Washington

The US Patent and Trademark Office has released revised guidelines for patent inspectors that require applicants to “explicitly identify a specific and substantial utility” for genes and gene products — in other words, to specify an immediate and identifiable benefit to the public.

The guidelines were revised because of concerns that “people would claim utilities for which they had no substantial showing”, says Todd Dickinson, the office's commissioner on patents and trademarks. Past applicants sometimes sought claims on ‘naked’ expressed sequence tags, he says, for which no known function was attributed. Those claims were rejected as too speculative, says Dickinson.

Some claimed ‘throw-away’ utility, saying that a protein could potentially be used as a food supplement or a shampoo additive. Applications quoting an unproven utility will now be rejected.

“We're trying to strike the right balance between the protection of innovation that these inventions represent and the access that the world — and in particular the research community — needs,” says Dickinson.

Patent examiners are applying the new guidelines to applications already in the pipeline, including some that were filed provisionally.

Celera Genomics of Rockville, Maryland, announced last October that it had filed 6,500 provisional applications on genes it discovered while sequencing its first billion base pairs of human DNA. The subset it sends for examination will be subject to the more stringent rules. Paul Gilman, Celera's director of policy and planning, says they “both expect and welcome” the new scrutiny.

Harold Varmus, outgoing director of the US National Institutes of Health, applauds the change. “I've been very pleased with the way [the patent office has] come closer to our position about the need to define specific utility,” he says. The guidelines, available at http://www.uspto.gov, are open for public comment until 22 March.