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Human embryonic stem (hES) cell research is a powerful tool for yielding information about the complex events that occur during
human development; in particular it allows researchers to gain a better understanding of the genetic and molecular controls
of cell division and differentiation, thus providing useful information about how diseases, such as cancer and birth defects,
arise. hES cells may also be used as in vitro model systems in drug discovery. However, it is believed that the most important potential for such cells is in the generation
of cells and tissues that could be used for cell based therapies, and it is hoped that research into such cells will lead
to therapeutic treatments to repair or replace damaged tissues, for example, in heart disease, spinal cord injuries and Parkinson's
disease.
In the US and in most Asian countries, all stem cells and their uses are patentable, whilst in Europe the situation is much
less clear. While patent protection for adult stem cells rarely presents any problems, the situation is complex with respect
to hES cells because they are still mainly derived from human embryos. This has also resulted in restrictions on hES cell
research funding.
Europe's stance on hES cell patentability
According to the European Patent Convention (EPC), it is not possible to patent the human body at the various stages of its
formation and development, or the simple discovery of one of its elements, including the sequence or partial sequence of a
gene.1 Nonetheless, an element isolated from the human body or otherwise produced by means of a technical process may constitute
a patentable invention, even if the structure of that element is identical to that of a natural element.
What are stem cells?
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The European Patent Office (EPO) has consistently granted patents concerning adult stem cells on the basis that they are novel
and non obvious isolated elements of the human body and because, so far, the patents sought have not given rise to any particular
ethical controversy. The question of whether inventions concerning hES cells are patentable has not, however, been straightforward.
Of particular relevance is the provision in the EPC excluding from patentability inventions that are contrary to public order
or morality. Specific guidance on the exact meaning of this in respect of biotechnological inventions is provided and the
EPC explicitly states that it is not possible to patent:
- Processes for cloning human beings.
- Processes for modifying the germ line genetic identity of human beings.
- Uses of human embryos for industrial or commercial purposes.
It is the explicit exclusion from patentability of uses of human embryos for industrial or commercial purposes that has created
the most controversy surrounding hES cells and their patentability on the grounds of public order and morality. While it is
clear that patents covering methods that generate stem cells or stem cell lines through the use (i.e., destruction) of human
embryos cannot be granted, the legislation is unclear on whether a stem cell itself, which has been generated by a method
that destroys embryos, is excluded from patentability.
UK IPO Guidelines
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Another question raised by the above exclusion from patentability of human embryos for industrial or commercial purposes is
whether uses of hES cells are patentable. One view is that the properties of hES cells are so similar to those of fertilized
cells that they should be treated the same for the purposes of patentability. On that basis, hES cells should not be patentable.
An opposing view is that hES cells cannot be considered as embryos because they are only pluripotent (i.e., cells that can
give rise to a number of cell types, but do lack the potential to develop into an entire human body) and not totipotent (i.e.,
cells that have the potential to develop into an entire human body).
The Enlarged Board of Appeal of the EPO recently had an opportunity to provide general guidance in this area in the Wisconsin
Alumni Research Foundation (WARF) application,2 which sought to patent primate embryonic stem cells. It chose not to do so and instead, the Enlarged Board of Appeal stressed
that its decision did not concern the general question of hES cell patentability. However, it ruled that the patenting of
inventions relating to hES cells is prohibited if they can only be obtained by the destruction of human embryos. This is irrespective
of whether the method involving the destruction forms part of the patent claims.
This decision is unsatisfactory because although it has not resulted in the prohibition of patents relating to hES cells,
it provides no guidance on any circumstances in which hES cells will be patentable.
