Ruling on stem cell research: ecj strengthens biotechnology company

Is an unfertilized human egg an embryo or just a clump of cells? This was the question addressed by the European Court of Justice in a lawsuit brought by a US company.

Supposed to be able to cure serious diseases one day: muscle cells derived from stem cells. Picture: reuters

An organism that cannot develop into a human being is not a human embryo under EU law. That was the ruling of the Court of Justice of the European Union on Thursday in a ruling on the patentability of biotechnological inventions. A company specializing in the development of new therapies for serious diseases such as Parkinson’s can thus, at least in theory, protect a new technology for the production of stem cells.

However, Advocate General Cruz Villalón pointed out in his opinion that the EU-wide exclusion of human embryos from patentability is only a minimum prohibition. Member states are allowed to extend the patent ban to other organisms for ethical or moral considerations.

The background to the decision was a lawsuit filed by International Stem Cell Corporation. The U.S. biotechnology company had applied to the relevant British authorities for two national patents for a technology used to produce pluripotent stem cells from parthenogenetically activated oocytes. The authorities rejected both applications on the grounds that the inventions in question involved the use and even the destruction of human embryos and were therefore not patentable under an EU ruling.

International Stem Cell then took the matter to the English High Court of Justice, which in turn turned to the European Court of Justice. In the proceedings, the company argued that the valid patent restrictions did not apply to its technology because the activated egg cell was incapable of developing into a human being without paternal DNA.

The British court therefore wanted the EU to clarify whether unfertilized human oocytes that have been stimulated to develop further via so-called parthenogenesis are to be regarded as human embryos. Such oocytes are not capable of developing into a human being.

Parthenogenesis is the term used to describe a procedure for the artificial creation of embryos that does not involve the fusion of male and female genetic material. The embryo develops from an unfertilized egg cell, and the entire genetic material is of female origin. In nature, so-called virgin generation occurs in some insect and reptile species, but not in mammals.

The International Stem Cell Corporation has developed a technology to produce so-called pluripotent stem cells from parthenogenetically activated oocytes. Pluripotent are cells that can differentiate into any cell type of an organism, but cannot form an entire organism. Pluripotent stem cells are thought to help cure serious diseases such as Alzheimer’s or Parkinson’s as well as repair tissue and organ damage.

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