RESTRICTED
WORLD TRADE IP/Q3/FRA/1
4February 1998
ORGANIZATION
(98-0383)
Council forTrade-Related Aspects Original: English/French
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
France1
Thepresent document reproduces thequestions puttothedelegation ofFrance andtheresponses
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?
TheNational Industrial Property Institute would accept aclaim toaright ofpriority based
onprior filing ofapatent application inanyWTO Member, evenifitisacountry availing itself of
thetransitional period.
Thisrecognition,whichpreservestherightsofthefilersconcerned,doesnotprejudgethevalidity
ofthepriority rightclaimed, amatter exclusively within thejurisdiction ofthecourts towhich itmight
bereferred.
Insofar astheStates concerned haveconcluded reciprocity agreements under which nationals
ofother WTO Members enjoy thispriority right, French nationals would likewise enjoy itthrough
theoperation ofthemost-favoured-nation clause (Article 4oftheTRIPS Agreement). Thecondition
1Asregards legislation relevant totheareas under review andnotified byFrance under Article 63.2ofthe
Agreemen t,referenceismadetodocumentsIP/N/1/FRA/1,IP/N/1/FRA/I/1,IP/N/1/FRA/P/1-2,IP/N/1/FRA/L/1
andIP/N/1/FRA/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/FRA/1
Page2
ofreciprocity provided forbytheIntellectual Property Code would thusbefulfilled andtherightof
priority strengthened.
II. REPLIES TOQUESTIONS POSED BYJAPAN
1. Inyour country, arethefollowing subject matters protectable bypatent: (1)plants and
animals, and(2)plant andanimal varieties?
Article L.611-17 oftheIntellectual Property Code (hereafter the"IPC") applies tothisissue.
Plantsandanimalswhicharenotobtainedusinganessentiallybiologicalprocesscanbeprotected
bypatent. However, plant andanimal varieties arenotpatentable. Inaccordance withArticle 27.3
oftheTRIPS Agreement, plant varieties canbeprotected byanewplant variety certificate incases
where theymeetthecriteria setoutintheUPOV Convention.
2. Inyour country, istheactofoffering forsaleincluded intheexclusive rights ofpatent?
Article L.613-3 oftheIPCapplies tothisquestion:
"The following shallbeprohibited, saveconsent bythepatent owner:
(a) Making, offering, putting onthemarket orusing aproduct which isthesubject matter
ofthepatent, orimporting orstocking aproduct forsuchpurposes; (...);
(b) offering, putting onthemarket orusing theproduct obtained directly byaprocess
which isthesubject matter ofthepatent orimporting orstocking aproduct forsuch
purposes."
3. Inyour country, what kinds ofactsarerecognized asexceptions totheexclusive rights
conferred byapatent right?
Article L.613-5 oftheIPCprovides that:
"The rights afforded byapatent shallnotextend to:
(a) Actsdoneprivately fornon-commercial purposes;
(b) actsdone forexperimental purposes relating tothesubject matter ofthepatented
invention;
(c) theextemporaneous preparation forindividual cases inapharmacy ofamedicine in
accordance withamedical prescription oractsconcerning themedicine soprepared."
4. Inyourcountry,inwhichcaseisusewithouttheauthorizationoftheright-holderpermitted,
including usebytheGovernment orbythird parties authorized bytheGovernment?
Other possible uses fallwithin thescope oftherules governing compulsory licences
(Articles L.613-11 toL.613-14 oftheIPC)andtoexofficio licences (Article L.613-16 toL.613-19
oftheIPC).IP/Q3/FRA/1
Page3
1. Consistency ofArticles L.613-11 toL.613-14 (compulsory licences) withArticle 31ofthe
TRIPS Agreement
(a) Theconditions setoutatArticle 31(h) oftheTRIPS Agreement arerepeated in
paragraphs 2and3ofArticle L.613-12 oftheIPC,which provide thatcompulsory
licences aregranted onconditions setbythetribunal degrande instance (court offirst
instance i.e.,theordinary court withjurisdiction inmatters ofcivillaw), notably as
regards theirduration, theirscope ofapplication andtheamount ofroyalties towhich
theygiverise.Thecourt canmodify theseconditions attherequest ofthepatent rights
holder orthelicensee.
(b) Article L.613-11(b) oftheIPCcorresponds tothecondition required byArticle 31(f)
oftheTRIPS Agreement (object ofsupplying thedomestic market).
(c) Inaccordance withArticle 31(g) oftheTRIPS Agreement, Article L.613-14 ofthe
IPCprovides forthepossibility forthecourts, attherequest oftherights holder or
oftheother licensees, torevoke adecision granting acompulsory licence.
(d) Adequate remuneration oftherights holder: seereply toquestion (a),inrelation to
Article L.613-12 oftheIPC.
