The patenting of prototype research animals greatly expanded their availability, accelerated the creation of lifesaving products, and improved U.S. positions in biotechnology markets.

In May of 1988, the U.S. Patent and Trademark Office Patent and Trademark Office, U.S. decided to grant the coinventors of a prototype animal the patent number 4,736,866. The subject matter of the patent was a genetically engineered mouse that generates cancer spontaneously. This “transgenic” mouse, marketed under the brand name OncoMouse, was the first of a specialized breed that provided faster and more reliable screening models for research and development. Genetic engineering;animals
OncoMouse[Oncomouse]
Patentability;animals
Transgenic animals
Biotechnology
[kw]Patent Is Granted for Genetically Engineered Mice (May, 1988)
[kw]Genetically Engineered Mice, Patent Is Granted for (May, 1988)
[kw]Mice, Patent Is Granted for Genetically Engineered (May, 1988)
Genetic engineering;animals
OncoMouse[Oncomouse]
Patentability;animals
Transgenic animals
Biotechnology
[g]North America;May, 1988: Patent Is Granted for Genetically Engineered Mice[06790]
[g]United States;May, 1988: Patent Is Granted for Genetically Engineered Mice[06790]
[c]Business and labor;May, 1988: Patent Is Granted for Genetically Engineered Mice[06790]
[c]Trade and commerce;May, 1988: Patent Is Granted for Genetically Engineered Mice[06790]
[c]Health and medicine;May, 1988: Patent Is Granted for Genetically Engineered Mice[06790]
Leder, Philip
Stewart, Timothy A.

The mouse, also known as the Harvard Mouse, was developed at Harvard University by Philip Leder and Timothy A. Stewart, who conducted research for the medical school, where Leder served as the chair of the department of genetics and Stewart was a postdoctoral fellow. Their work was primarily concerned with fundamental problems in genetics, particularly in the area of cancer (oncogenesis). They made a successful attempt in the early 1980’s to isolate a suspect gene, one of the so-called oncogenes. Oncogenes To prove that the gene could actually cause cancer in a living organism, they invented a transgenic mouse that was prone to cancer. Cancer;genetics

The patent office was faced with a unique and perplexing question when Leder and Stewart applied for a patent. Should it permit the inventors of transgenic mice protection under the law by granting them patents? In an April 3, 1987, ruling and a single-page memorandum titled “Animal-Patentability,” published on April 21, 1987, the patent office interpreted the law to authorize patents on transgenic animals. “Animal-Patentability” (U.S. Patent and Trademark Office)[Animal Patentability]

The patent office relied on the decision reached by the U.S. Supreme Court in the case of Diamond v. Chakrabarty
Diamond v. Chakrabarty (1980) (447 U.S. 303, 1980), which held that Congress intended to include all discoveries and inventions as patentable. The subject matter of this decision was a bacterium genetically engineered to break down crude oil. The Harvard researchers’ mouse was thus considered to have the same legal status as other nonnaturally occurring “manufactures” and “compositions of matter,” which are considered patentable under U.S. law.

A patent protects an invention for a period of seventeen years. Patent protection Patent laws usually give a patent holder the right to bring legal action against individuals who attempt to use or infringe on the invention or discovery without consent. In the United States, this right is guaranteed under the U.S. Constitution by the application and interpretation of Article I, section 8. Congress has the authority to promote the progress of science and useful arts by securing to authors and inventors, for limited times, the exclusive right to their respective writings and discoveries.

Patent protection differs across the global market. In many countries that have laws requiring the registration of patents, the first to register becomes owner. The International Convention for the Protection of Industrial Property, International Convention for the Protection of Industrial Property of which the United States is a member, attempts to provide international protection by requiring registration of patents only within the patent holder’s country.

Although the patenting of prototype animals is a contemporary issue, it took many years for scientists to acquire the skills necessary to create transgenic animals. The concept originated in 1865, when Gregor Mendel, Mendel, Gregor before a gathering of scientists, presented details that led to the unlocking of the mystery of heredity. Mendel’s experiments, which used common peas to show the passing of physical traits from one generation to the next, constituted the inception of modern genetics.

