ofArticle 31(i)oftheTRIPS Agreement. Thisanalysis forms partofthegeneral process
relating tothereflection oftheprovisions oftheTRIPS Agreement inRomanian patent legislation.
5. Articles50and51oftheRomanianPatentLawdonotlimitthegrantofcompulsorylicences
forsemiconductor technology topublic non-commercial useortoremedy anti-competitive practices
asisrequired byArticle 31(c) oftheTRIPS Agreement. Please describe themanner inwhich
theinterpretation ofthese provisions conforms withthecited TRIPS obligation.
Adraftamendment designed toreflect indomestic legislation theprovisions ofArticle 31(c)
oftheTRIPS Agreement isinthecourse ofpreparation.
6. Article34oftheTRIPSAgreementrequiresthattheburdenofproofininfringementactions
involving process patents bereversed inspecified circumstances. Romania 'sPatent Lawdoes
notappear tocontain aprovision thatwould reverse theburden ofproof insuchactions. Please
describe themanner inwhich Romanian lawconfirms withtheobligations ofArticle 34ofthe
TRIPS Agreement.
Seethereply toquestion No.3asked bytheEuropean Communities andtheirMember States.
7. Article 22ofRomania 'sLawontheProtection ofTopographies ofIntegrated Circuits
(No.16of6March 1995) defines what "exploitation ofatopography" means. Itisnotclear that
thedefinition includes alloftherights required tobeprovided under Article 36oftheTRIPS
Agreement, particularly withrespect toanarticle incorporating aprotected integrated circuit.
Please describe themanner inwhich Romania 'sLawprovides theprotection required byArticle 36.
Theprovisions oftheRomanian Lawdonotrefer explicitly to"anarticle incorporating a
protected integrated circuit".
Amore thorough analysis willbeneeded todetermine whether thisaspect isimplicitly covered
bysome oftheprovisions oftheLaw(Articles 22,27and40).Iftheconclusion isnegative, appropriate
amendments totheLawwillbeconsidered.
8. Please explain howundisclosed information isprotected inRomania, andthelegal basis
forsuchprotection.
With respect tothelegalbasis fortheprotection ofundisclosed information, seethereply to
question No.1 asked bytheEuropean Communities andtheirMember States. Romania willnotify
inthenearfuture therelevant legalprovisions inthisarea.
9. Please indicate thenature ofmeasures, ifany,thataretaken byjudicial authorities in
Romania toprotect theconfidentiality ofundisclosed information furnished byaparty tothe
court during legal proceedings, when theinformation hasbeenprovided either toenforce rights
insuchinformation, orforother purposes.
Theconfidentiality ofundisclosed information furnished byaparty tothecourt during legal
proceedings isguaranteed bytheprovisions ofcivilandcriminal law.
According totheprovisions ofArticle 121oftheCode ofCivilProcedure, thecourt maydecide
thatthehearings willtakeplace inchambers, ifpublic hearings could damage theparties, oratleast
oneofthem.IP/Q3/ROM/1
Page12
According toArticle 93(e) ofLawNo.92/1992, ontheOrganization oftheJudiciary, judges
andmagistrates areobliged, onpainofthepenalties provided bythelaw,topreserve theconfidentiality
oftheirwork.
10. Please explain themeasures, ifany,thathave been implemented inRomania toprotect
against unfair competition those parties thathave provided confidential testorother data
concerning apharmaceutical oragricultural chemical product toRomanian regulatory authorities
pursuant toarequest formarketing approval andhowsuch measures areconsistent with
Article 39.3oftheTRIPS Agreement. Please explain whether theinformation isprotected against
disclosure indefinitely, orisonlyprotected foraspecific period oftime.
Seethereply toquestion No.2asked bytheEuropean Communities andtheirMember States.