Stem cell patents: how to define an embryo

19 June 2013

UK legal experts are querying the 2011 Court of Justice of the European Union (CJEU)ruling that the products of research using stem cells derived from human embryos are not patentable (see previous news).
The UK High Court has itself requested clarification from the CJEU in Luxembourg; deputy judge Henry Carr QC believes their definition of a human embryo was too broad, including embryos incapable of developing into a fetus such as parthenotes, activated but unfertilised egg cells that can be used for the production of human stem cell lines. He argues that excluding technologies derived from such embryos fails to strike the balance indicated with the Biotech Directive, saying: “It is more akin to a total exclusion from patent protection of the fruits of stem cell research, to the detriment of European industry and public health”.
A stem cell company is also mounting a legal challenge to the 2011 CJEU ruling; International Stem Cell Corporation argues that human parthenotes are not actually capable of commencing the process of development of a human being and should be excluded from the scope of the decision. The company’s own intellectual property relates to pluripotent stem cells derived from parthenotes. However, parthenotes are also defined as human embryos by the National Institutes of Health (NIH) and federal laws in the US, so that new parthenogenetic stem cell lines are ineligible for federal funding.
Medical researchers in the field are reportedly angry that the ban on patents for products and technologies developed from research involving the destruction of human embryos is, as feared, acting as a disincentive to investment in Europe, especially when Asia remains an attractive market for stem cell research and development.

Meanwhile, the European Patent Office (EPO) recently revoked the European version of the original ‘Brüstle’ patent on a method for creating nerve cells from embryonic stem cells patent at the heart of the 2011 ruling, although the German version was allowed to stand by the German Federal Court of Justice provided it excluded any destruction of human embryos. 

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