Embryo stem cell research in doubt after European ruling

The ruling yesterday by the European Court of Justice that stem cells derived from human embryos cannot be patented on the surface has potentially dramatic implications for the level of investment required to develop viable therapeutic agents from this fledgling field. The logical argument goes that without the comfort of patent protection, European scientists and investors will shy away from what is already a very high-risk area of research.

Yet the issue of patent protection, coupled with the emotive and moral complications inherent in using embryo-derived stem cells, has already limited the development of this technology – just one agent has entered phase I trials so far. Conversely, research into the use of adult stem cells, which is unaffected by this ruling, has far outstripped embryonic stem cells and is now seen as offering a greater chance of clinical, regulatory and commercial success (Behind disappointment stem cell therapy showing pluripotential, October 12, 2010).

Bad day for innovation?

The European ruling in the case, which was referred by Germany's federal court, does not prevent scientists from experimenting with stem cells extracted from embryos that lead to the death of the embryo, but it removes one of the key commercial incentives for developing this technology in Europe.

“Without the comfort from patent protection it becomes very difficult to invest in research, which we expect will now dry up to a significant degree,” says Gordon Wright, partner at the patent attorney firm Elkington and Fife.

Mr Wright believes that basic and early stage research will continue, but mostly funded by government agencies. The key problem will arise when interesting research cannot be transferred into a new company or venture as investors, already shying away from high-risk technologies, will struggle to see how they can generate a return in the absence of core patent protection.

Wriggle room?

In terms of where research goes from here, Mr Wright highlights a few areas where there might be ‘wriggle room’ for scientists to still obtain viable patents – national courts have differing views on what is considered to be an embryo which may not follow the European court ruling; countries outside the European Union like Switzerland are not bound by this decision (although they are likely to adopt the European stance); some countries, like the UK, have laws on embryo research which are based on a scientific viewpoint and not bound by morality arguments, which is essentially the basis for the European verdict.

Overall, however, Mr Wright still views the ruling as ‘pretty definitive’ and suggests there is little way back from this, at least in terms of patent protection for this technology. Even if new agents in the US for example start to generate some really exciting clinical data to provide ammunition for European biotech companies to attempt to challenge the European ruling once more, Mr Wright believes that it is unlikely restrospective patents will be granted and years of valuable research time will have been lost.

In the absence of patent protection, one potential commercial incentive which could make up for it would be the regulatory data exclusivity period in Europe, which allows eight years before a generic version of a drug can be filed and normally a further two years before that generic is approved. Mr Wright suggests it is possible that the European Medicines Agency will look at this issue and ways that it might try to incentivise research in this field through this mechanism.

Adults to the fore

So far the US does support the issuing of patents for embryonic stem cells, but research in this field has been struggling from similar ethical and political issues. It only recently received a boost in 2009 when President Barack Obama overturned a long-standing ban on federal funding for stem cell research. (Democrat victory expected to boost stem cell research, November 4, 2008).

A year ago Geron started the first clinical trial of a human embryonic stem cell-based therapy, GRNOPC1, in ten patients with spinal cord injury.

Another US company in the field, Advanced Cell Technology, issued a statement yesterday suggesting that the European ruling will not affect its technology, which does not destroy the embryo in the process of extracting the stem cells. Shares in both companies appear unaffected so far by this ruling.

Yet the majority of research in the area is currently focused on adult stem cells - a number of candidates are already in phase II and I trials, such as those being developed by StemCells, a company researching human adult neural stem cells. So while the European ruling is likely to seriously curtail research efforts in one branch of stem cell research, it is not the damaging blow it initially appears.

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