WORLD TRADE 
ORGANIZATION 
Council on Trade-Related Aspects 
of Intellectual Property Rights IPIN/1IEEC/P/4 
12 February 1999 
(99-0555) 
MAIN DEDICATED INTELLECTUAL PROPERTY LAWS AND REGULATIONS 
NOTIFIED UNDER ARTICLE 63.2 OF THE AGREEMENT 
EUROPEAN COMMUNITIES 
The present document reproduces the text of Directive 98/44/EC of the European Parliament 
and of the Council of 6 July 1998 on the legal protection of biotechnological inventions, as notified by 
the European Communities under Article 63.2 of the Agreement by means of a communication from 
its Permanent Mission, dated 26 November 1998. IP/N/lIEEC/P/4 
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30.7.98 Official Journal of the European Communities L 213/13 
DIRECTIVE 98/-\4IEC OF THE EUROPEAN PARLl-\.,\IENT AND OF THE COUNCIL 
of 6 July 1998 
on the legal protection of biotechnological inventions 
THE EUROPE .... ='" P'-\RLl'-\~[E:-''T AND THE COUNCIL OF 
THE EUROPE'-\~ l~ION, 
Having regard to the Treaty establishing the European 
Community, and in particular Article 100a thereof, 
Having regard to the proposal from the Commission (1), 
Having regard to the opinion of the Economic and Social 
Committee (~), 
Acting in accordan.:e with the procedure laid down In 
Article 189b of the Treaty (l), 
(1) Whereas biotechnology and genetic engineering are 
playing an increasingly important role in a broad 
range of industries and the protection of 
biocechnological inventions will certainly be of 
fundamemal importance for the Community'S 
industrial development; 
(2) Whereas, in particular in the field Of genetic 
engineering, research and development require a 
considerable amount of high-risk investment and 
therefore only adequate legal protection can make 
them profitable; 
(3) 
(4) Whereas effective and harmonised protection 
throughout the ~[ember States is essential in order 
to m.tintain and encourage investment in the field 
of biorechnology; 
Whereas following the European Parliament's 
rejection of the joint text, appro~'ed by the 
Con.:iliation Committee, for a European 
Parliamem and Coun.:il Directive on the legal 
1'/ OJ C 296, 8.10.1996, p. 4 and OJ C .>1[, [1.10.1997, p. 
11. 
I!) OJ C 295, 7.10.1996, p. 11. 
i'l Opinion of the Europc;}n Parliament of 16 July 1997 (OJ C 
286, 21.9.1997, p. 87). Coun,il Common Position of 26 
February 1998 10J C 110,8.4.1'198, p. 1-) and Dedsion of 
the Europe.tn Parli.lment of tl ~I;}y 1998 (OJ C 167, 
1.6.1998). Coun.:il Dedsion of 16 June 1998. protection of biotechnologi.:al inventions (~), the 
European Parliament and the Council have 
determined that the legal protection of 
biotechnological inventions requires clarification; 
'(5) Whereas differences exist in the legal protection of 
biotechnological inventions offered by the laws and 
pra.:tices of the different Member Stares; whereas 
such differences could create barriers to trade and 
hence impede the proper functioning of the 
internal market; 
(6) Whereas such differences could well bccome 
greater as Member States adopt new and different 
legislation and administrative practices, or whereas 
national case-law interpreting such legislation 
develops differently; 
(7) 'Whereas uncoordinated development of national 
laws on the legal protection of biotechnological 
inventions in the Community could lead to further 
disin.:entives to trade, to the detriment of the 
industrial development of such inventions and of 
the smooth operation of the internal market; 
(8) Whereas legal protection of biotechnological 
inventions does not ne.:essitate the crearion of a 
separate body of law in place of the rules of 
narional parent law; whereas the rules of narional 
patent law remain the essential basis for the legal 
protection of biotechnological inventions gi"en that 
they musr be adapted or added to in certain 
specific Ct!spe.:ts in order ro take adequate a.:counr 
of te.:hnological developments involving biologi.:al 
material which also fulfil the requirements for 
parentability; 
(9) Whereas in .:ertain cases, su.:h as the exdusion 
from patenrability of plant and animal varieties 
a nd of essentially biological processes for the 
produ.:tion of plants and animals, .:ertain con.:epts 
