Human Genes Not Patentable, Supreme Court Says

The U.S. Supreme Court ruled this week that the mere act of isolating a DNA sequence does not make human genes patentable. Mary-Claire King, who helped discover the breast cancer gene at the center of the court dispute, discusses the ruling and its implications for genetics.

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IRA FLATOW, HOST:

This is SCIENCE FRIDAY. I'm Ira Flatow. Yesterday, the Supreme Court ruled that human genes cannot be patented. The case involves a dispute over patents held on the BRCA1 and the BRCA2 genes, the so-called breast cancer genes; and tests a company, Myriad Genetics, used to look for mutations to those genes.

In its unanimous ruling, the court found that just isolating a gene on a chromosome was not enough of an invention to qualify for patent protection. Separating a gene from its surrounding genetic material is not an act of invention, wrote Justice Clarence Thomas. Genes, the court found, are a product of nature.

But the court also found that some synthetic sequences of DNA, created in the laboratory, could be patented. The decision has big implications for biotech companies doing genetics research and for researchers who want free access to the genome for their own work and, of course, for the patients.

Mary-Claire King is a professor of medical genetics and of genome sciences at the University of Washington here in Seattle. Her work isolating a genetic marker for breast cancer led to the discovery of the gene at the center of this court case. Welcome back to SCIENCE FRIDAY.

MARY-CLAIRE KING: Thank you, it's so good to be back, Ira. Welcome to Seattle.

FLATOW: Well, thank you very much. I'm sure you've been talking about this. What's your opinion on the ruling?

KING: Well, I'm delighted. I'm absolutely high as a kite. I said yesterday, I'm high as the flag on the Fourth of July, and it's the way I still feel today.

FLATOW: And does this ruling change the way researchers will be able to work?

KING: It has a less of an impact on research, which has never been subject to the enforcement of a patent, than it does on the availability of this approach for patient care. The enforcement of the monopoly on testing by Myriad was in the realm of patient care, that is testing for patients who were referred by their physicians or genetic counselors for sequencing of BRCA1 and 2.

FLATOW: Does this mean that it will open up the realm of other people, other companies, coming up with a test also and maybe drive the price of the test down.

KING: That's exactly right, Ira. It will both drive the price of the test down, I expect, although as you can imagine scientists are not consulted on the pricing of tests, but it will do two very important things qualitatively. One is it will make it possible to use modern genomics approaches to evaluate these genes. The approach that Myriad uses is Sanger sequencing, which is a perfectly respectable approach, but it's certainly out of date now.

And it will also - the ruling will also allow us to incorporate BRCA1 and BRCA2 into panels of genes that include all of the genes that predispose to breast and ovarian cancer. We developed - for example we developed a panel like that back in 2010, have been using it for research in my lab, where no money changes hands, it's purely research, but now our hospital can use this panel, which we call BROCA, for patient care.

So it's really opened the entire research development sphere to the clinical sphere, and we're just enormously pleased that's happened.

FLATOW: So this is a win-win for everybody then? What about for companies or for the company that claimed the patent? Is it going to be losing money? Does it lose on this?

KING: Well, I certainly can't speak to Myriad's situation in particular. I have absolutely no knowledge of it. But I can speak to the question of the impact of this ruling on development in biotech generally. This is subtle but I think important point for us all to realize. The development of a genetic test, once a gene is discovered that is responsible for a particular serious condition, the development of the genetic test after that discovery is very quick.

It - the creative and economic investment is prior to discovery. This is in marked contrast to the development of, say, a drug, for which there must be, after the original discovery, millions and millions of dollars devoted to phase three testing, to clinical trials, to FDA approval and so on.

None of that expense applies to genetic testing, and hence the patent, which is limited to that abrogation of patents on genes, will have no impact at all on patents that are, in my view, appropriately given for drug discovery.

FLATOW: Well, thank you very much, Dr. King, for taking time to be with us today.

KING: My pleasure.

FLATOW: And congratulations, I think, are in order.

KING: Thank you very much.

FLATOW: Mary-Claire King is professor of medical genetics and of genome sciences at the University of Washington here in Seattle.

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