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Editorial: Supreme Court wisely applies old principles to new frontier of genetics

By applying old principles to new science, the U.S. Supreme Court found its way to the right decision in an important genetics case last week. The result will be lower costs, more alternatives and perhaps improved results in testing that can reveal whether women carry mutations that make them more susceptible to breast and ovarian cancer.

At issue were patents issued to Myriad Genetics, a company that was the first to isolate two genes, called BRCA1 and BRCA2, a research triumph that it patented. The patent protection gave the company a monopoly on the test it developed to detect mutations in the genes – and with it, monopoly pricing of $3,430 per test.

Given that as many as one in 400 American women may have the mutation, the sky was pretty much the limit for Myriad, which explains why the company vigorously defended its monopoly, warning off other providers that tried to offer competing tests.

In 2009, a coalition including the ACLU, researchers and women’s health advocacy groups sued, saying the patents should not have been granted in the first place. They won the first round in court but lost the second, leading both sides to a final stop: the Supreme Court.

The court’s verdict, written by Justice Clarence Thomas, was unanimous – and, despite the complexity of the underlying science, it was as simple as it was wise.

Patent law, Thomas wrote, isn’t intended to protect the discovery of phenomena that exist in the natural world. Patents are about invention, he said, not discovery.

Because Myriad didn’t invent the two genes in question, the ruling said, the company wasn’t entitled to patent protection, despite achieving what Thomas described as a “medical breakthrough.”

It’s an old principle – Thomas cited a 1948 case involving a company that combined several bacteria to good effect but didn’t get a patent because it didn’t actually invent anything – and it makes perfect sense even when applied to the new frontier that is genetic science.

In a corollary consistent with the main ruling, the court held that a Myriad patent for an altered version of the genes could be valid, provided that it meets other legal requirements, because the altered genes don’t exist in nature and thus are properly considered inventions.

Seizing on this, the company sounded what amounted to a minor note of victory. The more telling response came from the director of the National Institutes of Health, who told the Wall Street Journal that the ruling will make it easier to develop new combinations of tests and treatments, and Dr. Harry Ostrer, one of those who sued Myriad, who said the result will be lower costs and improvements in test quality.

The ruling may also affect patents that have been issued to companies that have isolated 4,000 additional genes. Given the potential of genetics science, the stakes could hardly have been higher.

Here’s how an essay in the Nation put it: “Will scientists and doctors be able to choose what genes they study and what treatments they develop, or will the corporations who own these genes be able to dictate the terms under which science and medicine may proceed?”

It’s a big question – and, thanks to the court, it now has a clear and simple answer, one that will serve the public well by speeding research with the promise of prolonging lives.

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