The European Court of Justice bans patents on human embryonic cells
The ruling, issued on Tuesday, 18 October , by the European Court of Justice on the patent-eligibility of cells and cell lines obtained from human embryos, has in the end come about in the terms in which many had hoped.
The ruling is subtle but clear. It affirms that a patent is possible on the use of human embryos if the invention has a diagnostic or therapeutic purpose with regard to the embryo in question. On the contrary, it cannot be the object of a patent if it is for scientific research. Moreover, the Court specifies that the procedures which allow for the extraction of human embryonic stem cells in their blastocyst stage — five days after fertilization — and bring about their destruction cannot be patented. In short, the Court has not intervened on the possible creation and subsequent suppression of human embryos, but banning patents places an important bulwark against these procedures.
This ruling was expected last May when there were numerous attempts to influence the judgment. On 28 April the magazine, Nature, published a signed appeal by Austin Smith of the Wellcome Trust Center of Cambridge and some of his colleagues (in Italy it was supported by UniStem of the University of Milan), giving rise to a debate intended to influence the court's decision to authorize the possibility of human embryonic stem cell patents. In that document, it was maintained that embryonic stem cells are only cell lines and not embryos. But the same document deliberately failed to mention that these lines are derived from the destruction of human embryos — human beings in the process of development — defined as "surplus of in vitro fertilized ovocites" (sic!). There are already hundreds of these lines, some say thousands, many of them patented in the United States.
The Court's ruling is due to a series of events that occurred after an appeal in Germany. Raising the case against the patents was Green-peace, which in 1999 challenged the patent of Professor Oliver Brustle, then at the University of Bonn, who in 1991 had obtained a patent for a procedure to produce nerve cells derived from so-called human embryonic stem cells from a stabilized and commercially available cell line. In its challenge, Greenpeace claimed that the patent violated the European Patent Convention (EPC 1973)\which bans patents on inventions, "contrary to public order or morality".
In 2006, the German federal court of Munich sided with Greenpeace and Brustle appealed to the European Court of Justice. On 10 March, the Advocate-General of the Court, Yves Bot, sent an official note to the Court re-iterating elements of the criteria which he maintained were fundamental considerations on reaching a final decision. It seems from the result that his suggestions were taken into account.
In this interesting document, which created agitation among many researchers, three fundamental principles were highlighted: cells at the first stage of a human body in development must be classified as embryos and therefore are not patentable; that such a definition applies both to ovocites which are transplanted with the nucleus of a mature cell (cloning) and cells obtained from ovocites for stimulation (parthenogenesis); that the blastocyst stage must be classified as an embryo.
As the Advocate-General asserted, the principle of the directive 98/44 on human dignity which "bans the use of human embryos for commercial and industrial ends" is a principle to be applied not only to the adult person and to the newborn, but also to the human body from its first stage of development. Therefore even the so-called embryonic stem cells which although not individually able to produce a complete human being — like the cells Brustle used — must be placed under the same rules, in so far as they cannot be obtained from the blastocyst without their own destruction and therefore without the destruction of the human embryo.