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4. Issues Posed by the New Mouse Genetics, and Possible Solutions
Pages 21-38

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From page 21...
... Within the scientific community, a major focus of concern about the granting of patent protection of animals has been scientific access to and exchange of research materials. The principal inventor of the oncomouse is Philip Leder, who was appointed to the faculty of Harvard University Medical School in 1981.
From page 22...
... During the next 2 years, exploiting the transgenic technology developed by Gordon and Ruddle, Leder and his collaborators developed the oncomouse by inserting the MYC oncogene attached to a specific promoter into the embryo of a normal mouse. The promoter is a mouse mammary-tumor viruspromoter that is expressed directly in breast epithelial cells, and mice with this oncogene reproducibly develop breast cancer.
From page 23...
... When Charles River Laboratories began talking to DuPont in 1988 about supplying the oncomouse, all the ingredients for success seemed to be present: the involvement of Harvard and DuPont, the first patent of an animal, a commodity labeled the "product of the year" by a major financial magazine, and the opportunity to distribute the animals worldwide. At the beginning, the oncomouse was a small part of the DuPont plan for a large biotechnology group that would sell reagents and develop other mouse models.
From page 24...
... That saved the original investigator much time and money that would have been required for breeding and shipping. There is a small market for genetically altered mice in the experience of the Jackson Laboratory.
From page 25...
... Given the picture of unpromising profits and a small market for transgenic mice that are essentially resources for a research laboratory, one participant mused, "Why would anybody ever go to the trouble and expense of making any of these mice available to anybody? " But with government encouragement of commercialization through Bayh-Dole and other means, a Patent Office that looks favorably on applications for patents of living things, and the increasing need to seek research funds from new sources, investigators and their universities might continue to harbor expectations that their mouse is a"million-dollar" bonanza.
From page 26...
... 26 Sharing Laboratory Resources ..
From page 27...
... The distribution of genetically altered mice is not as simple a matter as distributing cell lines or yeast strains, which investigators can do on their own with minimal interference with their research. If the involvement of private firms is needed, do private firms that develop or distribute genetically altered mice need patent rights to make these activities profitable?
From page 28...
... Because of their unique characteristics and requirements, genetically altered mice are more expensive to produce than normal strains. Economy-ofscale problems are associated especially with the production of rare strains.
From page 29...
... Possible Solutions: Advantages and Disadvantages of Different Distribution Options Those who make the mice available include the individual investigators who share the mice that they have developed; companies that have traditionally marketed specialty mice, such as Charles River Laboratories; biotechnology companies that may see transgenic mice intended for laboratory research as a sideline to other interests; not-for-prof~t organizations such as the Jackson Laboratory; and government research organizations such as the National Institutes of Health. Conditions of availability and motivating philosophies differ among them.
From page 30...
... For example, about 75°/0 of the mice that the Jackson Laboratory import either are actively infected with a mouse virus or are serologically positive for antibody against viruses. At least half the mice that come in show evidence of prior hepatitis virus infection.
From page 31...
... Furthermore, although many researchers are willing to share their resources, few are in a position to be or would wish to be seen as a primary resource for the distribution of laboratory animals. For-Profit Organizations Companies that maintain and distribute laboratory animals must, as a good business practice, produce a high-quality product and make it conveniently available (see Box 4.2 for two examples of firms that produce transgenic mice)
From page 32...
... 32 Sharing Laboratory Resources ..
From page 33...
... A national repository could be an entirely new entity or could be based at an existing organization that would already have the necessary facilities and expertise. Individual investigators might have more confidence in an existing facility operated by scientists who have been investigators themselves and might feel that it would be sympathetic to the tradition of sharing.
From page 34...
... :-: -- -- :. With enlargement of its facility, NIH might itself serve as a national repository for genetically altered mice.
From page 35...
... Individual investigators might provide the most rapid initial distribution of new strains, but costs and logistical problems severely limit the utility of this approach. Commercial firms might provide the most convenient and least expensive service for commonly used strains, but they might not be able to provide rare strains, and they might require restrictions on use of breeding to protect profitability.
From page 36...
... Investigators who had many different lines of transgenic mice in colonies could, with little expense and effort, start freezing their embryos to prevent loss by genetic or microbial contamination. Cryopreservation of embryos, although effective, is not the most efficient means of preserving genetic material.
From page 37...
... TBASE has undergone several schema revisions since it began, but the current schema appears to capture this rapidly moving field fully, and it is expected to remain stable. To accommodate the rich cross-links necessary in genetic databases, the current TBASE schema contains a number of links to other databases, including the Human Genome Data Base, Online Mendelian Inheritance in Man (OMIM)
From page 38...
... The second method of data acquisition is the processing of direct submission fortes, which consist of paper and electronic entry forms and templates. Appropriate paper entry forms have been designed for each of the three major TBASE object classes-Laboratory, DNA Construct, and Transgenic Line-closely following the format that is reflected by the recently revised schema.


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