No C 159/10 Official Journal of the European Communities 26. 6. 89 
Opinion on the proposal for a Council Directive on the legal protection of biotechnological 
inventions (*) 
(89/C 159/05) 
On 3 November 1989 the Council decided to consult the Economic and Social Committee, 
under Article 100A of the Treaty establishing the European Economic Community, on the 
abovementioned proposal. 
The Section for Industry, Commerce, Crafts and Services, which was responsible for preparing 
the Committee's work on the subject, adopted its Opinion on 5 April 1989. The rapporteur 
was Mr Sai'u. 
At its 265th plenary session (meeting of 26 April 1989) the Economic and Social Committee 
adopted the following Opinion by a majority vote in favour and 1 vote against, with 5 
abstentions. 
1. Introduction 
1.1. While acknowledging that the Commission has 
good reason to tackle the problems associated with 
the legal protection of biotechnological inventions, the 
Committee considers that the proposed Directive does 
not face up to all the issues and should be revised in 
the light of the comments and suggestions set out in 
this Opinion. 
1.2. This Directive concerns biotechnological inven­
tions. Biotechnology is understood as all the techniques 
that use or cause organic changes in any biological 
material, microorganisms, plants and animals, or that 
cause changes in inorganic material by biological 
means. Biotechnology covers areas in which inventive 
work is most active and promising and in which the 
results of that work have particular economic and social 
importance. 
1.3. Tiie existing legal protection as contained in the 
national legislation of the Member States is derived 
from international agreements concluded in the 1960's, 
namely: 
— the 1961 Convention of the International Union for 
the Protection of New Varieties of Plants (UPOV), 
— the 1963 Strasbourg Convention, 
whose principles were then incorporated in 
— the 1973 European Patent Convention, and 
— the 1975 Community Patent Convention. 
Under these Conventions only a few biotechnological 
inventions are patentable (microbiology). 
In general the legal situation suffers from deficiencies 
(') OJNoC 10, 13. 1. 1989, p. 3. as well as discrepancies in statutory law and regulations 
and their interpretation, and a shortage of case law. 
1.4. The aim of the Directive is to enable Community 
industry to keep pace with leading nations such as the 
US and Japan in the field of biotechnology and to close 
or narrow existing gaps. 
Its aim is also to further the internal market by eliminat­
ing existing national differences in the legal protection 
of biotechnological inventions, something which cannot 
be achieved by either the Community Patent Conven­
tion (CPC) or the European Patent Convention (EPC). 
Its provisions must be compatible with those of the 
existing international conventions. 
They are based on four principles: 
— discoveries as such are not regarded as patentable 
inventions: 
'It is not the discovery as such which is patentable, but 
its use for the purpose of transformation or multipli­
cation.' 
The demarcation between the simple discovery of a 
natural substance and its patentability depends on the 
degree of human technical intervention necessary to 
obtain it. 
— plant and animal varieties as such or essentially 
biological processes for the production of plants or 
animals are excluded from patent protection, 
— microbiological processes or the products thereof 
are eligible for patent protection, 
— methods for treatment of the animal body by sur­
gery or therapy are not regarded as inventions which 
are susceptible of industrial application if practised 
for a therapeutic purpose. 
26. 6. 89 Official Journal of the European Communities No C 159/11 
2. General comments 
2.1. The Committee approves the proposal for a 
Council Directive on the legal protection of biotechno-
logical inventions (COM(88) 496 final — SYN 159) 
provided that the following general and specific com­
ments are taken into consideration. 
2.2. Such a Directive is a first step towards an 
enlargement of the field of patentability. 
2.3. Agriculture is one of the sectors most directly 
concerned, being a principal consumer of the products 
of biotechnology. 
2.4. Consequently the Committee regrets that it was 
not possible to adopt an overall approach covering both 
the legal protection of biotechnological inventions and 
Community plant breeders' rights. 
2.5. The Committee is convinced* that such a dual 
approach would have led to a better balance between 
breeders' rights and patents, which preserved the rights 
and interests of the parties concerned (farmers, agricul­
tural cooperatives, breeders, researchers, industry). 
Although the Directive was drawn up in agreement 
with all the directorates concerned, the working 
method—i.e. dealing first with patentability and only 
afterwards with how this would affect breeders' rights-
—did not allow all the interested parties to have a fair 
say. 
