How Gene Patents Work


Even before the 2013 ruling that human genes could not be patented, the judicial road that has led to today's laws regarding patent rights to substances made inside the human body has not always been bump-free. As an example, in 1853, the Supreme Court denied one of Robert Morse's patent claims relating to the telegraph. Their reason? Electromagnetism -- the principle on which the device worked -- was "a principle of nature" and therefore couldn't be patented. Yet, in 1912, another court ruled that the patent issued for adrenaline was valid because the distilled type treated in a lab was different from than the kind found in natural sources. Then, shortly after World War II, another ruling was handed down by the Supreme Court that rejected patent claims on a mixture of bacteria that could only be made in the lab [source: Darnovsky and Reynolds].

One definitive step leading to genetic patents was taken in the first half of the 20th century when the Plant Patent Act of 1930 was passed, allowing plant breeders to patent new types of plant life. But aside from plants, 50 years would pass with the courts disallowing the patenting of "products of nature" until the landmark court case of Diamond v. Chakrabarty, in which the Supreme Court ruled that a life form (in this case a strain of bacteria) could, in fact, receive a patent.

This was followed by the first gene patent to be issued in 1982 to the University of California for an engineered hormone involved with breast development in pregnant women [source: DeGiulio]. In the same year, the first recombinant (meaning engineered) genetic product -- insulin -- was also patented. More patents would follow, but it wasn't until the announcement near the end of 2000 that the Human Genome Project had almost completely mapped our DNA that the race to obtain genetic patents really sped up.

Because the United States Patent and Trademark Office (USPTO) was barraged with patent requests for both individual genes and gene sequences -- and in some cases, the applicants didn't even understand what the function of the genetic material was -- it issued new guidelines in 2001, stipulating that in order to apply for a genetic patent, a company or research institute needed to show "specific, credible and substantial" uses for it [source: AMA].

Although that requirement slowed things down a bit and made the patent application process available only to those who had conducted substantial research, to date, there are more than 3 million genome-related patent applications on file [source: Oak Ridge National Laboratory].

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