No to the patentability

According to the conclusions expressed on 10 March by the Advocate General of the EU Court of Justice, Yves Bot, “totipotent cells that have the intrinsic capacity to evolve into a complete human being should be qualified from a legal viewpoint as human embryos and, therefore, their patentability should be excluded”. Reaffirming the validity of this position, on the eve of the sentence of the European Court of Justice expected this week, is the objective of the letter signed by fifteen distinguished European scientists and academics that will be sent to the prestigious scientific journal “Nature”. It’s the first time, emphasized the Advocate General, that the Court has been called to pronounce on the notion of the “utilization of human embryos for industrial or commercial purposes”, provision for which is granted by Directive 98/44 CE on the legal protection of biotechnological inventions. After having pointed out that significant differences exist between the provisions of member states and the impossibility – in the present state of scientific knowledge – to use a criterion which may be admitted by all member states, Yves Bot refers to the provision of the directive (art. 5, no. 1) which safeguards the “human body, in the various stages of its constitution and development”. The case arises after the declaration of invalidity, by the German Bundespatentgericht (federal patents’ tribunal), of a patent relating to isolated and purified cells, produced on the basis of human embryonic stem cells. The German Bundesgerichtshof (Federal Court of Appeal), to which recourse was made in appeal by the holder of the patent, decided to suspend the judgement and to ask the European Court of Justice to pronounce on the interpretation, in particular, of the notion of “human embryo”, undefined by the above-cited Directive 98/44.Human embryos cannot be patented. “Having the intrinsic capacity to evolve into a complete human being”, totipotent cells “should be qualified from the legal viewpoint as human embryos and, therefore, their patentability should be excluded”. The fifteen scientists start out from this declaration of principle enunciated by Advocate General Bot. In their view, therefore “human embryonic stem cells should not be considered patentable”. “Scientific data – they affirm – indicate that the cycle of life of the human being coincides with the formation of its genetic identity, materialized in the DNA that contains the genetic makeup of each individual human being”. Since the development of human life “through the embryonic and foetal phases must be considered a continuous process”, it follows, in the view of the letter’s signatories, that “the human embryo, in each of its phases of development, must be considered a human being with potentialities and not just a ‘potential human being'”.“No” to the destruction of embryos. Due to the ability of stem cells to continuously multiply themselves, many scientists in recent years have developed techniques to derive human embryonic stem cells (hesc) “through a process that usually destroys the donor embryos”, the letter continues. With reference to the interest in hesc lines as “source of cell lines that can be maintained in vitro to be used as mere basic material for possible therapeutic or diagnostic ends in regenerative medicine”, the fifteen scientists explain that the blastomeres (i.e. each of the cells into which the egg fertilized during the process of segmentation is divided) “can give rise, in suitable conditions, to an embryo”. “They are, in other words, living parts of embryos” and it is “extremely debatable whether a cell extracted from a living organ can be considered a patentable invention”. Moreover, underlines the letter, “the use of embryos for therapeutic ends implies the destruction of the embryos themselves, in other words the destruction of human lives in their most precocious phases”.Respect for the dignity of the person. Calling this practice “morally unacceptable”, the scientists point out that after over ten years’ use, hesc have produced no results in regenerative medicine, nor any significant progress in the diagnosis and therapy of diseases. “Scientific and technological progress ought to be always guided by respect for the intrinsic dignity of each human being, the intention to contribute to the common good, and recognition of the finiteness of the human condition”, warn the signatories of the letter, suggesting as alternatives the use of adult stem cells or the more recent technology of cellular reprogramming that generates induced pluripotent stem cells (IPS) and “offers important prospects for regenerative medicine, widely accepted from the scientific and ethical viewpoint”. “Cell lines or inventions derived from these sources – conclude the academics – can be patented so long as they are not obtained to the detriment of an embryo, and do not involve the destruction of a human life”.