On Thursday 10 March 2011, Advocate General Bot delivered his opinion in relation to Case C-34/10, a reference to the European Union Court of Justice from the German Federal Court of Justice (Bundesgerichtshof) in Oliver Brüstle v Greenpeace eV.
Article 6(1) of European Directive 98/44 on the legal protection of biotechnological inventions ("Biotech Directive") states that "inventions shall not be considered patentable where their commercial exploitation would be contrary to ordre public or morality". Article 6(2)(c) goes on to state this includes "uses of human embryos for industrial or commercial purposes".
The questions referred to the Court of Justice were:
1. What is meant by the term “human embryos” in Article 6(2)(c) of Directive 98/44?
- Does it include all stages of the development of human life, beginning with the fertilisation of the ovum, or must further requirements, such as the attainment of a certain stage of development, be satisfied?
- Are the following organisms also included: unfertilised human ova into which a cell nucleus from a mature human cell has been transplanted; unfertilised human ova whose division and further development have been stimulated by parthenogenesis?
- Are stem cells obtained from human embryos at the blastocyst stage also included?
2. What is meant by the expression “uses of human embryos for industrial or commercial purposes”? Does it include any commercial exploitation within the meaning of Article 6(1) of [Directive 98/44], especially use for the purposes of scientific research?
3. Is technical teaching to be considered unpatentable pursuant to Article 6(2)(c) of the Directive even if the use of human embryos does not form part of the technical teaching claimed with the patent, but is a necessary precondition for the application of that teaching:
- because the patent concerns a product whose production necessitates the prior destruction of human embryos,
- or because the patent concerns a process for which such a product is needed as base material?
Brüstle held a German patent filed in 1997 covering isolated and purified neural precursor cells, processes for their production from embryonic stem cells (ESCs) and certain therapeutic uses of those precursor cells such as Parkinson's disease. Greenpeace brought an action in the German Federal Patents Court (Bundespatentgericht) to invalidate certain patent claims as far as they related to ESCs. Greenpeace was successful and Brüstle appealed to the German Federal Court of Justice which referred the questions to the Court of Justice.
Advocate General Bot gave a carefully considered opinion being well aware of the fact that no definition of "embryo" had been drafted on a EU-wide level previously and this definition was absent from the Biotech Directive. The national legislation of various EU countries gave no assistance either as there was no consensus across the jurisdictions. He considered that scientific definitions were not the same as the purely legal one sought to be defined for the current purposes. He also pointed out that an inability to patent is not the same as a prohibition on the ability to undertake research although the purposes are significantly intertwined (particularly, economically).
He answered the questions as follows:
1. The Biotech Directive is a harmonisation directive and therefore, it is essential that the meanings of the terms used in it are the same and interpreted similarly across Member States otherwise patentability would differ depending on national jurisdiction.
- The definition of "embryo" includes those first few totipotent cells (cells that can develop into an entire human being) formed following conception. It did not include pluripotent cells as although they were capable into developing into many forms of cells, they could not develop into an entire being.
- Bot also considered that every totipotent cell regardless of method of derivation would also fall within the definition of "embryo". Therefore, unfertilised human ova into which a cell nucleus from a mature human cell has been transplanted, and unfertilised human ova whose division and further development have been stimulated by parthenogenesis, were also "embryos".
- As blastocysts contained of an inner cell mass made up of totipotent cells, Bot considered that these too fell into the definition of "embryo".
2. “Uses of human embryos for industrial or commercial purposes" can include uses for the purposes of scientific research depending on scale. However, this becomes irrelevant if the use would still be considered against ordre public or morality. For this reason, although pluripotent cells are primarily not caught by the definition of "embryo", where the harvesting of pluripotent cells necessitates the destruction of an embryo, this process cannot be patentable.
3. Similarly, although the patent claims do not include the destruction of or reference an embryo, if the invention claimed necessitates the prior destruction of embryos in order to obtain a base material (totipotent or pluripotent cells), the invention is excluded from patentability.
This opinion is not unexpected and sits consistently with the scientific definition of "embryo". The UK allows research on embryos up to 14 days' old with a licence from the Human Fertilisation and Embryology Authority. However, how popular this research will be following this Opinion (assuming the Court of Justice concurs with it) will be another issue for the UK (and EU) medical research industry given it will be unlikely that the research will result in a patentable right. In addition, how far a patent examiner believes an invention in this field reaches back and relies upon ESCs even when not mentioned in the claims, will undoubtedly be a contentious point going forward.