In a landmark decision, the European Union (EU) Court of Justice has determined that EU patent law does not protect neural precursor cells and the processes for their production from embryonic stem cells. Brüstle v. Greenpeace e.V., Case C-34/10 ECJ (October 18, 2011).
More particularly, the court ruled that “any human ovum after fertilisation, and non-fertilised human ovum into which the cell nucleus from a mature human cell has been transplanted, and any non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis constitute a ‘human embryo,’” and that “it is for the referring court to ascertain, in the light of scientific developments, whether a stem cell obtained from a human embryo at the blastocyst stage constitutes a ‘human embryo’ within the meaning of Article 6(2)(c) of Directive 98/44 [the EP law which bars patents on inventions “where their commercial exploitation would be contrary to ordre public or morality.”]. The court also determined that the use of human embryos for scientific research is covered by the “exclusion from patentability concerning the use of human embryos for industrial or commercial purposes” under Directive 98/44. Uses of human embryos “for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it” are, however, patentable, according to the court. The court further stated, “Article 6(2)(c) of Directive 98/44 excludes an invention from patentability where the technical teaching which is the subject-matter of the patent application requires the prior destruction of human embryos or their use as base material, whatever the stage at which that takes place and even if the description of the technical teaching claimed does not refer to the use of human embryos.”
This ruling extends to embryonic stem lines which were established in the laboratory many years ago and where the invention itself does not involve obtaining new embryonic stem cells. This decision is based on the argument that even established embryonic stem cell lines were originally derived from fertilized eggs. At present, many European countries allow embryonic stem cells to be obtained from the large numbers of surplus embryos produced during fertility treatment. Several hundred such cell lines are now available to researchers worldwide. The cells, once obtained, can be grown and multiplied in the lab to give ‘cell lines’ that are able to produce an almost infinite number of embryonic stem cells and can be converted into all the different cell types of the body. This gives embryonic stem cells enormous potential for medical research and cell therapies for a range of conditions, including, e.g., Parkinson’s Disease and Alzheimer’s Disease.
Scientists are concerned that the verdict, which is legally binding for all EU states, will drive development of stem cell therapies outside Europe. However, there still exist other territories, such as the US, where no such ban exists. Earlier this year, the US Supreme Court upheld President Obama’s overturning of the Bush administration’s ban on federal funding for stem cell research, making the US market more attractive than it has been previously.
The underlying case will now return to the referring German court, which will rule on whether the invention counts as the commercial or industrial exploitation of a human embryo. It is considered likely that the patent will be found to do so and will be invalidated.