In 1973, a team of researchers successfully transferred a gene from a mammal into a bacterium. The bacterium followed the foreign gene’s instructions, resulting in the first successful cloning of a gene. By the end of the twentieth century, hundreds of scientific papers had been published describing strains of transgenic animals with symptoms of diseases ranging from arthritis to obesity. Thousands of varieties of mice with brand names such as MutaMouse were developed to provide models for testing treatments.

All organisms begin life as single cells. In multicellular organisms such as humans, numerous divisions of the original fertilized egg lead to a remarkable degree of cellular organization and complexity. New cells originate from other living cells. The dividing cell is called a mother cell, and its descendants are called daughter cells. The mother cell transmits copies of its hereditary information to the daughter cells through deoxyribonucleic acid (DNA). By studying the structure of DNA, Recombinant DNA technology genetic engineers learned how they could manipulate DNA to construct organisms with desirable combinations of traits. The method is called gene splicing or DNA recombination.

Most techniques of genetic engineering require that the gene for the desired trait be isolated and then introduced into the organism being engineered. DNA recombination stabilizes the new gene so that it becomes a permanent part of the recipient’s genetic library. Thus, through cell division with the modified DNA, a new animal with the desired traits is created.

The potential research applications for transgenic animals are many, and demand quickly grew. After receiving the patent on their transgenic mouse, Leder and Stewart assigned ownership of the patent to their employer, Harvard University, which then licensed the invention to the Du Pont Corporation. Du Pont Corporation[Dupont Corporation];OncoMouse[Oncomouse] OncoMouse was produced at Du Pont’s Charles River Laboratories Charles River Laboratories and then distributed to laboratories engaged in developing diagnostic tests and therapies for breast cancer.

Most biotechnology products come from multifaceted networks of companies rather than from the sort of integrated, vertical organizations that are conventional in most industries. The biotechnology industry is markedly specialized: One company’s expertise may be in researching science-based products, another may handle clinical trials or develop initial plants for production, and still others market the products. Partly as a result of these innovative networks, animal breeding laboratories such as Charles River Laboratories, Hazleton Research Products, Hazleton Research Products and Stratagene Cloning Systems Stratagene Cloning Systems became market-driven and highly competitive. The variety of transgenic mice (touted as “designer mice”) increased at a remarkable rate. Researchers in California created a mouse that carries the gene for beta-amyloid protein. The mouse forms brain deposits that characterize Alzheimer’s disease, a degenerative disorder. At Lawrence Berkeley Laboratory, Lawrence Berkeley Laboratory scientists invented a mouse protected from cardiovascular disease by an implanted gene that produces “good” cholesterol.

One impact of the availability of transgenic animals lies in the potential cost savings to industries that utilize animals. Consider the advantages to be gained from the use of the transgenic mouse distributed as MutaMouse, MutaMouse[Mutamouse] which was developed in the Netherlands by TNO Laboratories and is marketed in the United States by Hazleton Research Products. MutaMouse contains a transplanted gene that does not instantly affect it. After the mouse is exposed to a specific disease and dies, researchers extract the foreign gene to determine whether the gene has mutated. The 1969 test used to determine whether the artificial sweetener cyclamate was a cancer-causing agent required more than three hundred laboratory rats and took more than two years to complete. If MutaMouse had been available at the time, only thirty mice would have been needed, and the test would have taken approximately two weeks.

As the new generation of biotechnology drug research companies began using transgenic mice, the change placed substantial pressure on pharmaceutical companies. Collaborative efforts between the two industries have been minimal, possibly because drug researchers for pharmaceutical companies are primarily chemistry specialists, whereas genetic engineers come predominantly from the biology fields. Chemistry researchers rely on a hit-or-miss screening process for thousands of compounds; only about one in ten thousand such trials will produce a marketable product. Genetic engineers, in contrast, generally attempt to isolate large protein compounds, with one of every ten trials proving successful. A biotechnology company can produce a marketable drug for less than half the money it costs to discover a chemical drug.

