Highest court in Europe limits stem cell patents

On 18 October 2011, the European Court of Justice (ECJ), ruled that stem cell processes which require the use and prior destruction of human embryos are contrary to morality and therefore cannot be patented [Brüstle v Greenpeace e.V (Case C-34/10)]. While the full implications of the ruling are not yet clear, it is expected to have an impact on stem cell research in Europe and on patent protection strategies for companies doing stem cell research.

The case concerned a German patent filed in 1997 by stem cell researcher, Dr Oliver Brüstle, covering isolated and purified neural precursor cells, processes for producing them from embryonic stem cells and the use of neural precursor cells for treatment of neural defects. Initially, Greenpeace succeeded in annulling the patent in a German court and, on appeal, the German federal court of justice asked the ECJ to consider whether the use of human embryos for industrial or commercial purposes was within the legal protection available to biotechnological inventions.

The ECJ found that any human ovum after fertilization, any non-fertilized human ovum into which the cell nucleus from a mature human cell has been transplanted, and any non-fertilized human ovum whose division and further development have been stimulated by parthenogenesis constitute a ‘human embryo’ and are consequently not patentable. The decision means that under EU law, stem cell processes requiring the use of human embryos are not, generally speaking, patentable.

The ECJ did not specifically rule that Dr Brüstle’s patent was invalid and left open the question of whether stem cells obtained from a human embryo at the blastocyst stage constitutes a ‘human embryo’. This was to be ascertained by the referring court in light of scientific developments.

The European Patent Office stopped granting patents to inventions involving human embryonic stem cells in 2006, although some national patent offices continued to grant them. It remains to be seen how national patent offices will interpret the ECJ decision.

Contact: If you have any specific enquiries about stem cell patents, please contact Debra Tulloch.