2. Compatibility ofArticles L.613-16 andL.613-17 oftheIPC(compulsory licence granted
intheinterests ofpublic health) withArticle 31oftheTRIPS Agreement
Itshould firstbepointed outthatthecompulsory licences referred toinArticles L.613-16
toL.613-19 oftheIPCcanonlyberequested where there isahigher general interest andwhere a
domestic patent isnotexploited, where therearenoapplications forthecompulsory licence inrelation
tothispatent andwhere theproduct isnotimported intothedomestic market. Further, nocompulsory
licences havebeenissued sofar.
Apatent isplaced under therulesgoverning compulsory licences byadecision oftheministry
responsible forindustrial property attherequest oftheMinister ofHealth. Pursuant togeneral legal
principles andnotably theprinciple thatownership rights mustberespected, theholder mustfirstbe
informed.
- Compulsory licences canonlybeissued where, onpublic health grounds, itisurgent
tosupply thedomestic market withsufficient quantities oftheproduct oraproduct
ofsufficient quality covered bythepatent inquestion. Itshould benoted thatin
practice, nocompulsory licences haveeverbeengranted onthisbasis. Thepublic
istobeinformed ofthedecision submitting thelicence totherules governing
compulsory licences byanorder oftheminister responsible forindustrial property,
issued attherequest oftheminister responsible forpublic health (Article L.613-16
oftheIPC). Theright-holders havetobeconsulted inthedrafting ofthisorder. Hence,
Article 31(b) oftheTRIPS Agreement iscomplied with.
- Thescope andtheduration (Article 31(c) oftheTRIPS Agreement) ofthelicence are
specified inasecond order issued bytheminister responsible forindustrial property
which grants thislicence onacase-by-case basis(firstparagraph ofArticle L.613-17
oftheIPC).
- Article L.613-13 oftheIPCasamended bythelawof18December 1996 specifies
thatcompulsory licences andexofficio licences arenon-exclusive, inaccordance with
Article 31(d) oftheTRIPS Agreement.IP/Q3/FRA/1
Page4
- Article L.613-16 specifies thatcompulsory licences intheinterests ofpublic health
aregrantedinordertoremedycaseswheresuppliesareavailableonthedomesticmarket
ininsufficient quantity orquality oratabnormally highprices. ThisArticle mustbe
interpreted inconjunction withArticle L.613-11 which states thatimports aretobe
assimilated toexports. Thecondition setoutatArticle 31(f) istherefore fulfilled.
- Applying theprinciple of"parallel procedures" (principe duparallélisme desformes )
theauthority which tookadecision canrepeal it.Ifandwhen thecircumstances which
originally ledtotheorder being taken cease toexist, theorder canberepealed. Where
theinitial order ismaintained despite theconditions nolonger being fulfilled, thepatent
holder canchallenge theorder before theadministrative courts onthebasis ofthe
relevant provisions oftheTRIPS Agreement (i.e.Article 31(g) oftheTRIPS
Agreement).
- Paragraph 3ofArticle L.613-17 oftheIPCprovides thatwhere theparties failto
reach anagreement, which must beapproved bythetwoministers concerned, the
amount ofroyalties isdetermined bythetribunal degrande instance .Theright-holder
thushasaguarantee, inaccordance withArticle 31(h) oftheTRIPS Agreement. Appeal
before theCourt ofAppeals ispossible.
- Anyadministrativeactwhichconstitutesgroundsforcomplaintcanbechallengedbefore
theadministrative courts through illegality proceedings (with aviewtothecancellation
ofthedecision) orfullrelief proceedings (with aview totheaward ofdamages).
Paragraph (i)ofArticle 31oftheTRIPS Agreement isthuscomplied with.
- Article 613-17 paragraph 3oftheIPCprovides thatwhere anout-of-court agreement
isnotreached, "theamount ofroyalties issetbythetribunal degrande instance ".
Thecondition setoutinparagraph (j)ofArticle 31oftheTRIPS Agreement istherefore
met.
3. Questionsrelatingtoexofficiolicencesfortheneedsofthedomesticeconomy(ArticleL.613-18
oftheIPC)
(a) Importation assimilated totheexploitation ofapatent:
Article L.613-11 asmodified byArticle 5oftheLawof18December 1996
specifies that"theimportation ofproducts thatarethesubject matter ofapatent
manufactured inaStatewhich isparty totheAgreement Establishing theWorld Trade
Organization isdeemed toconstitute theexploitation ofthepatent".
(b) Consistency withArticle 27oftheTRIPS Agreement:
Inview oftheforegoing, Article L.613-11 oftheIPCcomplies withthe
obligation nottodiscriminate astowhether products areproduced locally orimported.
