Stem Cell Researchers in the European Union were struck by bad news on October 18, 2011, when the Court of Justice of the European Union released a judgement confirming the European Union’s generally strict approach to patent protection of embryonic stem cells.
The verdict, being legally binding for all EU member states, leaves scientists concerned for the future of stem cell research in Europe. In the reference for a preliminary ruling (case C34/10) regarding the interpretation of Article 6(2)(c) of Directive 98/44/EC on the legal protection of biotechnological inventions, the Court of Justice of the European Union has ruled that “the exclusion from patentability concerning the use of human embryos for industrial or commercial purposes in Article 6(2)(c) of the Directive also covers use for purposes of scientific research”.
Furthermore the Court has adopted a broad definition of the term “human embryo” leaving little room for researchers to avoid this provision. The reference to the Court of Justice of the European Union has been made in proceedings brought by Greenpeace e.V., who filed for annulment of German patent DE 19756864 concerning isolated and purified neural precursor cells produced from embryonic stem cells and used to treat neurological diseases, such as Parkinson’s disease.
The Bundespatentgericht (Federal Patent Court of Germany) ruled in favor of Greenpeace e.V., and decided that the patent was invalid. The patent holder filed appeal at the Bundesgerichtshof (Federal Court of Justice of Germany) that decided to refer questions of the interpretation of the relevant provision of Directive 98/44/EC, to the Court of Justice of the European Union.
Directive 98/44/EC on the legal protection of biotechnological inventions defines in Article 6(2)(c) that the use of human embryos for industrial or commercial purposes is considered contrary to ordre public or morality. The Court of Justice of the European Union ruled that:
- 1. The concept of the “human embryo” within the meaning of Article 6(2)(c) of the Directive must be understood in a wide sense including not only a fertilized ovum, but also a non-fertilized human ovum into which the cell nucleus from a mature human cell has been transplanted, as well as a non-fertilized human ovum whose division and further development have been stimulated by parthenogenesis, since they are both capable of commencing the process of development of a human being.
- 2. The exclusion from patentability concerning the use of human embryos for industrial or commercial purposes in Article 6(2)(c) of the Directive also covers use for purposes of scientific research, only use for therapeutic or diagnostic purpose which is applied to the human embryo and is useful to it being patentable.
- 3. Inventions are excluded from patentability if the technical teaching 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 is in line with decision G02/06 of the Enlarged Board of Appeal of the European Patent Office. The Court of Justice of the European Union refers the question of whether stem cells obtained from a human embryo in the blastocyst stage (about 5 days after fertilization) are included in the definition of “human embryo” back to the Bundesgerichtshof. It will now need to be ascertained whether these cells are already capable of developing into a human being or not, to decide whether or not they are excluded from patentability.
The verdict of the Court of Justice of the European Union does not only leave researchers in doubt of whether they will be able to successfully continue their stem cell research in Europe, but will consequently harm the future and development of medical sciences in Europe, giving major advantages to countries with less strict approaches. It is therefore questionable up to which point the European Union can maintain its strong view when facing the pressure of the international competition in this art.