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European Court Rules on Patentability of Stem Cells

February 28, 2012

The EU’s top court has decided that, for the purposes of patent law at least, human life begins at fertilisation.

The European Court of Justice made its ruling in a reference from a German court on the interpretation of the EU Biotechnology Directive. The reference was made in proceedings brought by Greenpeace seeking the annulment in Germany of a patent held by Professor Dr Brüstle, a director of the Institute for Reconstructive Neurobiology at Bonn University. Dr Brüstle’s patent related to neural precursor cells, the production of such cells from embryonic stem cells, and the use of such cells for the treatment of neurological conditions. Greenpeace grounded its case for annulment of the patent on the Biotechnology Directive which excludes from patentability “the uses of human embryos for industrial or commercial purposes”. 

The European Court was asked to interpret the concept of the “human embryo” for the purpose of ascertaining the scope of the prohibition on patentability. Focusing on the commencement of the process of development of a human being, it held that the concept includes: (i) a human ovum after fertilisation; (ii) a non-fertilised human ovum into which the nucleus from a mature human cell has been transplanted (i.e., a clone); and (iii) a non-fertilised human ovum the division and development of which has been stimulated by artificial means. The Court noted that while the latter two types of organism have not, strictly speaking, been the object of fertilisation, they are nevertheless capable of commencing the process of development of a human being.

Dr Brüstle’s patent concerned stem cells obtained from a human embryo at the blastocyst stage (i.e., the stage the embryo reaches five days after fertilisation). The European Court left it to the German Court to decide whether such cells are capable of commencing the process of development of a human being and so fall within the concept of a “human embryo” for the purposes of the Directive.

Moreover, the European Court held that the use of human embryos for scientific research falls within the prohibition on the patentability of embryos used for industrial or commercial purposes. The grant of a patent, it stated, implies its industrial or commercial application. The only exception to the prohibition on patentability is the use of the embryo for therapeutic or diagnostic purposes which benefit the embryo itself.

Finally, the Court concluded that an invention cannot be patented where the implementation of the invention requires either the prior destruction of human embryos or their use as base material, even if the application for the patent does not mention the use of embryos. The fact that the destruction of the embryos may have occurred at a stage long before the implementation of the invention is irrelevant.

The decision has been welcomed by those opposed to stem cell research. However, others have expressed concern about the potential adverse effect it may have on medical and scientific research in the EU. Investors may decide to invest in a jurisdiction where there are fewer, or less stringent, restrictions on the patenting of stem cells, such as America or Asia. Researchers may decide to base themselves in a jurisdiction where they can capitalise on their research by patenting it. While stem cell treatments can still be developed in the EU outside the patent system on a non-commercial basis, the attraction to investors and researchers of a jurisdiction offering patent protection cannot be underestimated.

Contributed by John Magee and Carol Plunkett