The biotechnology and pharmaceutical industries are business concerns. It is therefore understandable that the announcement made by the European Court of Justice on the 18 October 2011 would send shock waves through the these sectors. The Justices ruled that stem cells from human embryos cannot be patented. The feeling is summed up by the comment of Professor Pete Coffey of the Institute of London, a researcher of stem cell use.
"Devastating" is what he called the decision (BBC).
The decision reached by the court has a prior history. During 2004, Greenpeace challenged a patent grant issued in 1997. That patent, owned by Mr Oliver Bruestle, concerns the "isolated and purified neural precursor cells produced from human embryonic stem cells used to treat neurological diseases". The Patent court ruled the patent invalid, stating that Mr Bruestle’s patent required precursor cells from human embryo cells and was in contradiction of the European Patent Directive which explicitly excludes patents that commercialise the use of human embryos. Bruestle appealed and the matter was referred to the European Court of Justice to define the term ‘human embryo’.
The court ruled that it considers that any ovum, as soon as it is fertilised, must be regarded as an embryo. Importantly, it also states that a non-fertilised human ovum into which the cell nucleus from a mature human cell has been transplanted, and a non-fertilised ovum whose division has been stimulated by parthenogenesis, must also be classified as a ‘human embryo’. Hence Mr Bruestle’s patent fell foul of this and has been decreed invalid.
Greenpeace has reacted by issuing a statement which says that "By blocking the patenting and commercialisation of human embryos the European Court of Justice has today strengthened the protection of human life against commercial interest within the EU". Many church and human right groups have also expressed this sentiment. It must be noted that Greenpeace has stressed that it has no objection to the experiments per se – only the commercialisation thereof.
The scientific lobby appears to have a stronger argument in that it states that the ruling will impede European research into stem cell therapies and drive the research abroad – to North America and, more frequently recently, to Asia. The underlying argument lies with the fact that patents are important if pharmaceutical companies are to recoup their investment costs and eventually show a profit. There is also concern that the ruling will threaten the future of European medical research since large companies may now prefer to invest elsewhere, rather than risking losing their R&D investment.
It is curious that neither group has given indication of what would be of best benefit for prospective, and sometimes desperate, patients who are in urgent need of new therapies. Whatever the arguments, and much like the arguments following the release of the human genome code, the patent story is not going to go away for awhile.