Brussels, 18/10/2011 (Agence Europe) - A process that uses stem cells obtained from human embryos and which leads to the destruction of the latter cannot be patented. This exclusion from patenting does not only cover the use of human embryos for industrial and commercial purposes but also their use for scientific research. It can only be patented when it is used for therapeutic or diagnostic purposes applicable to the human embryo and beneficial to it.
This is the main thrust of an important ruling made on Tuesday 18 October in Case C-34/10 which could have significant repercussions, particularly on the pharmaceutical industry. The German Federal Court asked the European Court of Justice: (1) to interpret the notion of “human embryo” with regard to the directive on the legal protection of biotechnological inventions (98/44/EC) and to explain whether an exclusion from patenting of the human embryo covers all stages of life beginning with the fertilisation of the egg or simply the stages that begin when the embryo begins to develop (blastocyst stage); (2) whether exclusion from patenting covers the notion of “use of the embryo for industrial and commercial purposes” in the sense of the directive also covering its use for scientific research; (3) if an invention should be excluded from patenting which, although not having the use of human embryos as its objective, would focus on a product that includes the preliminary destruction of human embryos or a process which requires a basic material obtained from the destruction of human embryos.
On the first point, the ECJ indicates that the notion of human embryo must be understood in its broadest sense, in so far as the legislator aimed to exclude any possibility of patenting that could affect respect for human dignity. This notion covers all stages of development in human life from the fertilisation of the egg, and includes all human eggs that have not been fertilised and into which a human cell nucleus has been implanted, as well as non-fertilised human eggs whose division and further development have been stimulated by pathogenesis. In the latter case, even if there has been no effective fertilisation, the process can ultimately conclude with the development of a human being. As regards stem cells obtained at the blastocyst stage (5 days after fertilisation), which concerns the main question in this case, the ECJ explains that it is up to the national legal authorities to determine whether these will naturally trigger the process of development of a human being and is therefore part of the concept of a non-patentable “human embryo”.
With regard to the second point, the ECJ points out that the granting of a patent for an invention implies, in principle, its industrial and commercial exploitation. Consequently, the use of human embryos for scientific research, which is the subject of a patent request, cannot be distinguished from industrial and commercial use and therefore is not covered by the patented process. Nonetheless, the Court points out that the directive does not prohibit the use of embryos for industrial and commercial purposes when the embryo is used for therapeutic or diagnostic purposes applicable to the human embryo and beneficial to it.
On the third question, which focuses on the invention covered in the main case (production of neural precursor cells produced from human embryo stem cells used for the treatment of neurological disease) the Court excludes patenting from such an invention when its implementation requires the prior destruction of human embryos or their use as basic material even if during the request for patents, the description of the process does not mention the use of human embryos.
Peter Liese MEP, speaking on behalf of the EPP Group, as well as the Commission of Episcopates of the European Union (COMECE), welcomed this decision by the ECJ, which, according to the European bishops constitutes a major stage in the protection of life in EU legislation and should therefore have a positive impact on concrete policies on the funding of research at EU level. (FG/transl.fl)