Stem cells are a class of biological cells that are
characterised by their ability to replicate and develop into the
various tissue types of the body. Whereas adult stem cells act to
repair damaged tissue and regenerate cells during natural
biological turnover, embryonic stem cells are able to differentiate
into any embryonic tissue, a condition known as
"pluripotent". Adult stem cells can be extracted from a
range of sources, notably, bone marrow, adipose tissue and blood,
but embryonic stem cells can only be extracted from a developing
human embryo, which can result in its destruction. This latter
feature has given rise to the controversy surrounding embryonic
stem cell research.
The interest in embryonic stem cells is based on their ability
to create or regenerate human tissues and organs from cells
prepared in a lab. When exposed to the right biological conditions,
these cells have the potential to heal damaged heart and spinal
cord tissue, reverse diabetes, and treat a range of cancers.
The controversy surrounding the source of stem cells has been
ongoing for many years. Early work sourced embryonic stem cells
from aborted foetuses and embryos donated by couples undergoing IVF
treatment. This led to considerable opposition prompting George W.
Bush to issue an executive order in 2001 limiting research in the
US to existing cell lines, although this was subsequently reversed
by Barack Obama in 2009. In several countries, inventions which are
based on embryonic stem cell research where embryos were destroyed
are not patentable for ethical reasons. However, the question of
human embryo destruction may no longer be an issue since the
discovery of a method for reprogramming human adult stem cells to a
pluripotent state. This has the potential to negate the need for
obtaining stem cells from embryos and offers alternative
possibilities for disease treatment.
Although this development means that ethical considerations
relating to embryo destruction may no longer be a prohibitive
factor in obtaining patent protection for stem cells, protecting
the intellectual property (IP) rights of commercial stem cell
products can still be complicated. This is particularly so in
defining the scope of the claims of a patent application. Relative
to pharmaceuticals, proteins and nucleic acids, which have defined
structures and are easily characterised, stem cells are by their
nature complex and difficult to define. Under different culture
conditions, any given stem cell can produce a range of unique cell
lines and express widely diverse biological markers. Drafting
claims for such inventions and convincing a patent office that such
an invention is novel can be significant challenges.
An additional element for patentability is enablement. This
requires that the patent specification provide sufficient
information for a person skilled in the art to be able to replicate
the claimed invention. Method claims describing
isolation/extraction of stem cells or their use in drug screening
usually do not pose a problem in this regard. Clinical applications
of stem cells, however, can be difficult to successfully reproduce
due to the unpredictable nature of the cells and their therapeutic
The impact of IP on stem cell research has recently come under
the spotlight in the US with the non-profit advocacy group,
Consumer Watchdog, challenging the legality of several stem cell
patents held by the University of Wisconsin-Madison. The advocacy
group wants an appeals court to invalidate the patents based on
their similarity to previous work. They also want an earlier US
Supreme Court ruling limiting ownership rights of human genes to
apply to stem cells. The motive behind the challenge is based on
the opinion that these patents hinder US stem cell research.
Consumer Watchdog says they drive up research costs by requiring
companies and some academics to pay considerable licensing fees to
the university and question whether such a barrier to entry is in
the best interests of society, particularly given the huge
potential for new stem cell-derived therapies.
Managing the protection of IP rights, maintaining commercial
viability, and enabling access to novel medical therapies are all
important policy goals to be pursued in order to achieve the
greatest societal benefit from stem cell technologies.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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