In late October, the Court of Justice of the European Union(CJEU) issued a judgment in the case of Brüstlev. Greenpeace, banning the issuance of patents for stem cells on ethicalgrounds.
Oliver Brüstle is the patent holder for isolated andpurified neural precursor cells produced from human embryonic stem cells(hESCs) used to treat neurological diseases.
The Federal Patent Court ruled that Brüstle's patent wasinvalid, as it covers processes for obtaining precursor cells from hESCs. Onappeal, the CJEU was asked to interpret the concept of "human embryo," which isnot defined in Directive 98/44/EC on the legal protection of biotechnologicalinventions.
The purpose of Directive 98/44 is to establish a frameworkfor the legal protection of biotechnological inventions. Article 6.1 providesthat inventions must be considered unpatentable where their commercialexploitation would be contrary to public order or morality.
The court was asked, "What is meant by the term 'humanembryos" in Article 6(2)(c) of Directive 98/44 ?" Article 6.2.c. cites the useof human embryos for industrial or commercial purposes as an example ofinventions that are considered unpatentable.
The question is whether the exclusion from patentability ofthe human embryo covers all stages of life from fertilization of the ovum, orwhether other conditions must be met—for example, that a certain stage ofdevelopment be reached.
The case raised very interesting legal and ethical issues,in particular how the right to human dignity related to the dispute. Although afundamental right under German constitutional law and jurisprudence, the rightto human dignity has been recognized as an unwritten principle of EU law, andundoubtedly played a significant part in the outcome of this case.
The development from conception begins with a few totipotentcells. Each cell has the capacity to develop into a complete human being. Thecourt viewed totipotent cells as representing the first stage of the humanbody, and ruled they must therefore be legally categorized as embryos.
The court emphasized that whether this categorization mustbe recognized from before or only after implantation is irrelevant. This meansthat every totipotent cell, whatever the means by which it has been obtained,is an embryo, and that any patentability must be excluded. This definitioncovers unfertilized ova into which a cell nucleus from a mature cell has beentransplanted.
The court ruled that characterizing a totipotent cell as anembryo does not resolve the issue, as an embryo quickly develops into ablastocyst made up of pluripotent cells that can develop into all kinds ofcells to form all the organs of the human body. These cells cannot developseparately into a complete human being. While the court found that blastocystsas a whole must be categorized as an embryo, it said individual pluripotentcells in isolation are not.
Most of the EU member states take the view that pluripotentstem cells are not human embryos given that hESCs, taken in isolation, are nolonger capable of developing into a complete individual. However, the courtsaid it is not possible to ignore the origin of this pluripotent cell. Thecourt interpreted Article 6.2.c. of Directive 98/44/EC on the legal protectionof biotechnological inventions as an invention that must be excluded frompatentability where the application of the technical process for which thepatent is filed necessitates the prior destruction of human embryos or theiruse as base material, even if the description of that process does not containany reference to the use of human embryos.
The exception to the non-patentability of uses of humanembryos for industrial or commercial purposes concerns only inventions fortherapeutic or diagnostic purposes that are applied to the human embryo and areuseful to it. If you read the ruling as saying that any invention based onhESCs is unethical and therefore cannot be patented, then the ruling will havemajor implications for the commercialization of stem cell-based technologies inthe EU, especially if it fosters the idea that stem cell research is inherentlyimmoral.
It will take several years for the European Patent Office,national patent offices and various courts to take up the issue and interpretthe decision. In one view, companies may end up relying on keepingmanufacturing processes a trade secret instead of relying on patents since theEuropean Medicines Agency keeps data submitted for regulatory approval privatefor eight years and blocks others from using this information for twoadditional years.
While the decision could spur development oftherapies—because it could free up hESC research from patent infringement—itcould still prove to be harmful, as the far-reaching decision bans patents onany downstream products using cell lines that required the destruction of humanembryos for violating respect for human dignity.