Subject: U. S. Allows Gene-Altered Animal Patents Date: Published: 4/20/87 124 lines Source: Wall Street Journal. Copyright Dow Jones & Co. Inc. U. S. Allows Gene-Altered Animal Patents --- Policy May Spur New Biotechnology Industry --- By Jerry E. Bishop Staff Reporter of The Wall Street Journal The ability to patent genetically altered animals could spur the development of a new animal biotechnology industry comparable to the present biotechnology industry. So say researchers who are in the early stages of developing genetically altered cattle, swine, chickens and laboratory animals. The new industry, which is literally and figuratively in its embryonic stages, is already working on inserting genes into livestock that would render the animals resistant to diseases. It also is working on genetically altering laboratory animals so they will mimic human diseases and thus become models for testing of new drugs. In the not-too-distant future, genetic manipulation might lead not only to more productive farm animals but to the use of animals to produce pharmaceuticals and industrial enzymes, the researchers suggest. Though an animal biotechnology industry has been in the cards since scientists in 1980 first transferred a "foreign" gene into a mouse, its prospects brightened markedly over the weekend with a new policy statement by the U. S. Patent Office. The office announced that it "will consider applications for patents on new types of animals produced by human intervention." The statement follows an April 3 ruling by the office's appeal board that man-made animals are patentable. These developments reversed its previous position that plants and microorganisms could be patented but that multicellular animals couldn't. In its April 3 decision, the appeal board refused to patent a process to make larger oysters by putting them under pressure. It said the development couldn't be patented because it wasn't original enough. But, the board said, the fact that it was a multicellular animal was irrelevent to whether it could be patented. The issue, it ruled, "is simply whether that subject matter is made by man," rather than nature. The ruling stems from the Supreme Court's 1980 Chakrabarty decision, in which the court ruled that genetically engineered microorganisms could be patented. About two years ago, the patent office's appeal board ruled that genetically altered plants also could be patented. But until the April 3 ruling, the office hadn't recognized animals as patentable. A spokesman for the U. S. Patent Office said two or three applications have been rejected by its examiners since the Supreme Court's Chakrabarty decision, but until recently none of the rejections had been appealed. He said the office has 15 applications pending for patents on genetically engineered animals. Lisa Raines, a lawyer for the Industrial Biotechnology Association, called the decision "a major breakthrough," though she said none of the association members were seeking to patent genetically engineered animals. Jeremy Rifkin, president of the Foundation on Economic Trends and a persistent opponent of genetic engineering, said he hopes to organize a coalition to lobby Congress to block animal patents. He said such patents "can only lead to the wholesale genetic altering and mutation of animals." He warned that "the diversity of the existing animal gene pool may be polluted and destroyed." Meanwhile, researchers agreed that the new patent policy is a logical extension of previous rulings that permit the patenting of microorganisms and plants that are altered by genetic engineering rather than natural breeding. "The decisions on microorganisms and plants established that it isn't a question of whether (the invention) is a life form but whether it involved creativity and innovation," said Stephen Holtzman, vice president and chief operating officer of Embryogen Inc., Athens, Ohio. "Broadening this (patentability) to higher animals, other than humans, of course, is commensurate with these previous decisions," Mr. Holtzman said. Closely held Embryogen was formed under the aegis of an Ohio state program to commercialize research on genetic engineering of animals performed by Ohio University's Edison Animal Biotechnology Center. The center's director is Thomas Wagner, one of the scientists who in 1980 successfully inserted a rabbit gene into a mouse, producing the world's first genetically engineered mammal. Researchers subsequently inserted a gene for rat growth hormone into a mouse and produced a giant mouse. Until now, one of the obstacles to development of an animal biotechnology industry has been the uncertainty over patenting the animal itself, Mr. Holtzman said. "If you invent a new widget, say, you can patent both the widget and the process for making it. But animals reproduce themselves" and pass on their genetic traits to their offspring, he explained. Thus, even though an inventor were to patent a process for genetically altering an animal, there was nothing to prevent someone else from taking the animal and, by natural breeding, producing a whole herd of animals possessing the newly inserted genetic trait. Embryogen just in recent weeks contracted with Upjohn Co., the big Kalamazoo, Mich.-based drug maker, to work on genetically altered laboratory animals, Mr. Holtzman said. The goal is to develop such animals as mice that have conditions similar to human ailments and that can serve as experimental models and test animals for human drugs. "For instance, it would be great to have a mouse with AIDS on which you could test drugs to treat AIDS," he said. Since only humans and chimpanzees develop acquired immune deficiency syndrome, they currently are the only test subjects for anti-AIDS drugs. [59 lines irrelevant to AIDS omitted -- sysop.] --- Robert E. Taylor contributed to this article. (This article is made available here by Dow Jones Co. for the personal and non-commercial use of callers to this bbs, in the hope that it will be of some help to those who are suffering from the disease and others who are seeking to help them.)