(c) Consistency ofArticle L.613-18 IPCwithArticle 31oftheTRIPS Agreement:
- ThisArticle isintended toapply onlywhere thefactofnotexploiting apatent
ofwhich thesubject matter isnotamedicine -or,asaresult of
Article L.613-11, thefactofnotimporting thepatented product -seriously
damages economic development andthepublic interest. Inthesame wayas
forexofficio licences granted inthepublic interest, thisArticle onlyapplies
incases ofnational emergency, andhasnever been applied. Itshould beIP/Q3/FRA/1
Page5
underlined thatFrench administrative lawisveryrestrictive asregards the
Government ortheadministration depriving persons oftheirownership rights.
Theright-holder issummoned tosatisfy theneeds ofthedomestic economy bytheminister
responsible forindustrial property. Ifwithin aperiod ofoneyear(which under certain conditions
canexceptionally beprolonged attherequest oftheright-holder) theright-holder hasnottaken any
measures toexploit thepatent (orhaveitexploited), theConseil d'Etatcanpassanorder submitting
thepatent totherules governing exofficio licences.
Article L.613-18 oftheIPCistherefore consistent withparagraph (b)ofArticle 31ofthe
TRIPS Agreement.
- Asregards allother issues, Articles L.613-13 andL.613-18 areconsistent withthe
obligations setoutatArticle 31oftheTRIPS Agreement, intheterms mentioned in
relation totheconsistency ofArticles L.613-16 and17IPC.
4. Questions relating toexofficio licences granted intheinterests ofnational defence
(Article L.613-19 oftheIPC)
- Where theMinister ofDefence considers thatintheinterests ofnational defence -and
therefore, fornon-commercial purposes -apatent which hasbeenfiledorgranted must
beexploited bytheState, theState canobtain alicence thereof. Applying general
legalprinciples,theright-holdermustbenotified.Article31(b)oftheTRIPSAgreement
isthuscomplied with. Itshould benoted thatinpractice, noexofficio licences have
everbeenissued onthisbasis.
- Thescope andtheduration (Article 31(c) oftheTRIPS Agreement) ofthelicence are
specified inanorder issued bytheminister responsible forindustrial property who
grants thislicence (Article L.613-19, paragraph 2oftheIPC).
- Article L.613-13 IPC,asamended bytheLawof18December 1996, specifies that
compulsory licences andexofficio licences arenon-exclusive, thuscomplying with
Article 31(d) oftheTRIPS Agreement
- Iftheorder ismaintained despite theconditions nolonger being met,thepatent owner
canchallenge theorder before theadministrative courts based ontherelevant provisions
oftheTRIPS Agreement (Article 31(g)).
- Paragraph 4ofArticle L.613-19 oftheIPCprovides thatwhere theparties failto
reach anamicable agreement, theamount oftheroyalties issetbythetribunal degrande
instance .Theright-holder thushasaguarantee, inaccordance withArticle 31(h)
oftheTRIPS Agreement.
- Anyadministrativeactwhichconstitutesgroundsforcomplaintcanbechallengedbefore
theadministrative courts through illegality proceedings (with aviewtothecancellation
ofthedecision) orfullrelief proceedings (with aview totheaward ofdamages).
Paragraph (i)ofArticle 31oftheTRIPS Agreement isthuscomplied with.
- Paragraph 4ofArticle L.613-19 oftheIPCprovides thatwhere theparties failto
reach anout-of-court agreement, "theamount oftheroyalties shallbelaiddown by
thetribunal degrande instance ".Thecondition setoutatparagraph (j)ofArticle 31
oftheTRIPS Agreement istherefore fulfilled.IP/Q3/FRA/1
Page6
5. Non-voluntary licences inrelation topatents forsemi-conductor technologies (Article 31(c)oftheTRIPS
Agreement)
NewArticle L.613-19-1 oftheIPC(Article 9ofthelawof18December 1996) provides that:
"Ifthepatent relates toaninvention intheareaofsemi-conductor technology, a
compulsory orexofficio licence maybegranted onlywhere ittobeusedforpublic
non-commercial useorinorder toremedy ananti-competitive practice following a
court procedure."
Thepurpose ofthisArticle istoprovide forthecontents ofArticle 31(c) oftheTRIPS
Agreement.
5. Inyourcountry, howistheobligation under Articles 34.1and34.2oftheTRIPS Agreement
regarding theshiftoftheburden ofproof incivilproceedings forpatent infringement related
toaprocess patent implemented?
TheLawof18December 1996 amending theIntellectual Property Code introduced anew
Article L.615-5-1 toChapter VoftheIPCrelating tolegalproceedings. Article L.615-5-1 repeats
thetwooptions setoutinArticle 34oftheTRIPS Agreement expressis verbis .
6. TheIntellectual Property Code L.611-12 prescribes thatapriority right based onan
application previously filedinanon-Paris Convention Contracting country isenjoyable ifthe
saidcountry treats French citizens inthesame way. Doapplications from alltheWTO Member
countries enjoy apriority right under thisprovision? Ifnot,please explain theconsistency with
Article 4oftheParis Convention applied byArticle 2.1oftheTRIPS Agreement.
Article L.611-12 oftheIPCwasamended bytheLawof18December 1996 soastoextend
thepriority righttoWTO Member countries which arenotparty totheParis Convention.
7. TheIntellectual Property Code L.611-17(a) prescribes thatanyinventions prohibited from
usebylawsandregulations areexcluded from patentability. Please explain theconsistency with
Article 27.2oftheTRIPS Agreement which prescribes thatexclusion from patentability shall
notbemade merely because theexploitation isprohibited bydomestic law.
Article L.611-17(a) provides thatinventions thepublication ortheimplementation ofwhich
isagainst public order oragainst public morals areexcluded frompatentability. ThisArticle specifies
that"theimplementation ofsuchaninvention isnotexcluded from patentability merely byvirtue of
itbeing prohibited byaprovision ofalaworregulation". Itistherefore consistent withArticle 27.2
oftheTRIPS Agreement.
8. TheIntellectual Property Code L.613-11(a) prescribes thatacompulsory licence may
besetinthecasewhere theexploitation ofapatented invention hasnotcommenced orsincere
andeffective preparation hasnotbeenmade inaterritory oftheEuropean Community. Given
thatanexploitation ofaninvention isprimarily doneinthecountry where theinvention wasmade,
doesthisprovision discriminate against inventions inother WTO Member countries infavour
ofthose inECmember countries? Please explain theconsistency withthemost-favoured-nation
clause ofArticle 4oftheTRIPS Agreement.
Article L.613-11 oftheIPCwasamended bytheLawof18December 1996 insuchaway
astoextend theassimilation ofimportation toexploitation toproducts patented inamember Stateof
theWTO. Thisnewwording istherefore consistent withArticles 4and27.1oftheTRIPS Agreement.IP/Q3/FRA/1
Page7
III. REPLIES TOQUESTIONS POSED BYTHE UNITED STATES
1. Section L.611-10(2) oftheFrench Patent Lawprovides that"programs forcomputers"
arenotconsidered tobeinventions. Please explain whether, under thisprovision, inventions within
thecategories specified below arenoteligible tobepatented under French law,notwithstanding
thefactthattheinvention isnovel, involves aninventive step, andisuseful:
(a) Process inventions which, inwhole orinpart, consist ofsteps thatareperformed
byacomputer andaredirected byacomputer program;
(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.
Ifanyofthese inventions arenoteligible tobepatented, please explain howthisprovision
oftheFrench patent lawcomplies withtheobligations ofArticle 27oftheTRIPS Agreement,
which mandates patent eligibility forallcategories ofinvention without discrimination.
French andEPO(European Patent Office) caselawaccept thatincertain cases, software is
eligible tobepatented. Indeed, intheSchlumberger (1981) case,theParisCourt ofAppeals considered
thataprocess oneorseveral steps ofwhich wereperformed byacomputer directed bysoftware was
eligible tobepatented.
Further, Article 10oftheTRIPS Agreement refers tosoftware inthesection entitled "copyright
andrelated rights". Article L.112-2.13 oftheIntellectual Property Code (hereafter "IPC") and
Article L.123-1 oftheIPCareconsistent withArticle 10oftheTRIPS Agreement.
[Follow-up question from theUnited States]
Intheresponse toquestion No.1fromtheUnited States, France hasindicated thatincertain
cases, patents canbegranted forsoftware inFrance. Could France clarify whether thiswould
bethecasefortheproducts specified inquestions (b)(i) and(b)(ii) ofquestion No.1from the
United States, byanswering these questions ineither theaffirmative orinthenegative.
b(i): Acomputer program which isstored onaphysical medium (such asafloppy diskor
computer memory) isnoteligible tobepatented.
b(ii): Acomputer whose novelty arises primarily duetoitscombination withaspecific
computer program isonlyeligible tobepatented ifitproduces anovel technical effect
(forexample, increasing thecomputer ’smemory, increasing performance speed).
