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March 1997
The Message of the Mutant Mouse

By Molly Edwards

 

 

It began nearly 20 years ago when a patent was granted by the U.S. Patent Office to Anand Chakrabarty for a genetically-altered bacterium capable of degrading oil. The issue was appealed and in 1980 went all the way up to the Supreme Court which ruled, 5 to 4, that the bacterium was not a product of nature but a "human-made invention." In 1985, the U.S. Patent Office conferred patentable status on plants, seeds, and plant tissues, and two years later on "multi-cellular living organisms, including animals."

The following year, two researchers at Harvard University took out the first ever patent - number 4,736,866 -žon a living being: in this case, a mouse. The two researchers, sponsored by the chemical company du Pont, had altered the animal's genes through the process of recombinant DNA technology or, in layman's terms, "genetic manipulation." The resulting rodent was what is known as "transgenic" (the mixing of genes between different species to produce new entities), and carried a human breast cancer gene, or oncogene. The "oncomouse" (or more accurately OncoMouseó) has a predisposition to cancer; and, because the oncomouse has the ability to reproduce, any offspring spawned by this creature will have the same defective genetic make-up. Any products from the oncomouse are subject to royalty payments to the Charles River Biotechnology Services, Bausch and Lomb Co., Mass. In other words, the oncomouse is for sale: for anywhere from $50 to $195, (VISA or Mastercard accepted) one can choose between a variety of five oncomice with different genetically-imposed diseases.

Patent Law

In 1992, the oncomouse was accepted as a patentable being by the European Patent Office. Nevertheless, there has been resistance to the patenting of animals such as the oncomouse. The European Patent Office, for instance, received 17 formal legal oppositions to the patent. A bill to place a moratorium on the patenting of transgenic animals was introduced in the House of Representatives in 1988, but was killed in the Senate after committee members agreed that such a moratorium would damage U.S. scientific competitiveness worldwide.

In 1989, the Animal Legal Defense Fund sued the patent commissioner of the oncomouse. Still, at the end of several litigious battles, the patent remained legal. While the British and French have granted animal patents, the Danish parliament has prohibited them. The oncomouse is still under litigation in Canada because officials firmly believe that humans cannot patent life forms. After a 10 year investigation, the Canadian government denied a patent for the Harvard-produced rodents. The case has since been appealed to the Federal Court of Canada.

Designer Mice

The oncomouse is not alone as a genetically-altered mouse. There are at least five oncomice strains as well as something called an ImmortoMouseΠat Charles River Laboratory alone. Elsewhere, a strain of mouse - TIM or transgenic immunodeficient mouse - has been developed to carry certain aspects of the human immune system. These so-called "AIDS mice" are susceptible to getting HIV infection which normal mice are not. There are also about 200 so-called "knockout" mice, where, in an attempt to investigate the role of a particular gene, a gene is "knocked out" from the germ-line of the mouse. This means that the mouse's sperm and eggs don't have the gene and therefore the progeny of the mice do not have it either. Overall, scientists have genetically inflicted about 100 different diseases on specially-created mice.

According to a number of sources, results of research -žoften high profile - with genetically-altered mice have been mixed. Occasionally there seems to be no effect when the gene has been "knocked out," raising the question as to whether the gene is or is not important. The results are partly inconclusive because other genes seem to step in and take over for functions from genes that are missing.

One of the most disturbing features of the oncomouse is that the company that holds the patent on the rodent also owns patent rights on any animal infected with the oncogene. Therefore, hypothetically, species throughout the entire animal kingdom are possible oncogene recipients. Presently, only the mouse has been genetically altered in this fashion. But myriad opportunities exist to change that fact.

 


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