NL tegen de Octrooirichtlijn 98/44 EU (het beroepschrift)
Bron: Europees Hof van Justitie
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Official Journal Court of Justice of the European Communities Information
Action brought on 19 October 1998 by Kingdom of the Netherlands against European
Parliament and Council of the European Union
An action against the European Parliament and the Council of the European Union
was brought before the Court of Justice of the European Communities on 19 October
1998 by the Kingdom of the Netherlands, represented by Marc Fierstra and Ivo
van der Steen, Assistant Legal Advisers in the Ministry of Foreign Affairs,
The Hague, acting as Agents.
The applicant claims that the Court should:
1. Declare Directive 98/44/EC void; and
2. Order the defendant to pay the costs.
Pleas in law and main arguments
- Incorrect legal basis: Directive 98/44/EC is not primarily directed towards
the harmonisation of national patent law principles and moreover goes further
than such harmonisation by creating new patent rights of Community origin.
Specifically, a patent is created over living products of biotechnological
processes and the Directive also regulates the scope of that patent protection
in a manner which differs from current patent law. Recital 15 in the preamble
to the Directive is wrong in stating that no prohibition exists in national
patent law or the European Patent Convention which precludes a priori the
patentability of biological matter; in any event, that statement is not valid
for the Netherlands.
Article 100a of the EC Treaty should therefore not have been chosen as the
legal basis but rather, if it were really thought necessary to regulate biotechnological
inventions in order to achieve, in the framework of the common market, one
of the objectives of the Community, Article 235. A procedure in which a qualified
majority is sufficient was thus wrongly chosen for the adoption of Directive
98/44/EC, when a procedure for which a unanimous vote is prescribed was appropriate.
- * Infringement of the second paragraph of Article 3b of the EC Treaty (the
principle of subsidiarity) or, in the alternative, of the combined provisions
of Articles 3b and 190 of the EC Treaty: The patent laws of the Member States
are almost completely harmonised following alignment with the European Patent
Convention. The clarification of the protection of biotechnological inventions
which is, according to recital 4 in its preamble, the aim of Directive 98/44/EC
should therefore ensue from the implementation of the European Patent Convention.
It is thus an aim eminently suitable for being achieved by the Member States.
Indeed, such an approach is preferable in view of the fact that the European
Patent Convention applies also in States other than the Member States of the
European Union. Nor, thus, is it established that this matter concerns a Community
objective which, by reason of the scale or effects of the abovementioned action,
can be better achieved by the Community, or in any event it is not clear from
the statement of reasons for the contested measure that this is so.
- Breach of the principle of legal certainty: The Netherlands Government
takes the view that it is only to a limited extent that Directive 98/44/EC
removes any uncertainty regarding the patenting of biotechnological inventions,
whereas it gives rise at the same time to new uncertainties.
- Breach of obligations under international law:
- Notwithstanding Article 1(2) of Directive 98/44/EC, Member States are
denied the opportunity of choosing whether or not to make use of the possibility
of an exclusion under Article 27(3)(b) of the TRIPS Agreement.
- Directive 98/44/EC was not drawn up in accordance with the provisions
of Article 2 of the Agreement on Technical Barriers to Trade, or in any
event it is not apparent from the statement of reasons for the Directive
that this was so.
- Infringement of the European Patent Convention.
- Infringement of the Convention on Biological Diversity.
- Breach of fundamental rights:
- Violation of human dignity: The human body is the bearer of human dignity.
Under Directive 98/44/EC, it will be possible to make isolated parts of
the human body patentable. Such treatment of living human material as
an object is unacceptable in the context of human dignity.
- Violation of patients' right to self-determination: Not the slightest
provision is made as regards possible recipients of biotechnologically
treated material, or at least material which has been obtained through
the application of biotechnology. This means that a patient may be treated
with such material without his knowledge
- and thus without his consent
- even where, had he been made aware of it, he would have refused
- Infringement of Article 100a, taken together with Article 189b(2), of the
EC Treaty: The activities of the Commission are governed by the principle
of collegiality. The Commission's proposal, which was an indispensable prerequisite
for the contested Directive, should have been drawn up by the college of commissioners
in the definitive text in which it was submitted to the European Parliament
and the Council, because it is an essential part of the Community legislative
process. In view of the general scope of the measure adopted by the European
Parliament and the Council on the basis of that proposal, the text should
also have been available for consideration by all the members of the college
in all the official languages at the time when the Commission took its decision.