«) OJ C 68, 20.3.1995, p. 26. IPIN/IIEECIP/4 
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L 213/14 Offidal Journal of the European Communities 30.7.98 
in national laws based upon international patent 
and plant variety conventions have created 
uncertainty regarding the protection of 
biote.:hnological and certain microbiological 
inventions; whereas harmonisation is necessary to 
clarify the said uncertainty; 
(10) Where.ls regard should be had ro the potential of 
the de\'e1opment of biotechnology for the 
environment and in pa~icular the utiliry of this 
technology for the development of methods of 
cultivation which are less polluting and more 
economical in their use of ground; whereas the 
patent s~'stem should be used to encourage 
resean:h into. and the application of, such 
processes; 
(11) Whereas the development of biotechnology is 
important to developing countries, both in the field 
of health and combating maior epidemics and 
endemic diseases and in that of combating hunger 
in the world; whereas the patent system should 
likewise be used to encourage resean:h in these 
fields; whereas international procedures for the 
dissemination of such technology in the Third 
World and to the benefit of the population groups 
concerned should be promoted; 
(12) Whereas the Agreement on Trade-Related Aspeces 
of Intellectual Property Rights (TRIPs) (1) signed 
by the European Community and the Member 
States. has entered into force and provides that 
patent protection must be guaranteed for produces 
and processes in all areas of technology; 
(13) Whereas the Community's legal framework for the 
protection of biotechnological inventions can be 
limited to laying down certain prin.:iples as they 
apply to the patenrctbility of biologiClI material as 
such. such prin.:iples being intended in parti.:ular 
to determine the difierence between invcntions and 
discoveries with regard to the patentabilit;: of 
certain elemenrs of human origin, to the scope of 
protection conferred by a patent on a 
biotedmological in'·enrion. to the right to use a 
deposit me.:hanism in aJdition to written 
descriptions and lastly to the option of obtaining 
non-exclusive compulsory Ii.:ences in respect of 
interdependence between plant varieties and 
inventions, and conversely; 
(I) OJ L 336. 13.11.1994. p. 113. (14) Whereas a patent for im'ention does not authorise 
the holder to implement thar invention, but merely 
entitles him to prohibit third parties from 
exploiting it for industrial and commercial 
purposes; whereas, consequently, ·substantive 
patent law cannot serve to replace or render 
supertluous national, European or international 
law which may impose restrictions or prohibitions 
or which concerns the monitoring of research ilnd 
of the use or commercialisation of its results, 
notably from the point of view of the requirements 
o( public health; safety, environmental protection, 
animal welfare, the preservation of genetic diversity 
and compliance with certain ethical standard~; 
(15) \,('hereas no prohibition or exclusion exists in. 
national or European patent law (Munich 
Convention) which pw:ludes <l priori the 
patemability of biologkal matter; 
(16) Whereas patent law must be applied so as to 
respect the fundamental principles safeguarding the 
dignity and integrity of the person; whereas it is 
important to assert the principle that the human 
body, at any stage in its formation or development, 
including germ cells, and the simple discovery of 
one of its elements or one of its produces, 
including the sequence or partial sequence of a 
human gene, cannot be patented; whereas these 
principles are in line with the criteria of 
patentability proper to patent law, whereby a mere 
discovery cannot be patented; 
(17) Whereas significant progress in the treatment of 
diseases has alreadv been made thanks to the 
existence of medi~inal products derived from 
elements isolated from the human body and/or 
otherwise produ.::ed. such medicinal 'products 
resulting from technical processes aimed at 
obt,lining elements similar in structure to those 
existing ~.Hurally in the human bodr and whereas. 
