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Patently Unsatisfactory?: Community Legislative Competence and the ECJ Biotech Decision

Published online by Cambridge University Press:  06 March 2019

Malcolm MacLaren

Extract

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On 9 October 2001, the European Court of Justice dismissed (1) a challenge by the Netherlands with the support of Italy and Norway against the Community Directive on the legal protection of biotechnological inventions. (2) Although the Biotech Directive relates to a wide range of public concerns and the Application for its annulment was based on a half-dozen different pleas, the following article will focus on the case as it relates to European Community treaty limitations. It will critically examine the perspectives on the principles of harmonisation and subsidiarity presented in the Application, the Advocate General's Opinion and the Court's Judgment within the broader context of the Community/Union's past and future development. The examination will reveal that in this case the Court has foregone a good opportunity to delimit 'positive integration'. (3) It could have made an important contribution to the on-going discussion about power-sharing between the national and supranational levels. While the judgment does strongly affirm the positive integration paradigm, the margins of the EU's legislative policy competences remain blurred due to its oft-opaque reasoning. The judgment raises, directly and indirectly, as many questions as it answers.

Type
Research Article
Information
German Law Journal , Volume 2 , Issue 18 , 2001 , E5
Copyright
Copyright © 2001 by German Law Journal GbR 

References

(1) EC, Case C-377/98: Judgment of the Court of Justice of the European Communities in The Kingdom of the Netherlands v European Parliament and Council of the European Union; online: http://europa.eu.int/cj/index.htm; hereinafter ‘Judgment’. For a press report on the decision, see “EuGH weist Klage gegen Gen-Richtlinie ab”, NEUE JURISTISCHE WOCHENSCHRIFT, 9 October 2001, archived at newspaper website without page citation.Google Scholar

(2) EC, Directive 98/44 of the European Parliament and of the Council of 6 July 1998 on the Legal Protection of Biotechnological Inventions, OJ L (1998) No L213 at 13, hereinafter ‘the Biotech Directive’ or ‘the Directive’.Google Scholar

(3) The harmonisation programme exemplified by the Directive is an instance of ‘positive integration’, as opposed to the ‘negative integration’ achieved by ECJ decisions rendering ‘inapplicable’ domestic provisions contrary to EC law.Google Scholar

(4) Alan Dashwood, The Limits of European Community Powers, (1996) 21 E.L. Rev. 113, p. 114.Google Scholar

(5) Article 1(2), EU Treaty.Google Scholar

(6) Dashwood, p 113.Google Scholar

(7) The interaction between ethics and patent policy is a complex issue, which will not be treated here. Hopefully it suffices to note that public uncertainty may arise not only out of the ethics of using patented inventions but also out of the ethics of a market-based patent system that has the potential to “encourage the development of morally suspect activity.” E.R. Gold and A. Gallochat, The European Biotech Directive: Past as Prologue, European Law Journal, Vol. 7, No. 3, September 2001, 331, p. 333.Google Scholar

(8) The discussion here will focus on the jurisdictional foundations of the Directive rather than on the provisions themselves. For a more detailed description of the provisions, see, ibid., p. 343ff.Google Scholar

(9) EC, Case C-377/98: Action brought on 19 October 1998 by Kingdom of the Netherlands against European Parliament and the Council of the European Union, OJ Information (1998) No 98/C378/13.Google Scholar

(10) This theme will be treated more extensively later in this article.Google Scholar

(11) Gabriel Gloeckler et al., Guide to EU Policies, Blackstone: London, 1998, p. 20.Google Scholar

(12) Josephine Steiner and Lorna Woods, Textbook on EC Law (6th ed.), Blackstone Press: London, 1998, p. 123.Google Scholar

(13) Ibid., p. 124.Google Scholar

(14) Dashwood, p. 114.Google Scholar

(15) Ibid., p. 115.Google Scholar

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(17) Ibid., p. 115.Google Scholar

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(19) EC, Case C-377/98: Opinion of the Advocate General, F.G. Jacobs, 14 June 2001; hereinafter ‘Opinion’.Google Scholar

(20) Judgment at paragraph 13.Google Scholar

(21) Judgment at paragraph 14.Google Scholar

(22) Opinion at paragraph 45.Google Scholar

(23) Ibid.Google Scholar

(24) Judgment at paragraph 19.Google Scholar

(25) Judgment at paragraph 23.Google Scholar

(26) Judgment at paragraph 26.Google Scholar

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(28) See infra.Google Scholar

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(30) Opinion at paragraph 47.Google Scholar

(31) Opinion at paragraph 48.Google Scholar

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(44) Judgment at paragraph 17.Google Scholar

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(47) Judgment at paragraph 24; with reference to point 59 of Opinion 1/94 of 15 November 1994 ([1994] ECR I-5267).Google Scholar

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(60) Ibid., Part II generally.Google Scholar

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(63) In the ‘Tobacco Advertising’ decision, the Court characterized a directive approximating national measures relating to the advertising and sponsorship of tobacco products as an invalid attempt to regulate public health. The invalid Directive did not contribute to the elimination of obstacles to the free movement of goods and services or to the elimination of the distortion of competition. See Germany v Parliament and Council above.Google Scholar

(64) As one observer noted, “the real battlefield is regulation by the Community in areas in which Member States may feel that they do not want any regulation at all” and not how high the level of protection in the Community harmonising measures is. J.H.H. Weiler, The Constitution of Europe, 1999, p. 71.Google Scholar

(65) Dashwood, p. 122.Google Scholar

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(67) Dashwood, p. 122.Google Scholar

(68) Gold, p. 361f.Google Scholar

(69) Pope Pius XI in his Encyclical of 1931, Quadragesimo Anno, as quoted in Dashwood, p. 115.Google Scholar

(70) Gold, p. 343.Google Scholar

(71) Ibid., p. 351.Google Scholar

(72) ECONOMIST, 3 November 2001, p. 68.Google Scholar

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(74) The Community has been trying since 1975 to create Community-wide patents. As Gold notes, many difficulties plague the most recent proposal, the draft Council Regulation of 2000. These include language (the proposal would require the patent to be filed in either English, German or French with subsequent translation into the other two languages) and the jurisdiction of courts (the proposal calls for the creation of a centralised judicial system). “It is therefore unlikely that a Community Patent will come into existence anytime soon.” Gold, pp. 334 and 354.Google Scholar

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(76) Ibid.Google Scholar

(77) Gold, p. 361.Google Scholar

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(80) Weiler, p. 43 inter alia.Google Scholar

(81) Gold, p. 361.Google Scholar

(82) Opinion at paragraph 226.Google Scholar

(83) Opinion at paragraph 228.Google Scholar