“Human embryo": autonomous concept of EU law
• 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.
Human embryo within the meaning of Article 6 (2) (c) biotechnology directive
• any human ovum after fertilisation, any non-fertilised human ovum into which the cell nucleus from a mature human cell has been transplanted and any non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis constitute a ‘human embryo’ within the meaning of Article 6(2)(c) of the Directive;
• it is for the referring court to ascertain, in the light of scientific developments, whether a stem cell obtained from a human embryo at the blastocyst stage constitutes a ‘human embryo’ within the meaning of Article 6(2)(c) of the Directive.
32 In that regard, the preamble to the Directive states that although it seeks to promote investment in the field of biotechnology, use of biological material originating from humans must be consistent with regard for fundamental rights and, in particular, the dignity of the person. Recital 16 in the preamble to the Directive, in particular, emphasises that ‘patent law must be applied so as to respect the fundamental principles safeguarding the dignity and integrity of the person’.
Article 6 (2) (c) biotechnology patent directive excludes from patentability use of human embryos for scientific research
• that the exclusion from patentability concerning the use of human embryos for industrial or commercial purposes in Article 6(2)(c) of the Directive also covers use for purposes of scientific research, only use for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it being patentable.
Article 6 (2) (c) Biotechnology Directive: no patentability if technical teaching requires (i) prior destruction of human embryos, or (ii) their use as base material
• that Article 6(2)(c) of the Directive excludes an invention from patentability where the technical teaching which is the subjectmatter of the patent application requires the prior destruction of human embryos or their use as base material, whatever the stage at which that takes place and even if the description of the technical teaching claimed does not refer to the use of human embryos.