consequently, research aimed at obtaining and 
isolating such elements yaluable to medicinal 
production should be encouraged br means of the 
patent system: 
(18) Whereas. since the patent srstem provides 
insuffi.:ient in.::entive for encour.lging research into 
and production of biotechnological medicines 
which are needed to combat rare or 'orphan' 
diseases. the Community and the ~!ember St . .ltes 
have a duty to resp"and adequately to this 
problem; IP/NIl/EEC/P/4 
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3007098 Official Journal of the European Communities L 213/15 
j19) 
,10) 
i~l) Whereas account has been taken of Opinion !\:o 8 
of the Group of Advisers on the Ethical 
Implications of Biotechnology to the European 
Commission; 
Whereas, therefore, it should be made clear that an 
invention based on an element isolated from the 
human body or other.vise produced by me,\Os of a 
techni.:al process, which is susceptible of industrial 
application, is noc excluded from patentabiliry, 
e\Oen where the structure of t~t element is 
identi.:al to that of a natural ele!~ent, given that 
the rights conferred by the patent do not extend to 
the human body and its elements in cheir natural 
environment; 
Whereas such "n element isolated from the human 
body or ocheC'ovise produced is not excluded from 
patentability sin.:e it is, tor example, the result of 
technical processes used to identify, purify and 
classify it and to reproduce it outside the human 
body, techniques which human beings alone are 
capable of putting into practi.:e and which nature 
is in.:apable of accomplishing by itself; 
Whereas the discussion on the patentability of 
sequen.:es or partial sequen.:es of genes is 
controversial; whereas, according to this Directive, 
the granting of a patent for inventions which 
concern su.:h sequen.:es or partial sequences should 
be subje.:r to the same criteria of patentability as in 
all other areas of technology: novelty, inventive 
step and industrial applkation; whereas the 
industrial application of a sequence or partial 
sequence must be disclosed In the patent 
application as filed; 
Whereas a mere D0<'A sequen.:e without indication 
of a fun.:tion does not contain amo techni.:al 
information and is therefore not a ° patentable 
invention; 
W'hereas, in order to .:omply with the industrial 
application criterion it is nece~sary in cases where a 
sequen.:e or partial sequence of a gene is used to 
produ.:e a protein or part of a protein, to specify 
whi.:h protein or parr of a protein is produ.:ed or 
what function it performs; 
. 25 ~ 'Xl"hereas, for the purposes of inc~rpreting rights 
.:onferred by a patent, when sequences overlap 
only in parts which are not essential to the 
invention. each sequen.:e will be considered as an 
independent sequen.:e in patent law terms; (26) 
(27) 
(28) 
(29) 
(30) 
(31) 
(32) Whereas if an invention is based on biological 
material of human origin or if it uses such 
material, where a patent application is filed, the 
person from whose body the material is taken 
must have had an opportunity of expressing free 
and informed consent thereto, in accordance with 
nationJl law; 
\'{'hereas if an invention is based on biologi.:al 
material of plant or animal origin or if it uses su.:h 
material, the patem application should, where 
approgriate, indude information on the 
geographkal origin of such material, if knO\\ll; 
whereas this is without prejudice to the processing 
of patent applications or the validity of rights 
arising from granted pdtents; 
'X'hereas this Directive does not in any way affect 
the basis of .:urrenr patent law, according to which 
a patent may be granted for any new application 
of a patented product; 
Whereas this Directive is without prejudice to the 
exclusion of plant and animal varieties from 
patentability; whereas on the other hand inventions 
'which concern plants or animals are patentable 
provided that the appli.:ation of the invention is 
nor rechnkally confined to a single plant or animal 
variery; 
Whereas the concept 'plant variety' is defined by 
the ,legislation protecting ilew varieties, pursuant to 
whkh a variety is defined by its whole genome and 
therefore possesses individuality and is dearly 
distinguishable from orher varieties; 
Whereas a plant grouping which is characterised 
by a particular gene (and not its whole genome) is 
nor covered by the protection of new varieties and 
is therefore not excluded from patentability even if 
it .:omprises new varieties of plants; 
Whereas. however. if an in,oention consists onlv in 
geneti.:ally modifying a parti.:ular plant ,oarioer:o, 
