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IMPORTANT LEGAL NOTICE - The source of this
judgment is the web site of the Court of
Justice of the European Communities. The information in this database has
been provided free of charge and is subject to a Court of Justice of the
European Communities disclaimer and
a copyright notice. This electronic version is not authentic and is subject
to amendment.
JUDGMENT OF THE COURT
9 October 2001 (1)
(Annulment - Directive 98/44/EC - Legal protection of
biotechnological inventions - Legal basis - Article 100a of the EC Treaty (now,
after amendment, Article 95 EC), Article 235 of the EC Treaty (now Article 308
EC) or Articles 130 and 130f of the EC Treaty (now Articles 157 EC and 163 EC) -
Subsidiarity - Legal certainty - Obligations of Member States under
international law - Fundamental rights - Human dignity - Principle of
collegiality for draft legislation of the Commission)
In Case C-377/98,
Kingdom of the Netherlands, represented by M.A. Fierstra and I. van
der Steen, acting as Agents,
applicant,
supported by
Italian Republic, represented by U. Leanza, acting as Agent, assisted
by P.G. Ferri, avvocato dello Stato, with an address for service in Luxembourg,
and by
Kingdom of Norway, represented by H.W. Longva, acting as Agent,
interveners,
v
European Parliament, represented by J. Schoo and E. Vandenbosch,
acting as Agents, with an address for service in Luxembourg,
and
Council of the European Union, represented by R. Gosalbo Bono, G.
Houttuin and A. Lo Monaco, acting as Agents, with an address for service in
Luxembourg,
defendants,
supported by
Commission of the European Communities, represented by K. Banks and P.
van Nuffel, acting as Agents, with an address for service in Luxembourg,
intervener,
APPLICATION for annulment of Directive 98/44/EC of the European Parliament
and of the Council of 6 July 1998 on the legal protection of biotechnological
inventions (OJ 1998 L 213, p. 13),
THE COURT,
composed of: G.C. Rodríguez Iglesias, President, P. Jann, F. Macken, N.
Colneric and S. von Bahr (Presidents of Chambers), C. Gulmann, D.A.O. Edward, A.
La Pergola, J.-P. Puissochet (Rapporteur), L. Sevón, M. Wathelet, V. Skouris and
J.N. Cunha Rodrigues, Judges,
Advocate General: F.G. Jacobs,
Registrar: H.A. Rühl, Principal Administrator,
having regard to the Report for the Hearing,
after hearing oral argument from the parties at the hearing on 13 February
2001, at which the Kingdom of the Netherlands was represented by J. van Bakel,
acting as Agent, the Italian Republic by D. Del Gaizo, avvocato dello Stato, the
Kingdom of Norway by H. Seland, acting as Agent, the European Parliament by J.
Schoo and E. Vandenbosch, the Council by G. Houttuin and A. Lo Monaco and the
Commission by K. Banks and P. van Nuffel,
after hearing the Opinion of the Advocate General at the sitting on 14 June
2001,
gives the following
Judgment
- By application lodged at the Court Registry on 19
October 1998, the Kingdom of the Netherlands brought an action under Article
173 of the EC Treaty (now, after amendment, Article 230 EC) for annulment of
Directive 98/44/EC of the European Parliament and of the Council of 6 July
1998 on the legal protection of biotechnological inventions (OJ 1998 L 213, p.
13, hereinafter the Directive).
- The Directive was adopted on the basis of Article
100a of the EC Treaty (now, after amendment, Article 95 EC), and its purpose
is to require the Member States, through their patent laws, to protect
biotechnological inventions, whilst complying with their international
obligations.
- To that end the Directive determines inter
alia which inventions involving plants, animals or the human body may or
may not be patented.
- The applicant states, as a preliminary point, that
it is acting at the express request of the Netherlands Parliament, in the
light of the opposition expressed there to genetic manipulation involving
animals and plants and to the issuing of patents for the products of
biotechnological procedures liable to promote such manipulation.
- By order of the President of the Court of 28 April
1999, the Commission of the European Communities was granted leave to
intervene in support of the forms of order sought by the European Parliament
and the Council of the European Union. By orders of the President of the Court
of 3 May 1999 the Italian Republic and the Kingdom of Norway were granted
leave to intervene in support of the forms of order sought by the Kingdom of
the Netherlands.