Most of the solutions adopted are those suggested by 
the World Intellectual Property Organization (WIPO), 
whose 1987 study was based on consultations represent­
ing industry's interests only. 
Furthermore, such a dual approach would have been 
more likely to avoid the risks inherent in an extension 
of the protection of biotechnological inventions and the 
interrelation between the effects of patents and plant 
breeders' rights, i.e. the possibility of double protection 
to the detriment of farmers and consumers. 
In fact the EPC no longer regulates these issues and 
hence the European Patent Office has no competence 
in the matter. 
2.6. The distinction between (a) 'traditional' plant 
varieties, i.e. those produced by familiar selection 
methods and covered by the specific, proven legal pro­
tection provided by breeders' rights under the UPOV 
Convention, and (b) the 'new' plant varieties, i.e. those 
which incorporate the findings of biotechnological 
research, seems likely to lead to legal disputes where a 
biological invention is incorporated in a plant variety. 2.7. The Committee suggests the setting-up of a 
licence system which would be a fair solution favouring 
neither the one nor the other of the parties concerned. 
The plant breeder wishing to use a patented invention 
for breeding purposes would have to ask the patentee 
for a licence contract against payment of a reasonable 
fee. 
This payment would exhaust the patentee's rights to 
the variety subsequently created by the breeder. 
2.8. To facilitate research, the Directive should per­
mit the same automatic free access for the purpose of 
plant research as is laid down for existing varieties 
under the UPOV Convention. 
2.9. This system should be arranged in such a way 
that plant breeders who use a biotechnological inven­
tion, either directly or through a variety, can share in 
its cost; the aim would be to encourage the continuous 
improvement of varieties and to avoid the emergence 
of monopolies ultimately detrimental to innovation. 
2.10. The Committee also has misgivings about the 
possible combined effect of the two rules—the patent­
ability of living matter and the extension of patent­
ability. These cumulative effects are likely to reduce the 
scope of the UPOV Convention and hence might lead 
to the disappearance of the independent breeder. 
2.11. Furthermore, the Committee believes that the 
Directive will go only part way to achieving one of its 
main objectives, namely to put Europe on an equal 
footing with Japan and the US in obtaining patents. 
2.12. In the Committee's view this can only be 
achieved if researchers are better motivated. Such 
motivation hinges on the emergence of a genuine inven­
tors' charter and this is something which the Directive 
does not address. 
It should be noted that in twenty years the Japanese 
have lodged and obtained five times more patents than 
any other country in the world. 
2.13. This Japanese efficiency derives from, among 
other things, their legislation on the protection of inven­
tions, drawn up in 1967 and based on 
— the first inventor system, and 
— the law of motivation. 
No C 159/12 Official Journal of the European Communities 26. 6. 89 
The Committee thinks that the Commission should 
give urgent consideration to the drafting of an EC 
Directive designed to have the same beneficial effects 
in motivating researchers by recognizing their rights 
and guaranteeing them a share in the fruits of their 
inventions. 
2.14. It is a pity that the present draft Directive does 
not provide for the alignment of the Member States' 
arrangements for settling disputes which may arise 
between industrial property law and labour law, as well 
as the question of jurisdiction. 
Would it not be worth extending to the rest of the 
Community the principle of a national commission 
for the inventions of employed persons introduced in 
France by Article 6Sbis of the law of 13 July 1976? 
2.15. While endorsing the patentability of living mat­
ter with the exception of plant and animal varieties, 
the Committee would point out that this new situation 
of extended patentability could raise ethical problems 
in respect of some applications, e.g. those involving 
animals where possible secondary effects should be 
taken into account, especially the pain which the ani­
mals may suffer. 
The Committee also regrets that human beings per se 
are not expressly mentioned in the Directive as not 
being patentable. 
In fact the Directive does not expressly provide for its 
non-application to biotechnological processes modify­
ing man's genetic inheritance for reasons other than 
maintaining or improving health. 
3. Specific comments 
3.1. Article 3 
This Article is too general. It does not state sufficiently 
clearly that Article 2(1) of the UPOV Convention must 
be respected; this obliges contracting States to provide 
only one form of legal protection for the same genus 
or species. 
The text does not state expressly that a variety is not 
patentable because covered by breeders' rights. 