and it a new plant variety is bred, it will still be 
excluded from poltentability even if the genetic 
modifi.:ation is the result not of an essentially 
biological process but of a biote.:hnological 
process; 
(33) Whereas it is ne~essary to define for the purposes 
of this DireL1:i,oe when a process for the breeding of 
plants and animals is essentially biologkal; IP/N/1/EEC/P/4 
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L 213116 Official Journal of the European Communities 30.7.98 
(34) Whereas this Directive shall be without prejudice 
to concepts of invention and disco\'ery, as 
developed by national, European or international 
patent law; 
(35) Whereas this Directive shall be without prejudice 
to the provisions of national patent law whereby 
processes for treatment of the human or animal 
body by surgery or. therapy and diagnostic 
methods practised on The human or animal body 
are exduded from patentability; 
(36) \,('hereas the TRIPs Agreement provides for the 
possibility that members of the World Trade 
Organisation may exclude from patentabiliry 
inventions, the prevention within their territory of 
the commercial exploitation of which is necessaty 
to protect ordre public or morality, including to 
protect human, animal or plant life or health or to 
avoid serious prejudice to the environment, 
provided that such exclusion is not made merely 
because the exploitation is prohibited by their 
law; 
(37) Whereas the principle whereby inventions must be 
excluded from patentability where their 
commercial exploitation offends against ordre 
public or moraliry must also be stressed in this 
Directive; 
(38) Whereas the operative part of this Directive should 
also include an illustrative list of inventions 
excluded from patentability 50 as to provide 
national courts and patent offices with a general 
guide to interpreting the reference to ordr<! pl/blic 
and morality; whereas this list obviously cannot 
presume to be exhaustive; whereas processes, the 
use of which offend against human dignity, such as 
processes to produce chimeras from germ cells or 
totipotent cells of humans and animals, are 
obviously also excluded from patentabilit}i; 
(39) \~'hereas ordre public and morality correspond in 
particular to ethical or moral principles recognised 
in a ~lember State, respect for which is particubrly 
important in the field of biotechnology in view of 
the potential scope of inventions in this field and 
their inherent relationship to living matter; whereas 
such ethical or moral principles supplement the 
stand.ud legal examinations under patent law 
regardless of the technical field of the invention; (40) Whereas there is a consensus within the 
Community that interventions in the human germ 
line and the doning of human beings offends. 
against ordre public and morality; whereas it is 
therefore important to exclude unequivocally from 
patentability processes for modifying the germ line 
genetic identity of human beings and processes for 
cloning human beings; 
(41) Whereas a process for cloning human beings may 
be defined as any process, including techniques of 
embryo splitting, designed to create a human being 
with the same nuclear genetic information as 
another living or deceased human being; 
(4.2) \\"hereas, moreover, uses of human embtyos for 
industrial or commercial purposes must also be 
excluded from patentability; whereas in any case 
such exclusion does not affect inventions for 
therapeutic or diagnostic purposes which c' ·are 
applied to the human embryo and are useful to 
it; 
(43) Whereas pursuant to Article F(2) of the Treaty on 
European Union, the Union is to respeCt 
fundamental rights, as guaranteed by the EUropean 
Convention for the Protection of Human Rights 
and Fundamental Freedoms signed in Rome on 4 
November 1950 and as they result from the 
constirutional traditions common to the Member 
States, as general principles of Community law; 
(44) Whereas the Commission's European Group on 
Ethics in Science and ~ew Technologies evaluates 
all ethical aspects of biotechnology; whereas it 
should be pointed out in this connection that that 
Group may be consulted only where biotechnology 
is to be evaluated at the level of basic ethical 
principles, induding where it is consulted on 
patent law; 
(45) \X'hereas processes for modifying the genetic 
identit ... of animals which are likelv to cause them 
sufferi~g without any substantiJl m'edical benefit in 
terms of research, prevention, diJgnosis or therapy 
to man or animal, and also animals resulting from 
such processes, must be excluded from 
patenrability; 
(46) \X'her~"s, in view of the fact that the fun .. -tion of a 