Admissibility of intervention by the Kingdom of Norway
- The Parliament and the Council submit that the
statement lodged on 19 March 1999 by the Kingdom of Norway merely draws the
attention of the Court to certain problems which the implementation of the
Directive might pose in connection with the Agreement on the European Economic
Area (hereinafter the EEA Agreement), without itself seeking the form of order
sought in the application or seeking annulment of the Directive. Consequently,
it does not constitute an intervention in support of the forms of order sought
by the Kingdom of the Netherlands and is therefore not admissible.
- In that regard, Article 37 of the EC Statute of the
Court of Justice provides that applications to intervene are to be limited to
supporting the form of order sought by one of the parties.
- As it states in its conclusion, the statement lodged
by the Norwegian Government seeks to make the point that [s]everal of the
questions presented by the Netherlands Government in its action for annulment
of Directive 98/44 may have a bearing on whether or not the Directive falls
within the EEA Agreement and on the implementation of the Directive into the
EEA Agreement, and to request the Court to take due account of the arguments
set out by the Norwegian Government in that connection.
- Although, read literally, the objective so described
appears different from that which a statement in intervention can legitimately
pursue, it is clear that the intention of the Norwegian Government was not to
seek further forms of order in addition to those sought by the applicant nor
to ask the Court to rule on separate issues, but to contribute to the success
of the action of the Netherlands Government by shedding further light on the
dispute.
- That analysis is confirmed by the fact that all
the arguments contained in the Norwegian Government's statement reiterate, and
on some points develop, the views stated in the application of the Kingdom of
the Netherlands.
- The statement lodged by the Kingdom of Norway
taken overall and in its context, must therefore be held to be admissible as a
statement in intervention in support of the forms of order sought by the
applicant.
The pleas relied on in the application
- The applicant puts forward six pleas: that Article
100a of the Treaty was the incorrect legal basis for the Directive, breach of
the principle of subsidiarity, breach of the principle of legal certainty,
breach of obligations in international law, breach of the fundamental right to
respect for human dignity and breach of procedural rules in the adoption of
the Commission's proposal.
The first plea
- The applicant submits that the Directive does not
fall within the definition of measures for approximation of the provisions
laid down by law, regulation or administrative action in Member States which
have as their object the establishment and functioning of the internal market,
and was incorrectly adopted on the basis of Article 100a of the Treaty.
- In the first place, the differences in the laws
and practices of the Member States and the likelihood of their becoming
greater, to which the fifth and sixth recitals of the preamble to the
Directive allude, stating that they could create barriers to trade, do not
exist or only concern secondary issues which do not justify harmonisation.
- In that regard, it must be borne in mind that
recourse to Article 100a as a legal basis is possible if the aim is to prevent
the emergence of future obstacles to trade resulting from multifarious
development of national laws provided that the emergence of such obstacles is
likely and the measure in question is designed to prevent them (Case C-350/92
Spain v Council [1995] ECR I-1985, paragraph 35, and Case
C-376/98 Germany v Parliament and Council [2000] ECR I-8419,
paragraph 86).
- The examples given by the Parliament and the
Council suffice to establish that, even if the relevant national provisions
predating the Directive are most often taken from the Convention on the Grant
of European Patents, signed at Munich on 5 October 1973, (hereinafter the
EPC), the differing interpretations to which those provisions are open as
regards the patentability of biotechnological inventions are liable to give
rise to divergences of practice and case-law prejudicial to the proper
operation of the internal market.
- Moreover, in addition to the risk of divergent
trends, at the time the Directive was adopted marked differences with
significant consequences were already apparent between certain national laws
on specific points such as the patentability of plant varieties and that of
the human body,
- By requiring the Member States to protect
biotechnological inventions by means of their national patent law, the
Directive in fact aims to prevent damage to the unity of the internal market
which might result from the Member States' deciding unilaterally to grant or
refuse such protection.
- However, the applicant submits, secondly, that if
the application by the Member States of the relevant provisions of
international law left a measure of legal uncertainty, it should have been
removed not by Community harmonisation but by renegotiation of international
legal instruments such as the EPC, in order to clarify their rules.
