Patentability of stem cells
Following on from the European Patent Office’s Enlarged Board of Appeal decision in
G2/06 to revoke a patent for a method of obtaining embryonic stem cell cultures, which
necessarily involved the destruction of a human embryo, the question of patenting stem
cell technology has again been raised.
In this regard, the German Patent Court has now referred questions to the European Court
of Justice (ECJ) regarding the correct interpretation of Article 6 of Directive 98/44/EC on
the legal protection of biotechnological inventions. This Directive indicates subject matter
that shall be considered unpatentable, including the use of human embryos for industrial
or commercial purposes.
Greenpeace had brought a case to revoke Brüstle's German patent covering the use of
certain cells for the treatment of neural deficiencies, such as Parkinson’s disease or
multiple sclerosis. Greenpeace argued that a human embryo had been killed to harvest
the cells, because originally the stem cells were derived from blastocysts and human life
starts with the fusion of sperm and ovum, meaning blastocysts are embryos in the sense
of the law.
The patentee asserted that in the UK, France, Spain, Sweden and Denmark the term "embryo" refers to fertilized eggs 14 days after fertilization, whereas the patent claims the use of stem cell lines harvested from blastocysts 4 to 5 days after fertilization. Therefore the patent only utilises products that are not correctly viewed as embryos.
Following the referral, the ECJ will now have to rule on what is meant by "human embryo"
in the context of EU law. Further, if the blastocysts used are viewed as human embryos,
the ECJ will then need to decide whether the therapeutic applications covered by the
patent are correctly viewed as commercial or industrial purposes. It is to be hoped that
the ECJ will provide more general guidance on patentability in this field, as compared to
the EPO decision that was clearly limited to addressing the specific facts of the case.
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