First patent issued for engineered animal.

First Patent Issued for Engineered Animal

Marking a highly controversial scientific and legal landmark, the U.S. Patent and Trademark Office this week issued the first U.S. patent on a higher animal. The patent -- granted to Harvard University for a "transgenic nonhuman eukaryotic animal" designed for use in cancer research -- culminates more than a year of debate about the ethical and economic implications of a 1987 Patent Office decision to allow such patents. This week's action comes as Congress is about to consider two bills that would preclude the issuing of patents on higher animals. It lends support to the bio-technology industry's claim that the Patent Office is not the proper place to debate the ethics of genetic engineering.

"A patent does not grant any affirmative rights" to create or experiment with genetically engineered animals, said Donald J. Quigg, commissioner of patents, at a Washington, D.C., press conference. A patent precludes others from using or selling a technology for 17 years. Rules for the actual use of that technology "are going to be determined by the regulatory bodies and by the Congress, as they decide where they want to draw the line," Quigg added. A congressional subcommittee investigating the pros and cons of animal patents is deadlocked on the issue (SN: 4/9/88, p.231).

As might be expected for a first-of-its-kind patent, the Harvard patent appears broad in its claims. The application claims rights to any gene-altered, nonhuman mammal, "preferably a rodent such as a mouse," whose cells have been engineered to contain an "activated oncogene sequence." Oncogenes are pieces of genetic material that are involved in the triggering of many forms of cancer. By splicing an oncogene sequence into a very early animal embryo, researchers can create an animal that is especially susceptible to cancer-causing substances, or carcinogens.

"This sensitivity [to carcinogens] will permit suspect materials to be tested in much smaller amounts than the amounts used in current animal carcinogenicity studies and thus will minimize one source of criticism of current methods, that their validity is questionable because the amounts of the tested material used are greatly in excess of amounts to which humans are likely to be exposed," the patent documents state. Scientists expect the animals also will be useful for testing the effectiveness of substances thought to protect against the development of cancer, and as a source of cells for experiments related to carcinogenesis. The technique is expected to be commercialized by DuPont Co. of Wilmington, Del., through a licensing arrangement with Harvard.

Because the oncogene sequence will be contained in all the test animals' cells, including their sex cells, offspring will contain identical sequences. Therefore, according to the Patent Office, the patent will cover those offspring as well. Indeed, the patent covers all animals whose "ancestors" have been altered by the patented technique.

Although initial experiments at Harvard used mouse breast-cancer oncogenes inserted into mice, the patent documents imply that future experiments would use human oncogenes -- perhaps injected into rhesus monkeys.