Oliver Brüstle v Greenpeace eV.
Date: 2011-10-18
25. It must be borne in mind that, according to settled case-law, the need for a uniform application of European Union law and the principle of equality require that the terms of a provision of European Union law which makes no express reference to the law of the Member States for the purpose of determining its meaning and scope must normally be given an independent and uniform interpretation throughout the European Union (see, in particular, Case 327/82 Ekro  [1984] ECR 107, paragraph 11; Case C-287/98 Linster  [2000] ECR I-6917, paragraph 43; Case C‑5/08 Infopaq International  [2009] ECR I‑6569, paragraph 27; and Case C-467/08 Padawan  [2010] ECR I‑0000, paragraph 32).
26. Although the text of the Directive does not define human embryo, nor does it contain any reference to national laws as regards the meaning to be applied to those terms. It therefore follows that it must be regarded, for the purposes of application of the Directive, as designating an autonomous concept of European Union law which must be interpreted in a uniform manner throughout the territory of the Union.
27. That conclusion is supported by the object and the aim of the Directive. It follows from recitals 3 and 5 to 7 in the preamble to the Directive that it seeks, by a harmonisation of the rules for the legal protection of biotechnological inventions, to remove obstacles to trade and to the smooth functioning of the internal market that are brought about by differences in national legislation and case-law between the Member States, and thus, to encourage industrial research and development in the field of genetic engineering (see, to that effect, Netherlands  v Parliament and Council , paragraphs 16 and 27).
29. That conclusion is also supported by the scope of the listing, in Article 6(2) of the Directive, of the processes and uses excluded from patentability. It is apparent from the case-law of the Court that, unlike Article 6(1) of the Directive, which allows the administrative authorities and courts of the Member States a wide discretion in applying the exclusion from patentability of inventions whose commercial exploitation would be contrary to ordre public  and morality, Article 6(2) allows the Member States no discretion with regard to the unpatentability of the processes and uses which it sets out, since the very purpose of this provision is to delimit the exclusion laid down in Article 6(1). It follows that, by expressly excluding from patentability the processes and uses to which it refers, Article 6(2) of the Directive seeks to grant specific rights in this regard (see Commission  v Italy , paragraphs 78 and 79).
30. As regards the meaning to be given to the concept of ‘human embryo’ set out in Article 6(2)(c) of the Directive, it should be pointed out that, although, the definition of human embryo is a very sensitive social issue in many Member States, marked by their multiple traditions and value systems, the Court is not called upon, by the present order for reference, to broach questions of a medical or ethical nature, but must restrict itself to a legal interpretation of the relevant provisions of the Directive (see, to that effect, Case C‑506/06 Mayr  [2008] ECR I‑1017, paragraph 38).
31. It must be borne in mind, further, that the meaning and scope of terms for which European Union law provides no definition must be determined by considering, inter alia, the context in which they occur and the purposes of the rules of which they form part (see to that effect, inter alia, Case C‑336/03 easyCar  [2005] ECR I‑1947, paragraph 21; Case C‑549/07 Wallentin-Hermann  [2008] ECR I‑11061, paragraph 17; and Case C‑151/09 UGT-FSP  [2010] ECR I‑0000, paragraph 39).
33. To that effect, as the Court has already held, Article 5(1) of the Directive provides that the human body at the various stages of its formation and development cannot constitute a patentable invention. Additional security is offered by Article 6 of the Directive, which lists as contrary to ordre public or 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. Recital 38 in the preamble to the Directive states that this list is not exhaustive and that all processes the use of which offends against human dignity are also excluded from patentability (see Netherlands  v Parliament and Council , paragraphs 71 and 76).
34. The context and aim of the Directive thus show that the European Union legislature intended to exclude any possibility of patentability where respect for human dignity could thereby be affected. It follows that the concept of ‘human embryo’ within the meaning of Article 6(2)(c) of the Directive must be understood in a wide sense.
36. That classification must also apply to a non-fertilised human ovum into which the cell nucleus from a mature human cell has been transplanted and a non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis. Although those organisms have not, strictly speaking, been the object of fertilisation, due to the effect of the technique used to obtain them they are, as is apparent from the written observations presented to the Court, capable of commencing the process of development of a human being just as an embryo created by fertilisation of an ovum can do so.
40. In that regard, it must be pointed out that the purpose of the Directive is not to regulate the use of human embryos in the context of scientific research. It is limited to the patentability of biotechnological inventions.