The race to patent genes and their protein products in the life sciences began in the late 1970s, with the cloning of genes, the products of which had the potential to be therapeutic products themselves. In that sense, the early patenting of genes encoding proteins such as human insulin, growth hormone, and factor VIII was analogous to the patenting of chemical drugs. To distinguish DNA from a naturally occurring product, the claims of the DNA patents specified recombinant materials, the processes for producing the protein in bacterial or yeast cells, and the material in a form that was “purified and isolated.”

In the early 1980s, a series of judicial and administrative decisions clarified patent law, although the statute describing patentable subject matter did not change. In Diamond v. Chakrabarty, the Supreme Court by a 5-to-4 vote confirmed:

  1. that Congress intended patentable subject matter to “include anything under the sun that is made by man” (here the Court quoted from the legislative history of the 1952 Patent Act, the current basic patent law);

  2. that “the laws of nature, physical phenomena, and abstract ideas have been held not patentable”; and

  3. that “the patentee has produced a new bacterium with markedly different characteristics from any found in nature and one having the potential for significant utility. His discovery is not nature’s handiwork, but his own; accordingly it is patentable subject matter under §101 [of the Patent Act].”

Thus, the Supreme Court ruled that a living, genetically altered organism may qualify for patent protection as a new manufacture or composition of matter. In fact, in spelling out its 1980 decision in Chakrabarty, the U.S. Supreme Court used much the same definition of patentable subject matter that had been in place since Thomas Jefferson wrote the Patent Act of 1793.

The United States and many other countries already allowed the patenting of products of nature in an isolated and purified state, when their purification led to a new use for that material. Domestic and international patent policies treated DNA sequences as “compositions of matter,” much like any other chemical formulae. Thus, the areas of biological discovery emerging from the HGP and related efforts—from gene sequences to proteins—are potentially patentable subject matter as long as the invention meets the standard criteria of novelty, utility, and nonobviousness, describes the invention (“written description”), and provides sufficient detail to enable others “skilled in the art” to make and use the invention (“enabling disclosure”). The “enabling disclosure” requirement mandates the creation of an instructional map that a practitioner in the inventor’s field can follow to create and use the invention.

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