Stem cell patenting

Author: Claire Baldock, Partner, Biotechnology & Life Sciences Group, Boult Wade Tennant

Abstract
The patenting of embryonic stem cell-related inventions appears to be as controversial as the technology itself. The author outlines the state of play in Europe and the United States as well as other selected territories. While Europe has the broadest statutory exclusions to patenting of inventions which might be regarded as unethical, it appears that a smooth ride for applicants and patent holders is not guaranteed elsewhere.

INTRODUCTION
Stem cell technology is one of those areas of science that is no longer solely the domain of scientists. Operating as it does at the boundary between medicine and ethics it has attracted the attention of a much wider public. On the one hand there is the fantastic potential to cure debilitating human diseases such as Parkinson's, Alzheimer's and diabetes, and on the other the inevitable association of stem cell research with the creation and manipulation of human embryos.

'Stem Cell' is in fact a very broad term encompassing any undifferentiated cell that when it divides, can either differentiate into a particular type of tissue or remain as a self-renewing daughter stem cell. This includes cells that are designated 'pluripotent' because they have the potential to differentiate into any cell in the body and those designated 'multipotent', which can differentiate into only a limited range of cell types. Pluripotent cells can be recovered from embryonic and foetal tissue while multipotent cells can be obtained from adult tissue as well. Recently, it has been reported that certain adult multipotent cells exhibit a phenomenon called 'transdifferentiation' whereby they have pluripotent properties again, so these categories may not be as distinct as first thought. Also categorised as a stem cell are cells designated 'totipotent' cells. These are the first eight or so cells of a newly fertilized egg, which have the potential to develop into a whole animal or human but lack the self-renewing quality of other stem cells. While all the above may be considered to be 'true' stem cells, in fact the term can also be used to describe other cells engineered by genetic manipulation to have 'stem cell-like characteristics. Although, then, the term 'stem cell' does not, implicitly, mean cells isolated from an embryo, it is human embryonic stem (hES) cells that are attracting the most interest. These are currently showing the greatest medical potential since stem cells available from adult tissues are low in abundance and not as easy to culture in the laboratory. This has been a limiting factor for their use so far.

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