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Patents and Genome-Wide DNA Sequence Analysis: Is it Safe to Go into the Human Genome?

Published online by Cambridge University Press:  01 January 2021

Robert Cook-Deegan  and
Subhashini Chandrasekharan
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Extract

Whether, and to what degree, do patents granted on human genes cast a shadow of uncertainty over genomics and its applications? Will owners of patents on individual genes or clusters of genes sue those performing whole-genome analyses on human samples for patent infringement? These are related questions that have haunted molecular diagnostics companies and services, coloring scientific, clinical, and business decisions. Can the profusion of whole-genome analysis methods proceed without fear of patent infringement liability?

Whole-genome sequencing (WGS) is proceeding apace. Academic centers have been performing whole-genome and -exome sequencing (WES) in research for at least five years, and academic clinical laboratories with national reach have been doing sequencing for clinical applications for almost as long. Companies have also been offering WGS and WES as a clinical service for a few years now. So far as we know, no one has been sued for infringement of “gene patents” for performing WGS.

Type
JLME Supplement
Information
Journal of Law, Medicine & Ethics , Volume 42 , Issue S1 , Fall 2014 , pp. 42 - 50
Copyright
Copyright © American Society of Law, Medicine and Ethics 2014

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