Craig Humphris, Senior Associate
Senior Member, Adelaide Chemical and Biological team
In October 2011, the Court of Justice of the European Union in Brüstle v Greenpeace e.V (Case C 34/10) prohibited the issuing of patents for stem cells on the basis of ethical grounds. Whether the European Patent Office will adopt the the ruling remains to be seen however until that time European patent applicants should ensure that their specification includes an example of the use of stem cells which are not human embryonic stem cells.
In the matter before the Court, Mr. Oliver Brüstle owns a patent for isolated and purified neural precursor cells produced from human embryonic stem cells. The Federal Patent Court held that Mr. Brüstle's patent was invalid because it covers processes for obtaining precursor cells from human embryonic stem cells. On an appeal, the Court of Justice interpreted the concept of 'human embryo' because this expression is not defined in Directive 98/44/EC on the legal protection of biotechnological inventions.
Directive 98/44 establishes a foundation for the legal protection of biotechnological inventions. Article 6(2)(c) of the directive provides that the use of human embryos for industrial or commercial purposes are unpatentable. The Court of Justice of the European Union considered whether the exclusion from patentability of the human embryo covers all stages of life from fertilization of the ovum or whether a certain stage of development need be reached.
The Court held that inventions relating to pluripotent stem cells can be patentable if they are not obtained to the detriment of an embryo. The Court held that because the facts of the matter concerned the removal of cells from the human embryo at the blastocyst stage, which necessarily entail the destruction of the human embryo, the process is not patentable. Article 6(2)(c) is to be construed that a human embryo applies from the fertilization stage to the initial totipotent cells and to the process of the development and formation of the human body, which includes the blastocyst.
The use of human embryos for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it is patentable, but their use for purposes of scientific research is not patentable.