Mouse Makes Others Roar

From the Cambridge City Council to Capitol Hill, last week's decision by the U.S. Patent Office to grant a Harvard Medical School professor the world's first patent for animals has brought legislators face-to-face with the ethical dilemmas created by the rapidly expanding field of biotechnology.

The patent office last week granted exclusive marketing rights to Harvard for a genetically altered strain of mice designed by Andrus Professor of Genetics Philip Leder '56. Although the new breed of mice was created for cancer research, the patent office's decision has come under attack by some members of Congress, who charge it has preempted congressional debate on the ethics of patenting animals.

Both the Senate and the House are considering separate pieces of legislation that would halt the granting of patents for genetically altered animals until Congress has thoroughly considered the ethical, economic and environmental issues involved. Although no one is suggesting ending genetic research on animals, critics say public debate is needed on the proper limits of "playing with nature."

The House bill, sponsored by Rep. Charles Rose (D-N.C.) and co-signed by 58 other members of Congress, would impose a two-year moratorium on the granting of such patents and also revoke the one granted to Harvard last week.

Moreover, the Cambridge City Council, with the support of Mayor Alfred E. Vellucci, is scheduled to debate a resolution Monday night condemning the patent office for its action and endorsing the House legislation. The resolution calls on Congress to "create strong regulatory mechanisms which would ensure that the public good is served by the introduction of a specific new animal" before such patents are granted.

However, in a letter sent to Congress on Monday, U.S. Commissioner of Patents and Trademarks Donald J. Quigg defended his office's decision to grant the mouse patent and denounced Congressional interference in the matter.

"Genetic manipulation of animals to develop new and improved breeds is being pursued in the United States, Japan and elsewhere and will continue to be pursued irrespective of whether patents are granted," Quigg writes in the letter.

"If this activity [of granting patents for animals] is to be regulated, it should be done through the normal regulatory process and not through placing a moratorium on issuing patents on a particular type of invention," the letter states. Quigg said that such regulation should be carried out by agencies such as the Food and Drug Administration, the Environmental Protection Agency, or the National Institutes of Health, rather than by Congress.

Congressional aides say that, although the House bill is still pending in subcommittee and is not likely to come to the floor for at least a month, the highly publicized mouse patent has focused congressional concern on the patenting of animals, which legislators previously had given low priority.

"Anytime you have an action like that, it gives the sponsors of the legislation an opportunity to make their point," says an aide to Rep. Bruce Morrison (D-Conn.), one of the four co-sponsors of the Rose bill.

Legislators also fear that the patent office's action will open the floodgates to an unlimited patenting of new breeds of animals. Fourteen thousand similar patent applications are currently pending on the office's caseload.

Experts on ethics in scientific research and animal rights advocates say they fear that, in the rush to make advances in genetics research, the moral questions of creating and patenting animals are being ignored.

"This brings us up against the question of when you create novelty in nature, in whose hands should these forms reside? In the hands of private industry?" says History of Science Professor Everett I. Mendelsohn. "We're creating a problem with a variety of social consequences."

"I would urge the scientific community to open up the social question to broad debate," Mendelsohn says. "It's the kind of issue that needs fairly broad discussion before it's locked into place."

Leder last week defended the patent office's approval of his mouse patent, saying that such licenses are needed to give industry incentive to sponsor scientific research.

A 1980 Supreme Court ruling allowing for patents for genetically altered microorganisms has been interpreted as clearing the way for legal licenses of all new types of life forms, excluding humans. In the last eight years, the rapidly expanding field of biotechnology has outpaced congressional legislation defining the scope of the ruling.

"We've been slow in picking up on these issues," Mendelsohn says. "Congress has been lazy. The scientific community has been less than fully thoughtful and less than fully candid."

"Because of the environmental and ethical impact of creating genetically altered animals for commercial exploitation, at least a two-year moratorium on the patents is advisable," says Leah D.T. Zuch, director of the Cambridge Committee for Responsible Research, an animal advocacy organization.

Robert Weissman '88-89, director of Harvard Watch, founded last year under the auspices of Ralph Nader to critique University policy in a variety of areas, says Harvard's decision to give marketing rights to DuPont Chemicals is in opposition to its stated policies in favor of the free flow of scientific information. DuPont provided the bulk of the funding for the Med School's mouse project.

"The patent does absolutely nothing to further research," Weissman says. "All that this can do is to decrease the flow of research communication between labs."

"They [officials in the patent office] chose [to give the patent] because it involved Harvard, Dupont and cancer research, and they thought it was the best way to legitimize this," Weissman says.