March
1997
The
Message of the Mutant Mouse
By Molly Edwards
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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 ImmortoMouseŒ at
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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