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OncoMouse: The Mouse That Disrupted Science

OncoMouse

In 1988, the US Patent Office awarded for the first time in history a patent for an animal to the Harvard University. The U.S. Patent Number 4736866 was for a small genetically engineered mouse, white and furry, with red beady eyes. His name was OncoMouse.

OncoMouse’s creators scientists Philip Leder and Timothy Stewart, however, had not created a better mouse. On the contrary, it was much worse. The Harvard scientists had genetically modified the mouse to make it highly susceptible to cancer, in the hope that this trait would make the mice useful test subjects for cancer research. The researchers created the mice by injecting known cancer genes into mouse embryos just after fertilization. The genetic modification not only made the mice prone to cancer, but also ensured that they would pass the cancer genes to their offspring, thus guaranteeing a continued supply of test subjects.

OncoMouse is what scientists call a “mouse model”—special strain of mice used to study a particular human disease or condition. Mouse models are the foremost research tool for studying human disease and human health. Mice share more than 95% of our DNA, which means that many diseases, including Alzheimer’s, diabetes, obesity, heart disease, and cancer, affect humans and mice in similar ways allowing scientists to study these diseases and how they might be treated in humans.

To enhance research, mice are genetically modified to make them more vulnerable to a particular disease. Researchers have created mice that develop breast cancer and diabetes. They have created mice with compromised immune systems to study cell transplantation strategies, AIDs, leukemia, etc., and mice that eat themselves to obesity. There are also so-called “humanized mice” carrying functioning human genes, cells, tissues, and even organs, so that scientist can test drugs and vaccines.

obese mouse

A mouse, genetically engineered to be obese, sits next to a healthy mouse.

OncoMouse was not the first model mouse to be created, but it was the first mammal to be patented. It wasn’t even the first time a life-form was patented. In the early 1970s, Ananda Mohan Chakrabarty, a genetic engineer working for General Electric, developed a new species of bacteria capable of breaking down crude oil, which he proposed as a mean to cleanup oil spills. At the time, four naturally occurring species of oil-metabolizing bacteria were known to exist. Chakrabarty’s modification produced a superior breed capable of digesting oil up to two orders of magnitude faster than the previous four strains.

Chakrabarty filed for a patent, but the patent office denied him because it involved a living organism. The case then went to the United States Supreme Court leading to a historic verdict. Ruling in favor Prof. Chakrabarty, the highest court of the country stated that “the fact that micro-organisms are alive is without legal significance for purposes of the patent law.”

A year after the decision, in 1981, the patent was granted, setting into a motion a long and drawn-out debate into the ethics of patenting life.

In an interview in 1987, OncoMouse’s creator Philip Leder remarked:

What really received a lot of publicity wasn’t the fundamental science that was generated by creating these animal models, but the fact that they were patented and that was grist for a lot of cartoonists mills...It’s both amusing of course and also ominous when you when you think about it…

The OncoMouse research was funded by the American chemical company DuPont, and the rights to the invention thus went to it. Many academics feared that DuPont would try to profit from the mouse and impose restriction over its use which would be harmful for science. And DuPont did exactly that. First they put a price on the mouse—$50 a piece, which was ten times the price Jackson Laboratory charged. Jackson Labs is a biomedical research institution and one of the world’s largest source of genetically modified mice. They already had OncoMouse in their repository, before the patent, for four years. To prevent researchers from getting an OncoMouse for free from a colleague, DuPont barred anyone from sharing an OncoMouse with another. DuPont also insisted upon royalties should any commercial breakthroughs be made using the Oncomouse.

dupont

But that was not all. DuPont tried to claim ownership of all genetically engineered mice bred for increased incidence of cancer, no matter when, who or how it was made. Leder and Stewart weren't the only guys with the big brains. In fact, two other geneticists, Ralph Brinster and Richard Palmiter had made their own “OncoMouse” two years before the Harvard scientists made theirs. According to the scope of the patent, those belonged to DuPont too, and any future mice researchers invented.

The research community became enraged and tried to negotiate with DuPont. Many scientists openly rebelled by distributing OncoMice. Eventually, DuPont agreed to allow researchers free use of the mice as long as they weren’t commercializing their work.

Ironically, at the same time that they were protesting DuPont’s patent enforcement, many scientists were patenting their own work. They realized that patents were the only way forward, because academics needed funds and without giving a private organization the right to profit, those funds were not forthcoming.

In 2005, the OncoMouse patent expired. DuPont tried to extend the patent, but the courts ruled against them. New technologies had made the OncoMouse obsolete anyway, so it didn’t matter. But the way the scientific community conducted research changed forever. The boundary between academic and commercial worlds became blurred as universities became more focused on profit. The joke that runs among academic circles is that Harvard is a hedge fund with a research university attached to it.

Many members of the public today distrust scientists and pharmaceutical companies accusing them of profiteering in the expense of human health. Others believe that for-profit companies are hampering research by holding dearly to their patents.

Harvard still regrets the way they handled the OncoMouse patents, giving DuPont these rights without protecting the research community.

“I think the lesson for the commercial companies was that Harvard became the poster boy for not how to handle a patent on a research tool. They got lots of bad publicity,” David Einhorn, House Counsel of Jackson Laboratory told Science History Institute.

“They made very little money on the patent. And I think that was a message for the commercial world not to overreach.”

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