A process which involves removal of a stem cell from a human embryo at the blastocyst stage, entailing the destruction of that embryo, cannot be patented.
Last week the Court of Justice of the European Union issued a judgment in the case of Brüstle v Greenpeace e.V (Case C 34/10) in which it banned the issuing of patents for stem cells on ethical grounds. Mr. Oliver Brüstle is the holder of a patent for isolated and purified neural precursor cells produced from human embryonic stem cells used to treat neurological diseases.
The Federal Patent Court ruled that Mr. Brüstle’s patent was invalid in so far as it covers processes for obtaining precursor cells from human embryonic stem cells. On appeal, the Court of Justice (CJEU) was asked to interpret the concept of ‘human embryo’ which is not defined in Directive 98/44/EC on the legal protection of biotechnological inventions.
The purpose of Directive 98/44 is to establish a framework for the legal protection of biotechnological inventions. Article 6(1) provides that inventions must be considered unpatentable where their commercial exploitation would be contrary to ordre public or morality. Article 6(2)(c) of the directive cites the use of human embryos for industrial or commercial purposes as an example of inventions which are considered unpatentable.
The question is whether the exclusion from patentability of the human embryo covers all stages of life from fertilization of the ovum or whether other conditions must be met, for example that a certain stage of development be reached.
The case raised very interesting legal and ethical issues, in particular how the right to human dignity related to the dispute. Although a fundamental right under German constitutional law and jurisprudence, the right to human dignity has been recognized as an unwritten principle of EU law, and undoubtedly played a significant part in the outcome of this case.
The Court was asked “What is meant by the term “human embryos” in Article 6(2)(c) of Directive 98/44 ?” Directive 98/44 stipulates that patent law must be applied so as to respect the fundamental principles safeguarding the dignity and integrity of the person. The question then is what form, what stage of development of the human body, must be given the legal categorization of ‘embryo’.
The development from conception begins with a few totipotent cells, which each cell has the capacity to develop into a complete human being. The Court viewed totipotent cells as representing the first stage of the human body and must therefore be legally categorized as embryos.
The Court emphasized that whether that categorization must be recognized from before or only after implantation is irrelevant. This means that every totipotent cell, whatever the means by which it has been obtained, is an embryo and that any patentability must be excluded. This definition covers unfertilized ova into which a cell nucleus from a mature cell has been transplanted.
The Court felt that characterizing a totipotent cell as an embryo does not resolve the issue since an embryo quickly develops into a blastocyst made up of pluripotent cells, which can develop into all kinds of cells to form all the organs of the human body. These cells cannot develop separately into a complete human being. While the court felt that blastocysts as a whole must be categorized as an embryo, an individual pluripotent cells in isolation is not.
Most of the EU Member States take the view that pluripotent stem cells are not human embryos given that embryonic stem cells, taken in isolation, are no longer capable of developing into a complete individual. However, the Court said it is not possible to ignore the origin of this pluripotent cell. The pluripotent stem cell in the present case is removed from the blastocyst, which the removal will destroy. The argument is that patentability depends on the way in which it has been removed and the consequences of such removal .
In comparing the situation to prisoners killed in order to remove organs for trafficking, the Court reasoned that even though the claims under the patent did not specify that human embryos are used for the exploitation of the invention, when they actually are, the patentability of such an invention must be excluded.
While the Court agreed that inventions relating to pluripotent stem cells can be patentable if they are not obtained to the detriment of an embryo, the cells at issue are removed from the human embryo at the blastocyst stage and they necessarily entail the destruction of the human embryo. The Court held that Article 6(2)(c) must be interpreted that a human embryo applies from the fertilization stage to the initial totipotent cells and to the entire ensuing 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.
The Court interpreted Article 6(2)(c) of Directive 98/44/EC on the legal protection of biotechnological inventions as an invention must be excluded from patentability where the application of the technical process for which the patent is filed necessitates the prior destruction of human embryos or their use as base material, even if the description of that process does not contain any reference to the use of human embryos.
The exception to the non-patentability of uses of human embryos for industrial or commercial purposes concerns only inventions for therapeutic or diagnostic purposes that are applied to the human embryo and are useful to it.
The holding and reasons of the case means that inventions making use of deposited cell lines which had originally been obtained by destruction of an embryo within the broad meaning of an embryo are not patentable. This applies even if the origin of the cell line is not part of the claim in question.
If you read the ruling as saying that any invention based on human embryonic stem cells is unethical and therefore cannot be patented, then the ruling will have major implications for the commercialization of stem cell-based technologies in the EU, especially if it fosters the idea that stem cell research is inherently immoral.
It will take several years for the European Patent Office, national patent offices and various courts to take up the issue and interpret the decision. In one view, companies may end up relying on keeping manufacturing processes a trade secret instead of relying on patents since the European Medicines Agency keeps data submitted for regulatory approval private for eight years and blocks others from using this information for two additional years.
While the decision could spur development of therapies since it could free up ES cell research from patent infringement, it could still prove to be harmful since the far-reaching decision bans patents on any downstream products using cell lines that required the destruction of human embryos for violating respect for human dignity.
Read the judgment (in English) here.