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4 August 2014 0 Comments
Posted in Opinion

Advocate General’s Opinion on Human Embryos – Light at the end of the tunnel?

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Advocate General Pedro Cruz Villalón has issued his opinion in case C-364/13 International Stem Cell Corporation (ISC) on the interpretation of Article 6(2)(c) of the Biotechnology Directive which provides that the uses of human embryos for industrial and commercial purposes cannot be patented.

ISC had applied for two national UK patents claiming methods of producing pluripotent human stem cell lines from unfertilised human ova activated by parthenogenesis. The UK Intellectual Property Office, however, held that the inventions concerned the uses of human embryos as defined by the CJEU in the Brüstle case, i.e. organisms “capable of commencing the process of development of a human being” and were therefore excluded from patentability under Article 6(2)(c) of Directive 98/44 as implemented into English law. The applications were consequently refused.

ISC appealed the decision to the High Court who in turn asked the CJEU to comment on whether “unfertilised human ova whose division and further development have been stimulated by parthenogenesis, and which, in contrast to fertilised ova contain only pluripotent cells and are incapable of developing into human beings, [are] included in the term “human embryos” in Article 6(2)(c) of Directive 98/44 on the Legal Protection of Biotechnological Inventions?”.

The referring court itself was clearly of the view that parthenogenetically-activated ova, incapable of developing into a human being, should not be regarded as human embryos and that the patents should therefore not have been disallowed.

The Attorney General agreed and concluded that such unfertilised human ova are not included in the term “human embryos” in Article 6(2)(c) as long as they are not capable of developing into a human being and have not been genetically manipulated to acquire such capacity.

There is obviously no guarantee that the CJEU will reach the same conclusion but the biopharmaceutical industry will undoubtedly see the opinion of the Attorney General as a welcome step away from the decision in the Brüstle case.

The opinion is available at this link.

For more information, please contact Thomas Bjorn

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