Test-Tube Life: Reg. U.S. Pat. Off.

By John S. DeMott

The Supreme Court protects the genetic engineers

When Thomas Jefferson, an an amateur scientist himself, wrote the nation's first patent law in 1793, he was deter mined to ensure that "ingenuity should receive a liberal encouragement." Under his law, "any new and useful art, machine, manufacture or composition of matter" was patentable and thus legally shielded from theft. Last week, in a 5-to-4 decision, the Supreme Court applied the Jeffersonian measure to one of the latest examples of human ingenuity. It ruled that new forms of life created in the laboratory could be patented.

The decision, climaxing an eight-year legal battle, should give a boost to an emerging industry, genetic engineering, which seeks to create new life forms. This promising field offers the prospect of advances in everything from medicine and food production to alternate energy forms. The court's ruling also revived fears -- vastly exaggerated in the opinion of most responsible scientists -- about the dangers of tampering with life.

The center of dispute was a new human-made variation of the common bacterium Pseudomonas. While working at General Electric's Schenectady, N.Y., labs in the early 1970s, Indian-born Microbiologist Ananda M. Chakrabarty made a significant discov ery. Chakrabarty knew that cer tain bacteria are able to break up hydrocarbons. What he found was that the genes responsible for this capacity are not contained in the bacterium's single chromosome, or principal repository of DNA, the genetic times Instead, they reside in small, auxiliary parcels of genes, called plasmids, elsewhere in the cell. Taking plasmids from three oil-eating bacteria, Chakrabarty transplanted them into a fourth, thereby creating a crossbred version with a voracious appetite for oil.

Freeze-dried until needed, then sprinkled on straw and tossed into the ocean, the superbugs could presumably make quick work of oil spills by breaking down the crude into harmless protein and carbon dioxide. Says Chakrabarty, 42, now a researcher at the University of Illinois Medical Center: "You can make tons of these microorganisms in a matter of days." Nor, he says, would the bacteria pose any danger. After the feast, they would die for want of oil.

When GE tried to patent the bacterium in 1972 under Chakrabarty's name,

U.S. patent officials balked. They argued, in effect, that if either Jefferson or Congress had intended life to be patentable, special laws would not have been needed to protect certain new plant hybrids like the Red American Beauty Rose. But when GE pressed its case, the Court of Customs and Patent Appeals rejected the Government's argument, and the Supreme Court last week went along with that position. As Chief Justice Burger explained, the issue is "not between living and inanimate things, but between products of nature--whether living or not --and human-made inventions."

Though GE was pleased by the decision, it seems in no rush to exploit the bug commercially. Ronald Brooks, head of the GE environmental unit where Chakrabarty did his work, says that the company would entertain licensing agreements with those who want to develop the oil eater. But he adds that GE does not see a market big enough for it to become directly involved.

Others are less hesitant. Awaiting the outcome of the GE appeal are patent applications for at least 100 different kinds of organisms or processes to make organisms. All are products of genetic engineering activities in more than a dozen companies and countless university laboratories in the U.S. and abroad. Most of this work does not involve the relatively simple process of plasmid reshuffling used by Chakrabarty, but the more complex and promising technique of recombinant DNA, or gene splicing. With it, scientists actually break apart DNA, using so-called restriction enzymes, and isolate certain desirable genes. These genes are then inserted into plasmids, again using enzymes, and transferred into another bacterium. The recipient bug, in effect, becomes a new life form with all the characteristics and capabilities carried by the spliced-in genes.

Even in its infancy, the technology has led to the making of new bacteria that are in fact microscopic chemical factories. Already the common intestinal bacterium E. coli, the favorite tool of such researchers, has been genetically "re-engineered" to produce human insulin and interferon, the antiviral protein that could be effective against several types of cancer, as well as the hormone that stimulates growth in humans. In the future, scientists should be able to use such reprogrammed bugs to meet other medical needs: manufacturing malaria vaccine, for example, or creating chemicals to heal burns, kill pain or stanch the flow of blood from wounds.

Yet the new technology should ixtend far beyond medicine.

