The National Institutes of Health is hanging tough on its plansto patent some 2,700 partial gene sequences obtained in itslaboratories -- until an international agreement can benegotiated and U.S. patent law changed.

Before it will back off its controversial effort to patent the genesequences, the NIH would need acts of Congress andinternational agreements, NIH Director Bernardine Healy wrotein this week's edition of the New England Journal of Medicine.The NIH must first be assured that other countries won't dojust what some are urging the U.S. not to do: seek patents topartial genes.

The NIH would accept an international agreement that barspatenting of partial gene sequences if it could be assured thatpublishing such data would not impede the discover's ability tolater seek patent protection for the full gene, its expressionproducts and method of use, Healy wrote.

To this agenda for a treaty she added:

"A change in (U.S.) legislation could provide that protection inthis country."

TJ. Craig Venter, the NIH scientist responsible for decoding thismassive swath of DNA bases, is already talking to senators Hillabout modifying the patent laws to favor such protection forpartial sequences. Venter recently quit his position at theNational Institute of Neurological Diseases and Stroke to foundthe private, non-for-profit Institute of Genomic Research inGaithersburg, Md.

"A lot of people have voiced the opinion that because thesequences were 'partial' that that was a very early stage,"Venter explained to BioWorld on Thursday.

"The sequence information we have is so absolutely specificthat it renders everything 'obvious' (in patent terms) from thatpoint forward." He added: "Working closely with Dr. Healy atNIH, I am talking to people in the Senate."

Specifically, "what we're trying to do is propose legislation thatwould allow patents at a later stage, when there is morecomplete information, when we have gene expression and moredetailed knowledge of biological function or the therapeutic useof something," Venter said. "We're just trying to react to thislegal dilemma that's created by the current law. So we'rehoping perhaps to get the 'obviousness' definitions changed."

Rebecca S. Eisenberg, a law professor at the University ofMichigan, observed, "We have to get those patents now becausethere might be no patent protection available later.

"What's interesting about this is that the U.S. biotechnologyindustry does not seem to be concerned about that," she toldBioWorld. "Virtually unanimously, it seems to be saying, 'We'lltake our chances on that.' "

She added, "The companies that need to put money on theirbets seem to be saying, 'We don't want NIH to obtain thesepatent rights in order to protect our interest in exclusivity.'They seem reasonably confident they will be able to obtainpatent protection on their subsequent innovations."

Venter said it would be "highly desirable" if other countries,including Japan, France and England -- the principal countriesusing the same approach and instruments as the U.S. -- wouldagree not to patent these genes, or pass similar legislation topublish the data and patent therapeutic applications later."Whether it would be achievable or not, I don't know," he said.

"It's hard for me to fault the Japanese," he said, "because theyrecognize the importance of my approach, and they 'readopting it faster than the U.S. government."

Venter's new institute is financed by a $70 million, 10-yeargrant from the for-profit biotechnology company, HumanGenomic Sciences. It will develop therapeutic and diagnosticapplications from the gene-discovery work for which theinstitute is now tooling up. "Our stated goal," Venter said, "is todiscover the majority of human genes over the next three tofive years."

Eisenberg said a geneticist recently told her that "there mightbe more of a problem when the subsequent product is not aprotein, but something closer to the DNA fragment itself -- saya sequence-based diagnostic or screening test rather than atherapeutic protein. There might be few steps between thepartial sequence and that DNA probe, so those early sequencesmight be 'obvious' inventions."

-- David N. Leff Science Editor

(c) 1997 American Health Consultants. All rights reserved.

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