RESTRICTED
WORLD TRADE IP/Q3/ITA/1
14November 1997
ORGANIZATION(97-5015)
Original: English/French Council forTrade-Related Aspects
ofIntellectual Property Rights
REVIEW OFLEGISLATION INTHE FIELDS OFPATENTS, LAYOUT DESIGNS
(TOPOGRAPHIES) OFINTEGRATED CIRCUITS, PROTECTION OF
UNDISCLOSED INFORMATION AND CONTROL OF
ANTI-COMPETITIVE PRACTICES IN
CONTRACTUAL LICENCES
Italy1
Thepresent document reproduces thequestions puttothedelegation ofItalyandtheresponses
given inthereview oflegislation onpatents, layout-designs (topographies) ofintegrated circuits,
protection ofundisclosed information andcontrol ofanti-competitive practices incontractual licences
attheCouncil 'smeeting of26-30 May1997.2
_______________
I. REPLY TOTHE GENERAL QUESTION ONPRIORITY RIGHTS3
Doesyourcountry recognize aright ofpriority onthebasis ofanearlier patent application
filedinanyother WTO Member byanational ofaWTO Member?
Yes. Inthisconnection, under Article 11oftheImplementing Regulations ofthePatent Law,
approved byDecree No.244of5February 1940, asamended byArticle 44ofDecree No.338of
22June1979, aperson filing apatent inItalymayclaim priority ofafiling "made under theterms
andwiththeeffects laiddown inexisting international conventions". Forthispriority toberecognized,
thefilermust provide documentary evidence ofthepriority invoked, including, where appropriate,
evidence thatheisthesuccessor intitleoftheoriginal filer. Thisevidence, which maytaketheform
ofacertificate signed bythePatent Office andtranslated intoItalian, must mention thename ofthe
rightholder andthedateoffiling forwhich priority isclaimed, aswellasthetitle,description and
drawings oftheinvention concerned. Theperson filing thepatent application inItalyisresponsible
forthecomplete accuracy ofthetranslation ofthepriority certificates submitted totheItalian Office.
1Asregards lawsandregulations relevant totheareas under review asnotified byItalyunder Article 63.2
oftheAgreemen t,referenceismadetodocumentsIP/N/1/ITA/1andAdd.1-2,IP/N/1/ITA/1/P/1-2,IP/N/1/ITA/I/1
andIP/N/1/ITA/L/1, IP/N/1/ITA/G/1 andIP/N/1/ITA/O/1.
2Theminutes ofthemeeting have been circulated indocument IP/C/M/13.
3Atthemeeting oftheTRIPS Council of27February 1997, Members agreed torespond tothisquestion
inthecontext ofthepresent review (document IP/C/M/12, paragraph 18).IP/Q3/ITA/1
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II. REPLIES TOQUESTIONS POSED BYJAPAN
1. Inyour country, arethefollowing subject matters protectable bypatent: (1)plants and
animals, and(2)plant andanimal varieties?
InItaly, plantvarieties canbeprotected onlyinaccordance withtherulesofDecree No.974
of12August 1975, which exclude thepatentability ofplants assuch. Animal breeds andessentially
biologicalprocessesfortheproductionofanimalsarenotprotectablebypatent;however,thisprohibition
doesnotapply tomicrobiological processes andtheproducts obtained bytheseprocesses (seeArticle 13
ofDecree No.1127 of29June1939, which isinconformity withtheprovisions ofArticle 53ofthe
European Patent Convention).
2. Inyour country, istheactofoffering forsaleincluded intheexclusive rights ofpatent?
Yes. Actsofputting onthemarket, including theactofoffering forsale,areincluded within
thescope oftheexclusive rights ofthepatent owner (seeArticle 1bis,paragraph 1,subparagraph (a)
ofDecree No.1127of29June1939, asamended byArticle 12ofDecree No.198of19March 1996).
3. Inyour country, what kinds ofactsarerecognized asexceptions totheexclusive rights
conferred byapatent right?
Theexclusive rightisnotinvocable inthecaseof:
(a) Actsinaprivate place andforapurpose other thancommercial; and
(b) experiments (seeArticle 1ofDecree No.1127 of29June1939).
4. Inyourcountry,inwhichcaseisusewithouttheauthorizationoftherightholderpermitted,
including usebytheGovernment orbythird parties authorized bytheGovernment?
