Progress or Peril?

Are such rough clues really useful? Companies think so. They've filed thousands of EST patent applications, often for defensive purposes. Since ESTs partially describe what a full gene might look like, they file the EST applications to prove they're working on particular genes. When they go to patent the full gene, which is far more valuable, they can use the EST application in case someone else claims to have discovered the full gene.

"This is the Golden Age of medical research," says Roy Whitfield, chief executive officer of Incyte Pharmaceuticals Inc. of Palo Alto, Calif. "We're staking claim at the first possible opportunity we have. [But] if it weren't for the patent system, would people be doing all this research?"

Probably not, researchers agree.

Another worry: If would-be monopolists tie up specific genes with patents, they could restrict further research by others. Or they might charge such high license fees to use their gene, that doctors would be unable to use it to cure someone. The potential already exists in medical diagnostics, where firms can insist they alone will conduct tests using a specific gene, says Jon Merz, a bioethicist at the University of Pennsylvania.

Such scenarios seem unlikely, argues Mr. Whitfield of Incyte. "I can't imagine us going after an academic who's doing research on a gene."

In fact, the company encourages such research. The more uses scientists find for its genetic material, the more valuable the company's patent becomes. Incyte already has received patents on some 250 full-length genes, up from about 50 a year ago.

Many observers believe companies will work out cross-licensing and other technology-sharing agreements so that research can go forward. Still, the potential exists for patent holders to create such a thicket of claims and counterclaims that scientists will steer clear of certain genes.

"It becomes a difficult line to draw," acknowledges John Lynch, an intellectual property attorney at Arnold White & Durkee in Menlo Park, Calif. And "it happens in all technologies. There are individuals in the electronics industry ... who are standing there with their palms up when they really haven't contributed to the major advance that's being marketed."

The third worry is more subtle: Will the increasing private-sector funding narrow the scope of scientific inquiry to genes that bring the most profit?

The issue is already bubbling up in agricultural biotechnology. The influx of corporate money is spurring rapid advances in crops grown by farmers who can afford to pay for the new wonder seeds. But there's little incentive for companies to develop new genetic variations for impoverished farmers in the developing world, even though they're in more dire need of the advances.

Earlier this month, for example, Swiss researcher Ingo Potrykus announced a new variety of vitamin-rich rice that should measurably improve the diet of the world's rice-eating poor. But his funding came from foundations and the public sector. Left to the giant seed companies, the research would never have taken place, he says.

"When physicians become researchers, they take a new hat," says Wailoo of the University of North Carolina. When they also become stockholders in a genetics-research company, they put on a third hat. "It poses real dangers for patients who can enter clinical situations not knowing fully what they're getting into." And it may affect how they treat patients, he adds.

"There are dynamic tensions and there are tradeoffs," says Leslie Platt, president of the Foundation for Genetic Medicine, a nonprofit education group affiliated with George Mason University in Manassas, Va. But the best way to minimize the downside is to couple the privileges of the patent system with the obligation to follow recognized best practices in the industry, he adds.

Ethical dilemmas will likely loom larger in the human field than in agriculture, researchers agree. "You can engage in a whole series of failed experiments in the agricultural world until you strike the right approach to applying genetic engineering to plants," Wailoo says. But "human beings are not like tomatoes.... You can't afford those kinds of failures." It's too early to tell if society is striking the right balance, he adds. "We're just lifting up the tent flap.... I'm not sure any of us comprehend what a watershed of change in the human condition we're in."

(c) Copyright 1999. The Christian Science Publishing Society

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