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Organisms obtained by mutagenesis : Decision of the Court of Justice of the European Union (25 July 2018)

20 August 2018

The Court of Justice of the European Union in its ruling of July 25, 2018 (C-528/16) took the view that organisms obtained by mutagenesis are Genetically Modified Organisms (GMOs, within the meaning of Article 2(2) of Directive 2001/18/EC). Thus, organisms obtained by recent mutagenesis methods such as the CRISP Cas9 technique will need to get through the lengthy approval process of European Union.

Many breeders and scientists have hoped that this technology would be considered outside the scope of the Directive like irradiation techniques because it does not introduce foreign material into the organism.

It should be reminder that GMOs obtained by means of mutagenesis techniques that have conventionally been used for various applications and have a long safety record are excluded from the scope of the said Directive (Article 3(1) together with Annex I B point 1 and recital 17). They are also not subject to the obligations of Directive 2002/53/EC (Article 4(4)) governing the inclusion in the ‘common catalogue of varieties of agricultural plant species the seed of which may be marketed’.

GMOs not being excluded from the scope of patentability under the European Patent Convention, this ECJ ruling does not impede the possibility to protect this kind of invention by a patent.

We will be pleased to provide you with more information on this decision and assist you in the protection of your innovations in that area.

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