On October 18, 2011, the European Court of Justice (“ECJ”) held that the European Union’s Biotechnology Directive prohibits the patenting of a process which involves removal of a stem cell from a human embryo at the blastocyst stage, and requires the destruction of that embryo. Brüstle v Greenpeace e.V., Case C-34/10 (ECJ Oct. 18, 2011). The court’s decision was delivered in response to a reference by the Bundespatentgericht (Federal Patent Court of Germany) in a case in which the nongovernmental organization Greenpeace challenged a patent relating to isolated and purified neural precursor cells produced from human embryonic stem cells, which were used to treat neurological diseases.
Article 6(2)(c) of Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions (the “Biotechnology Directive”) provides in pertinent part that “uses of human embryos for industrial or commercial purposes” may not be patented. Although the Directive does not define the term “embryo,” the ECJ held that the term must be interpreted expansively in order to give full meaning to the prohibition of the Directive. As explained in the court’s press release, the court determined that,
[A]ny human ovum must, as soon as fertilised, be regarded as a ‘human embryo’ if that fertilisation is such as to commence the process of development of a human being. A non-fertilised human ovum into which the cell nucleus from a mature human cell has been transplanted and a non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis must also be classified as a ‘human embryo’. Although those organisms have not, strictly speaking, been the object of fertilisation, due to the effect of the technique used to obtain them they are capable of commencing the process of development of a human being just as an embryo created by fertilisation of an ovum can do so.
Turning to the specific process of obtaining neural precursor cells which was the subject of the patent in suit, the court found the process to be non-patentable because it necessarily involves the destruction of a human embryo. Here again, the synthesis from the court’s press release is helpful in describing the court’s holding:
[The patented process] presupposes that stem cells are obtained from a human embryo at the blastocyst stage and, secondly, that the removal of a stem cell entails the destruction of that embryo. Not to exclude from patentability such an invention claimed would allow a patent applicant to avoid the non-patentability by skilful drafting of the claim. In conclusion, the Court holds that an invention is excluded from patentability where the implementation of the process requires either the prior destruction of human embryos or their prior use as base material, even if, in the patent application, the description of that process, as in the present case, does not refer to the use of human embryos.
The court was careful to point out that a process whose aim is improving the health of a human embryo, such as by correcting a malformation and improving the chances of life, would not be subject to the prohibition on patenting. Similarly, EU member nations remain free to grant patents covering inventions relating to stem cells from non-embryonic sources–such as amniotic fluid, umbilical cord blood, and cells with induced pluripotency.