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

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

DOI: 10.2174/9789815080629123010004

The Regulation of Human Genome Editing

Pp: 40-59 (20)

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Abstract

SHS investigation development is considered from the geographical and historical viewpoint. 3 stages are described. Within Stage 1 the work was carried out in the Department of the Institute of Chemical Physics in Chernogolovka where the scientific discovery had been made. At Stage 2 the interest to SHS arose in different cities and towns of the former USSR. Within Stage 3 SHS entered the international scene. Now SHS processes and products are being studied in more than 50 countries.

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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