Theuseofapatent without theauthorization oftheright holder ispermitted onlyafterthe
issue ofacompulsory licence oranexpropriation order (seeArticles 54etseq.ofDecree No.1127
of29June1939, asamended byArticles 17,18,19,20,21and22ofDecree No.198of
19March 1996). Withrespect tothegranting ofanon-exclusive compulsory licence, Decree No.360
of18April 1994isapplicable. Ithassimplified theprocedure inthefollowing way: interested parties
must submit anapplication totheItalian Patent andTrademark Office indicating, inparticular, the
remuneration offered forthelicence inquestion; theOffice notifies theapplication, including theoffer
ofremuneration, totheowner ofthepatent andhissuccessors intitle,asrecorded intheRegister,
within 60daysofreceiving theapplication; theowner, orhissuccessors intitle,cansubmit aformal
objection, withduegrounds, totheOffice andtheOffice, afteramandatory attempt atconciliation
between theparties, rulesontheobjection andissues orrefuses toissuethelicence. Theprocess should
becompleted within aperiod of180daysandtheparties concerned canhaverecourse tothecourts.
5. Inyourcountry, howistheobligation under Articles 34.1and34.2oftheTRIPS Agreement
regarding theshiftoftheburden ofproof incivilproceedings forpatent infringement related
toaprocess patent implemented?
Theobligations under Articles 34.1and34.2oftheTRIPS Agreement wereimplemented by
Article 2ofDecree No.1127 of29June1939, asamended byArticle 13ofDecree No.198of
19March 1996.IP/Q3/ITA/1
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III. REPLIES TOQUESTIONS POSED BYUNITED STATES
1. Article 54ofRoyal Decree No.1127of29June 1939, asamended, provides forcompulsory
licensing ofpatents under certain circumstances. Thelawdoesnotappear tolimitsuchlicensing
inconnection with semiconductor technology topublic non-commercial useortoremedy an
adjudicated violation ofcompetition laws. Please explain howthelawisadministered inamanner
consistent withArticle 31(c) oftheTRIPS Agreement.
InItaly, topographies andsemiconductor products arenotprotectable bypatent butbyasui
generis rightgranted following aregistration procedure. LawNo.70of21February 1989 doesnot
provide forcompulsory licences withrespect tosuch rights, apart from theexceptional caseof
exploitation byathirdparty before theregistration ofthissuigeneris rightorbefore theformal notice
bytheowner oftheapplication forregistration. Insuchacase,iftheowner refuses togiveacontractual
licence, theAdministration delivers anon-exclusive compulsory licence tothethirdparties, oncondition
ofanequitable remuneration andwithin thelimits ofthepre-registration exploitation (seeArticle 18
ofLawNo.70of21February 1989, asamended byArticle 29ofDecree No.198of19March 1996).
2. Through operation ofadecree of1996, Italy hasindicated thatitincorporates the
obligations oftheTRIPS Agreement directly within Italian law. Certain elements oftheTRIPS
Agreement areoptional andrequire theWTO Member tomake adecision ofwhether ornotto
apply theoptional element. Please explain whether, under Italian law,
(a) aparty canrelydirectly onelements oftheTRIPS Agreement inthecourse of
enforcing patent rights;
(b) whether Italyexcludes patent protection forplants andanimals, orforplant and
animal varieties, pursuant toArticle 27.3(b).
Asaresult ofLawNo.747of29December 1994, Italyratified theMarrakesh Agreement,
including theTRIPS Agreement, theentry intoforce ofwhich required theinclusion, inthedomestic
legalorder, ofthecompulsory rulesofthesaidAgreement. Ontheother hand, theoptional elements
ofthisAgreement canbecome mandatory onlyasaresult ofadomestic lawexercising theoptions
allowed bythesaidTRIPS Agreement.
Consequently, thedirect application ofthecompulsory rules oftheAgreement canberelied
upon onlyinthecontext ofanaction whereby theparties canchallenge anincorrect implementation
oftheobligations andprovisions oftheAgreement. Ifthejudge accepts theparties 'allegations, he
refers thecasetotheConstitutional Court which candeclare thedomestic lawvoidasnotbeing in
conformity withtheprovisions oftheAgreement. InItaly, plantvarieties canbeprotected byapatent
onlyinaccordance withtheprovisions ofDecree No.974of12August 1975, which excludes the
patentability ofplants assuch. Animal breeds andessentially biological processes fortheproduction
ofanimals arenotprotectable bypatent; however, thisprohibition doesnotapply tomicrobiological
processes andtheproducts obtained bythese processes (seeArticle 13ofDecree No.1127 of
29June1939), which isinconformity withtheprovisions ofArticle 53oftheEuropean Patent
Convention.
