An Introduction to Legal, Regulatory and Intellectual Property Rights Issues in Biotechnology

The Regulation of Human Genome Editing

Author(s): Alessandro Stasi and Tan Weng Chiang David

Pp: 40-59 (20)

DOI: 10.2174/9789815080629123010004

* (Excluding Mailing and Handling)

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.


Keywords: Human genome project, Human growth hormone, Human genes, Myriad controversy, Recombinant DNA.

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