patent is to reward the inventor for his creative 
efforts by granting an exclusive but time-bound 
right, and thereby encourage inventive activities. IP/N/lIEEC/P/4 
Page 6 
Official Journal of the European Communities L 213117 
the holder of the patent should be entitled to 
prohibit the use of patented self-reproducing 
material in situations analogous to those where it 
would be permirted to prohibit the use of patented, 
non-self-reproducing products, that is to say the 
production of the patented product itself; 
Whereas it is necessary to provide for a first 
derogation from the rights of the holder of the 
patent when the propagajing material 
incorporating the protected invention is sold to a 
farmer for farming purposes by the holder of che 
patent or with his consent; whereas that initial 
derogation must authorise the farmer to use the 
product of his harvest for further multiplication or 
propagation on his own farm; whereas the extent 
and the conditions of that derogation must be 
limited in accordance with the extent and 
conditions set Out in Council Regulation (EC) ~o 
2100/94 of 27 July 1994 on Community plant 
variety righ ts (1); 
ISI Whereas only the fee envis.lged under CommWlicy 
law relating to plant variety rights as a condition 
for applying the derogation from Community plant 
variety rights can be required of the farmer; 
49) \Vhereas, however, the holder of the patent may 
defend his rights against a turner abusing the 
derogation or against a breeder who has developed 
a plant variety incorporating the protected 
invention if the larter fails to adhere. to his 
commitments; 
i ,0) Whereas a second derogation from the rights of 
the holder of the patent must authorise the farmer 
to use protected livestock for agricultural 
purposes; 
·51) Whereas the extent and the conditions of that 
second derogation must be dete;mined by national 
laws, reguLltions and practi.:es, since there is no 
Community legisbtion on animal variety rights; 
i 52) Whereas, in the field of exploitation of new plant 
ch.uacteristics resulting from genetic engineering, 
gu.uanteed access must, on payment of a fee, be 
,I) OJ L 227. 1.9.1994. p. 1. Regulation as amended by 
Regulation (EO No 2506/95 (O] L 258, 28.10.1995, p. 3). granted in the form of a compulsory licence where, 
in relation to the genus .or species concerned, the 
plant variety represents signifi..:ant technical 
progress of considerable economic interest 
compared to the invention claimed in the patent; 
(53) Whereas, in ,the field of the use of new plant 
chara~"teristics resulting from new plant varieties in 
genetic engineering, guaranteed access m lIst, on 
payment of a fee, be granted in the form of a 
compulsory licence where the invention represents 
significant technical progress of considerable 
economic interest; 
(54) Whereas Article 34 of the TRIPs Agreement 
contains detailed provisions on the burden of proof 
which is binding on all Member States; whereas, 
therefore, a provision in this Directive is not 
necessary; 
(55) Whereas following Decision 93/626IEEC (2) the 
Community is party to the Convention on 
Biological Diversity of 5 June 1992; whereas, in 
this regard, Member States must give particular 
weight to Article 3 and Article g(j), the second 
sentence of Article 16(2) and Anicle 16(5) of the 
Convention when bringing into force the laws, 
regulations and administrative provisions necessary 
to comply with this Directive; 
(56) Wnereas the Third Conference of the Parties to the 
Biodiversity Convention, which took place in 
November 1996, no[(d in Decision HIII7 that 
'further work is requited to help develop a 
common appreciation of the telationship between 
intellectual property rights and the relevant 
provisions of the TRIPs Agreement and the 
Convention on Biological Diversity, in particular 
on issues relating to technology transfer and 
conservJtion and sustainable use of biological 
diversity and the fair and equitable sharing of 
benefits arising out of the use of genetic resources, 
including the protection of knowledge, innovations 
and practices of indigenous and local communities 
embodying traditional lifestyles relevant for the 
conservation and sustainable use of biological 
diversity' , 
e) 01 L 309, 3\,12.1993, p. \. IPINIl/EEC/P/4 
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L 213/18 Official Journal of the European Communities 30.7.98 
HA VE ADOPTED THIS DIREcrJVE: 
CHAPTER I 
Patent ability 
Article 1 
1. M.:mber States shall protect biotechnological 
inventions under nJrional pJtent law. They shall, if 
necessary, adjust their national patent law to take 
account of the provisions of this Directive. 
