Brussels, 15 Apr 2003
The UK has clarified its position on inventions involving human embryonic stem cells by outlining under what circumstances it would consider granting them a patent.
In a practice notice published on 11 April, the UK patent office states that the commercial exploitation of certain types of stem cells 'would not be contrary to public policy or morality in the United Kingdom and so they should not be excluded from patentability.'
The crucial issue, as far as the UK authorities are concerned, is whether or not the human stem cells in question have the potential to develop into an entire human body. In the case of human totipotent cells, which do, the patent office will not consider the granting of a patent.
Nor will patents be granted for processes of obtaining stem cells from human embryos, as the use of human embryos for industrial or commercial purposes does not qualify as a patentable invention.
However, as long as an invention involving human pluripotent stem cells (which cannot develop into an entire human body) fulfils the requirement of being novel and non-obvious, and is not excluded on moral grounds, a patent can be granted.
The approach outlined by the patent office is intended to be compatible with the EU directive on the patentability of biotechnological inventions, which the country has transposed into its own national law. As the directive does not explicitly address the issue of inventions involving embryonic stem cells, however, the position adopted by the UK could reveal whether such an approach to stem cell patenting is compatible under the current legal framework.
In the practice notice, the patent office emphasises the 'enormous potential of stem cell research [...] to deliver new treatments for a wide range of serious diseases', and warns that without the commercial protection provided by patents, inventors may not be prepared to undertake the investment and research needed to make such breakthroughs.
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