Recent advances in biotechnology have created many public policy and legal issues, one of the most significant of which is the treatment of biotechnological industrial products, particularly under the patent system. Patents represent one of several types of intellectual property; their ownership confers the right to exclude others from benefitting from the tangible products of a proprietary subject matter. Intellectual property law and its protections will play a major role in the rate at which biotechnology develops in the United States. In this article biotechnological intellectual property issues are reviewed in the context of their underlying legal requirements. The implications of other factors, such as international competition, research funding, and gene ownership, are also considered.
KIE: Legal ownership of industrial products of biomedical research is discussed as a question of intellectual property rights. Attention is focused on the major role played by the U.S. patent system in establishing such rights, as illustrated by the case of products of recombinant DNA research. Trade secret, copyright, and trademark protections are also considered, as are policy issues such as international competition in the development of biomedical technologies and financing arrangements.