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Monday, March 06, 2000

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The Scientist Biotech Faces Evolving Patent System
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"How do efforts to improve the system affect the success of biotechnology? Three recent developments could provide clues. First, the U.S. Patent and Trademark Office (PTO), burdened by thousands of applications for gene patents, is proposing new guidelines under which it could reject many pending and future applications. Second, Congress recently enacted the most extensive revision of the patent statute since 1984, and though the law could extend the lives of many biotech patents, it's not entirely benign. Finally, as holders of biotech patents begin to enforce their ownership rights, some scientists want to change a system that they contend denies them affordable, or indeed any, access to disease-linked genes."

"Just to say 'I have a piece of DNA, and it is useful as a gene probe' isn't good enough to pass the [new] utility test," says John Doll, director of biotechnology patent examination at PTO. "What you're going to have to say is, 'My particular piece of DNA probes for this particular gene, disease state, or location on a chromosome.' If you're going to be patenting a chromosome marker, you'll have to tell us what you're marking."

In applying the "substantial" utility requirement, he continues, "we're no longer going to accept 'throw-away utilities.' If you've developed a new transgenic mouse, it will no longer be acceptable as 'snake food.' You have to tell us what the real-world utility is for that mouse. And if you have proteins, you cannot say this protein is a source of an amino acid or is an animal feed supplement.""

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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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