Biomedical Engineering Reference
In-Depth Information
Patent reform is an ongoing area of concern for future developments
in stem cell research (Harrison, 2011). There is currently a bill
before the US Congress advocating for transformations in the way
that patents can be challenged in the legal system by third parties,
the implementation of the first to file ruling rather than first to
invent, and a change in the way that damages for patent infringement
is calculated (Harrison, 2011). How this might impact on iPSCs is
largely speculative at this stage, but the ongoing disputes over patent
rights in hESC have demonstrated that patent challenges can have a
severely disruptive impact.
More controversial perhaps is the suggestion that iPSCs are so
easy to produce that the commercial incentive for patent protection
or significant financial investment might turn out to be negligible.
Due to social, ethical, legal and technical reasons, pluripotent cells
have been precious and scarce resources not easily accessible - until
now, that is (Sipp, 2009). The advent of the capacity to induce
pluripotency is argued to have radically altered how its value is
configured (Sipp, 2009). In essence, iPSC technology is argued to
have 'democratized' the field of pluripotent cells, allowing more
researchers to enter into stem cell research with much less of the
regulatory entanglement that has been associated with hESC research
(Sipp, 2009).
Current commercial models include focusing on developing
proprietary techniques for the production of iPSCs. Ongoing debates
about the efficacy and safety of the methods used for inducing
pluripotency have led to a range of different techniques being
developed. For example, Fate Therapeutics has developed a chemical
process that impacts on the differentiation of iPSCs after they have
achieved pluripotency, in contrast to other methods based on
introducing viruses or genetic modification into the cells (Lin et al.,
2011). As different techniques become more established there could
potentially be a wide range of options for developing
iPSC-based technologies. Alternatively, in years to come it could also
be established that one method is superior to the others and the field
will become less diverse than it currently is. At this stage though, the
field is open.
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