Written answers

Tuesday, 8 November 2011

Department of Enterprise, Trade and Innovation

EU Directives

9:00 pm

Photo of Willie O'DeaWillie O'Dea (Limerick City, Fianna Fail)
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Question 200: To ask the Minister for Jobs, Enterprise and Innovation if he has held any discussions with representatives of the biotechnology or pharmaceutical industry in relation to the decision of the European Court of Human Rights to limit their ability to patent stem cells; his views that the decision will have an adverse effect on jobs here; and if he will make a statement on the matter. [33112/11]

Photo of Richard BrutonRichard Bruton (Dublin North Central, Fine Gael)
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The decision the Deputy is referring to is the Court of Justice of the European Union (CJEU)Case C-34/10, also known as the Brüstle case. This highly technical case centred on the Court's interpretation of EU Directive 98/44/EC on the legal protection of biotechnological inventions.

This decision results from a referral to the German Court, in relation to a German patent granted to Oliver Brüstle in 1999. This patent concerned the generation of brain cells derived from embryonic stem cells and their use for the treatment of neural disorders such as Parkinson's disease.

On the fundamental question of what is meant by the term 'human embryo' the CJEU concluded that any human ovum must, as soon as fertilised, be regarded as a 'human embryo' within the meaning and for the purposes of the application of Article 6(2)(c) of the Directive, if that fertilisation is such as to begin the process of development of a human being. On the more specific question as to whether an invention is unpatentable, even though its purpose is not the use of human embryos per se, but rather the use of a product whose production necessitates the prior destruction of human embryos or a process requiring a base material obtained by the destruction of human embryos. When considering this question, the Court noted the November 2008 decision of the European Patents Office Enlarged Board of Appeal that the patentability of products prepared exclusively by a method involving the destruction of human embryoswas to be rejected. The Court concluded that the Directive excludes an invention from patentability where the patent application requires the prior destruction of human embryos or their use as base material, even if the description of the claimed invention does not refer to the use of human embryos.

It now remains to be seen how the European Patents Office and the national courts will interpret the wording of the CJEU. Accordingly, it is not possible, at this stage, to indicate if the CJEU's decision will impact adversely on job creation in Ireland.

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