US Patents Issued for Two Transgenic Mice

THE logjam of patents on genetically engineered animals has broken at the United States Patent and Trademark Office.

Ohio University in Athens has received a patent on a mouse engineered to produce interferon - a key component of animal immune systems. GenPharm International Inc., of Mountain View, Calif., has received patents on two altered mice. One has no immune system. This allows researchers to give it a human one for study. The other mouse is designed for cancer research.

These are the first patents issued in more than four years on what geneticists call transgenic animals. Harvard University broke open this field when it patented a mouse designed for cancer research in April 1988. The Patent Office has since received many animal patent applications. But it has been slow to act. Ohio University spokesman Brian McNulty says he believes other applicants also will soon receive patents.

The mice these new patents cover are research animals. The commercial market for them is relatively small. It is the agriculturally important animals that can be engineered to produce better meat, resist disease, or have other desirable traits that are the main commercial prize. If biotechnologists are to develop such animals, they need assurance their efforts will have patent protection. Thus, the fact that patents have been granted on research animals is "a necessary step in the evolution of this techn ology," according to Carl Pinkert, editor of the industry journal Transgenic Research.

Ohio University molecular biologist Thomas Wagner agrees. Referring to the mouse he and Xiao Chen developed, he said: "The value of this development has yet to be determined. Of greater importance is that animal patents with implications for human and animal health are issuing again."

The Ohio University mouse typifies the kind of transgenic research animal now being developed. The term transgenic means that an organism - plant or animal - has received new genetic characteristics that are transmitted to succeeding generations. In this case, Drs. Wagner and Chen have given a mouse the ability to produce interferon. This protein helps an animal immune system resist viruses. It is generally produced as part of the immune system's response to a viral invasion. However, the Ohio University

mouse does not need the stimulus of such an invasion to produce interferon.

Chen says mice are a preferred "model animal" for studying physiological systems of mammals, including humans. "We think this [mouse] model has the potential for many kinds of studies." He adds that interferon may cause changes in other parts of the body besides the immune system. He says that the transgenic mouse is showing subtle behavorial changes he does not understand. "The whole story of interferon has yet to be told," he says.

Meanwhile, the fact that animal patents are beginning to flow does not mean legal, social, and ethical issues involved have been resolved. In the US and European Community, legislatures and courts have yet to decide what such patents should cover. Should they include the techniques used to produce a novel animal - effectively locking up a whole research field - or should they cover only the animal itself? Should farmers who buy transgenic animals have the right to breed them and sell their offspring? Or should the patentholder own the progeny? Should patents be granted on animal life forms at all?

Since Harvard received the first mouse patent, Congress has considered several bills but has yet to act. Some proposed legislation would impose a moratorium on animal patents or ban them altogether. So far, Congress has rejected such extreme measures. Other bills would give farmers the right to breed patented animals and would explicitly ban patenting humans.