Should patents on the products of embryonic stem cell research be allowed? The European Court of Justice said no, but the question has remained unanswered in Germany - until now.
The German constitution, called the Basic Law, guarantees freedom of research. It also guarantees every human being the right to life. These two principles come into conflict when faced with the matter of human stem cell research. At least, they do if you take the view that life begins at conception rather than birth, because research is done using early-stage embryos, or more specifically the stem cells extracted from them. The embryos die during this process - though technology is being developed to prevent this.
The German parliament, the Bundestag, has introduced a law that places strict limits on this research. For instance, scientists can only use stem cell lines that were imported before May 1, 2007, a restriction meant to hinder the production of stem cells, and therefore the death of embryos, as a result of demand from Germany.
Some German scientists want to patent the results and developments they have invented through their stem cell research, and the Federal Court of Justice (BGH) pronounced a verdict on this legal question on Tuesday (27.11.2012). The court made clear that no patents may be issued on stem cell research if human embryos have been killed in the process. With that verdict, the court put itself in line with a ruling made by the European Court of Justice (ECJ) in 2011.
But the court did allow patents resulting from research on cell-lines taken from embryos which were no longer capable of further development or which were created using any other method in which embryos did not have to be destroyed. And it ruled that embryonic stem cells could not be considered to have the same rights as embryos.
As a result of those findings, it approved a patent application by the Bonn-based researcher Oliver Brüstle on a procedure by which so-called "neural precursor cells" could be extracted from stem cells.
Such a patent is mainly a financial issue. "The patent does not constitute permission to produce or sell, and it doesn't constitute permission to destroy embryos either," Tade Matthias Spranger, a lawyer specializing in bio-medical regulation, told Deutsche Welle. "The patent only bestows a single right - namely the inventor's right to deny commercial use to a third party."
European court's fundamental ruling
In 2004, the environmental organization Greenpeace successfully challenged Brüstle's original patent, lodged in 1999, at the federal patent court on the grounds of violation of moral principles. But Brüstle appealed, which brought the case before the BGH.
The BGH referred the case to the ECJ in Luxembourg, to clarify the European law's interpretation, since there is an EU directive on patent law for stem cell research. This directive states that no patents may be issued for inventions whose commercial use would violate moral principles. This is especially true of the use of human embryos for industrial or commercial purposes. In an October 2011 ruling, the ECJ made clear that any product of research into human stem cells cannot be patented if the embryos have to be killed for it.
Brüstle then submitted a subsidiary application for the use of cells taken from embryos which had ceased development. It's this application which has now been approved.
No disadvantage to science
But in contrast to the question of patentability, there is no uniformity in Europe on the general legal stance on stem cell research. Britain, Sweden, and Belgium have very liberal rules - the UK even allows the production of human embryos for research purposes, under certain conditions. But the laws are much stricter in Germany, Norway, and Italy.
This patchwork of different legal situations has arisen because the legislative power on stem cell research lies in the hands of nation states. The EU has generally kept out of the debate up until now, and the latest German ruling will not change that.
Ingrid Schneider, political scientist specializing in the patenting of biotechnology at the University of Hamburg, does not believe that science has been weakened by this verdict. "It doesn't limit the freedom to research," she said. In fact, there could even be benefits for science: "The researchers don't have to make sure they are not violating any patents - they have the freedom to carry out their research."
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