- That argument is unfounded. The purpose of
harmonisation is to reduce the obstacles, whatever their origin, to the
operation of the internal market which differences between the situations in
the Member States represent. If divergences are the result of an
interpretation which is contrary, or may prove contrary, to the terms of
international legal instruments to which the Member States are parties, there
is nothing in principle to prevent recourse to adoption of a Directive as a
means of ensuring a uniform interpretation of such terms by the Member States.
- Moreover, it does not appear, in the present case,
that such an approach is inconsistent with the Member States' honouring their
obligations under the EPC or is unsuitable for achieving the objective of
creating uniform conditions for the patentability of biotechnological
inventions.
- Accordingly, there was nothing to prevent the
Community legislature from having recourse to harmonisation by means of a
directive in preference to the more indirect and unpredictable approach of
seeking to amend the wording of the EPC.
- Thirdly, according to the applicant, the Directive
goes beyond what ought to fall within the definition of a measure for
approximation of the legislation of the Member States, given that, in fact, it
creates a new type of property right distinct in several respects from the
rights covered by existing patent law. In particular, apart from the fact that
it concerns products previously excluded from patentability in certain Member
States such as the Kingdom of the Netherlands, the Directive is different from
existing patent law in that, by virtue of Articles 8 and 9, the protection it
provides for applies not only to specific biological material but also to
biological material obtained from it by reproduction or multiplication, and
that under Article 11 the right of the holder of the patent, as against
farmers, is limited.
- As the Court has already stated at point 59 of
Opinion 1/94 of 15 November 1994 ([1994] ECR I-5267), the Community is
competent, in the field of intellectual property, to harmonise national laws
pursuant to Article 100 of the EC Treaty (now Article 94 EC) and Article 100a
of the Treaty and may use Article 235 of the EC Treaty (now Article 308 EC) as
the basis for creating new rights superimposed on national rights, as it did
in Council Regulation (EC) No 40/94 of 20 December 1993 on the Community trade
mark (OJ 1994 L 11, p. 1).
- The patents to be issued under the Directive are
national patents, issued in accordance with the procedures applicable in the
Member States and deriving their protective force from national law. As the
creation of a Community patent is neither the purpose nor the effect of the
Directive, it does not introduce a new right which would require recourse to
the legal basis afforded by Article 235 of the Treaty. That view is not
affected by the fact that the inventions covered were not previously
patentable in certain Member States - that, indeed, is precisely why
harmonisation was warranted - nor by the fact that the Directive makes certain
clarifications and provides for derogations from patent law as regards the
scope of the protection.
- Fourthly, and finally, the Italian Government
takes the view, in its intervention in support of the applicant, that the
Directive should have been adopted on the basis of Articles 130 and 130f of
the EC Treaty (now Articles 157 EC and 163 EC), and not Article 100a of the
Treaty since the chief aim of the Directive, as the first three recitals of
the preamble show, is to support the industrial development of the Community
and scientific research in the genetic engineering sector.
- The legal basis on which an act must be adopted
should be determined according to its main object (see Case C-155/91
Commission v Council [1993] ECR I-939, paragraphs 19 to 21).
Whilst it is common ground, in that regard, that the aim of the Directive is
to promote research and development in the field of genetic engineering in the
European Community, the way in which it does so is to remove the legal
obstacles within the single market that are brought about by differences in
national legislation and case-law and are likely to impede and disrupt
research and development activity in that field.
- Approximation of the legislation of the Member
States is therefore not an incidental or subsidiary objective of the Directive
but is its essential purpose. The fact that it also pursues an objective
falling within Articles 130 and 130f of the Treaty is not, therefore, such as
to make it inappropriate to use Article 100a of the Treaty as the legal basis
of the Directive (see, by analogy, Case C-62/88 Greece v Council
[1990] ECR I-1527, paragraphs 18 to 20).
- It follows that the Directive was correctly
adopted on the basis of Article 100a of the Treaty and that the first plea
must, therefore, be rejected.
The second plea
- The applicant submits that the Directive breaches
the principle of subsidiarity laid down by Article 3b of the EC Treaty (now
Article 5 EC) and, in the alternative, that it does not state sufficient
reasons to establish that this requirement was taken into account.
- It should be borne in mind that, under the second
paragraph of Article 3b of the EC Treaty, in areas which do not fall within
its exclusive competence, the Community is to take action only if and in so
far as the objectives of the proposed action cannot be sufficiently achieved
by the Member States and can therefore, by reason of the scale or effects of
the proposed action, be better achieved by the Community.
