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Of mice & money: the story of the world''s first animal patent.

Publication: Daedalus
Publication Date: 22-MAR-02
Format: Online
Delivery: Immediate Online Access

Article Excerpt
In April of 1988, the United States Patent and Trademarks Office issued the first patent on a living animal in the history of the world's patent systems. Awarded to Harvard University, the patent covers a laboratory mouse that one of its scientists had genetically engineered to be to cancer....

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...supersusceptible The Patent Office's adventurousness gratified biotechnologists, but it also disquieted many clerics. The World Council of Churches attacked animal patenting, declaring that it "removes the distinction between life and nonlife" and admonishing that "the gift of life from God... should not be regarded as if it were a chemical product." Other critics warned that animal patenting would spread beyond the laboratory to agriculture, where it would work harmful economic effects. The Patent Office, they said, had been high-handed in expanding the scope of patent protection to higher life forms on its own. So controversial a policy initiative was properly a matter for Congress. (1)

In a congressional hearing on genetically engineered animals the year before, Congressman Mike Synar, a wry Democrat from Oklahoma, remarked that few lawyers knew anything about patent law. "Everyone knows it is not part of the bar exam, so to hell with it." (2) But like many other branches of law -- in the areas of, for example, business, regulation, and civil rights -- patent law is also a branch of political economy. And in recent years, the part of it that concerns the patenting of life, especially animals and genes, has also become, for the first time, a branch of ethics.

What is patentable according to statute dates back to the patent law of 1793, which declared, in language written by Thomas Jefferson, that patents could be obtained for "any new and useful art, machine, manufacture, or composition of matter, or any new or useful improvement thereof." Jefferson's phrasing remained -- and remains -- at the core of the u.s. patent code, except for the eighteenth-century word "art," which was replaced in a 1952 congressional overhaul of patent law by the word "process." (3)

The code said nothing about patenting life, but a key precedent discouraging it was established in 1889, when, in a landmark ruling, the u.s. commissioner of patents rejected an application for a patent to cover a fiber identified in the needles of a pine tree. He noted that ascertaining the composition of the trees in the forest was "not a patentable invention, recognized by statute, any more than to find a new gem or jewel in the earth would entitle the discoverer to patent all gems which should be subsequently found." The commissioner added that it would be "unreasonable and impossible" to allow patents upon the trees of the forest and the plants of the earth. (4)

The commissioner's ruling formed the Of basis of what came to be known as the money "product of nature" doctrine -- that while processes devised to extract what is found in nature can be patented, objects discovered there cannot. They are not inventions, nor can they as a class be made anyone's exclusive property. In the Plant Patent Act of 1930, Congress granted patentability to one class of living products: plants that could be reproduced asexually. There was no other extension of patent law to vital entities for forty years, but then along came Ananda Chakrabarty, a biochemist at the General Electric Company, who in 1972, having bio engineered a bacterium to consume oil slicks, filed for a patent on the living, altered bacterium.

The U.S. Patent Office denied him a patent, arguing that no patent could be issued on a living organism, not least because it was a product of nature. Chakrabarty appealed his case through the courts, and at the end of 1979 it reached the United States Supreme Court under the rubric of Diamond v. Chakrabarty, in recognition of the fact that the position of the Patent Office was formally defended by Sidney Diamond, the current patent commissioner.

By the time the case arrived at the Court, it had become highly charged by the social and economic stakes that surrounded the swiftly accelerating commercialization of molecular biology. In the 19705 the new techniques of recombinant DNA were beginning to be exploited by adventurous startups such as Genentech. Companies were being founded at a rapid pace, while major pharmaceutical firms as well as several oil and chemical giants were plunging into work with recombinant DNA, initiating research programs of their own, giving research contracts to the startups, and even obtaining an equity interest in some of them. Biotechnology firms and firms eager to get into biotechnology sought connections with universities. In return, the universities could expect dividends from the biotechnology industry in the form of gifts, research grants, and license fees for the use of patents covering the valuable research products of their laboratories.

Chakrabarty had not used the technique of recombinant DNA to engineer his oil-eating bacterium, but the issue his case raised - the patentability of living organisms -- spoke directly to the rapidly increasing stake in biotechnology patents. Ten amicus briefs were filed in the case. Most supported Chakrabarty and came from economically interested organizations including Genentech, the Pharmaceutical Manufacturers Association, the American Patent Law Association, the New York Patent Law Association, and the American Society for Microbiology. The University of California also submitted a friend-of-the-court brief. It...

NOTE: All illustrations and photos have been removed from this article.



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