Source: EURLEX
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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 inventions. 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

(') O J N o C 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 eliminating existing national differences in the legal protection
of biotechnological inventions, something which cannot
be achieved by either the Community Patent Convention (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 multiplication.'

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 surgery 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 biotechnological inventions (COM(88) 496 final — SYN 159)
provided that the following general and specific comments 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, agricultural 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 representing 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 protection 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 permit 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 invention, 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 patentability of living matter and the extension of patentability. 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 inventors' 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 inventions, 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 matter 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 animals 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 modifying 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 exploitation'.

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 accordance 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 inventor 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.

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 favourably 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 questions 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

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.

I. GENERAL COMMENTS

1. The Economic and Social Committee is fully awa

(*) OJN0C6O, 9. 3. 1989, p. 11.

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