Abstract
With the progress of DNA sequencing technology and its falling costs, the
number of gene patents is dramatically growing. This chapter aims to shed light on the
regulation of human genome editing and its impact on health research. By analyzing
legal provisions and cases, this paper assesses whether genetically modified forms of
life meet the statutory requirements of utility, novelty, and non-obviousness under
patent law. The nature of the patentable subject matter of living organisms and genes in
the U.S. is also examined in detail.
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