These restrictions asregards eligibility tobepatented arenotinconsistent withArticle 27of
theTRIPS Agreement, which doesnotrequire thatproducts which arenotinventions, onthebasis
thattheyhavenotechnical effect, beeligible tobepatented. Theprotection ofcomputer programs
assuchfallswithin thescope ofArticle 10oftheTRIPS Agreement.IP/Q3/FRA/1
Page8
2. Please indicate whether inventions consisting ofnucleic acidsequences thatcorrespond
toorarederived from human genetic material canbepatented inFrance iftheyarenew,involve
aninventive stepandarecapable ofindustrial application. Ifthisisnotthecase, please identify
theprovisions ofFrench lawthatpreclude thepatenting ofsuchinventions, andexplain howsuch
provisions areconsistent withArticle 27oftheTRIPS Agreement. Please identify anddescribe
anyother restrictions thatareplaced onthepatenting oforenjoyment ofpatent rights inrespect
ofinventions inthefieldofbiotechnology.
Therelevant Articles oftheIPCareArticles L.611-16 andL611-17. Only thefollowing
arenoteligible tobepatented:
- Surgical ortherapeutic methods oftreatment ordiagnosis ofhumans oranimals. This
exclusion doesnotapply toproducts (notably substances orcompositions) which are
necessary inorder toimplement oneofthese methods.
- thehuman body, itselements (organs, tissues: marrow, cells,...) anditsproducts (i.e.
outgrowths oftheepidermis, excretions, bodily fluids :blood, sperm, sweat, urine,
tears, ...)assuch, andthesimple knowledge ofthepartial orcomplete structure of
ahuman gene;
- newplant varieties;
- animal varieties oressentially biological processes fortheproduction ofplants or
animals. Thisexclusion doesnotrelate tomicro-biological processes ortheproducts
thereof.
Theexclusions described atthefirst,thirdandfourth indents areconsistent withArticle 27.3
oftheTRIPS Agreement. Theexclusion provided foratthesecond indent isanapplication oftraditional
principles relating totheexclusion from patentability, which isconsistent with
Article 27.1(patent ofinventions -andnotdiscoveries -only).
[Follow-up question from theUnited States]
Initsanswer toquestion No.2from theUnited States, France hasindicated thatpatents
cannot beobtained forproducts from human beings orfor"thesimple knowledge ofthepartial
orcomplete structure ofahuman gene". Could France please indicate thebasis ofFrench law
thatdefines thisexclusion, andindicate whether, under thatauthority, thefollowing subject matter
would beexcluded:
(a) Achemical structure consisting ofanucleotide sequence thatisidentical toa
nucleotide sequence ofahuman gene;
(b) acomposition thathasbeen isolated from ahuman being comprising various
chemical compounds, suchasproteins, nucleic acidsequences, carbohydrates, etc;
and
(c) acellthathasbeenisolated from ahuman being andhassubsequently beenaltered
soastoestablish animmortalized celllinethatisfunctionally equivalent tothe
cellasitexists inthehuman being.
Thelegalbasis forparts andproducts ofthehuman body being excluded from patentability
is,aswehavealready mentioned, Article L.611-17 oftheIPC.IP/Q3/FRA/1
Page9
(a) Achemical structure consisting ofanucleotide sequence thatisidentical toanucleotide
sequence ofahuman geneiseligible tobepatented ifithasbeenisolated from the
human body;
(b) acomposition thathasbeenisolated from ahuman body andpurified, comprising
variouschemicalcompounds,suchasproteins,nucleicacidsequencesandcarbohydrates
iseligible tobepatented;
(c) acellthathasbeenisolated fromthehuman body, andhassubsequently beenaltered
soastocultivate acelllinethatisfunctionally equivalent tothecellasitexists inthe
human body iseligible tobepatented.
3. Sections L.613-11 toL.613-14 oftheFrench Patent Lawestablish asystem forthegrant
ofcompulsory 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 of
licence;
(b) Article 31(f) thatthelicence permit use"predominantly forthesupply ofthe
domestic market oftheMember authorizing suchuse";
(c) Article 31(g) thattheFrench Government terminate acompulsory licence "ifand
when thecircumstances which ledtoitcease toexistandareunlikely torecur";
and
(d) Article 31(h) thataright-holder shall bepaid "adequate remuneration inthe
circumstances ofeach case, taking intoaccount theeconomic value ofthe
authorization".
(a) Theconditions setoutatArticle 31(b) oftheTRIPS Agreement arerepeated in
paragraphs 2and3ofArticle L.613-12 oftheIPC,which provides thatcompulsory
licences aregranted under theconditions setbythetribunal degrande instance (i.e.the
ordinary court inmatters ofcivillaw), notably inrelation totheirduration, theirscope
ofapplication andtheamount ofroyalties towhich theygiverise. These conditions
canbemodified bythecourt, attherequest ofthepatent right-holder orthelicensee.
(b) Article L.613-11(b) oftheIPCcorresponds tothecondition setoutbyArticle 31(f)
oftheTRIPS Agreement (object ofsupplying thedomestic market).
