In the EU, stem cells unpatentable if an embryo is destroyed
In late October, the Court of Justice of the European Union (CJEU) issued a judgment in the case of Brüstle v. Greenpeace, banning the issuance of patents for stem cells on ethical grounds.
Oliver Brüstle is the patent holder for isolated and purified neural precursor cells produced from human embryonic stem cells (hESCs) used to treat neurological diseases.
The Federal Patent Court ruled that Brüstle’s patent was invalid, as it covers processes for obtaining precursor cells from hESCs. On appeal, the 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 public order or morality.
The court was asked, “What is meant by the term ‘human embryos” in Article 6(2)(c) of Directive 98/44 ?” Article 6.2.c. cites the use of human embryos for industrial or commercial purposes as an example of inventions that 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 development from conception begins with a few totipotent cells. 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 ruled they must therefore be legally categorized as embryos.
The court emphasized that whether this 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 ruled that characterizing a totipotent cell as an embryo does not resolve the issue, as an embryo quickly develops into a blastocyst made up of pluripotent cells that 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 found that blastocysts as a whole must be categorized as an embryo, it said individual pluripotent cells in isolation are not.
Most of the EU member states take the view that pluripotent stem cells are not human embryos given that hESCs, 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 court interpreted Article 6.2.c. of Directive 98/44/EC on the legal protection of biotechnological inventions as an invention that 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. If you read the ruling as saying that any invention based on hESCs 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—because it could free up hESC research from patent infringement—it could still prove to be harmful, as 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.