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Global Dimensions of Intellectual Property Rights in Science and Technology
quences of a variety of genes; the proteins coded for and produced by these genes, however, have not yet been isolated and their function is unknown without further research. Admittedly, the utility requirement for granting a patent is not satisfied. Nevertheless, a cautious lawyer would wonder exactly what additional steps would be necessary (by the sequencer or by someone else) before patentability becomes possible and, in the face of this legal uncertainty, might wonder whether it would be malpractice not to file an immediate application.
The problems just identified are likely to change over the coming years. At some point, cloning and sequencing procedures will be regarded as obvious rather than novel, so that rights, if any, will be more likely to go to the discoverer of a pharmacologically active substance than to its cloner. The human genome project will move most human and some nonhuman research toward a pattern in which the researcher begins with a sequence and then looks for therapeutic activity (which may, in some cases, be suggested by the sequence's location on the gene). Because the sequence is known, it is obvious, and because the protein is directly coded, it may be obvious as well. Hence, the protein may be unpatentable (although its three-dimensional folding pattern may be difficult enough to reconstruct to provide a basis for nonobviousness). Sooner or later, the focus of biotechnology will move past natural proteins. Agricultural biotechnology has long been concentrating on transgenic plants and animals rather than therapeutic products; human biotechnology will probably look for new products not found in nature and for new ways to use them.
The fact that living organisms are involved in biotechnology (and especially in agricultural biotechnology) poses a different group of questions. Some are ethical. Some are technical—for example, defining the appropriate scope of intellectual property protection. The obvious example of such a technical question is whether a patent should be regarded as reaching the progeny of a patented life form. By traditional law, the seller of a patented item exhausts his or her rights in the item, so that the buyer is entitled to use it as he or she sees fit. By definition, however, the reproduction of a patented article is an infringement of the patent. Clearly, this is a logical standoff between two traditional doctrines that can only be resolved by a policy analysis exploring the economic and innovation incentives of the two alternatives. That policy analysis might reach one result for a yeast, which has to be multiplied for many generations as part of a single fermentation application, and a different result for a chick bred for sale for meat production.
Outline of Solutions, Thus Far
The intellectual property community has worked extensively—but almost entirely autonomously—in an effort to face these issues. It was a U.S.