2. This Directive shall be without prejudice to the 
obligations of th.: M.:mber Srares purSUJnt to 
int.:rnational agre.:ments, and in particular the TRIPs 
Agreement and the Convention on Biological Diversity. 
Article 2 
1. For the purposes of this Directive, 
(a) 'biological material' means any material contammg 
genetic information and capable of reproducing itself 
or being reproduced in a biological system; 
(b) 'mierobiologieal process' means any process involving 
or performed upon or resulting in microbiological 
material. . 
2. A process for the production of plants or animals is 
essentially biological if it consists entirely of natural 
ph.:nomena such as crossing or selection. 
3. The concept of 'plant variety' is defined by Article 5 
of Regulation (EC) ~o 2100/94. 
A.rticle 3 
1. For the purposes of this Directi\'e, inventions which 
are new. which involve an im'entive stt:p and which are 
susceptible of industrial applicJtion shall be patentable 
even if th.:y concern a product consisting of or containing 
biologkal material or a pro.:ess by means of whkh 
biologkal material is produced, pro.:essed or used. 
2. Biologieal material which is isolated from its natural 
environment or produced by means of a technical process 
may be th.: subject of an im·t:ntion even if it previously 
occurred in nature. Article 4 
1. The following shall not be patentable: 
(a) plant and animal \'arietiesj 
(b) essentially biological processes for the production of 
plants or animals. 
2. Inventions' which concern plants or animals shall be 
patentable if the technical feasibility of the invention is 
not confined to a particular plant or animal variety. 
3. Paragraph 1 (b) shall be without prejudice to the 
patentability of inventions which concern a 
microbiological or orher rechnical process or a product 
obtained by means of such a process. 
Article 5 
1. The human body, at the various stages of its 
formation and development, and the simple discovery of 
one of its elements, including the sequence or partial 
sequence of a gene, cannot constitute patentable 
inventions. 
2. An element isolated from the human body or 
otherwise produced by means of a technical process, 
including the sequence or partial sequence of a gene,' may 
constitute a patenrable invention, even if the structure of 
that element is identical to that of a natural element. 
3. The industrial application of a sequence or a partial 
sequence of a gene must be disclosed in the patent 
application. 
Article 6 
1. Im'enrions sh.IlI be considered unpatentable where 
their commerdal exploitation would be contrary to orJre 
public or morality; howe\'er, exploitation shall not be 
deemed to be so conrrary merely because it is prohibited 
by law or regulation. 
2. On the basis of paragraph 1, the following, In 
pJrti.:uiar, sh,tll be considered unpatentable: 
(a I processes for cloning hum.ln beings; 
(b) processes for modifying the germ line genetic identity 
of human beings; 
(c) uses of human embryos for industrial or commercial 
purposes; IPINIliEECIP14 
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.llt-.98 --Official Journal of the European Communities L 213/19 
J' rroces~es for modifying the genetic identity of animals 
which are likely to cause them suffering without any 
substantial medical benefic to man or animal, and 
Jlso animals resulting from such processes. 
.-\rticle 7 
The Commission's European Group on Ethics in Science 
Jnd ~ew Technologies evaluates all ethical aspects of 
~iotechnology. 
CHAPTER II 
Scope of protection 
Article 8 
1. The protection conferred by a patent on a biological 
mJterial possessing specific characteristics as a result of 
the invention shall extend to any biological material 
derived from that biological material through 
propagation or multiplication in an identical or divergent 
iorm and possessing those same characteristics. 
