No to patenting

On October 18, in the Judgement on the case C-34/10, the Court of Justice of the European Union ruled that a process which involves the removal of a stem cell from a human embryo at the blastocyst stage, entailing the destruction of that embryo, cannot be patented. The Court in Luxembourg was poised to make a decision regarding the appeal filed by German researcher Oliver Brüstle to the Federal High Court of Germany (Bundesgerichtshof) after the Federal Patent Court of Germany (Bundespatentgericht), responding to a nullity claim by Greenpeace, ruled against the patent-eligibility of a procedure, developed by the German researcher, whereby “totipotent” cells are extracted by human embryonic stem cells. The preliminary opinion issued past March 10 by the Advocate General of the Court Yves Bot, confirmed the “non-patenting eligibility” of embryonic stem cells.For therapeutic or diagnostic purposes. On examination of the concept of ‘human embryo’, which is missing in the Directive 98/44/CE on the legal protection of biotechnological inventions, the European Court of Justice (ECJ) affirms that ” on the basis of a legal interpretation of the relevant provisions of the Directive”, the context and aim of the Directive “show that the European Union legislature intended to exclude any possibility of patentability where respect for human dignity could thereby be affected”. There ensues that “the concept of ‘human embryo’ must be understood in a wide sense”. In the view of the Court, “any human ovum must, as soon as fertilized, be regarded as a ‘human embryo’ if that fertilization is such as to commence the process of development of a human being. A non-fertilized human ovum into which the cell nucleus from a mature human cell has been transplanted and a non-fertilized human ovum whose division and further development have been stimulated by parthenogenesis must also be classified as a ‘human embryo'”. The Court notes that “the grant of a patent for an invention implies, in principle, its industrial or commercial application”, and that “the use of human embryos for purposes of scientific research which is the subject-matter of a patent application cannot be distinguished from industrial and commercial use and, thus, avoid exclusion from patentability”. Consequently, the ECJ concludes that scientific research “entailing the use of human embryos cannot access the protection of patent law”. As for the question on the patentability of an invention involving the production of neural precursor cells, the Court points out, firstly, that “this presupposes that stem cells are obtained from a human embryo at the blastocyst stage and, secondly, that the removal of a stem cell entails the destruction of that embryo”. Not to exclude from patentability such an invention claimed “would allow a patent applicant to avoid the non-patentability by skilful drafting of the claim”. In conclusion, the ECJ holds that “an invention is excluded from patentability where the implementation of the process requires either the prior destruction of human embryos or their prior use as base material”.A milestone in the defense of life. The Commission of the Bishops’ Conferences of the European Community (COMECE), commenting on the ruling described it as “a broad, scientific sound definition of a human embryo” and “a milestone in the protection of Human life in EU legislation”. The ECJ, COMECE declared in a statement, “had to give a clear legal interpretation of the concept of human embryo”. COMECE said it “welcomes the Judgement” described as “broad and scientifically sound”. The COMECE bishops equally welcome the decision that the removal of a stem cell from a human embryo implying the destruction of that embryo cannot be patented either. COMECE expects, as a positive consequence of this judgement, “the push forward that may now be given to scientific research on alternative sources”, which “remained till now in the shadow of research on human embryonic stem cells”, and points out that “the use of adult stem cells, stem cells derived from umbilical cord blood and others, offer, in some cases already, significant possibilities for regenerative medicine. These methods enjoy wide acceptance both on scientific and ethical grounds. According to the bishops, the judgement can foster “existing and promising fields of research which can combine the respect of human life with efficient and innovative treatments for healing people”. Therefore this Judgement of the ECJ “has to be welcomed as a milestone in the protection of Human life in EU legislation, that will most likely have a positive impact in concrete Policy fields like the Funding of Research in the EU”.