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Path Opened for Landmark Stem Cells Test Case

The way has been opened for a landmark test case before the European Court of Justice which will determine the future course of human stem cell research. The court will consider whether artificially stimulated ova that are incapable of developing to term should nevertheless be classified as ‘human embryos’.

International Stem Cell Corporation (ISCC) applied to patent an innovative technique whereby ova are activated by a process of parthenogenesis in the absence of sperm. Such activated ova – known as parthenotes – whilst containing maternally derived chromosomes, cannot develop to term because of the absence of any paternal DNA and usually survive for only about five days.

The technique is viewed as a vital means of harvesting human stem cells for research purposes; however the application was refused on the basis that paragraph 3(d) of schedule A2 of the Patents Act 1977 specifically excluded from patentability ‘uses of human embryos for industrial and commercial purposes’.

ISCC challenged that refusal on the basis that, as parthenotes are ‘incapable of commencing the process of development of a human being’, they should not be viewed as human embryos. Whilst expressing a preliminary view in agreement with the company, the High Court ruled that the issue was not ‘acte clair’ and referred the matter to the European Court of Justice for determination.

The court emphasised that the purpose of Article 6(2)(c) of Directive 98/44/EC (the Biotech Directive) was to balance the medical value of stem cell research against the competing policy objective of safeguarding the dignity and integrity of the person. The court noted that stem cells have the potential to revolutionise the treatment of human conditions, including cancer, heart disease and spinal injuries.

As parthenotes are incapable of developing into human beings and are not the same as fertilised ova at any stage, the court expressed the preliminary view they should not be classified as human embryos and thus excluded from patent protection. To rule otherwise would discourage stem cell research and exclude its fruit from patent protection ‘to the detriment of European industry and public health’.

However, the court accepted arguments put forward by the Comptroller General of Patents that the issue of whether parthenotes are embraced within the definition of ‘human embryo’ is not clear cut and that a reference to the ECJ was therefore required.