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

• Published in: The Journal of law, medicine & ethics Vol. 42; no. s1; pp. 42 - 50
• Main Authors: Cook-Deegan, Robert, Chandrasekharan, Subhashini
• Format: Journal Article
• Language: English
• Published: Los Angeles, CA Blackwell Publishing Ltd 01.09.2014; SAGE Publications; Cambridge University Press
• Subjects: Companies; Genome, Human; Genomes; Genomics; High-Throughput Nucleotide Sequencing; Humans; Infringement; Laboratories; Liability; Patents as Topic - legislation & jurisprudence; Sequence Analysis, DNA; United States
• ISSN: 1073-1105; 1748-720X; 1748-720X
• DOI: 10.1111/jlme.12161

Some claims in patents on individual genes and methods of detecting variations appear to be infringed by whole‐genome and all‐exome sequencing and genomic analysis. But what is the real risk of infringement liability? The risk is probably low. This is partly because it will rarely make sense to sue, but also because the patent‐holder may well lose if they do sue. Courts have recently narrowed standards of patentable subject matter, invalidating broad method claims and DNA‐based claims for sequences that would be found in nature. Moreover, claims broad enough to cover WGS are likely to be invalid on other grounds, and not worth risking a lawsuit to enforce.