Kingdom of the Netherlands v European Parliament and Council of the European Union.
Date: 2001-10-09
15 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).
16 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.
18 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.
24 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).
25 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.
27 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.
28 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).
37 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.
38 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.
39 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.
52 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).
53 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).
54 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).
71 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.
72 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.
73 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.
74 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.
75 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.
76 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.