NIH scientists expect to sequence the genes expressed in thehuman brain over the next two to five years, using automatedtechnology that can read DNA at the rate of 168 genes a day.
The scientists reported Thursday in Nature that they haveadded 2,300 new sequences of brain genes to the 347 genesthat they identified last June.
The NIH on Wednesday said it had filed for patents on about2,400 of the DNA fragments, called "expressed sequence tags"(ESTs), although critics have noted that most of the sequenceshave yet to be shown to have therapeutic utility.
As many as 30,000 of the body's 50,000 to 100,000 genes maybe expressed in the brain. And of the estimated 5,000 humangenetic diseases, one in four affects the brain and nervoussystem.
At least one of the sequences published last summer hasalready provided "a major lead on a new disease gene"involved in the neurologic disorder called Angelman'ssyndrome, said NIH scientist J. Craig Venter.
Some of the technology to decode gene libraries of messengerRNA was developed at the NIH, but is now availablecommercially. "Anyone can duplicate in three months whattook us five years" to accomplish, Venter told BioWorld.
If the NIH patent succeeds, Prudential Bache analyst JosephEdelman suggested it may create the commercial incentive tocreate companies that do custom gene sequencing. Biotechcompanies generally look for a therapeutic protein and thenwork backward to find the gene.
Other analysts, executives and academics have expressedconcern about a rush by companies to patent genes, creatingfurther complications for biotech companies that already spenda lot of time in patent litigation.
"I think it's significant, and I don't think the companies areprepared," said Edelman. "A company could develop somethingand then find that the NIH has filed for patents on it."
"It's ridiculous to think that you can patent sequences withoutunderstanding what they do," said Frank Baldino, Cephalonpresident and CEO. But, he added, it is hard enough to deal withcompetitors who turn out to already own patents on a hot newdiscovery, so it would be "a nightmare" if an NIH patent isapproved.
But Athena Neurosciences Inc. senior scientist Ivan Lieberburgcalled such thinking an "overreaction," noting that the SouthSan Francisco neurosciences company is quite busy with itsown projects. The NIH move is just "one of these things thatwill have to be sorted out in the patent courts," Lieberburgsaid.
Patent lawyers at Genentech Inc., considered to be among thebest biotech companies at sequencing, declined to speculate onwhether the NIH application will succeed. But Susan Rogers,spokeswoman for the South San Francisco, Calif., company, said,"We are concerned about the future impact, what complicationscould result" if the patent is granted.
Ray Bartus, Cortex Pharmaceutical Inc. executive vice presidentand chief scientific officer, said that patents often make it moreexpensive to develop products. "But on the other hand," theexecutive for the Irvine, Calif., said, "they can help commercialdevelopment by (giving) proprietary protection."
-- Roberta Friedman, Ph.D. Special to BioWorld
(c) 1997 American Health Consultants. All rights reserved.