Dispute over patenting of genes in US

The US National Institutes of Health (NIH) and the Patenting and Trademark Office (USPTO) are in disagreement over the patenting of genes with no known function, according to a news report in last week's Nature.

USPTO officials say that patents can be granted on genes with no known function if they are sufficiently similar to another gene of known function. This is on the basis that the two genes will make proteins that behave in a similar way. But NIH officials argue that even a single DNA base-pair difference in a gene can change its function.

The USPTO is currently revising its rules for awarding gene patents, making the criteria stricter. Most of the draft changes have been widely welcomed, as they would prevent, for example,  the patenting of genes to use merely as 'hooks' to fish out other genes. But its proposals on patenting novel DNA sequences similar to known genes have provoked criticism.

'Finding partial sequence similarity is an obvious and non-inventive step', according to the National Advisory Council for Human Genome Research. Other critics point out that granting patents on the basis of similarity would reduce the incentive to patent holders to investigate the gene further, but would allow them to claim the rights to the results of other researchers who later did so.

The USPTO will publish a final version of the new regulations in three months, but says it is not anticipating 'major changes' from the current draft. Comments on the new guidelines can be viewed at the USPTO's website