The U.S. Supreme Court announced its five-to-four decision that a live, human-made microorganism is patentable. The decision allowed emerging biotechnology companies to acquire patent protection for their living products and to capitalize on the revolution in genetic engineering.

The legal ruling in Diamond v. Chakrabarty was actually a narrow interpretation of patent law. Did Chakrabarty’s microbe constitute a “manufacture or composition of matter” within the meaning of the patent rules? Did Congress intend the patent rules to be liberal enough to include genetically engineered bacteria or conservative enough to completely exclude bacteria as the 1977 Plant Variety Protection Act implied? Wallace, Lawrence G.
McKie, Edward F., Jr.

Facts of nature, including physical laws such as Albert Einstein’s theory of relativity and Isaac Newton’s law of gravity, were not patentable. They were considered to be “free to all and reserved exclusively to none.” Naturally occurring living organisms were also not patentable. In Funk Brothers Seed Company v. Kalo Inoculant Company (1948), Funk Brothers Seed Company v. Kalo Inoculant Company (1948) the Supreme Court had ruled that simply finding useful bacteria in nature and producing an inoculum from them was not patentable. Chakrabarty’s microbe, however, was genetically engineered. An individual bacterium might have some of the properties found in his microbe, but no single bacterium had all of the properties in his microbe. This made Chakrabarty’s living organism unique.

The Supreme Court knew the impact that its decision would have on biotechnology; however, it rejected arguments against patenting the organism based on the potential hazards of genetic research. These were congressional and executive, but not judicial, concerns. As far as the Supreme Court was concerned, “whether [Chakrabarty’s] claims were patentable might have determined whether research efforts were accelerated by the hope of reward or slowed by want of incentives but that was all.” It was not up to the courts to debate the potential ecological damage of releasing or creating genetically engineered organisms. As it turned out, the debate over the potential ecological damage of releasing or creating genetically engineered organisms became a greater burden to the use of biotechnology than to the patenting of biotechnology products.

Scientists themselves considered the possibility that genetic engineering presented biological and ecological hazards. During the Asilomar Conference in California in 1975, scientists composed a set of self-imposed rules for doing research. The National Institutes of Health (NIH) approved a less restrictive set of rules for the performance of research in genetic engineering in 1979. Genentech, a biotechnology company, made Wall Street history in 1980 when its stock rose from thirty-five dollars to ninety-five dollars per share after trading for only thirty minutes. The new age of biotechnology looked as if it had arrived. Its promise, however, was not realized in the 1980’s.

Genetically engineered or patented organisms had to be released before they could be marketed. Legal action by activists such as Jeremy Rifkin in the United States and the ecologically oriented Green Party in Germany effectively stopped scientists from releasing genetically engineered organisms until the close of the 1980’s. Environmental activists often vandalized experiments with genetically engineered organisms. In 1987, Earth First! Earth First! activists damaged research plants in Northern California treated with genetically engineered bacteria that reduced frost damage. In 1989, activists destroyed a plot of genetically engineered potatoes in the Netherlands.

In 1985, the federal courts ruled that private companies did not require NIH approval to field-test genetically engineered organisms. Biotechnology companies, however, still needed approval from the Environmental Protection Agency Environmental Protection Agency;genetically altered organisms (EPA), which treated the release of genetically engineered organisms in the same manner as the release of other substances. Consequently, the regulatory steps that the EPA established to ensure safe release became expensive obstacles for biotechnology companies.

Genetically engineered products eventually appeared in the world market. Nogall, a genetically engineered bacterium used as a pesticide, went on sale in Australia in 1989. Several plant and animal products containing genetically engineered material were available to the public by the mid-1990’s, including milk from cattle that had been treated with recombinant bovine somatotropine (rBST), a hormone that enhances milk production; plants that contained genetic information for a natural toxin (from the Bacillus thuringiensis bacterium) that made the plants resistant to caterpillar damage; tobacco plants infected with a virus that gave the plants greater resistance to further viral infection; and the Flavr Savr tomato, Flavr Savr tomato produced by Calgene, Incorporated, Calgene, Incorporated of Davis, California, which remained firm while ripening on the vine because it had recombinant genetic material inhibiting the enzyme that causes tomatoes to soften.

Patenting Chakrabarty’s original organism was easier than using it in the natural environment. Many people believed that opportunities to use even naturally occurring oil-degrading microorganisms were so limited that the time and expense required to make a genetically engineered microbe to carry out the same tasks were not worth the effort and were unnecessary. Chakrabarty’s patented bacterium proved no more effective than simple mixtures of organisms used to break down oil and was never field-tested. The effects of major oil spills at sea, such as those of the Amoco Cadiz in 1978 and the Exxon Valdez in 1989, were treated through the inoculation of the oil with mixtures of oil-degrading organisms and the addition of fertilizer to enhance the growth of naturally occurring organisms. Supreme Court, U.S.;patent rights
Patentability;microorganisms
Microbiology
Genetic engineering

• Dayan, Anthony, Peter Campbell, and Thomas Jukes, eds. Hazards of Biotechnology: Real or Imaginary. New York: Elsevier Applied Science, 1988. The scientists’ perspective: advanced and technical. The first chapter is in favor of biotechnology. The second chapter presents a more balanced approach to the ecological consequences of biotechnology. The remaining chapters deal with specific cases.
• Gibbs, Jeffrey, Iver Cooper, and Bruce Mackler. Biotechnology and the Environment: International Regulation. New York: Stockton Press, 1987. Regulatory aspects of biotechnology from around the world are useful for understanding some of the restrictions that inhibit the development of biotechnology.
• Lappé, Marc. Broken Code: The Exploitation of DNA. San Francisco: Sierra Club Books, 1984. Takes a restrained approach to the uses of biotechnology. Somewhat more balanced than Rifkin’s book.
• Rifkin, Jeremy. Algeny. New York: Viking Press, 1983. Conversational, philosophical, and totally opposed to the idea of biotechnology. A good contrast to the other reference selections.
• U.S. Congress. Office of Technology Assessment. Bioremediation for Marine Oil Spills. Washington, D.C.: U.S. Government Printing Office, 1991. Offers a nontechnical description of bioremediation and its use in environmental cleanup. Focus on the Exxon Valdez oil spill is particularly relevant.
• Wade, Nicholas. The Ultimate Experiment: Man-Made Evolution. New York: Walker, 1977. Very good source of information about the early days of biotechnology. Deals in a nontechnical manner with the restrictions imposed on scientists (and imposed by scientists themselves) when the first genetic engineering experiments were run. Reveals the decisiveness with which the science community first approached genetic engineering and biotechnology.
• Winston, Mark L. Travels in the Genetically Modified Zone. Cambridge, Mass.: Harvard University Press, 2002. Balanced work based on the author’s discussions about genetically modified organisms with government officials, farmers, and activists in Canada, the United States, and Europe.
• Witt, Steven. Biotechnology, Microbes, and the Environment. San Francisco: Center for Science Information, 1990. Short, balanced primer on biotechnology and microorganisms. Presents the process and problems of biotechnology in easily understood terms. Includes summaries and illustrations.

Genentech Is Founded

Berg, Gilbert, and Sanger Develop Techniques for Genetic Engineering

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

Patent Is Granted for Genetically Engineered Mice

Genetically Engineered Rabies Vaccine Is Released

Genetically Engineered Food Reaches Supermarkets