(c) Article L.613-14 oftheIPCprovides, inaccordance withArticle 31(g) oftheTRIPS
Agreement, thepossibility forthecourt, attherequest oftheright-holder ortheother
licensees, torepeal thedecision which granted acompulsory licence.
(d) Adequate remuneration oftheright-holder: seereply toquestion (a)relating to
Article L.613-12 oftheIPC.
4. Sections L.613-16 andL.613-17 oftheFrench Patent Lawestablish asystem ofexofficio
licences inthecaseofpatents granted formedicines andforprocesses forproducing medicines,
forproducts necessary inobtaining such medicines orforprocesses formanufacturing such
products. Please explain how thisauthority concerning exofficio licences complies with
Article 31(b), (c),(d),(f),(g),(h),(i),and(j)oftheTRIPS Agreement.IP/Q3/FRA/1
Page10
Itshould firstbepointed outthatthecompulsory licences referred toinArticles L.613-16
toL.613-19 oftheIPCcanonlyberequested where thereisahigher general interest, where adomestic
patent isnotexploited, where there arenoapplications forthecompulsory licence inrelation tothis
patent andwhere theproduct isnotimported intothedomestic market. Further, nocompulsory licences
havebeenissued attoday’sdate.
Apatent isplaced under therulesgoverning compulsory licences byadecision oftheMinistry
responsible forindustrial property attherequest oftheMinister ofHealth. Pursuant togeneral legal
principles andnotably theprinciple following which ownership rights mustberespected, theholder
must firstbeinformed.
- Compulsory licences canonly beissued where, onpublic health grounds, itisurgent
tosupply thedomestic market with sufficient quantities oftheproduct oraproduct
ofsufficient quality covered bythepatent inquestion. Itshould benoted thatinpractice,
nocompulsory licences have ever been granted onthisbasis. Thepublic istobe
informed ofthedecision submitting thelicence totherules governing compulsory
licences byanorder oftheminister responsible forindustrial property, issued atthe
request oftheminister responsible forpublic health (Article L.613-16 oftheIPC).
Theright-holders have tobeconsulted inthedrafting ofthisorder. Hence, Article 31(b)
oftheTRIPS Agreement iscomplied with.
- Thescope andtheduration (Article 31(c) oftheTRIPS Agreement) ofthelicence are
specified inasecond order issued bytheminister responsible forindustrial property
which grants thislicence onacase-by-case basis (first paragraph ofArticle L.613-17
oftheIPC).
- Article L.613-13 oftheIPCasamended bytheLaw of18December 1996 specifies
thatcompulsory licences andexofficio licences arenon-exclusive, inaccordance with
Article 31(d) oftheTRIPS Agreement.
- Article L.613-16 specifies thatcompulsory licences intheinterests ofpublic health
aregranted inorder toremedy cases where supplies areavailable onthedomestic market
ininsufficient quantity orquality oratabnormally high prices. This Article must be
interpreted inconjunction with Article L.613-11 which states thatimports aretobe
assimilated toexports. Thecondition setoutatArticle 31(f) istherefore fulfilled.
- Applying theprinciple of"parallel procedures" (principe duparallélisme desformes )
theauthority which tookadecision canrepeal it.Ifandwhen thecircumstances which
originally ledtotheorder being taken cease toexist, theorder canberepealed. Where
theinitial order ismaintained despite theconditions nolonger being fulfilled, thepatent
holder canchallenge theorder before theadministrative courts onthebasis ofthe
relevant provisions oftheTRIPS Agreement (i.e.Article 31(g) oftheTRIPS
Agreement).
- Paragraph 3ofArticle L.613-17 oftheIPCprovides thatwhere theparties failto
reach anagreement, which must beapproved bythetwoministers concerned, the
amount ofroyalties isdetermined bythetribunal degrande instance .Theright-holder
thushasaguarantee, inaccordance withArticle 31(h) oftheTRIPS Agreement. Appeal
before theCourt ofAppeals ispossible.
- Anyadministrativeactwhichconstitutesgroundsforcomplaintcanbechallengedbefore
theadministrative courts through illegality proceedings (with aviewtothecancellationIP/Q3/FRA/1
Page11
oftheact)orfullrelief proceedings (with aview totheaward ofdamages).
Paragraph (i)ofArticle 31oftheTRIPS Agreement isthuscomplied with.
- Article 613-17 paragraph 3oftheIPCprovides thatwhere anout-of-court agreement
isnotreached, "theamount ofroyalties issetbythetribunal degrande instance ".
Thecondition setoutinparagraph (j)ofArticle 31oftheTRIPS Agreement istherefore
met.
[Follow-up question from theUnited States]
Please indicate whether thelawof18December 1996 hasbeen notified totheTRIPS
Council.
