Was it need or greed? Prudent or outrageous?
At the same time that the United States is engaging in an unprecedented international scientific effort to locate and identify ("map") all human genes, the National Institutes of Health has applied to patent hundreds of genes whose purpose is not yet known, unleashing a hail of outspoken criticism from scientists abroad and at home. And NIH plans to seek patents on possibly thousands more partial genes.
"This is just nonsense," said Sydney Brenner, a leading British molecular geneticist involved in Great Britain's gene mapping program. "It's aroused a lot of fury on the part of most scientists. I think it will be counterproductive in the long run." NIH should reconsider its application, Dr. Brenner suggested.
The action and resulting controversy are a reminder that the commercialization of molecular biology, a field which is only twenty years old, harbors many unresolved questions of scientific, government and public policy.
A spotlight of attention from the scientific community and the lay press has been turned on the NIH move to patent large sequences of genes for which an NIH researcher has only bits of information. The custom has been that patents are sought for individual genes and gene proteins after scientists isolated them, knew what function they serve and wanted to use them in some diagnostic or therapeutic way.
The NIH patent application is for both a process used by J. Craig Venter, of the National Institute of Neurological Disorders and Stroke, and the partial genes he is locating by using this technique. The process locates portions of gene sequences. The sequence of a gene is the order in which its four basic building blocks -- adenine, cytosine, guanine and thymine -- occur. The order of the four building blocks determines the function of every gene in every living thing, including humans.
Genes determine physical shape, growth, looks, inherited talents, some psychological tendencies and susceptibility to some diseases. A human has between 50,000 to 100,000 genes located on 23 pairs of chromosomes tucked inside the nucleus of every cell.
Dr. Venter sees his work, using an automated sequencing technique, as a shortcut in genetic research.
But critics share Dr. Brenner's view: "One should get patents on inventions," he said. "There's no invention here. When you get the full sequence of the gene and you find the protein [manufactured at the gene's order] and you find a use for it, then [you] should be the one rewarded with a patent," he said.
Some observers of the growth of biotechnology see the NIH action as a stark example of the conflict government and universities face in balancing the pressure for commercial competitiveness with traditional scientific sharing of research findings.
"That is a tremendous tension," Kevin O'Connor, senior legal analyst for the Congressional Office of Technology Assessment, said last week. "Biology as it has developed is based on peer pTC review, publishing, sharing results. The scientific culture has been one of great openness. But as we get to the commercial use, it is based on being competitive, having business secrets, getting to market as quickly as possible, making a buck. It is two different cultures that are clashing.
"The rush to patent and the rush to commercially exploit may well lead to reluctance [among scientists] to exchange material," said Mr. O'Connor, who directed the OTA project on patenting life in 1989 and an OTA report issued last week entitled "Biotechnology in a Global Economy."
The biotechnology report says that the United States leads the world in the commercial development of biotechnology, because has both a strong research base and the industrial capability to transfer research findings into commercial products.
Certainly NIH has felt pressure from Congress and the White House to get laboratory research into the hands of industry.
"While there may be differences of opinion within the NIH community and in the larger scientific community as to whether certain results arepatentable, at NIH there are no differences of opinion about the value of technology transfer and its relevance to biomedical research," said Reid G. Adler, director of the NIH Office of Technology Transfer, which was created only a few years ago.
"What better strategic message could the research community send to Congress to embellish your own funding requests than evidence of your commitment to transfer technology at the earliest possible moment," Mr. Adler said in defense of the NIH patent move.
Some scientists and biotech watchers see the NIH application as an inevitable test case. "It goes against the grain, really," said Dr. Victor McKusick, a Hopkins geneticist who is one of the leaders of the $3 billion, 15-year international effort to map all human genes. "But it's nonetheless a valid question that has to be explored. It's a question of intellectual property rights."