A Mouse That Roared

By Christine Gorman

In biotechnology labs across the country, researchers hailed the decision as long overdue. Last week the U.S. Patent and Trademark Office awarded a patent to Harvard University for the development of a genetically engineered mouse. Although plants and bacteria have been patented for years, the Harvard award was the first ever for an animal. On Capitol Hill, however, angry Congressmen promptly called for a two-year halt to any future animal patents until the risks and benefits can be better assessed. Fumed Republican Senator Mark Hatfield of Oregon: "The Patent Office is playing fast and loose with a serious issue."

The Harvard mouse is certainly not the sort of creature that Dr. Frankenstein would have created. In 1982 Harvard Medical School Geneticists Philip Leder and Timothy Stewart developed a technique for producing mice that were highly susceptible to breast cancer; they modified a naturally occurring gene to make the mice more sensitive to cancer-causing agents, then injected the altered DNA into the embryos. By subjecting the adult mice to carcinogens and studying the malignancies that develop, scientists will have a unique opportunity to analyze the complex interplay between environmental and hereditary origins of cancer -- and possibly even produce more sensitive diagnostic tests for human breast cancer. Harvard has granted an exclusive license to produce the patented mice to Du Pont, the Delaware-based chemical giant.

The problem, say critics, is not with a few altered lab mice, but with the broader commercial applications of gene-transplant technology. Theoretically, any gene could be inserted into any embryo. Scientists, for example, have already produced mice that manufacture human insulin. Until now, such animals have existed only in laboratories, not in the marketplace. Patenting them would change that. Critics are concerned that the potential to make millions of dollars on, say, animal-generated pharmaceuticals will drive biotech companies to produce generations of bizarre creatures whose release into nature could have unforeseen consequences.

To minimize any such risks, two bills currently before Congress call for a moratorium on granting animal patents until the issues can be examined more completely. Farm groups, for example, feel genetically altered livestock could raise production costs, since farmers might have to pay royalty fees to biotech concerns every time their prize livestock give birth. Says Howard Lyman, an analyst for the National Farmer's Union: "This is an economic issue for us."

Others worry about the animals themselves. Yale Lecturer Gul Agha, founder of a watchdog group called the Cambridge Committee for Responsible Research, is concerned about the quality of life for the new breeds. Producing a cow that gives three times as much milk as a normal Guernsey, he notes, could mean producing a cow that lives in acute discomfort. Says he: "We have the prospect of creating animals that may be in continual agony." Others fret that the release of genetically engineered animals, such as fatter mice or more aggressive game fish, might result in ecological disaster.

Proponents argue that awarding animal patents and allowing the commercialization of the field are vital to protecting the American edge in biotechnology. At least ten other countries now permit researchers who genetically alter animals to patent their sentient inventions. "We're being chased day and night by Japan," says Richard Godown, president of the Industrial Biotechnology Association. Animal breeders, he points out, have created and exploited new life forms for years. In Godown's view, the new gene-transfer technology merely represents a more efficient method of animal husbandry. Maybe. But now that scientists have created a better mouse, they will have to assure the public that it has little to fear from the technology that spawned it.

With reporting by Robert Buderi/Boston and Dick Thompson/Washington