There has been little notice of the Canadian government's recent action in a 15-year patent dispute with Harvard University, even though it may restoke the fires of controversy about the patenting of life.1 Last month, the government appealed to the Canadian Supreme Court the award to Harvard of a patent on a transgenic mouse.2 The university filed the patent application in June 1985 for the Harvard Oncomouse, so named because it is genetically engineered to be susceptible to cancer.1 The Canadian Patent Office rejected the claim in 1993, arguing that the animal was made primarily by nature, not by humans. The Commissioner of Patents upheld the rejection in 1995, as did a federal trial court in 1998 Then, a federal appeals court reversed both in August 2000 and approved the patent, stating that it was not prohibited by the Canadian Patent Act.1,3
The next month, the Canadian Biotechnical Advisory Committee responded by recommending that Parliament consider amending the Patent Act to prohibit animal and plant patents, while a committee minority recommended an appeal of the oncomouse patent to the Canadian Supreme Court.1 The Canadian government did the latter on Oct. 2 and stated that a "public dialogue" on the issue of animal patents was needed. A court response is expected within a year.
In contrast to the United States and most developed countries, animals and plants remain unpatentable under Canadian law.3,4 The public dialogue requested by the Canadian government on this issue can reinvigorate the voices of opponents to life patents, recently muted in North America but remaining loud in Europe and the Third World.4
Controversy also surrounded the patenting of the Harvard mouse in the United States, but it has died down since its peak in the 1980s.2,4 The U.S. oncomouse patent was awarded in April 1988, years after Harvard's 1984 application for the "transgenic nonhuman mammal." The seeds of this approval were planted by the 1980 U.S. Supreme Court Diamond v. Chakrabarty decision about a patent process as tortuous as the Canadian mouse's.5 A 1972 patent for oil-digesting bacteria developed for use in treating oil spills was first denied by the patent examiner who reasoned that microorganisms are "products of nature" and not patentable subject matter under U.S. patent law. On appeal, the patent board agreed that patent law did not cover "living things." The Court of Customs and Patent Appeals, however, ruled "that the fact that microorganisms are alive is a distinction without legal significance for patent law." The patent commissioner appealed to the U.S. Supreme Court, where in a 5-4 decision, Chief Justice Warren Burger held that "a live, human-made microorganism is patentable subject matter. [The inventor's] discovery is not nature's handiwork, but his own."
The Court explained that the dissenters' arguments against patentability, based on the potential hazards of genetic research, should be addressed to Congress, not the judiciary branch. But patent applications for other animals were still denied until 1987, when the PTO in Ex Parte Allen found that a radiation-induced variety of oysters was patentable subject matter.2 Although the oyster patent was eventually denied on other grounds, the Allen decision reinforced the developing view that multicellular animals and plants altered by humans could be patented.2,3
On April 7, 1987, four days after the Allen decision, the U.S. Patent Commissioner issued a rule stating that "The PTO now considers nonnaturally occurring, nonhuman, multicellular living organisms, including animals, to be patentable subject matter." The PTO specifically excluded humans from patentable subject matter and agreed on an eight-month moratorium on animal patents. Then on April 12, 1988, the PTO issued the patent for the Harvard transgenic oncomouse.3
Public outrage about the mouse patent was reflected in the 1989 Animal Legal Defense Fund challenge of the PTO rule in federal court. But the court held that the ALDF had no standing to sue. Concern about animal patents was also expressed in several sessions of Congress in 1987 and 1989, when former U.S. Sen. Mark Hatfield unsuccessfully introduced legislation to place a moratorium on animal patents. So the U. S. federal judiciary's basic holding on the patentability of animals is still intact. Patents have now been granted for scores of transgenic animals in the United States and in most developed countries. The Harvard mouse was ultimately patented in Europe in 1992 and in 1994 by Japan. So only Canada is out of the first-world fold of animal patents.3
Animal patent laws are far from settled. Although animal patents have been allowed in most developed countries for decades, opposition to them still exists, especially in Europe and more so in undeveloped countries that characterize patent law as biopiracy.4 Although the impact of the Harvard mouse patent process in Canada could be just a squeak, it is more likely that opponents of patenting life will use the surrounding controversy to once again roar their opposition to all biopatents.
L.J. Deftos, M.D., J.D., is a professor of medicine at the University of California, San Diego, and a staff physician at the San Diego VA Medical Center.
1. URL: strategis.ic.gc.ca.
2. R.E.Gold, "Biomedical patents and ethics," McGill Law Journal, 45:413, 2000. 3. E. Morin, "Of mice and men: ethics of patenting animals," Health Law Journal, 5:147, 2000.
4. D.R. Downes, "How intellectual propery could be a tool to protect traditional knowledge," Columbia Journal of Environmental Law, 25, 2000.
5. Diamond v Chakrabarty, U.S. 447:303, 1980.