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21 July 2014Biotechnology

CJEU opinion on embryos builds on Brüstle decision

The Attorney General (AG) for the Court of Justice of the European Union (CJEU), Pedro Cruz Villalón, has issued an opinion on the meaning of the term ‘human embryos’ that could "significantly restrict" the scope of the Brüstle decision of 2011.

The English High Court referred the case to the CJEU after the UK Intellectual Property Office (UKIPO) refused a patent application by International Stem Cell Corporation.

The UKIPO rejected the application as the invention disclosed constituted the use of human embryos.

Human embryos are a source of stem cells, which can be used to create human organs and tissues. The use of human embryos for industrial purposes is not patentable under the European Patent Convention for ethics reasons.

International Stem Cell Corporation’s application covered a process in which unfertilised ova are stimulated to divide and reach a stage in development where stem cells may be isolated.

The CJEU was posed the question: “Are unfertilised human ova whose division and further development have been stimulated by parthenogenesis, and which, in contrast to fertilised ova, contain only pluripotent cells and are incapable of developing into human beings, included in the term ‘human embryos’ in Article 6(2)(c) of Directive 98/44 on the Legal Protection of Biotechnological Inventions?”

The question was almost identical to that posed to the CJEU by the Federal Patent Court of Germany in the Brüstle case of 2011, although technological advances since then meant that the AG had a different opinion.

The AG decided that such ova should not be included in the term ‘human embryos’, “as long as they are not capable of developing into a human being and have not been genetically manipulated to acquire such a capacity.”

Jason Rutt, an executive at Rouse in London, explained that in Brüstle, the court defined human embryos as including not only unfertilised ova, but also “any not fertilised ovum whose division and further development have been stimulated by parthenogenesis”.

However, “new scientific knowledge, specifically the phenomenon of ‘genomic imprinting’, states that whilst an ovum can be stimulated to produce all the cell types found in a human, in the absence of paternal DNA it cannot develop into a human,” he said.

“This position was accepted by all parties, but this understanding was not present at the time of Brüstle.”

The AG’s decision is not binding but Rutt said it could “significantly restrict” the scope of Brüstle.

“It’s a calmly rationalised opinion based on new knowledge not available at the time of Brüstle. It walks a clear line to exclude the sci-fi horrors of the abuse of human embryos whilst allowing the use of techniques to generate stem cells which may alleviate much human misery. It seems a very sensible position,” he added.

Andy Sanderson, senior associate at Potter Clarkson, said that although a different conclusion from that of the Brüstle decision was reached, the AG’s rationale for reaching his opinion appears consistent with that of Brüstle.

However, he said, the AG’s caveat that parthenotes should not have been “genetically manipulated” to be capable of developing to full term could be interpreted in different ways, and he wondered if Villalón should have just said “manipulated” instead.

“You can imagine people who are against the opinion arguing that point quite strongly,” he said.

“It could be argued that the mechanism that prevents mammalian parthenotes from developing full term (and, therefore, the process for removing it) isn’t a genetic manipulation but, rather, an epigenetic one,” he said, adding that it is possible to alter gene expression without altering the identity of the genome.

“Alternatively, although it’s hard to imagine now, there’s always a possibility that people could manipulate parthenotes nongenetically but still manage to get them to develop into a human being, for example by providing the embryonic cell types normally absent from mammalian parthenotes.”

However, Sanderson wondered if the AG’s caveat is redundant in view of the Biotech Directive’s explicit prohibition of processes for the genetic manipulation of human germlines.

He is also concerned that the AG’s opinion stressed the view that individual states may still prohibit the patenting of parthenotes if it is considered to be against public morality, potentially resulting in a patchwork of litigation and protection across Europe.

All in all however, he said, the AG’s opinion appeared in principle well-reasoned and sensible.