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(Nov 07, 2011) On October 18, 2011, the European Court of Justice (ECJ) adopted a landmark decision in the case of Oliver Brüstle v. Greenpeace e.V. and held that a process that involves the removal of a stem cell from a human embryo, resulting in the destruction of the embryo, cannot be patented. The ECJ further held that European Union Directive 98/44/EC on the Legal Protection of Biotechnological Inventions, which prohibits the patentability of the use of human embryos for commercial or industrial purposes, also prohibits the use of embryos for scientific research. In addition, the ECJ made the clarification that the use of human embryos for therapeutic or diagnostic purposes, which are applied to the human embryo and are useful to it, are patentable. (Judgment of the ECJ (Grand Chamber) (Oct. 18, 2011), EUR-LEX.)
The case was referred to the ECJ by the German Federal Court of Justice (Bundesgerichtshof) for a preliminary ruling concerning the interpretation of article 6(2)(c) of Directive 98/44/EC. The need for such a ruling arose during proceedings brought by the nongovernmental organization Greenpeace, which requested Germany's Federal Patent Court (Bundespatentgericht) to annul a patent granted to Oliver Brüstle. The patent concerned "isolated and purified neural precursor cells, processes for their production from embryonic stem cells and the use of neural precursor cells for the treatment of neural defects." (Id.) Greenpeace challenged the patent, and the Federal Patent Court ruled that, based on German law, the patent at issue was invalid insofar as it covers precursor cells obtained from human embryonic stem cells and processes for the production of those precursor cells. Oliver Brüstle appealed against that judgment to the German Federal Court of Justice. (Press Release, No. 112/11,Court of Justice of the European Union, A Process Which Involves Removal of a Stem Cell from a Human Embryo at the Blastocyst Stage, Entailing the Destruction of That Embryo, Cannot Be Patented (Oct. 18, 2011).)
The ECJ reviewed the applicable international law, that is, the Agreement on Trade-Related Aspects of Intellectual Property Rights and the Convention on the Grant of European Patents, as well as Directive 98/44/EC and its domestic implementation in Germany. Directive 98/44/EC provides that the human body while it is being formed and developed cannot be the subject of a patentable invention. Article 6 of the Directive offers additional safeguards by excluding from patentability as contrary to public order or morality "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." (Judgment of the ECJ, supra.) As Recital 38 of the Directive states and the ECJ has affirmed, any process whose use may offend human dignity is not patentable. (Id.)
The German Federal Court of Justice posed questions to the ECJ and included a request that the ECJ provide an interpretation of the concept of "human embryo" within the meaning of article 6(2)(c) of the Directive. On this key issue, the ECJ held that any human ovum, after fertilization, must be regarded as a "human embryo." In addition, the ECJ held that "any non-fertilised human ovum into which the cell nucleus from a mature human cell has been transplanted and any non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis constitute a 'human embryo'… ." (Id.)
With regard to the specific issue that was the subject matter of Brüstle's patent application – whether stem cells taken from a human embryo at the blastocyst stage are included in the concept of "human embryo" within the meaning of article 6(2)(c) and as defined by the ECJ – the ECJ held that such a decision lies within the jurisdiction of the German Federal Court of Justice. The latter has to decide on this issue and whether the patent application is valid. (Id.)
Reactions to the ECJ Ruling
Bio-ethicists endorsed the decision of the ECJ, which was heralded Lasse Bruun, International Senior Campaigner of Greenpeace, as a victory for the protection of human life and dignity against commercial interests. (Greenpeace Welcomes European Court of Justice Ruling on Stem Cells Patents, GREENPEACE INTERNATIONAL (Oct. 18, 2011).) On the other hand, the bio-medical industry was deeply disappointed at the outcome. Brüstle stated that the decision of the ECJ is "regrettable" because it means that EU researchers who engage in permitted research on human embryos for scientific purposes cannot enjoy the fruits of their labor, while researchers in the United States and Asia will be free to do so. (Antony Blackburn-Starza, Ban on Embryonic Stem Cell Patents by European Court of Justice, BIONEWS (Oct. 24, 2011).)
|Author:||Theresa Papademetriou More by this author|
|Topic:||Intellectual property More on this topic|
|Jurisdiction:||European Union More about this jurisdiction|
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Last updated: 11/07/2011