Patenting the Oncomouse

After the Chakrabarty ruling, several critics insisted that the decision appeared to leave no legal obstacle to the patenting of higher forms of life—plants, animals, and possibly human beings—or, by implication, to the genetic engineering of such life forms. Harvard University and Philip Leder moved to take advantage of the legal opening presented by Chakrabarty. A distinguished biomedical scientist, Leder was appointed in 1981 to the faculty of the Harvard University Medical School. In conjunction with his recruitment, the DuPont Corporation gave Harvard $6 million for support of Leder’s research. The principal quid pro quo was simple: Although Harvard would own any patents that might arise from Leder’s research, DuPont would be entitled to an exclusive license on any and all such patents.

Over the next two years, Leder and his collaborator Tim Stewart developed a so-called oncomouse—a mouse genetically engineered to be highly susceptible to certain types of cancer. They accomplished this feat by exploiting the then-recently developed transgenic technology to insert the myc oncogene, tied to a mammary-specific promoter, into the new embryo of a normal mouse. Leder wondered whether his mice might be eligible for patent protection because they formed a man-made model system for the study of cancer, including the testing of its causes and therapies. Given the Chakrabarty decision, Harvard’s lawyers saw no legal basis for excluding claims on animals, and on June 22, 1984, on behalf of Harvard University, filed an application for a patent on Leder and Stewart’s invention. The main utilities claimed were straightforward, including the use of such animals as sources of malignant or proto-malignant tissue for cell culture and as living systems on which to test compounds for carcinogenicity or—in the case of substances such as Vitamin E—for the ability to prevent cancer. The claims extended to any transgenic mammal, excluding human beings, containing in all its cells an activated oncogene that had been introduced into it, or an ancestor, at an embryonic stage. In April 1988, a U.S. patent was awarded to Harvard University on any nonhuman mammal transgenically engineered to incorporate in its genome an oncogene tied to a specific promoter. It was the first patent on a living animal in the history of the world’s patent systems.

all method-of-use patents have been handled in this manner. For example, in the United States, Myriad Genetics holds a patent for diagnostic testing for breast cancer susceptibility based on the BRCA genes. Myriad chose to exercise its patent rights by remaining the sole provider of the test, which indicates whether a person carries a mutation in BRCA genes. In 1997, cancer genetics laborato-

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