Small enterprises such as Amgen, Centocor, Genentech, Genzyme, and ImmuLogic became the biotechnology industry’s leaders, attracting talented management and serious financial support. Executives from large pharmaceutical companies such as SmithKline, Squibb, Abbott Laboratories, and Bristol-Myers relinquished relatively secure positions to lead these firms. Further, biotechnology stocks reached record highs on the stock exchanges.

High-technology enterprises tend to make their own products obsolete by inventing superior ones and granting licenses to anyone interested, including competitors. It seemed possible that this strategy would become routine in the biotechnology industry.

The need for biotechnology firms to bring new products into the marketplace rapidly created conflicts with some U.S. laws. These conflicts held the potential to have significant effects on the industry’s ability to generate profits or even to survive. Most biotechnology firms were small and were established in connection with particular drugs or therapies, and, like all small businesses, they faced difficulty surviving in an increasingly competitive industry. Still, the numbers of firms continued to grow, and the profitability of the biotechnology sector continued into the twenty-first century.

With the growth of the biotechnology industry, some gene-splicing activities drew concern from the American public and from animal-rights advocates in particular. In one instance, researchers effectively transferred human genes into mice. In another, a failed attempt was made to transfer a human growth-hormone gene to pigs to make them leaner and larger for the production of pork. The U.S. government came under pressure to set limitations on such experiments, but several attempts by Congress to impose moratoriums on the patenting of animals proved futile. The Transgenic Animal Patent Reform Act of 1989, Transgenic Animal Patent Reform Act (1989) however, successfully placed limitations on the transplanting of human genes by preventing the patenting of human beings. During congressional subcommittee hearings on the act, John Hoyt, the president of the Humane Society of the United States, rebuked the patent office for its decision to grant patents on animals. Genetic engineering;animals
OncoMouse[Oncomouse]
Patentability;animals
Transgenic animals
Biotechnology

• Bailey, Ronald. “Thoroughbred Mice.” Forbes, June 25, 1990, 138-139. Offers an excellent analysis of the practical advantages associated with the transgenic mice industry.
• Brum, Gil D., Larry McKane, and Gerald Karp. Biology: Exploring Life. 2d ed. New York: John Wiley & Sons, 1994. Basic textbook devotes some attention to explaining, on a basic to intermediate level, the processes involved in genetic engineering. Includes illustrations, bibliography, and index.
• Bylinsky, Gene. “Biotech Firms Tackle the Giants.” Fortune, August 12, 1991, 78-82. Presents an informative view of the business environment that is affiliated with the new generation of biotechnology drug research companies.
• Crabb, Charlene. “Of Mice and Men: Tinkering with Rodents to Probe Heredity’s Mysteries.” U.S. News & World Report, November 4, 1991, 70. Describes the various types of transgenic mice being developed.
• Harris, Charles E., Jr. Applying Moral Theories. 3d ed. Belmont, Calif.: Wadsworth, 1997. Provides a concise and understandable discussion of four major ethical theories. Includes bibliography and index.
• McKelvey, Maureen. Evolutionary Innovations: The Business of Biotechnology. New York: Oxford University Press, 1996. Examines the commercial development of biotechnology. Features figures, bibliographic references, and index.
• Peters, Tom. Liberation Management: Necessary Disorganization for the Nanosecond Nineties. New York: Alfred A. Knopf, 1992. Presents well-researched information on the cutting edge of marketing trends and modern organizational structures in U.S. enterprises at the end of the twentieth century.
• Wheale, Peter R., René von Schomberg, and Peter E. Glasner, eds. The Social Management of Genetic Engineering. Brookfield, Vt.: Ashgate, 1998. Collection of essays addresses the social aspects and ethics of genetic engineering in humans. Includes bibliographic references and index.

Genentech Is Founded

Berg, Gilbert, and Sanger Develop Techniques for Genetic Engineering

U.S. Supreme Court Grants a Patent for a Living Organism

Geneticists Create Giant Mice

Eli Lilly Releases the First Commercial Genetically Engineered Medication

FDA Approves a Genetically Engineered Vaccine for Hepatitis B

Genetically Altered Bacteria Are Released into the Environment

Genetically Engineered Rabies Vaccine Is Released

Genetically Engineered Food Reaches Supermarkets