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TRANSGENIC ANIMALS U.S. Patent No. 4,736,866 Issued:April 1988 to Philip Leder and Timothy Stewart Assigned tHarvard University Prosecuted by:Fish & Richardson Litigated by:Ottawa office of Toronto’s Smart & Biggar; David Morrow and Steven Garland, lead partners Some patents achieve their notoriety in the marketplace, others in the courtroom; the Harvard mouse grabbed headlines the day it was granted. This was the first patented transgenic animal, a mouse that contained genes from another species. These particular genes, called oncogenes, trigger cancer growth. By inserting them into a mouse, researchers can study the effects of cancer-fighting drugs and suspected carcinogens without human testing. Researchers can explore potential treatments — and cures — more effectively, and more safely than otherwise possible. Harvard’s patent was particularly broad, covering any nonhuman mammal that had an oncogene inserted. The discovery led other scientists to develop — and patent — their own transgenic animals, using all sorts of genes. Yet from day one, the patent, and the science behind it, have been extremely controversial. Some question whether people should have an exclusive right to an animal — even a genetically altered one. Others argue that genetically altering nature is in itself troublesome. Initially the Patent Office rejected the Harvard mouse application on the ground that animals were not a category of patentable subject matter, says Paul Clark, now a name partner at Boston’s Clark & Lebling, who prosecuted the patent. Clark visited the examiner to argue against the decision, but to no avail. Shortly after that, however, Clark’s luck changed. The Patent Office had approved a controversial patent on an oyster, lifting the ban on animals and saving the mouse. In Canada, Harvard’s mouse has been the subject of a decade-long legal battle, stemming from the Canadian Patent Office’s refusal, in August 1993, to award it a patent, holding that the mouse was mainly the work of nature, not man. That decision was reversed by an appellate court in August 2000, but the Canadian Supreme Court has agreed to hear the matter. Alan Cohen is a free-lance writer based in New York City. His e-mail is [email protected].

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