3. Please explain whether anyinventions arenoteligible tobepatented under Italian law,
notwithstandingthefactthattheinventionsatisfiesthecriteriaofbeingnovel,involvinganinventive
step, andbeing useful, inparticular withrespect totheinventions specified below:
(a) Process inventions which, inwhole orinpart, consist ofsteps thatareperformed
byacomputer andaredirected byacomputer program;IP/Q3/ITA/1
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(b) product inventions consisting ofelements ofacomputer-implemented invention,
including inparticular:
(i) machine-readable computer program code stored onatangible medium
suchasafloppy disk, computer hard drive orcomputer memory; and
(ii) ageneral purpose computer whose novelty over theprior artarises
primarily duetoitscombination withaspecific computer program.
According toItalian law(seeArticles 12-16 ofDecree No.1127of23June1939, asamended
byDecree No.198of13March 1996), anyinvention maybepatented which meets theconditions
ofnovelty, aninventive stepandbeing capable ofindustrial application. Cases ofnon-patentability
areexceptional andarespecifically indicated bythelaw. Aninvented process ispatentable, evenif
ithasbeenimplemented ordirected byacomputer program, provided thattheprotection bypatent
oftheprocess, andoftheproducts manufactured bymeans ofthisprocess, isnotincompatible with
protection ofthecopyright forthecomputer program assuch. Ontheother hand, evenifnovel and
original, intellectual creations which areessentially duetospecific computer programs canbeprotected
onlybythecopyright.
4. Please indicate whether anycompulsory licences under apatent havebeenissued inItaly
since 1January 1993.
Since 1January 1993, andtodate, nocompulsory licence under apatent hasbeenissued by
Italy.
5. Please explain themeasures, ifany,thathavebeenimplemented inItalytoprotect against
unfair competition those parties thathave provided confidential testorother dataconcerning
apharmaceutical oragricultural chemical product toItalian regulatory authorities pursuant to
arequest formarketing approval. Please explain howsuchmeasures, ifany,areconsistent with
Article 39.3oftheTRIPS Agreement.
Theprotection ofconfidential information, inaccordance withArticle 39.3oftheTRIPS
Agreement, isguaranteed inItalybyArticle 6bisofDecree No.1127 of29June1939, asamended
byArticle 14ofDecree No.198of19March 1996. Paragraph 2ofthatArticle prohibits thedisclosure
ofconfidential datasubmitted tothecompetent authorities toobtain approval formarketing
pharmaceutical oragricultural chemical products.
[Follow-up question from theUS]
Weappreciate thatItaly protects confidential testdatasubmitted toItalian regulatory
agencies tosupport anapplication formarketing approval ofapharmaceutical oragricultural
chemical product against disclosure. Please explain howItaly protects suchdataagainst unfair
commercial use,including bypreventing later applicants from relying directly orindirectly on
theoriginal datatosupport their applications formarketing approval.
Asalready explained inreplying toquestion 5asked bytheUnited States, ourlawsprohibit
thedisclosureofconfidentialdatasubmittedtothecompetentauthoritiestoobtainapprovalformarketing
pharmaceutical oragricultural chemical products (seeArticle 6bis(2)ofDecree No.1127 of
29June1939, asamended byArticle 14ofDecree No.198of19March 1996).
Inaddition, under paragraph 1ofthesaidArticle 6bis,thesame confidential information is
protected, inageneral way,byforbidding toanythirdparty including -ofcourse -competitors, theIP/Q3/ITA/1
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acquisition, direct useordisclosure toanyother thirdparties ofsuchconfidential information anddata.
Thisisoncondition thattheinformation, including data,inquestion: (a)issubject toreasonable steps,
bythepersons lawfully incontrol thereof, tokeepitsecret; and(b)isnotgenerally known toorreadily
accessible byexperts andoperators inthesector concerned.
According toArticle 2598 oftheCivil Code, which isrecalled intheabove-mentioned
Article 6bis,inthecaseofaviolation ofthesaidprohibitions, theinjured party cantakelegalaction
against theauthor oftheviolation andaskthecourt to:
(a) Prohibit theactsofviolation;
(b) award damages; and
(c) order thepublication ofitsruling inthedaily press, attheexpense oftheparty
responsible.