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Opinion 2.105 - Patenting Human Genes

A patent grants the holder the right, for a limited amount of time, to prevent others from commercializing his or her inventions. At the same time, the patent system is designed to foster information sharing. Full disclosure of the invention--enabling another trained in the art to replicate it--is necessary to obtain a patent. Patenting is also thought to encourage private investment into research. Arguments have been made that the patenting of human genomic material sets a troubling precedent for the ownership or commodification of human life. DNA sequences, however, are not tantamount to human life, and it is unclear where and whether qualities uniquely human are found in genetic material. Genetic research holds great potential for achieving new medical therapies. It remains unclear what role patenting will play in ensuring such development. At this time the Council concludes that granting patent protection should not hinder the goal of developing new beneficial technology and offers the following guidelines:

(1) Patents on processes--for example, processes used to isolate and purify gene sequences, genes and proteins, or vehicles of gene therapy--do not raise the same ethical problems as patents on the substances themselves and are thus preferable.

(2) Substance patents on purified proteins present fewer ethical problems than patents on genes or DNA sequences and are thus preferable.

(3) Patent descriptions should be carefully constructed to ensure that the patent holder does not limit the use of a naturally occurring form of the substance in question. This includes patents on proteins, genes, and genetic sequences.

One of the goals of genetic research is to achieve better medical treatments and technologies. Granting patent protection should not hinder this goal. Individuals or entities holding patents on genetic material should not allow patents to languish and should negotiate and structure licensing agreements in such a way as to encourage the development of better medical technology. (V, VII)

Issued June 1998 based on the report "Patenting the Human Genome," adopted December 1997.