A patent is a legal protection that allows an inventor to reap the exclusive economic benefits of her invention for a number of years. The U.S. Patent and Trademark Office began allowing genetic researchers to patent genes in 1980 and has since allowed gene fragments to be patented as well. Gene patenting is controversial within the scientific community as researchers debate its effect on medical research, particularly regarding patents on human gene sequences.
Patents are available for any new and useful composition of matter, like a gene sequence, that is invented or discovered by someone. The subject of a patent must be new or novel and not obvious to the casual observer, according to the United States Patent and Trademark Office. A patent grants to the inventor or discoverer the right to prevent others from making, using or selling the item that is the subject of the patent for 20 years. After 20 years, the item can be manufactured or sold by anyone, so the inventor loses the competitive advantage conveyed by the patent.
Natural items are generally not patentable, according to the Human Genome Project. Genes were considered non-patentable natural items before 1980. In that year, the U.S. Supreme Court allowed a patent to be issued for a genetically modified bacteria, determining that the item at issue was not found naturally in the environment. Genes become patentable when a gene or gene fragment is isolated and modified to be different, by some degree, than it occurs in nature, and the person applying for the patent must demonstrate that the gene has some commercial use. The U.S. Patent and Trademark Office also allows for patenting of the entire genetic code of a new plant species, allowing plant breeders a 20 year monopoly on plants that they invented through their breeding programs.
Holding a patent on a gene sequence allows a pharmaceutical company, agricultural development company or academic institution to profit from the discovery, thus funding the facilities and personnel necessary to support their research. However, any other researcher wishing to study a patented gene sequence must pay the patent holder for an exemption or license to do so. The patent holder has no legal obligation to grant anyone permission to use the patented gene sequences, even the 20 percent of the human genome that is held under private patents. This may have the effect of stifling innovative research into medical advancements.
Genes in Public Domain
Not all researchers choose to patent the patentable genes they identify. For example, the Human Genome Project places all its research and genetic sequence identification in a publicly accessible data bank and has not filed patents on the subjects of its research. Keeping gene information in the public domain encourages wide-spread medical and scientific research, according to biotechnology advisor Alan R. Williamson. Once a gene sequence has been published in the public domain, it is open to everyone to use, and no future user may file a patent on it. Keeping gene sequences in the public domain makes research and development of valuable medical advancements cheaper and faster, according to the Human Genome Project.
References & Resources
- Indiana University School of Medicine Center for Bioethics: Commercialization and Gene Patenting: PredictER Law and Policy Update
- Human Genome Project: Genetics and Patenting
- Trends in Genetics: Gene Patents: Socially Acceptable Monopolies or an Unnecessary Hindrance to Research?
- United States Patent and Trademark Office: General Information Concerning Patents
- Justia.com: Diamond v. Chakrabarty
- Comstock/Comstock/Getty Images