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Thursday, 17 July 2014

Biopatent Opinion: will it be "ova and out" for pluripotent human cells?

Advocate General Cruz Villalon published his Opinion today in Case C‑364/13 International Stem Cell Corporation v Comptroller General of Patents, a reference to the Court of Justice of the European Community from the Patents Court, England and Wales, of the following 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?’
Says the Advocate General, in his advice to the CJEU:
"Unfertilised human ova whose division and further development have been stimulated by parthenogenesis are not included in the term ‘human embryos’ in Article 6(2)(c) of Directive 98/44 ... on the legal protection of biotechnological inventions as long as they are not capable of developing into a human being and have not been genetically manipulated to acquire such a capacity".
The IPKat will soon be hosting a more analytical guest post by biotewch wiz Shohta Ueno, but he thought that interested readers should at least know that the 80-paragraph Opinion is now available online.


Anonymous said...

This seems the correct conclusion. However paragraph 80 (quoted in the IPKat article) raises interesting issues by mentioning 'have not been genetically manipulated to acquire such a capacity'. That seems to shift the definition of a 'human embryo' to something that can develop into a human being, rather than something derived by human sperm and ova. So in the future, when the technology becomes available, if we took a skin cell made it temporarily totipotent to manufacture some liver cells, and then turned it back into a skin cell, would it be classed as a human embryo during the time it was totipotent? In theory the totipotent cell could have become a human being, but it was derived from a skin cell and surely we don't care about the dignity, sacredness etc of skin cells? I ask the question knowing there is no easy answer.

The other problem with using a test relating to 'capable of developing a human being' is that it is not always easy to tell whether a given cell can develop all the way to a human being, and it is an unethical experiment to carry out.

Anonymous said...

I agree with this comment. The AG does seem to have defeated his own reasoning and the Commission's request not to have shifting sands a apart of the approach.

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