When the National Institutes of Health announced last yearthat it was applying to patent some 2,700 partial cDNAsequences from the laboratory of J. Craig Venter, it found thatit had ventured into a minefield of scientific, industrial, legaland political controversy. Three back-to-back articles inFriday's issue of Science blaze cautious trails through thisexplosive terrain.

Rebecca S. Eisenberg, a law professor at the University ofMichigan, led off the 16-page series by restating the main prosand cons of the NIH initiative:

Pro: NIH asserts that patent protection at this stage may benecessary to ensure that private companies will be willing todevelop products related to the partial genes.

Con:Opponents argue that the issuance of patents to those whorandomly sequence partial cDNAs could undermine theincentives of firms to take up the more costly work ofsystematically finding genes of interest.

Will government patenting of partial cDNA sequences ofunknown function promote technology transfer to the privatesector for the development of useful products, as NIHmaintains? "This argument," states Eisenberg, "rests on twopremises, both questionable but neither clearly wrong."

Pemise No. 1: The agency would do well to claim patent rightssufficiently broad to make their licensing attractive as afinancial incentive to bring new products to market.

Premise No. 2: If the NIH doesn't act now to obtain these rights,"firms interested in marketing products related to thesequences will not be able to secure effective monopolies in thefuture."

Venter's partial sequences, which he obtained at the NationalInstitute of Neurological Disorders and Stroke before he left theNIH, correspond to genes expressed in human brain tissue. Aresuch sequences patentable?

"Traditional patent doctrine," observes Eisenberg, "suggests twogrounds for rejecting all of the claims:"

Ground No. 1: Things that exist in nature or are phenomena ofnature.

Courts will have to decide in the present environment ofjudicially shifting sands as the science of molecular biologyevolves.

Ground No. 2: The discoveries claimed lack of "utility" because"NIH has not identified the genes that the partial sequencesbelong to, the proteins those genes code for, or the functionsthose proteins perform."

Reid G. Adler, who directs the NIH Office of TechnologyTransfer, rests his agency's case for patenting the sequences onthe statement: "The biotechnology industry is criticallydependent upon patent protection to maintain its threatenedleadership in highly competitive world markets."

The biotechnology industry, through its trade associations,apparently remains unconvinced. Adler cites this reaction tothe NIH patenting initiative:

"The Industrial Biotechnology Association (IBA), whichrepresents 80 percent of U.S. investment in biotechnology,recommended unanimously on June 10 that NIH unilaterallyadopt a policy that it would file patent applications claiminggenes only when the complete coding region and its biologicalfunction are known."

In the third article, attorney Thomas D. Kiley, a director ofvarious private and public biotechnology companies, weighedin with this opening salvo: "The NIH proposal for patents isonly an extreme example of a widespread practice inbiotechnology that seeks to control not discoveries, but themeans of making discoveries."

As for the NIH rationale, Kiley writes wryly: "In short, we areto patent research that the government does to encouragedevelopment that the government doesn't do."

But Harvard biologist Walter Gilbert, who shared the 1980Nobel prize in chemistry for co-inventing gene sequencing, toldBioWorld on Friday: "It's my view that cDNA sequences will notactually turn out to be patentable, except possibly for very,very minor specific uses. I don't think there's any reason forNIH to claim the gene. Even for the specific uses, they will havetrouble proving novelty, if not obviousness. I think it's atempest in a teapot."

-- David N. Leff Science Editor

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

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