Thelawof18December 1996 waspublished withFrance ’sreplies tothequestions posed by
Japan. Itshould shortly bepublished under reference IP/C/N (notification ofnational
legislations).4
5. Section L.613-18 oftheFrench Patent Lawestablishes asystem ofexofficio licences in
thecaseofpatents thatarenotworked soastosatisfy therequirements ofthenational economy.
With respect tothisprovision oftheFrench Patent Law:
(a) Please indicate whether theGovernment ofFrance considers theimportation of
products covered byapatent5tosatisfy 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 of
theFrench 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.
(a) Importation assimilated totheexploitation ofapatent
Article L.613-11 asamended byArticle 5oftheLawof18December 1996specifies
that"theimportation ofpatented products manufactured inaState which isparty to
theAgreement Establishing theWorld Trade Organization isdeemed toconstitute the
exploitation ofapatent".
(b) Consistency withArticle 27
Inviewoftheforegoing, Article L.613-11 oftheIPCcomplies withtheobligation
nottodiscriminate astowhether products areproduced locally orimported.
4LawNo.96-1106 hasbeen circulated asdocument IP/N/1/FRA/I/1/Add.1.
5AccordingtotheUSdelegation,theterm"coveredbyapatent"asusedheremeansthattheproductiscovered
directly byaproduct patent claim orindirectly asaproduct produced byapatented process.IP/Q3/FRA/1
Page12
(c) Consistency ofArticle L.613-18 IPCwithArticle 31oftheTRIPS Agreement
ThisArticle isintended toapply onlywhere thefactofnotexploiting apatent ofwhich
thesubject matter isnotamedicine -or,asaresult ofArticle L.613-11, thefactof
notimporting thepatented product -seriously damages economic development and
thepublic interest. Inthesame wayasforexofficio licences granted inthepublic
interest, thisArticle onlyapplies incases ofnational emergency, andhasnever been
applied. Itshould beunderlined thatFrench administrative lawisveryrestrictive as
regards theGovernment ortheadministration depriving persons oftheirownership
rights.
Theright-holder issummoned tosatisfy theneeds ofthedomestic economy bytheminister
responsible forindustrial property. Ifwithin aperiod ofoneyear(which under certain conditions
canexceptionally beprolonged attherequest oftheright-holder) theright-holder hasnottaken any
measures toexploit thepatent (orhaveitexploited), theConseil d'Etatcanpassanorder submitting
thepatent totherules governing exofficio licences.
Article L.613-18 oftheIPCistherefore consistent withparagraph (b)ofArticle 31ofthe
TRIPS Agreement.
Asregards allother issues, Articles L.613-13 andL.613-18 areconsistent withtheobligations
setoutatArticle 31oftheTRIPS Agreement, intheterms mentioned inrelation totheconsistency
ofArticles L.613-16 and17oftheIPC.
6. Section L.613-19 oftheFrench Lawestablishes asystem ofexofficio licences toallow
theworking ofapatented invention inorder tomeetdefence requirements irrespective ofwhether
theworking istobedone bytheState itself oronitsbehalf. Please explain howthisprovision
oftheFrench patent lawcomplies withArticles 31(b), (c),(d),(f),(g),(h),(i),and(j)oftheTRIPS
Agreement.
- Where theMinister ofDefence considers thatintheinterests ofnational defence -and
therefore, fornon-commercial purposes -apatent which hasbeenfiledorgranted must
beexploited bytheState, theState canobtain alicence thereof. Applying general
legalprinciples,theright-holdermustbenotified.Article31(b)oftheTRIPSAgreement
isthuscomplied with. Itshould benoted thatinpractice, noexofficio licences have
everbeenissued onthisbasis.
- Thescope andtheduration (Article 31(c) oftheTRIPS Agreement) ofthelicence are
specified inanorder issued bytheminister responsible forindustrial property who
grants thislicence (Article L.613-19, paragraph 2oftheIPC).
- Article L.613-13 IPC,asamended bytheLawof18December 1996, specifies that
compulsory licences andexofficio licences arenonexclusive, thuscomplying with
Article 31(d) oftheTRIPS Agreement.
- Iftheorder ismaintained despite theconditions nolonger being met,thepatent owner
canchallenge theorder before theadministrative courts based ontherelevant provisions
oftheTRIPS Agreement (Article 31(g) oftheTRIPS Agreement).
- Paragraph 4ofArticle L.613-19 oftheIPCprovides thatwhere theparties failto
reach anamicable agreement, theamount oftheroyalties issetbythetribunal degrande
instance .Theright-holder thushasaguarantee, inaccordance withArticle 31(h)
oftheTRIPS Agreement.IP/Q3/FRA/1
Page13
- Anyadministrativeactwhichconstitutesgroundsforcomplaintcanbechallengedbefore
theadministrative courts through illegality proceedings (with aviewtothecancellation
ofthedecision) orfullrelief proceedings (with aview totheaward ofdamages).