- The objective pursued by the Directive, to ensure
smooth operation of the internal market by preventing or eliminating
differences between the legislation and practice of the various Member States
in the area of the protection of biotechnological inventions, could not be
achieved by action taken by the Member States alone. As the scope of that
protection has immediate effects on trade, and, accordingly, on
intra-Community trade, it is clear that, given the scale and effects of the
proposed action, the objective in question could be better achieved by the
Community.
- Compliance with the principle of subsidiarity is
necessarily implicit in the fifth, sixth and seventh recitals of the preamble
to the Directive, which state that, in the absence of action at Community
level, the development of the laws and practices of the different Member
States impedes the proper functioning of the internal market. It thus appears
that the Directive states sufficient reasons on that point.
- The second plea in law must, therefore, be
rejected.
The third plea in law
- The applicant submits that, rather than helping to
remove the legal ambiguities described in the recitals, the Directive tends to
exacerbate them, thus breaching the principle of legal certainty. First, it
gives the national authorities a discretion in applying concepts expressed in
general and ambiguous terms, such as ordre public and morality which
appear in Article 6. Second, there are unclear provisions whose relationship
with one another is ambiguous existing side by side in the Directive,
particularly as regards the patentability of plant varieties, mentioned in
Article 4(1) and (2), in Articles 8 and 9, and in the 31st and 32nd recitals
of the preamble to the Directive.
- The two specific grounds relied on by the
applicant in support of its submission of breach of legal certainty should be
examined separately.
- As regards, first, Article 6 of the Directive,
which rules out the patentability of inventions whose commercial exploitation
would be contrary to ordre public or morality, it is common ground that
this provision allows the administrative authorities and courts of the Member
States a wide scope for manoeuvre in applying this exclusion.
- However, that scope for manoeuvre is necessary to
take account of the particular difficulties to which the use of certain
patents may give rise in the social and cultural context of each Member State,
a context which the national legislative, administrative and court authorities
are better placed to understand than are the Community authorities. That sort
of provision, which allows patents to be refused where there is a threat to
ordre public or morality is, moreover, a well known one in patent law
and appears inter alia in the relevant international legal instruments,
such as the EPC.
- Furthermore, the scope for manoeuvre left to
Member States is not discretionary, since the Directive limits the concepts in
question, both by stating that commercial exploitation is not to be deemed to
be contrary to ordre public or morality merely because it is prohibited
by law or regulation, and by giving four examples of processes or uses which
are not patentable. Thus, the Community legislature gives guidelines for
applying the concepts at issue which do not otherwise exist in the general law
on patents.
- Finally, a directive cannot be considered contrary
to the principle of legal certainty if it relies, as regards the conditions
for its implementation, on concepts known to the laws of the Member States,
specifying, as here, their scope and limits and taking account, in order to do
so, of the specific nature of the subject-matter.
- Article 6 of the Directive is not therefore such
as to exacerbate the legal uncertainty which the Directive seeks to alleviate.
- Second, as regards the patentability of plant
varieties, examination of the provisions mentioned in the application reveals
no inconsistency.
- As the Parliament and the Council explained in
their defence, Article 4 of the Directive provides that a patent may not be
granted for a plant variety but may be for an invention if its technical
feasibility is not confined to a particular plant variety.
- That distinction is made clear by the 29th to 32nd
recitals of the preamble to the Directive, which indicate that plant varieties
as such are covered by the legislation on protection of new plant varieties,
but that the protection of new varieties applies only to varieties which are
defined by their whole genome. For plant groupings of a higher taxonomic level
than the variety, defined by a single gene and not by the whole genome, there
is no risk of conflict between the legislation on new varieties and the
legislation on patents. Thus, inventions which incorporate only one gene and
concern a grouping wider than a single plant variety may be patented.
- It follows that a genetic modification of a
specific plant variety is not patentable but a modification of wider scope,
concerning, for example, a species, may be.
- Articles 8 and 9 of the Directive do not concern
the principle of patentability but the scope of the protection conferred by
the patent. According to those provisions, the protection extends to any
biological material derived through propagation or multiplication from the
biological material containing the patented information. The protection
conferred by the patent may therefore cover a plant variety, without that
variety being patentable in itself.
