Saturday 14. December 2019
#139 - June 2011

 

The Brüstle case: a milestone in the legal protection of human life in Europe?

 

The Advocate General delivered an Opinion on the definition of the human embryo that can lead to unparalleled consequences

 

A patent grants to its owner the exclusive right to commercially exploit his invention. An invention is a new product or a new process for doing something that entails a new solution for a given problem. Excepting the patent's owner, no one else can use or sell such an invention without his consent. Thereby, the patentability of an invention – the legal possibility of setting up a temporary monopoly and receiving the corresponding rents – functions as a powerful economic incentive for research and innovation.

Now, can the ‘production’ of a human embryo or of human embryonic stem cells (hESC) be patented as an invention? The question was posed after Mr. Oliver Brüstle obtained a patent related to some cells produced from hESC to treat a neural disease such as Parkinson's. Afterwards, however, following an application by Greenpeace, a global environmental organisation, the Federal Patent Court of Germany declared this patent invalid.  Mr. Brüstle appealed to the German Federal Court of Justice, which referred the case to the European Court of Justice (ECJ) for interpreting, in a preliminary ruling, the term “human embryo” as used in Directive 98/44/EC of 6 July 1998 which rules on the patenting of “biotechnological inventions”. Its Article 6 lays down that “uses of human embryos for industrial or commercial purposes” are not patentable as “their commercial exploitation would be contrary to ordre public or morality”.

 

On 10 March 2011, the Advocate General of the ECJ, Mr. Yves Bot, delivered an Opinion considering a human embryo as any totipotent cell which “has the capacity to develop into a complete human being”, and which is, therefore, “the first stage of the human body”, after fertilisation. In his perspective, the means by which the totipotent cell was obtained – cloning for example – is irrelevant. Mr. Bot’s understanding is not far from that of the Church.

Furthermore, the Advocate General, following a Resolution that the European Parliament adopted on 26 October 2005, sustained that a procedure using hESC, derived from human embryos which are thereby destroyed and used “as a simple base material”, is not patentable.  This question touches of course huge economic interests.

Some voices then appeared claiming that, in the light of the principle of subsidiarity, and this being at stake an ethical issue, the definition of human embryo should be devolved to the Member States.

However, “human embryos”, unlike “person” or “legal personality”, constitute a scientific concept, and what Article 6 rules is not an ethical issue, but exclusively the question of hESC patenting, given their possible commercial and industrial exploitation, in the strict and narrow context of the internal market.

 

In fact, the legal basis of the Directive is Article 114 of the Treaty on the Functioning of the European Union (TFEU) - concerning the approximation of the laws of the Member States - that has as its aim the establishment of the internal market, together with its objectives, laid down by Article 26 TFEU, of free movement of goods, persons, services and capital. These freedoms pursue fair competition and equality among economic agents within the European Union. If the granting of a patent is left dependent on different national definitions and regimes, fair competition will be under threat and some European economic agents will be discriminated vis-à-vis others, jeopardising the very objectives underpinning this piece of legislation.

 

What is expected from the ECJ, in the light of the principle of uniformity, is an interpretation which preserves the unity and coherence of EU Law, in order to avoid discriminations among EU citizens and economic agents. Should the devolution occur, an EU action justified by the identified need to strengthen the internal market – through the approximation of the laws of the Member States and, consequently, the required modification of the national laws in the specific field here discussed – would lack any meaningful content. The principle of the minimum level of harmonisation at EU level and the principle of effectivity and efficacy of EU Law would be infringed.

Judgment on the Brüstle case is expected next Summer.

 

José Ramos-Ascensão

 

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