Shaping Life In the Lab

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this mixed bag of genes a chimera (after the mythological beast that was part lion, part goat, part serpent). Such a plasmid could then be inserted into E. coli. And as the bacteria replicated, the transplanted DNA would be copied down to the last step on the spiral staircase. Any product ordered up by the inserted genes—the antiviral agent interferon, for instance, or perhaps an enzyme to break down oil molecules—would also be made in the offspring. And in abundance: dividing once every 20 minutes, the original bacterium would undergo a population explosion. In 24 hours, a single bug could result in billions of bugs, all of them churning out the desired product.

At first Cohen and Boyer balked at seeking a patent for their work. But Stanford's licensing director, Neils Reimers, changed their minds by citing the case of Alexander Fleming, the British discoverer of penicillin. Fleming had also refused to take out a patent, thinking that this would ensure penicillin's widespread availability. Instead, since no company would take the financial risk of making it without patent protection, the wonder drug did not go into production until World War II, some 14 years after Fleming had identified it.

Cohen and Boyer's own reluctance was overcome just in time: they signed the patent application only a week before the deadline expired. Any royalties were to be turned over to their universities. For a while, it looked as if there might be no royalties for anybody. The U.S. Patent Office refused to grant the application, contending that new life forms were not patentable. But that view was overturned in last June's U.S. Supreme Court decision. Though the test case involved an oil-eating bacterium developed by crossbreeding techniques, the ruling was also held applicable to gene splicing generally. Cohen and Boyer wound up holding the first patent in the recombinant DNA field.

A natural product like synthetic interferon cannot be patented, so what Cohen and Boyer actually did patent was the basic gene-splicing method they had pioneered. Some scientists like James Watson contend, however, that other gene splicers will easily circumvent such legal protection by making just slight changes in their techniques to avoid patent infringement.

There are certain to be more patent lawsuits, but they are most likely to affect individual scientists and companies, not the future of products created by gene splicing. The multiplication of such products, moreover, does not appear in doubt. A new study scheduled to be released this week by the congressional Office of Technology Assessment lists no fewer than 48 human hormones that may soon be manufactured by minute, gene-spliced organisms. This will vastly increase medicine's arsenal of drugs. Many researchers, for instance, are working on vaccines for stubborn tropical diseases. Concludes the congressional study: "These may profoundly affect the lives of tens of millions of people."

One team of doctors has already tried "gene therapy," the effort to correct hereditary defects like the blood disease thalassemia by replacing abnormal genes with normal ones created by splicing techniques. These initial experiments failed abysmally and were widely criticized as premature. Until much more is learned about how humans might be made to acquire new genes, and how those genes are