- Finally, Article 12 covers, through a system of
compulsory licences, cases where the exploitation of a patent issued for a
biotechnological invention would infringe a prior plant patent, and vice
versa.
- Therefore, the two grounds relied on by the
applicant to support its plea that the Directive gives rise to legal
uncertainty do not justify its annulment.
- The third plea must, therefore, be rejected.
The fourth plea
- The applicant submits that the obligations created
by the Directive for Member States are incompatible with those resulting from
their international undertakings, even though, according to Article 1(2) of
the Directive, it does not affect obligations under international agreements.
In particular, the Directive breaches the Agreement on Trade-Related Aspects
of Intellectual Property Rights (hereinafter TRIPs), as set out in Annex 1 C
to the Agreement establishing the World Trade Organisation (hereinafter the
WTO Agreement), approved on behalf of the European Community, as regards
matters within its competence, by Council Decision 94/800/EC of 22 December
1994 (OJ 1994 L 336, p. 1), the Agreement on Technical Barriers to Trade
(hereinafter the TBT Agreement), the EPC and the Convention on Biological
Diversity signed on 5 June 1992 in Rio de Janeiro (hereinafter the CBD),
approved by the European Community by Council Decision 93/626/EEC of 25
October 1993 (OJ 1993 L 309, p. 1).
- As their main argument, the Parliament and Council
submit that the EPC does not create obligations for the Community, which is
not a party to it. As regards the other three international legal instruments
cited, the Council submits that the legality of a Community instrument can be
called in question on grounds of breach of international agreements to which
the Community is a party only if the provisions of those agreements have
direct effect. That is not so in the present case.
- It is common ground that, as a rule, the
lawfulness of a Community instrument does not depend on its conformity with an
international agreement to which the Community is not a party, such as the
EPC. Nor can its lawfulness be assessed in the light of instruments of
international law which, like the WTO agreement and the TRIPS and TBT
agreements which are part of it, are not in principle, having regard to their
nature and structure, among the rules in the light of which the Court is to
review the lawfulness of measures adopted by the Community institutions (Case
C-149/96 Portugal v Council [1999] ECR I-8395, paragraph 47).
- However, such an exclusion cannot be applied to
the CBD, which, unlike the WTO agreement, is not strictly based on reciprocal
and mutually advantageous arrangements (see Portugal v Council,
cited above, paragraphs 42 to 46).
- Even if, as the Council maintains, the CBD
contains provisions which do not have direct effect, in the sense that they do
not create rights which individuals can rely on directly before the courts,
that fact does not preclude review by the courts of compliance with the
obligations incumbent on the Community as a party to that agreement (Case
C-162/96 Racke [1998] ECR I-3655, paragraphs 45, 47 and 51).
- Moreover, and in any event, this plea should be
understood as being directed, not so much at a direct breach by the Community
of its international obligations, as at an obligation imposed on the Member
States by the Directive to breach their own obligations under international
law, while the Directive itself claims not to affect those obligations.
- For that reason at least, the plea is admissible.
- The applicant argues essentially, first, that
Article 27(3)(b) of the TRIPS Agreement allows Member States not to grant a
patent for plants and animals other than micro-organisms, whereas the
Directive does not allow Member States that possibility.
- In that regard, suffice it to note that, while the
Directive does deprive the Member States of the choice which the TRIPS
Agreement offers the parties to that agreement as regards the patentability of
plants and animals, the option taken in Article 4 of the Directive is in
itself compatible with the Agreement, which, moreover, does not prevent
certain party States adopting a common position with a view to its
application. The joint selection of an option offered by an international
instrument to which the Member States are parties is an act that falls within
the approximation of laws provided for by Article 100a of the Treaty.
- Second, it is claimed that the Directive contains
technical regulations within the meaning of the TBT Agreement which should
have been notified to the secretariat of the World Trade Organisation.
- It is, however, established that the Directive
does not in any event contain any technical regulations within the meaning of
the TBT Agreement, such a regulation being defined in Annex I to the WTO
Agreement as a document which lays down product characteristics or their
related processes and production methods. It is therefore not necessary to
rule on the extent to which the legal protection of biotechnological
inventions might fall within the scope of the TBT Agreement.
