Bioethics and Patent Law: The Case of the Oncomouse

Animals are called "transgenic" when DNA from other species has been artificially introduced into their genome. Transgenic animals have been developed for potentially beneficial applications, such as medical research, enhanced food production, and the production of proteins or organs. But the genetic manipulation of animals, particularly mammals, also raises a host of ethical issues that can be highly controversial.

Such issues are much wider than the questions relating to patentability. And governments may of course at any stage of research and development directly outlaw any technology deemed inherently unacceptable. But it is notable that some controversial new technologies only surface publicly when they reach the patent office.

So what has happened when inventors have sought to patent transgenic animals?

Harvard’s oncomouse

Among the first transgenic animals to be produced was the oncomouse. Researchers at Harvard Medical School in the early 1980s produced a genetically modified mouse that was highly susceptible to cancer, by introducing an oncogene that can trigger the growth of tumors. The oncomouse (from the Greek word for tumor) was conceived as a valuable means of furthering cancer research. Harvard College sought patent protection in the United States and several other countries.

The case raised general ethical issues regarding transgenic technology in itself. But it also raised two key issues for the patent system:

* should patents be granted at all for animals or animal varieties, particularly for higher-order animals such as mammals, even if they do otherwise meet patentablility criteria (novelty, industrial applicability/usefulness, inventive step etc.)?

* how should moral implications be addressed in relation to specific cases, e.g. the question of suffering caused to the transgenic animal?

These issues have been resolved differently by the patent authorities of different countries, as the following examples illustrate.

United States - patent granted

The United States Patent Office in 1988 granted a patent no. 4,736,866 to Harvard College claiming "a transgenic non-human mammal whose germ cells and somatic cells contain a recombinant activated oncogene sequence introduced into said mammal…" The claim explicitly...