Scientists are talking about creating bugs that will enable plants to "fix" nitrogen directly from the air, thereby reducing the dependence on fertilizers. Others could be created to make amino acids, a building block of proteins and thus a basic food source. Some organisms, like Chakrabarty's oil eater, might be developed to degrade metals and other materials; these could help mining companies leech ores from hard-to-reach veins or assist in the cleanup of such toxic waste sites as Love Canal. Even the energy crisis might be alleviated by the genetic engineers, who are devising new ways of using yeast to make alcohol, and other superbugs for making fuels, antifreeze compounds and plastics. Says Molecular Biologist Herman Lewis, the National Science Foundation's adviser on recombinant DNA: "Theoretically, any process occurring in nature can be harnessed for man's use. We could even learn how to duplicate photosynthesis, the basic energy-converting process in green plants." Basically, says Eli Lilly Vice President for Research Irving Johnson "You're talking about a process that could affect all living species. I can't think of a single event that is as broad as that, except maybe the discovery of atomic particles."

With so much research already going on, the Supreme Court's decision mainly gives formal sanction to what had been happening for some time, a classic example of the law's lagging behind technology. Millions of dollars have been invested without patent protection. Says Bernard Talbot, special assistant to the director of the National Institutes of Health: "Recombinant DNA work is going on in numerous labs. This would have gone on whatever the court decided." Chief Justice Burger himself acknowledged that a patent law "will not deter the scientific mind from probing into the unknown any more than Canute could command the tides."

The most important patent application now pending is for the key gene-splicing processes developed by Microbiologists Stanley Cohen of Stanford and Herbert Boyer of the University of California: both have signed over royalty rights to their respective universities, but Boyer is a major stockholder in Genentech Corp., a Bay Area genetic engineering firm, and obviously stands to make money from the process. No one quarrels with that. But there is a mixed view of just how much good will accrue from the introduction of patents to the infant industry.

Biochemist Ronald Cape, chairman of Berkeley's Cetus Corp., a rival firm, sees patents as increasing the "free flow of ideas." More companies and investors are sure to plunge into the expensive business with less fear of having ideas stolen, or at least with an assurance of legal recourse if they are. But others fear that just the opposite will happen: that scientists will be cautious about sharing information, long an essential part of the scientific process. Warns M.I.T.'s Jonathan A. King, a molecular biologist: "Now you have the prospect of keeping a strain [of bacteria] out of circulation until you have the patents." Wolfgang Joklik, chairman of Duke University's department of microbiology and immunology, wants to see scientists rewarded for what they do. But he adds with concern, "I just don't want to see organisms patented for commercial exploitation. I would like to be sure that everything is available for basic research."

There will almost certainly be efforts to get around the patents of others through slight variations. Says James Watson, Nobel laureate and co-discoverer in the 1950s of the double-helix structure of DNA: "It will be awfully hard to show uniqueness, to prove that one man's microbe is really different from another's." That, says J. Leslie Glick, president of Genex Corp. in Bethesda, Md., could lead to modifying bacterial strains mainly for "defensive reasons, a waste of research." Lawyers especially stand to gain if patenting life becomes their way of making a handsome living. Quipped Stephen Turner, president of Bethesda Research Laboratories: "I call this the Patent Lawyer's Employment Act of 1980."

For others, the decision stirred renewed anxieties. They argue that altering life, to say nothing of patenting it, is not the wisest of human activities. Better, they say, to leave the doomsday bugs to fiction. Said the Peoples Business Commission, a Washington-based consumer group, in a hyperbolic press release greeting the court's decision: "The Brave New World that Aldous Huxley warned us of is now here." Nobel Laureate George Wald, a guru of various antiestablishment causes, echoed those concerns. If the GE bug ever gets loose in the world, he said, "it could digest petroleum that has not been spilled. You can't put bacteria on a leash once you introduce them into the environment."

Chakrabarty, who stands to make no money from his discovery because GE will own the patent, crisply dismisses such dissent. "I can't respond to imaginary scenarios," he told TIME Correspondent

David Jackson. He insists that his Pseudomonas is safe, although it was developed before the Government imposed strict containment rules for lab experiments with such organisms. Indeed, in the past few years, researchers in dozens of labs have been performing similar experiments, and as Burger put it, there has been no "gruesome parade of horribles" forecast by the naysayers to the new research. Yet with Shakespeare, Burger acknowledged, "It is sometimes better to 'bear those ills we have than fly to others that we know not of.' " If Hamlet's wisdom had prevailed, there probably would be no such thing as genetic engineering with all its potential for good. For that matter, there probably would be no science.

With reporting by Evan Thomas

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