TITLE: Action brought on 19 October 1998 by Kingdom of the Netherlands against European Parliament and Council of the European Union PUBLICATION: Official Journal of the European Communities DATE: 5 December 1998 SOURCE: Steve Emmott, Green Group, European Parliament NOTE: In June 1998, the European Union adopted a directive on the patenting of biotechnological inventions, binding on all 15 member states. Four months later, the Dutch government challenged the legality of the directive at the European Court of Justice. Below is an official account of the Dutch government's arguments. Until the European Court reaches a decision on the case, the directive -- which must be implemented at national level within two years of its adoption -- remains valid. Further information may be requested from Steve Emmott at the European Parliament, details below. 5.12.98 C378/13 Official Journal of the European Communities Case 377/98 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 of the European Parliament and of the Council [1] void; and 2. order the defendant to pay the costs. Pleas in law and main arguments adduced in support: 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 3(B) OF THE EC TREATY (THE PRINCIPLE OF SUBSIDIARITY) OR, IN THE ALTERNATIVE, OF THE COMBINED PROVISIONS OF ARTICLES 3(B) 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 such treatment. Infringement of Article 100(a) 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. [1] Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions (OJ L 213, 30.7.1998, p. 13). Steve Emmott Advisor, Genetic Engineering Green Group in the European Parliament 1047 Brussels Belgium Tel/Fax: (32-2) 284 20 26 Email: