Food for Thought: Europe Will have to Buy Stem Cell Therapies in the US, Asia

The European Court of Justice today ruled that biological procedures cannot be patented if they are based on the prior destruction of human embryos, with “human embryo” defined in the broadest possible sense.

Background of the ruling is a patent filed by German stem cell researcher Oliver Bruestle in 1997. The patent covers isolated and purified neural precursor cells produced from human embryonic stem cells and used for the treatment of neurological diseases. The cells are already being used clinically for the treatment of patients suffering from Parkinson`s disease.

Greenpeace filed an opposition to the patent and after the Federal Patent Court, Germany, ruled that the patent was invalid in so far as it covers processes for obtaining precursor cells from human embryonic stem cells, Bruestle appealed to the Federal Court of Justice, Germany, which referred the case to the European Court of Justice, saying the concept of ‘human embryo’ was not defined in EU Directive 98/44/EC on the legal protection of biotechnological inventions. The question was whether the exclusion from patentability of the human embryo covers all stages of life from fertilization of the egg or whether other conditions must be met, for example that a certain stage of development is reached.

Today, the European Court of Justice stated that its decision was not about ethical or moral questions, but solely on the legal interpretation of the EU Directive, adding that the Directive defines “human embryo” in the widest possible sense, i.e. every human egg able to divide must be classified as a “human embryo”.  This even comprises enucleated eggs, into which the cell nucleus of a human body cell has been transplanted, as well as non-fertilized human eggs, in which cell division and further development have been stimulated without fertilization, e.g. by parthenogenesis. Taking the definition even further, it adds that all inventions that are based on the prior destruction of human embryos or their prior use as base material are excluded from patentability.

Greenpeace hailed the decision as a “landmark case”, stating the ruling was protecting humans from being commercially exploited. The press release was illustrated by the picture of a baby carrying a “patent clip” in its earlobes.

Oliver Bruestle, who was placed under police protection together with his family when the campaign against his patent application was started, commented that fundamental research on human embryonic stem cells can still take place in Europe – however, it means that “others will pick the fruits in the U.S. and in Asia.”

The ruling is the result of the EU’s Directive, which was adopted in 1998 after a decade of debates and compromises between the EU member states, the EU parliament and the EU Commission.