Paragraph (i)ofArticle 31oftheTRIPS Agreement isthuscomplied with.
- Paragraph 4ofArticle L.613-19 oftheIPCprovides thatwhere theparties failto
reach anout-of-court agreement, "theamount oftheroyalties shallbelaiddown by
thetribunal degrande instance ".Thecondition setoutatparagraph (j)ofArticle 31
oftheTRIPS Agreement istherefore fulfilled.
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 after judicial or
administrative process tobeanti-competitive. Noprovision intheFrench patent lawappears
tolimit theavailability ofcompulsory licences withrespect topatented inventions inthefieldof
semi-conductor technology. Please explain howFrench lawcomplies with theobligations of
Article 31(c) oftheTRIPS Agreement.
NewArticle L.613-19-1 oftheIPC(Article 9oftheLawof18December 1996) provides
that:
"Ifthepatent relates toaninvention intheareaofsemi-conductor technology, acompulsory
orexofficio licence maybegranted onlywhere itistobeusedforpublic non-commercial
useorinorder toremedy ananti-competitive practice following acourt procedure."
Thepurpose ofthisArticle istoprovide forthecontents ofArticle 31(c) oftheTRIPS
Agreement.
8. PleaseindicatehowmanycompulsorylicencesonayearlybasishavebeengrantedinFrance
since 1January 1993.
After consulting theappropriate databases itappears thatnocompulsory licence forfailure
toexploit apatent hasbeenissued since 1993 andnoexofficio licences haveeverbeenissued.
9. Section L.613-3 oftheFrench Patent Lawdefines certain actsrelating toaproduct of
apatented process tobeactsofinfringement, consistent withtherequirements ofArticle 28.1(b)
oftheTRIPS Agreement. Please explain howFrench lawcomplies withtheobligations ofArticle 34
oftheTRIPS Agreement, which requires Members tomake available incivilproceedings toenforce
apatent theoption ofshifting theburden ofproof regarding useofapatented process toanalleged
infringer whohasproduced theidentical product asthatwhich isproduced byapatented process.
Article L.613-3 oftheIPCdefines therights deriving frompatents. Therelevant article here
isnewArticle L.615-5-1, inserted intoChapter VoftheIPCrelating tolegalproceedings bythelaw
of18December 1996. Article L.615-5-1 repeats thetwooptions setoutinArticle 34oftheTRIPS
Agreement expressis verbis .
10. Please describe howFrench authorities responsible forthegranting ofmarketing approval
forregulated products (e.g. pharmaceuticals, agricultural orother chemical products) handle
testdataprovided totheauthority forthepurpose ofobtaining marketing approval. Inparticular,
please explain thelegal oradministrative measures, ifany,thatserve toprotect suchdatafrom
disclosure tothepublic andfrom unfair commercial usebythird parties. Please explain also
howthese measures areconsistent withtheobligations ofArticle 39.3oftheTRIPS Agreement.IP/Q3/FRA/1
Page14
Confidential, commercial orpersonal datainpharmaceutical product marketing approval files
(hereafter "MA") filedpursuant totheFrench procedure cannot bedisclosed tothepublic inaccordance
withparagraph 5ofArticle 1oftheOrder of13March 1986 published intheOfficial Journal of
19March 1986.
Thesame rules govern datacontained inMAapplications filed pursuant toCommunity
Directive 65/65. Article 12ofRegulation 2309/93 establishing theEuropean Agency fortheEvaluation
ofMedicinal Products provides thatthirdparties mayhaveaccess toapartofthefileafterallconfidential
business information hasbeenremoved.
With respect toveterinary products, theapplicable legaldocument istheOrder issued bythe
Minister forAgriculture dated 22August 1985, applying theLawof17July1978 onaccess to
administrative documents (aswasthepreviously mentioned Order of13March 1985).
Asregards phyto-pharmaceutical products, please refer toArticle 11ofDecree No.94-359 of
5May1994relatingtothecontrolofphyto-pharmaceuticalproducts(O.J.of7May1994);thisdocument
repeats theprovisions ofArticle 13ofCommunity Directive 91/414 relating tomarketing of
phyto-pharmaceutical products. Further, anotice from theCommission forAccess toAdministrative
Documents (instituted bytheLaw of17July 1978) dated 9February 1996 specified thescope of
application oftheOrder of22August 1985 byforbidding the"toxicological study" ofphytosanitary
MAfiles from being divulged tothird parties andbyimposing thatthenominative datacontained in
the"efficiency study" section beremoved.
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