To the biotechnology community, the biodiversity treaty is agivaway from an intellectual property standpoint. The treatywas signed last summer in Rio de Janeiro by a multitude ofcountries worldwide, but not by the U.S.

As currently written, it says developed countries must worktoward requiring that companies that exploit resources fromthe developing world hand over the means of production ofany new products to the private sector in those developingcountries that were the source of the resources.

Concerns over intellectual property protection led to PresidentBush's refusal to sign the treaty, but president-elect Bill Clintonmay be relying heavily on his environmentalist vice presidentfor advice on biotechnology, causing a small tremor ofnervousness among some members of the biotechnologycommunity.

"In the treaty as it was signed, the country of origin (of thegenetic resources) can preempt any patent by any company,"said William Small, executive director of the Association ofBiotechnology Companies. "It's the same idea as the right ofeminent domain."

However, the biotech industry's fears that the newadministration will trade intellectual property for some forestson the other side of the globe appear to be unfounded. Gore,who is Clinton's expert on both the environment andbiotechnology, is bullish on both.

At this stage in the transition, Gore is not issuing statements,but his office referred BioWorld to an article he wrote in theOctober issue of The Journal of NIH Research.

In it, Gore said he sees biodiversity as vital to "several of theindustries most important to our economic well-being,including biotechnology." He goes on to say, "Genetic diversity ...is the lending library, on which the global biotechnologyindustry depends."

Gore also wrote that sustainable use of this resource requiresconservation, "equitable and open access to native resources,"and protection of intellectual property rights.

Gore's position would not surprise Peter Barton Hutt, formerchief counsel for the FDA. "Clinton has said that we need tofocus on technologies where we are leaders, and every one ofthose lists includes biotechnology," said Hutt, now an attorneyat Covington and Burling. "My judgment is he will doeverything he reasonably can to foster biotechnology."

The big question will be how to change the treaty to protectintellectual property. There are two possibilities.

-- The treaty would go into effect as is if and when 30countries ratify it. However, no country has ratified it so far. Ayear later the parties would meet again and the treaty could bemodified. It might be dangerous for the U.S. to become part ofthis process because any voting could pit about 20 developedcountries against 100 developing countries, said Jeff Kushan,intellectual property specialist at the U.S. Patent andTrademark Office. Kushan, a U.S. negotiator of the treaty whenit was being hammered out last May in Nairobi, was unable toget intellectual property protection language included.

-- Or the U.S. could wait for the treaty signatories to ask for itsparticipation. They might, Kushan said, because the U.S. has theforemost industry. Kushan said developing countries blockedhis efforts last May because they thought that Bush was tryingto gut the treaty -- a charge that Kushan denies -- and thatKushan was simply stalling.

"They have a better idea now how serious we are, and maybethey will be more receptive to the concerns we express," hesaid.

-- David C. Holzman Special to BioWorld

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

No Comments