The Gene Patent Decision Explained by the Supreme Court Blog: In Plain English

Lyle Denniston Reporter, SCOTUS Blog (Supreme Court of the United States Blog)

Gene Patent Decision: In Plain English

The Supreme Court long ago ruled that an inventor who discovers a phenomenon in nature, or figures out a "law of nature," cannot get an exclusive right to use or sell that by obtaining a patent from the federal government. Natural phenomena are the basic tools with which every would-be inventor starts, so locking up the right to use them in a monopoly held by a specific patent owner will frustrate others who might want to look for new ways to interpret that phenomena, the Court has said.

Special Envoy to the UN High Commissioner on Refugees, Ms Angelina Jolie at the launch of the UK initiative on preventing sexual violence in conflict, 29 May 2012.

The exclusion of natural substances from eligibility for patents was the theory on which the Court relied Thursday in its unanimous ruling that a company cannot get a patent monopoly on the use and study of human genes that it isolates in the bloodstream, and them takes them out — without changing their natural character — for research.

The case involved a Utah company’s patent for having isolated, outside the human body, two basic genes that contain natural phenomena which suggest that a woman who has them is at significantly higher risk of developing either breast cancer or ovarian cancer. The company had claimed that the act of locating these genes in blood, and then extracting them for study, was a true invention, something that did not exist before.

The Court said the company actually did not create anything at all, but simply extracted the genetic material from its location in human blood, and setting it apart for study.

The Court, however, said that the company might be eligible to get a patent when it created a synthetic form of those genes — in other words, a laboratory imitation of them. Such imitations, according to the ruling, do not exist in nature, and so do not run counter to the rule against patenting nature.

Opinion recap: No patent on natural gene work

Analysis

Pronouncing what may seem like a patent truism, the Supreme Court ruled unanimously on Thursday that biotech researchers have to create something to get monopoly protection to study and apply the phenomenon. Because Myriad Genetics, Inc., “did not create anything,” the Court struck down its patent on isolating human genes from the bloodstream, unchanged from their natural form. Because Myriad did create a synthetic form of the genes, however, that could be eligible for a patent, the Court concluded.

The decision was a major blow to a company that believed it had a right to be the sole user and analyst of two human genes, mutations in which show a high risk, for women found to have them in their blood, of breast and ovarian cancer. But the ruling will give medical and scientific researchers, and family doctors, greater opportunity to help women patients discover their potential vulnerability to those types of cancer.

In a way. the ruling was a silent tribute to screen actress Angelina Jolie, who recently gained huge notoriety not for her acting but for voluntarily having her breasts surgically removed after discovering that she had the threatening mutations in her body. She, of course, was able to pay the high cost of that test; now, women of less means will be able to afford it, and that was a key motivation for challenging Myriad’s patent rights.

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