Accordingly the Committee proposes that this Article 
be amended as follows: 
'Micro-organisms and the genetic components of plants 
and animals up to protoplasms shall be considered 
patentable subject matter.' 
This new wording of Article 3 would make it clear that 
a set body of genetic components forms a variety and 
is hence excluded from patent protection. Furthermore, classifications higher than varieties must 
remain outside any system of legal protection by 
patents. 
A new genus which complies with the characteristics 
of a variety may in fact be covered by breeders' rights 
protection. 
3.2. The EPC provides for the exclusion of human 
beings from patent protection but cannot oblige the 
Member States to comply. Therefore the Directive must 
contain a specific Article clearly stating that human 
beings are not patentable. 
3.3. Article 10 
At the end of the paragraph replace 'is used for other 
than private or experimental purposes' by 'is used for 
industrial purposes with a view to commercial exploi­
tation'. 
3.4. Article 12(2) 
The extension of protection to products obtained from 
a patentable process does not exclude plant or animal 
varieties from patentability. This clashes with lines 1 
and 2 of Article 3(1) which state 'other than plant or 
animal varieties'. 
Plants and plant material are patentable unless they 
are produced by a previously known biotechnological 
process [Article 3(2)], but there is still an ambiguity 
with regard to animal varieties. 
3.5. Article 13 
Patent law cannot apply to plants and/or animals in 
which the invention has been incorporated, in accord­
ance with the reworded Article 3. 
3.6. Article 14(3) 
Paragraph 3 represents a serious legal injustice as 
between the interests of the breeder and of the patentee. 
This provision is even superfluous as the patentee, by 
introducing a gene into a plant or animal, is behaving 
like a breeder. By creating a new variety he comes up 
against breeders' rights. 
Moreover, if a breeder has obtained a licence to an 
invention and does not exploit it, the patentee can 
enforce a dependency licence on grounds of market 
supply, as provided for under patent law. 
26. 6. 89 Official Journal of the European Communities No C 159/13 
Article 14(3) should be amended accordingly; an inven­
tor who is not a breeder may exploit his invention 
commercially if such exploitation is only possible in the 
form of a variety using a licensing arrangement. 
3.7. Article 15(3) b)(ii) 
Add: 
'And the right to exploit patented inventions with a 
view to obtaining an adequate offer in the marketplace 
on reasonable terms.' 
3.8. Article 17 
The Committee is not convinced of the need to derogate 
from ordinary law by reversing the burden of proof. 
The reversal of the burden of proof, besides changing 
the legal practice of many Member States, could place 
the breeder of a variety incorporating a biotechnologi-
Done at Brussels, 26 April 1989. 
I. GENERAL COMMENTS 
1. The Economic and Social Committee is fully awa-
(*) OJN0C6O, 9. 3. 1989, p. 11. cal invention in a difficult position, especially in view 
of the extension of patentability provided for elsewhere 
in the Directive. 
Looking at the Commission's position on the court of 
jurisdiction provided for in Article 14(4), there would 
seem to be a desire to treat breeders' rights less favour­
ably than patents. 
Moreover, the fact that national courts are to be 
entrusted with the task of resolving disputes between 
patentees and holders of breeders' rights on such ques­
tions as the significance of the technical progress or the 
amount of the royalties, inexplicably introduces the 
possibility of a distortion of competition. 
3.9. Article 19 a) 
The farming industry has reservations about edible 
fungi, cells and algae in view of the implications for 
plant breeders' rights. 
The Chairman 
of the Economic and Social Committee 
Alberto MASPRONE 
re of the scale and complexity of the phenomenon of 
poverty in the Community. In the information report 
drawn up by the Section for Social, Family, Educational 
and Cultural Affairs, the Committee set out the harsh Opinion on the proposal for a Council Decision establishing a medium-term Community 
action programme to foster the economic and social integration of the least 
privileged groups (*) 
(89/C 159/06) 
On 16 January 1989 the Council decided to consult the Economic and Social Committee, 
under Article 198 of the Treaty establishing the European Economic Community, on the 
abovementioned proposal. 
The Section for Social, Family, Educational and Cultural Affairs, which was responsible for 
preparing the Committee's work on the subject, adopted its Opinion on 13 April 1989. The 
rapporteur was Mr Burnel. 
At its 265th plenary session (meeting of 26 April 1989), the Economic and Social Committee 
adopted the following Opinion by a majority vote, with 1 abstention.