ECJ prohibits patents on Stem cells
In a landmark decision from 18 October, the European Court of Justice put an end to the patenting of stem cells. The Court has determined that any process that entails the destruction of embryos must be excluded from patenting. While supporters of the ruling welcomed a move that favours the comprehensive protection of human life, critics foresee a setback for the development of stem cell-based therapies.
With its decision to exclude embryonic stem cells from patenting, the Court follows the application from Advocate General Yves Bot from March 2011. The roots of the process date back to 1999, when Bonn-based neuropathologist Oliver Brüstle registered a patent for a process to extract nerve cells from human embryonic stem cells (hES cells). The intention was to use the technique to extract nerve cell lines, which would then serve in approaches to repair brain and spinal cord damage. The Patent Office in Munich did initially issue the patent, but in 2000 the environmental organisation Greenpeace lodged an objection against the issuance. A suit followed in 2004, and in 2006 the Federal Patent Court sided largely with Greenpeace. Brüstle lodged an appeal, and the case landed at the German Federal Supreme Court. Proceedings are still pending, although the judges have enquired at the European Court of Justice for the relevant EU standards.
At the ECJ, the issue of when an embryo can really be called an embryo played a crucial role. The Directive 98/44/EC is central for rulings on the protection of biotechnological inventions: “In addition, the use of human embryos for industrial or commercial purposes is also excluded from patentability.” Greenpeace is now arguing that the human ES cell lines originally derived from fertilised eggs, which therefore constitutes a prohibited use of human embryos, and thus a violation of public order. However, Brüstle has always emphasised that the patented process includes neither the use of embryos nor the extraction of hES cells, but is instead based on already established hES cell lines, which are internationally available and can be legally used for research in Germany.
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Every fertilised egg is an embryo
In its most recent ruling, the Court has chosen to accept a broadly defined concept of the human embryo: “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’.” In the view of the ECJ, this definition was the basis for legislating against patents that might involve interference with the respect for human dignity. The BGH process now continues following the ruling from the European Court of Justice. The Karlsruhe judges must now give a judgement that is line with the decision from Luxembourg.
There was a range of reactions in Germany to the verdict. “The ECJ has made it clear that economic interests do not stand above human life. This is an important point of orientation for the utilisation of scientific work,” said Federal Minister for Research Annette Schavan, who stressed that it had been correct to support research into adult stem cells, which are not affected by the judgment. No embryos are needed for so-called adult stem cells; instead, these cells are directly removed from the body. Mesenchymal stem cells, used for example for tissue regeneration, multiply very easily. In recent years, so-called induced pluripotent stem cells (iPS cells), which involve normal tissue cells being taken from the skin, for example, before being reprogrammed into stem cells in the laboratory, have moved into the spotlight for researchers. Many of the ethical problems of hES cells can be avoided with mesenchymal or iPS cells. “This verdict will drive investment into ethically acceptable alternatives,” expects MEP Peter Liese (CDU).
Embryonic stem cells the gold standard
It is nevertheless unlikely that the scientific community will mange entirely without hES cells. Before the publication of the judgment, a number of eminent scientists released a joint statement pleading for their continued use. Furthermore. it remains unclear whether iPS cells can in fact serve as an adequate substitute for embryonic stem cells. “The latter remains the most important benchmark for cell replacement therapies”, says stem cell expert Wolfgang Michael Franz from the University of Munich, and many experts agree. Many of the essential mechanisms of stem cell development are still poorly understood, and thus embryonic cells remain the yardstick for determining the true potential of future cell replacement therapies. Above all, many ongoing research projects that involve hES cells use them as a comparison. The stem cell register at the Robert Koch Institute provides an overview of all projects underway in Germany involving hES cells. (Click here to view the registry)
Stem cell researcher Brüstle on whose patent the ECJ has now decided was disappointed by the ruling. The decision would “in one sweep wipe out the fruits of years of transnational research by European scientists, and cede it to non-European countries.” European researchers will likely be able to continue with basic research, but medical procedures that emerge from this knowledge will implemented elsewhere, “and will ultimately be re-imported into Europe,” thinks Brüstle. In the opinion of most stem cell researchers in Europe, the judgment sends out the wrong message at a time when the first clinical trials for therapies based on hES cells are just underway.© biotechnologie.de/bk