2. The protection conferred by a patent on a process 
that enables a biological material to be produced 
possessing specific characteristics as a result of the 
invention shall extend to biological material directly 
obtained through that process and to any other biological 
material derived from the directly obtained biological 
material through propagation or 'multiplication in an 
identical or divergent form and possessing those same 
characteristics. 
Article 9 
The protection conferred by a patent on a product 
containing' or consisting of genetic information shJII 
extend to all material, save as provided in Article Sill, in 
which the produ<.:t in in.:orporated and in .... hich the 
geneti.: information is contained and periorms its 
funl."tion. 
Article 10 
The protection referred to in Artkles 8 and 9 sh.11I not 
extend to biologic:!1 material obtained from the 
propagation or ~ultiplil.:ation of biologi..:al material 
pbced on the market in the terrirory of a ~Iember State 
by the holder of the patent or with his consent, where the 
multiplication or propagation necessarily results irom the 
Jpplication for which the biological material was 
marketed, provided that the material obtained 'is not 
.;ubsequentl~· used for other proPJption or 
multiplication. Article 11 
1. By way of derogation from Articles 8 and 9, the sale 
or other form of commercialisation of plant propag.uing 
material to a farmer by the holder of the patent or with' 
his consent for <lgricultural use implies authorisation for 
the farmer to use the product of his harvest for 
propagation or multiplication by him on his own farm, 
the extent and conditions of this derogation 
corresponding to those under Article 14 of Regulation 
(ECl No 2100/94, 
2. By way of derogation from Articles 8 and 9, the sale 
or any other form of commercialisation of breeding stock 
or other animal reproductive material to a farmer by the 
holder of the patent or With his consent implies 
authorisation ior the farmer to use the protected livestock 
for an agricultural purpose. This includes making the 
'lnimal or other animal reproductive material available 
for the purposes of pursuing his agricultural activity but 
not sale within the framework or for the purpose of a 
commercial reproduction a.:rivity. 
3. The extent and the conditions of the derogation 
provided for in paragraph 2 shall be determined by 
national laws, regulations and practices. 
CHAPTER III 
Compulsory cross-licensing 
Article 12 
1. Where a breeder cannot acquire or exploit a plant 
variety right without infringing a prior patent, he may 
apply for a compulsory licence for non·exclusive use of 
the invention protected by the patent inasmuch as the 
Iken..:e is necessary for the exploitation of the plant 
variety to be protected, subject to payment of an 
appropriate royalty. Member States shall provide that, 
where such a licence is granted, the holder of the parent 
will be entitled ro a cross· licence on reasonable terms to 
use the protected vatiety. 
2. 'W'here the holder of a patent concerning a 
biotechnological invention cannot exploit it without 
infringing a prior plant variety right, he may apply for a 
compulsory licence for non·exclusive use of the plant 
variety protected by that right. subject to payment of an 
appropriate royalty. Member States shall provide that, 
where such a li..:en.:e is granred, the holder of the variety 
right will be entitled to a cross· licence on reasonable 
terms to use the prOtected invention. 
3. Applicants for the licences referred to in paragraphs 1 
and 2 must demonstrate that: IP/N/l/EEC/P/4 
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L 213120 Official Journal of the European Communities 30.7.98 
(a) they have applied unsuccessfully to the holder of the 
patent or of the plant variety right to obtain a 
contractual licence; 
(b) the plant variety or the invention constitutes 
significant techni.:al progress of considerable 
economic interest compared with the invention 
claimed in the patent or the protected plant variety. 
4. Each Member State shall designate the authority or 
authorities responsible for granting the licence. Where a 
licence for a plant variety can be gr~ted only by the 
Community PlJnt Variety Office, Anicle 29 of 
Regulation (Ee) No 2100/94 shall apply. 
