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Wednesday, April 26, 2000

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SF Gate Call It the Gene Rush -- Patent Stakes Run High
"After years of bickering, the patent office has proposed adding three simple words to its guidelines. To win a patent, applicants will have to describe a ``substantial, specific and credible'' use for their gene."

John Doll, who heads the patent office's biotech division, said the guidelines essentially group the huge backlog of 30,000 patent applications into three classes.

The first are genes isolated in a laboratory, whose purpose is likely to be known. Doll calls this ``wet biology.'' Government and academic scientists have used wet biology to patent genes for 20 years. These are not controversial.

Another class of applications cover ``naked DNA sequences.'' These were the sort of early, machine-generated gene discoveries that provoked alarm in the first place. The new guidelines rule them out.

The battleground is the large number of applications that fall in the middle. These are machine-discovered genes, but they aren't ``naked sequences.'' ."

"As the controversy over ``naked sequences'' festered, biotech companies got smarter about using their machines. When they discovered a new gene, they employed software that analyzed its structure and deduced its purpose. Doll called these ``in silico'' applications -- a reference to the fact that the gene's purpose was deduced through a computer analysis."

"``It's not important that you understand the function of the gene (to get a patent), it's only important that it have a commercial utility,'' Incyte's Scott said. "

Signals Homestead 2000: The Genome
""The analogy that I would use is that of a minefield," said Bob Levy, senior VP of science and technology for American Home Products. "We are spending an incredible amount of time now, when we find exciting targets and begin to validate them, in trying to define who has rights to what. And we're finding, in almost every product that we look at, that someone has patented the protein, the gene, a fragment, a diagnostic test." Levy noted that untangling patent rights, and determining which patents are dominant, are increasingly time-consuming and expensive tasks. And patent-holders must be paid. "The royalties that will be involved soon in some of the products that we are bringing to market, they're already up into the ten, fourteen, fifteen percent [range]," said Levy. "And that may increase with time.""

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Bioinformatics will be at the core of biology in the 21st century. In fields ranging from structural biology to genomics to biomedical imaging, ready access to data and analytical tools are fundamentally changing the way investigators in the life sciences conduct research and approach problems. Complex, computationally intensive biological problems are now being addressed and promise to significantly advance our understanding of biology and medicine. No biological discipline will be unaffected by these technological breakthroughs.


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