On 18 October 2011 the Court of Justice of the European Union ("CJEU") handed down a much anticipated judgment in Oliver Brüstle v Greenpeace e.V. on the patentability of inventions relating to stem cells.
The Court held that the Biotechnology Directive (98/44/EC) ("the Biotech Directive") excludes from patentability inventions in which the technical teaching requires the destruction of human embryos, whatever the stage at which that destruction takes place and even if the patent does not refer to the use of human embryos. The effect of this decision is that:
- "Human embryo" is to be interpreted widely to include a human ovum, as soon as it is fertilised, and non-fertilised cells capable of developing into a human being.
- Patents previously granted in EU Member states, requiring the use of neutral precursor cells obtained from cell banks, may be invalid.
- It remains to be seen if this decision has an impact upon investment and research in the EU.
Greenpeace brought proceedings against Oliver Brüstle, a German professor, to revoke his patent which was concerned with the use of embryonic stem cells to develop treatments for neurological disorders, such as the treatment of Parkinson's.
In arguing that stem cell inventions should not be patentable, Greenpeace relied upon the TRIPS Agreement and the European Patent Convention, which permit Member States to exclude from patentability inventions where it is necessary to do so to protect ordre public or morality; and Article 6(2)(c) of the Biotech Directive which denies patentability to inventions that use human embryos for industrial or commercial purposes.
The reference to the CJEU
The German Federal Patent Court ruled that the patent was invalid, in so far as it covered precursor cells obtained from human embryonic stem cells and the process for production of those precursor cells. The Federal Court of Justice, on appeal, referred a number of questions to the CJEU:
- What is meant by the term "human embryos" in Article 6(2) of the Biotech Directive?
- What is meant by "uses of human embryos for industrial or commercial purposes". Can use in research be patentable?
- Is a technical teaching unpatentable if the use of human embryos is a necessary precondition of the teaching, even though that use does not form part of the technical teaching?
The meaning of "human embryo"
In considering the meaning of "human embryo", the Court referred to the emphasis in the preamble to the Biotech Directive, that patent law must be applied so as to respect the fundamental principles safeguarding the dignity and integrity of persons. They also referred to the earlier decision in Netherlands v Parliament and Counsel (C-377/98), that the human body in various stages of formation and development cannot constitute a patentable invention, as well as the list in Article 6 of the Directive of actions that are contrary to ordre public or morality.
The Court concluded that the aim of the Biotech Directive is to exclude any possibility of patentability where respect for human dignity could be affected. Accordingly, the concept of "human embryo" must be interpreted widely.
It followed, the Court said, that a human ovum, as soon as it is fertilised, must be regarded as a "human embryo". Also included are non-fertilised cells capable of developing into a human being. These include non-fertilised ovum into which the nucleus from a mature human cell has been transplanted, and non-fertilised cells whose development has been stimulated by parthogenesis.
The Court left it for the national courts to ascertain, on the scientific evidence before them, whether a stem cell taken from a blastocyte is capable of being a "human embryo" and it will be interesting to see how the German court interprets this point when this case returns to them in due course.
Use for industrial or commercial purposes
The Court emphasised that the purpose of the Biotech Directive is only to limit the patentability of biotechnological inventions, it does not regulate the use of human embryos in scientific research.
However, they said that scientific research cannot be differentiated from acts of an industrial or commercial nature and so cannot benefit from patent protection.
Prior destruction of human embryos
Finally, the Court was asked whether an invention is unpatentable even though it does not teach the use of human embryos, but where it concerns a product or base material that requires prior destruction of an embryo.
Following the Enlarged Board of Appeal of the EPO's decision in WARF (G 02/06), inventions using neutral precursor cells obtained from a cell bank had been thought to be patentable. Cells in a cell bank are initially obtained from a human embryo, and the cell line is then maintained and made available to third parties. However, the Court held that an invention is unpatentable where the teaching requires the destruction of human embryos, whatever the stage at which that destruction takes place and even if the description does not refer to the use of human embryos.