We are hopeful that the non-binding opinion of the Advocate General in International Stem Cell Corporation v Comptroller General of Patents (the ISC case, C364/13) flags a more nuanced approach to the patentability of stem cell related inventions in Europe.
The case deals with a pair of patent applications filed in the UK and covering inventions relating to stem cells. The technology claimed involved stimulating unfertilised human egg cells into development (using a technique known as parthenogenesis) in order to produce pluripotent stem cells. ISC argued that their techniques should be patentable because what they were producing was not capable of full development into a human being.
The 2011 Brüstle decision of the European Courts took a strict view of the relevant law (the Biotechnology Directive, which prohibits patenting the use of human embryos for industrial or commercial purposes). In Brüstle, the court said that ‘any non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis constitute a ‘human embryo’’ . This seems to rule out patentability for ISC.
A European Patent Office appeal case decided in February this year (T 2221/10, Culturing stem cells/ TECHNION) took a similarly restrictive line. That decision concerned a patent that involved the use of human embryonic stem cells. The EPO appeal board said that destruction of human embryos would have been needed at some point in order to put the invention into effect, and so no patent should be allowed.
Europe’s strict approach can be contrasted with US patent laws, which have no specific restriction on stem cell related inventions. There, disputes tend to revolve around whether a patent is seeking to claim ‘products of nature’, and stem cell patents are more readily granted.
But in the ISC case the Advocate General has now said that the technique could be patentable; as current scientific knowledge stands, the stimulated human egg, or parthenote, can develop so far but no further. Unless the science moves on so that the parthenote can develop into a human being, the view of the Advocate General is that the technique does not come within the prohibition under the Biotechnology Directive. The Advocate General also emphasised the flexibility of individual EU states to determine what is and is not morally acceptable, with the list given in Article 6 of the Biotechnology Directive setting a minimum standard for what should be excluded from patentability.
The European court does not have to follow the Advocate General’s opinion; if it does we could end up with a much more flexible, but less certain, position. A more flexible approach to patentability of stem cell related inventions could prove a welcome development in the field of stem cell research, in particular in the advancing areas of cell therapy and regenerative medicine.