Ethics of owning parts of our genetic 'blueprint'

Like grizzled '49ers staking claim to California gold, biotech pioneers have been planting "no trespassing" signs along the length of the human genome.

They have rushed to patent the genes they discover, hoping to reap financial rewards from new drugs or treatments that might flow from research into human genes and their specific functions.

Now, as companies, universities, and private research institutions mine the data pouring out of the Human Genome Project, that trend is expected to accelerate. As a result, scientists and government officials are looking more deeply into the economic and ethical questions raised when companies hold exclusive rights to portions of humanity's genetic "blueprint."

Companies that hold patents on genes "will have control over the most valuable resource on earth," argues longtime biotech industry gadfly Jeremy Rifkin, director of the Foundation for Economic Trends in Washington. "They will have unprecedented commercial power to dictate the terms" for using genes.

His concerns are echoed worldwide. A European Union directive to establish a framework for patents on genes is facing political opposition in France and court challenges from the Netherlands and Italy. The directive is supposed to be adopted this month.

In the United States, groups ranging from the National Academy of Science to the American College of Medical Genetics have raised concerns about patenting human genes.

It would seem, however, that the issue of patenting genes has already been settled here. In 1980, the US Supreme Court upheld that organic life could be patented. In 1986, the US Patent and Trademark Office (PTO) issued 37 patents on genes. Last year, it issued nearly 2,500.

The basis for issuing gene patents rests in part on the notion that in isolating, cloning, and purifying a gene, researchers are producing an "invention."

The result "differs substantially from what it was in its natural form," says Stephen Kunin, deputy commissioner for patent policy at the US Patent and Trademark Office in Washington.

Moreover, he adds, the effort to purify a gene, along with solving the puzzle of its role, represents an investment of intellectual capital that can merit a patent.

Indeed, a gene is nothing more than a set of chemicals. "Nobody has any problem with a plastic material being patented," says Chuck Ludlam, vice president for government relations at the Biotechnology Industry Organization in Washington. "If you can extract [a chemical found in nature], copy it, understand it, and ascertain its commercial application, you can patent it."

Yet much of the time and "intellectual capital" invested in this process is increasingly done by computers, not humans. Today, researchers can extract human DNA from a hair, snip it into manageable pieces, run it through sequencing machines that operate with minimal human supervision, and then use computers to interpret the data.

Given what biologists have learned about proteins and enzymes during the past 50 years, "my cat Chester can look at a gene sequence and tell you what it does," says R. Rodney Howell, president of the American College of Genetic Medicine.

The notion of what a gene does touches on another aspect of patents: An invention must be useful. Here, the PTO is "raising the bar" on gene patents, says Mr. Kunin, by instructing examiners to look for "substantial utility," in addition to "specific, credible utility," for an invention claimed on a patent application. No longer could a company rush in the door to patent a gene that it claims could be useful at some future time as a tool for genetic research.

Many critics take a harder line. They say genes, even in purified form, are not inventions, and to treat them as such raises troubling issues.

For Dr. Howell, access to affordable medical care is one such issue. As genetic screening for disease becomes more common, for example, the cost of the tests could outpace patients' or their insurers' abilities to pay for them. "In genetic tests, you can't use the gene without a license" from the patent holder, he says.

Costs could skyrocket as genetic tests grow to screen for 1,000 or more genes at a time. Much would depend on how many different companies hold patents to those genes, and what their licensing terms are.

In addition, the cost of pharmaceuticals - already a hot-button issue in Congress - could continue to climb as biotech companies try to recoup their investment in gene hunting through large license fees.

Economics aside, some worry about defining the value of the primary components of organic life in commercial terms.

"We can't underestimate the impact of that on the sociology of our species," Mr. Rifkin says. Treating genes as commodities "writes intrinsic value [of life] right out of the equation."

(c) Copyright 2000. The Christian Science Publishing Society