The Advocate General has published an opinion concerning the interpretation of certain terms contained in Directive 98/44/EC, the "Biotech Directive". In particular the opinion focussed on interpretation of the term "human embryo". The AG considered that totipotent cells, those which have the capacity to evolve into complete human beings, as well as cells at the blastocyst stage of development, must be classified as human embryos and are therefore not patentable. In addition, procedures using pluripotent embryonic stem cells that necessitate destruction or modification of an embryo would not be patentable.
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The Advocate General has published an opinion concerning the
interpretation of certain terms contained in Directive 98/44/EC,
the "Biotech Directive". In particular the opinion
focussed on interpretation of the term "human embryo".
The AG considered that totipotent cells, those which have the
capacity to evolve into complete human beings, as well as cells at
the blastocyst stage of development, must be classified as human
embryos and are therefore not patentable. In addition, procedures
using pluripotent embryonic stem cells that necessitate destruction
or modification of an embryo would not be patentable.
The AG considered that the principle of 'human dignity'
within the Directive should be applied from fertilisation.
Therefore, the definition of 'human embryo' must include
totipotent cells and the blastocyst stage of development (about 5
days post fertilisation). Conversely, pluripotent embryonic stem
cells which, taken in isolation, are individually not capable of
developing into complete human beings, are not 'human
embryos'. Therefore, processes using such cells are patentable,
provided they are not obtained to the detriment of an embryo. The
AG further considered that it does not make a difference whether
the description in the patent contains references to the use of
human embryos. If the application of the technical process
necessitates prior destruction of human embryos or their use as a
base material, it is against public policy, and any such invention
is not patentable.
The AG noted, however, that the use of human embryos is not
prohibited where it concerns inventions for therapeutic/diagnostic
purposes which are applied to the human embryo and are useful to
it.
This opinion is important as it is the first time the Court of
Justice has been called upon to consider the interpretation of
these terms. The ruling of the Court of Justice of the European
Union will be given at a later date.
Click here to read the CJEU judgment (C34/10)
in full.
Click here to read the Curia Press Release
This article was written for Law-Now, CMS Cameron McKenna's free online information service. To register for Law-Now, please go to www.law-now.com/law-now/mondaq
Law-Now information is for general purposes and guidance only. The information and opinions expressed in all Law-Now articles are not necessarily comprehensive and do not purport to give professional or legal advice. All Law-Now information relates to circumstances prevailing at the date of its original publication and may not have been updated to reflect subsequent developments.
The original publication date for this article was 21/03/2011.
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