Patentability and Human Embryos: Case C-34/10 Oliver Brüstle vs. Greenpeace
Post by Chiara Berneri
Photo: euthman (CC via flickr)
In a judgment on the 18th of October 2011, Oliver Brüstle vs. Greenpeace (Case No. C-34/10), the European Court of Justice found that destructive research on human embryos cannot be patented. The Court established a broad definition of “human embryo” stating that cells that have the ability to develop into a human being (totipotent cells), although not fertilized, are to be legally regarded as human beings and are thus excluded from possible patentability.
The reference for a preliminary ruling concerned the interpretation of Article 6(2)(c) of Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions. The reference was made in proceedings brought by Greenpeace, seeking annulment of the German patent held by Mr Brüstle, which related to neural precursor cells, the processes for their production from embryonic stem cells and their use for therapeutic purposes.
Among the several questions that were posed, the first one was of particular ethical importance. In simple terms, the German referring Court was asking what was the meaning of the definition of “human embryos”, encompassed in Article 6(2)(c) of the Directive.
The European Court of Justice recognized that the Directive does not give a unilateral definition of human embryos. However, the Court realized the necessity of defining human embryos univocally all over Europe. In the view of the Court, a “cherry picking” approach is not desirable because this would likely hinder the “smooth functioning of the Common Market”.
In order to define human embryos the Court looked at the main scope of the Directive. First of all, it highlighted that Article 5(1) of the Directive provides that the human body at the various stages of its formation and development cannot constitute a patentable invention. Moreover, Article 6 of the Directive, lists as contrary to public order or morality, and therefore excluded from patentability, processes for cloning human beings, processes for modifying the germ line genetic identity of human beings and uses of human embryos for industrial or commercial purposes. Finally, recital 38 in the preamble to the Directive states that this list is not exhaustive and that all processes the use of which offends human dignity are also excluded from patentability.
The Court therefore underlined how the context and aim of the Directive shows that the European Union legislature intended to exclude any possibility of patentability where respect for human dignity could be affected. It followed that the concept of ‘human embryo’ within the meaning of Article 6(2)(c) of the Directive has to be understood in a wide sense, which includes not just fertilized human ovum but also 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. In fact, although these organisms have not been object of fertilization, “they are nevertheless capable of commencing the development process of a human being just like an embryo created by fertilization of an ovum can do so”.
This judgment, already subjected to a lot of criticism, it is considered by many to be a milestone in the protection of human life in Europe.