We reported in August on the opinion of the Advocate General in International Stem Cell Corporation v Comptroller General of Patents
The European court has now given its judgment in the case.
Following the Advocate General’s lead, the court has confirmed that patents can be granted in some circumstances for stem cell technology in which a human cell is stimulated to begin development.
The Biotech Directive (98/44/EC) prohibits patenting of uses of human embryos for industrial or commercial purposes. The reason for this restriction is that the patenting of the human body, at any stage of its formation and development is considered to be wrong in principle.
The question in this case revolved around technology to produce pluripotent stem cells using parthenogenetically activated human eggs. These cells were shown to be capable of developing for a few days, but not beyond that point. The court looked at whether such a cell should be considered to be a human embryo. The key point here is whether the cell ‘has the inherent capacity of developing into a human being’. That has to be decided ‘in the light of knowledge which is sufficiently tried and tested by international medical science’.
Although this decision provides a legally clear test, it includes a reference to ‘current scientific knowledge’. This appears to require analysis of the states of scientific knowledge at the time a decision on patentability is taken. Knowledge and techniques in the field move on quickly, so we can see situations arising where a method is deemed patentable because the resulting cells cannot develop beyond a few days. Changes in scientific knowledge could therefore mean that when the patent is looked at again (in a later validity challenge, for example) the cells could be made to commence full development and so the patent may be found to be invalid.