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

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.