- The applicant submits, thirdly, that Article 6(1)
of the Directive, which rules out the patentability of inventions whose
commercial exploitation would be contrary to ordre public or morality,
is incompatible with Article 53 of the EPC, which excludes from patentability
inventions the publication or exploitation of which would be contrary to
ordre public or morality. The difference in the terms used, it is
argued, has an effect contrary to Article 1(2) of the Directive on the
obligations which the EPC imposes on the Member States.
- However, the applicant in no way indicates in what
respect the slightly different wording used by the Directive on that point,
inspired by the wording of Article 27(3) of the TRIPS Agreement, requires
Member States to breach their obligations under the EPC in order to comply
with their obligations under the Directive. In the absence of specific
examples to the contrary, it seems reasonable to suppose that a breach of
ordre public and morality as regards a specific invention could be
equally well established by reference to its publication, exploitation or
commercial exploitation.
- Fourthly and finally, the applicant and, to a
greater extent, the Norwegian Government intervening in its support submit
that the very purpose of the Directive, which is to make biotechnological
inventions patentable in all the Member States, runs counter to the principle
of equitable sharing of the benefits arising out of the utilisation of genetic
resources, which is one of the objectives of the CBD.
- However, the risks described by the applicant and
that intervener are expressed in hypothetical terms and are not derived
directly from the provisions of the Directive but, at the very most, from the
use which might be made of them.
- It cannot be assumed, in the absence of evidence,
which is lacking in this case, that the mere protection of biotechnological
inventions by patent would result, as is argued, in depriving developing
countries of the ability to monitor their biological resources and to make use
of their traditional knowledge, any more than it would result in promoting
single-crop farming or in discouraging national and international efforts to
preserve biodiversity.
- Moreover, while Article 1 of the CBD states that
its objective is the fair and equitable sharing of the benefits arising out of
the utilisation of genetic resources, including by appropriate access to
genetic resources and by appropriate transfer of relevant technologies, it
specifies that this must be done taking into account all rights over those
resources and technologies. There is no provision of the CBD which requires
that the conditions for the grant of a patent for biotechnological inventions
should include the consideration of the interests of the country from which
the genetic resource originates or the existence of measures for transferring
technology.
- Finally, as regards the possibility that the
Directive might represent an obstacle in the context of the international
cooperation necessary to achieve the objectives of the CBD, it should be borne
in mind that, under Article 1(2) of the Directive, the Member States are
required to apply it in accordance with the obligations they have undertaken
as regards inter alia biological diversity.
- It follows from the foregoing that the fourth plea
must be rejected.
The fifth plea
- The applicant submits that the patentability of
isolated parts of the human body provided for by Article 5(2) of the Directive
reduces living human matter to a means to an end, undermining human dignity.
Moreover, the absence of a provision requiring verification of the consent of
the donor or recipient of products obtained by biotechnological means
undermines the right to self-determination.
- It is for the Court of Justice, in its review of
the compatibility of acts of the institutions with the general principles of
Community law, to ensure that the fundamental right to human dignity and
integrity is observed.
- As regards respect for human dignity, this is
guaranteed in principle by Article 5(1) of the Directive which provides that
the human body at the various stages of its formation and development cannot
constitute a patentable invention.
- Nor are the elements of the human body patentable
in themselves and their discovery cannot be the subject of protection. Only
inventions which combine a natural element with a technical process enabling
it to be isolated or produced for an industrial application can be the subject
of an application for a patent.
- Thus, as is stated in the 20th and 21st recitals
of the preamble to the Directive, an element of the human body may be part of
a product which is patentable but it may not, in its natural environment, be
appropriated.
- That distinction applies to work on the sequence
or partial sequence of human genes. The result of such work can give rise to
the grant of a patent only if the application is accompanied by both a
description of the original method of sequencing which led to the invention
and an explanation of the industrial application to which the work is to lead,
as required by Article 5(3) of the Directive. In the absence of an application
in that form, there would be no invention, but rather the discovery of a DNA
sequence, which would not be patentable as such.
- Thus, the protection envisaged by the Directive
covers only the result of inventive, scientific or technical work, and extends
to biological data existing in their natural state in human beings only where
necessary for the achievement and exploitation of a particular industrial
application.
