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Patenting Genes

Patent Requirements, The Patent Process

A patent is a legal right granted by the government that gives the patent-holder the exclusive right to manufacture and profit from an invention. While naturally occurring substances in their natural form are not patentable, a very wide range of biological materials have been the subject of patents. In 1980 the U.S. Supreme Court decision in Diamond v. Chakrabarty indicated that "anything under the sun made by man" is patentable. Under certain conditions, patent protection is available for genetic information, plants, non-human animals, bacteria, and other organisms.

For naturally occurring substances, patent protection can only be obtained if someone has changed the substance so that it is no longer the same as it is found in nature. For genes, this means that the particular gene of interest must be isolated from other genetic material, such as a chromosome. Although the Chakrabarty decision involved bacteria that were modified using recombinant DNA technology, this case has been viewed as mandating the patentability of other living organisms; nonnaturally occurring, nonhuman multicellular organisms such as transgenic animals, genetic materials, and purified biologically produced compounds such as enzymes. Other cases, such as the 1977 In re Application of Bergy and 1979's In re Kratz, have provided further support for the patentability of various biological materials, including cells, proteins, and organisms.

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Medicine EncyclopediaGenetics in Medicine - Part 3