CHAPTER IV 
Deposit, access and re-deposit of a biological material 
Article 13 
1. Where an invention involves the use of or concerns 
biological material which is not available to the public 
and which cannot be described in a patent application in 
such a manner as to enable the invention to be 
reproduced by a person skilled in the art, the desaiption 
shall be considered inadequate for the purposes of patent 
law unless: 
(a) the biological material has been deposited no later 
than the date on which the patent application was 
filed with a recognised depositary institution. At least 
the international depositary authorities which 
acquired this status by virtue of Article 7 of the 
Budapest Treaty of 28 April 1977 on the 
international recognition of the deposit of 
micro-organisms for the purposes of patent 
procedure, hereinafter referred to as the 'Budapest 
Treaty', shall be recognised; 
(bl the application as filed contains such relevant 
information as is available to the applicant on the 
characteristics of the biologil:al material deposited: 
(c) the patent application states the name of the 
depositOry institution and the accession number. 
2. Access to the deposited biologi<:al matetial shall be 
provided through the supply of a sample: 
(a) up to the first publication of the patent application, 
only to those persons who are authorised under 
national patent law; 
(b,\ benl.'een the first publication of the application and 
the grancing of rhe patent. to anyone tequesting it or, 
if the applicant so requests, only to an independent 
expert; (c) after the patent has been granted, and 
nonvithstanding revocation or cancellation of the 
patent, to anyone requesting it. 
3. The sample shall be supplied only if the person 
requesting it undertakes, for the term during which the 
pa tem is in force: 
(a) not to make it or any material deri\'ed from it 
available to third parties; and 
(b) not to use it or any material derived from it except 
for experimental purposes, unless the applicant for or 
proprietor of the patent, as applicable, expressly 
waives such an undertaking. 
4. At the appli<:ant's request, where an application is 
refused or withdrawn, access to the deposited material 
shall be limited to an independent expert for 20 years 
from the dare on which the patem application was filed. 
In that case, paragraph 3 shall apply. 
S. The applicant's requests referred to in point (b) of 
paragraph 2 and in paragraph 4 may only be made up to 
the date on which the technical preparations for 
publishing the patent application are deemed to have 
been completed. 
Article 14 
1. If the biologi<:al . material deposited in accordance 
with Article 13 ceases to be available from the recognised 
depositary institution, a new deposit of the material shan 
be permirted on the same terms as those laid down in the 
Budapest Treaty. 
2. Any new deposit shall be accompanied by a statement 
signed by the depositOr certifying that the newly 
deposited biological material is the same as that originally 
deposited. 
CHAPTER V 
Final provisions 
Artic:le 15 
1. Member States shall bring into force the laws, 
regulations and administrative provisions ne.:essary to 
comply with this Directive not later than 30 July 2000. 
They shall forthwith inform the Commission thereof. IPIN11IEECfP/4 
Page 10 
;0.7.98 Official Journal of the European Communities L 213/21 
~'hen Member States adopt these measures, they shall 
.L'ntain a reference to this Directive or shall be 
J-.:companied by such refetl!nce on the occasion of their 
"fficial publication. The methods of making sllch 
r~ference shall be laid down by Member States. 
2. Member States shall communicate to the Commission 
the text of the provisions of national law whkh they 
oldopr in the field cO\'ered by this Directive. 
Article 16 
The Commission shall send the European Parliament and 
the Council: 
la) every five years as from the date specified in Article 
15(1) a report on any problems encountered with 
regard to the relationship between this Directive and 
international agreements on the ptotection of human 
rights to which the Member States have acceded; 
(b) within two years of entry into force of this Ditective, 
a report assessing the implications fot basic genetic 
engineering research of failute to publish, or late publication of, papers on subjects which could be 
patentable; 
(c) annually as from the date specified in Article 15(1), a 
report on the development and implications of patent 
law in the field of biotechnology and genetic 
engineering. 
Article 17 
This Directive shall enter into force on the day of its 
publication in the Official JOIITnul of the ElIfopean 
Commllnities. 
Article 18 
This Directiv'e is addressed to the ~lember Stares. 
Done at Brussels, 6 July 1998. 
For the European Parli,zmmt 
The President 
J. M. GIL-ROBLES For the Council 
The Presidmt 
R. EDLINGER 