- Additional security is offered by Article 6 of the
Directive, which cites as contrary to ordre public and morality, and
therefore excluded from patentability, processes for cloning human beings,
processes for modifying the germ line genetic identity of human beings and
uses of human embryos for industrial or commercial purposes. The 38th recital
of the preamble to the Directive states that this list is not exhaustive and
that all processes the use of which offend against human dignity are also
excluded from patentability.
- It is clear from those provisions that, as regards
living matter of human origin, the Directive frames the law on patents in a
manner sufficiently rigorous to ensure that the human body effectively remains
unavailable and inalienable and that human dignity is thus safeguarded.
- The second part of the plea concerns the right to
human integrity, in so far as it encompasses, in the context of medicine and
biology, the free and informed consent of the donor and recipient.
- Reliance on this fundamental right is, however,
clearly misplaced as against a directive which concerns only the grant of
patents and whose scope does not therefore extend to activities before and
after that grant, whether they involve research or the use of the patented
products.
- The grant of a patent does not preclude legal
limitations or prohibitions applying to research into patentable products or
the exploitation of patented products, as the 14th recital of the preamble to
the Directive points out. The purpose of the Directive is not to replace the
restrictive provisions which guarantee, outside the scope of the Directive,
compliance with certain ethical rules which include the right to
self-determination by informed consent.
- The fifth plea must, therefore, be rejected.
The sixth plea
- Finally, the applicant argues that the Directive
is vitiated by breach of procedural rules in that it gives no indication that
the Commission's proposal was adopted by a college of members on the basis of
a text available in all the official languages.
- The Council takes the view that this plea is
inadmissible in so far as the applicant does not make clear whether it relates
to the original proposal or the amended proposal of the Commission and
furnishes no evidence in support of its plea.
- However, since the Directive states, in the
preamble, that it concerns the Commission proposal, referring in a footnote to
the editions of the Official Journal of the European Communities of 8
October 1996 and 11 October 1997, the plea must be taken to concern both the
proposal for a directive 96/C 296/03 submitted by the Commission on 25 January
1996 (OJ 1996 C 296, p. 4), and the amended proposal for a directive 97/C
311/05 submitted by the Commission on 29 August 1997 (OJ 1997 C 311, p. 12).
The plea is also sufficiently clear for the Court to be able to understand its
scope.
- After the Commission had provided, in its
statement in intervention, information to establish that the principle of
collegiality and the rules regarding languages applicable to its deliberations
had been respected, the applicant explained that its plea did not allege
breach of the principle of collegiality as such but the lack of any apparent
proof, in the wording of the Directive, that the principle was respected.
- In that regard, the obligation to state reasons
for directives under Article 190 of the EC Treaty (now Article 253 EC) does
not extend to a requirement that the signatures on proposals and opinions
mentioned in that article must include a summary of the facts to establish
that each of the institutions involved in the legislative procedure observed
its procedural rules.
- Furthermore, it is only where there is serious
doubt as to whether the procedure prior to its intervention was followed
properly that an institution is justified in investigating the matter. It has
not been established, or even alleged, that the Parliament or the Council had
valid reasons for believing that the Commission's examination of its proposal
did not follow the proper procedures in this case.
- The sixth plea, and the application in its
entirety, must, therefore, be rejected.
Costs
- Under Article 69(2) of the Rules of Procedure, the
unsuccessful party is to be ordered to pay the costs if they have been applied
for in the successful party's pleadings. Since the Parliament and the Council
have applied for an order that the Kingdom of the Netherlands bear the costs
and it has been unsuccessful, it must be ordered to pay the costs.
90. Pursuant to the first and second subparagraphs of Article 69(4) of
those rules, the Italian Republic, the Kingdom of Norway and the Commission,
which have intervened in the proceedings, are to bear their own costs.
On those grounds,
THE COURT
hereby:
1. Dismisses the application;
2. Orders the Kingdom of the Netherlands to bear the costs;
3. Orders the Italian Republic, the Kingdom of Norway and the Commission of
the European Communities each to bear their own costs.
| Rodríguez Iglesias Jann Macken
Colneric von Bahr Gulmann
Edward La Pergola Puissochet Sevón
Wathelet Skouris Cunha Rodrigues
|
Delivered in open court in Luxembourg on 9 October 2001.
R. Grass G.C. Rodríguez Iglesias
Registrar President
1: Language of the case: Dutch.
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URL: http://www.bailii.org/eu/cases/EUECJ/2001/C37798.html
