Law
5:06 pm
Mon April 15, 2013

Supreme Court Weighs Patenting Of Human Genes

Originally published on Tue April 16, 2013 7:44 am

In a case considered pivotal to the future of science and medicine, the justices of the U.S. Supreme Court seemed skeptical Monday about a claim that human genes can be patented.

Contending that genes can be patented are the biotech and pharmaceutical industries, which see patents as the keys to new scientific exploration. On the other side are doctors, patients and many scientists, who see gene patents as an attempt to monopolize and block future exploration in the new universe of genetics.

At issue in Monday's case were two genes, known as BRCA 1 and 2, which indicate a hereditary link to breast and ovarian cancer. Myriad Genetics, located in Utah, found and isolated the genes, and then patented them.

But the scientific and patient community rebelled, challenging the patents in court. And while they lost in the lower court, on Monday they seemed to have a more receptive audience at the Supreme Court.

Creating Incentives

Representing the patent challengers, lawyer Christopher Hansen told the justices that Myriad "deserves credit" for finding and isolating the two genes, but he said that the genes are products of nature and thus are not patentable.

Justice Samuel Alito asked: Suppose someone discovers a plant in the Amazon that treats breast cancer, and suppose a new way to extract the substance from the plant is found. You say it's not eligible for patenting?

It may be patentable, Hansen responded, if you've "transformed" what was in nature by concentrating it into a form that works in a way it did not work in nature.

But, asked Justice Elena Kagan, what are the incentives for companies to do what Myriad did if there is no patent? What's in it for them?

Other labs were looking for the BRCA genes when Myriad found them, Hansen replied, and those labs had announced they would not patent the genes if they were the first to find them.

Kagan eventually answered her own question by pointing out that Hansen could have said, "Notwithstanding that you can't get a patent on this gene ... there are still various things that you could get a patent on that would make this kind of investment worthwhile."

Justice Sonia Sotomayor agreed, remarking: Isn't the answer that "the isolation [of the gene] itself is not valuable," it's what you do with the isolated gene?

Where To Draw The Line?

Following lawyer Hansen to the lectern was Solicitor General Donald Verrilli, representing the government. He agreed with part of Hansen's argument, that genes cannot be patented. However, cDNA, a synthetic substance derived from DNA naturally found in the human body, he argued, can be patented.

"Are we fighting over nothing?" asked Sotomayor. If Myriad can patent the synthetic substance, "what does it matter" that they can't patent the gene itself?

Verrilli replied that allowing a patent on an isolated gene "would effectively pre-empt anyone else from using the gene itself for any medical or scientific purpose," and that is not true of a patent on the synthetic substance, which leaves the gene available for general research and "new uses."

Next up was Myriad's lawyer, Gregory Castanias, who took quite a beating from all quarters. His main argument was that by isolating the genes and taking them out of the body, Myriad had created a new substance deserving of a patent.

Sotomayor suggested that when she bakes chocolate chip cookies, using salt, flour, butter, eggs and sugar — all natural products — she might get a patent on her special cookies, but she couldn't get a patent on the natural ingredients.

"You haven't created a type of gene that does not exist in the body," added Justice Antonin Scalia.

In response, Castanias analogized the isolation of the genes to the creation of a baseball bat, which is made up of a natural substance — namely wood.

But the analogy didn't quite stick. Chief Justice John Roberts called out Castanias, noting that what Myriad did was to "snip" out the genes from other genetic material. "The baseball bat is quite different; you don't look at a tree and say, 'Well, I've cut the branch here and cut it here, and all of a sudden I've got a baseball bat.' You have to invent it."

Kagan followed up with her own example, asking, "Do you think that the first person who isolated chromosomes could have gotten a patent on that?"

Castanias replied, "In theory, that is possible."

How about "the first person who found a liver?" Kagan added.

Castanias drew the line there, maintaining that livers, kidneys, gallbladders are the same when taken out of the body as when in it, whereas Myriad, by isolating the genes, gave patients a new thing they didn't have before.

Justice Anthony Kennedy shot back, saying that would have been true with "atomic energy" and "electricity," but they are laws of nature that are not patentable.

"The patent law is filled with uneasy compromises," observed Justice Stephen Breyer. "On the one hand, we do want people to invent; on the other hand, we're very worried about them tying up ... a thing that itself could be used for further advance." So, if you develop a new process to extract sap from a plant in the Amazon that can cure cancer, of course you can patent the process, but "what you can't patent is the sap itself," he said.

Copyright 2013 NPR. To see more, visit http://www.npr.org/.

Transcript

ROBERT SIEGEL, HOST:

From NPR News, this is ALL THINGS CONSIDERED. I'm Robert Siegel.

MELISSA BLOCK, HOST:

And I'm Melissa Block.

The Supreme Court heard arguments today in a case with huge implications for medicine, science and business, at issue is whether human genes can be patented. On one side is the genetics testing company called Myriad. It and the biotech and pharmaceutical industries as a whole see patents as the keys to new scientific exploration. On the other side are doctors, patients and many scientists. They argue that gene patenting is an attempt to monopolize and block innovation in genetics.

NPR's legal affairs correspondent Nina Totenberg has our story.

NINA TOTENBERG, BYLINE: Everyone agrees that Myriad is justifiably proud of what it did in finding and isolating two genes that have mutations indicating a hereditary link to breast and ovarian cancer. But when Myriad patented those genes, the scientific and patient community rebelled. On the steps of the Supreme Court today were some of those who sued to challenge the patents, Dr. Harry Ostrer of Albert Einstein Medical College in New York.

DR. HARRY OSTRER: Right now, I can't offer a testing to my patients. I can't develop a better way of doing genetic testing.

TOTENBERG: Inside the Supreme Court, the justices seemed to become increasingly skeptical about allowing a patent on genes. Representing the patent challengers, lawyer Christopher Hansen told the justices that Myriad deserves credit for finding and isolating the two genes, but he said the genes are products of nature and are thus not patentable.

Justice Alito: Suppose someone discovers a plant in the Amazon that treats breast cancer and a new way is found to extract that. You say it's not eligible for patenting? Answer: It may be patentable if you've transformed what was in nature by concentrating it into a form that works in a way it did not work in nature.

Justice Kagan: What are the incentives for companies to do what Myriad did if there's no patent? What's in it for them? Answer: Other labs were looking for these genes when Myriad found them, except that those labs had announced that they would not patent the genes if they were the first to find them.

Justice Sotomayor: Isn't the answer that it's not the isolation of the gene that's valuable, it's what you do with it? Following lawyer Hansen to the lectern was Solicitor General Donald Verrilli, who agreed with part of Hansen's argument, that genes cannot be patented. However, synthetic DNA made from parts of real DNA, he argued, can be patented.

Justice Sotomayor: Well, if they can patent the synthetic substance, what does it matter? Answer: Allowing a patent on an isolated gene would effectively preempt anyone else from using the gene itself for any medical or scientific purpose. That is not true of a patent on the synthetic substance, which leaves the gene free for general use.

Next up was Myriad's lawyer, Gregory Castanias, who took quite a beating from all quarters. His main argument was that by isolating the genes and taking them out of the body, Myriad had created a new substance deserving of a patent. Justice Sotomayor suggested that when she bakes chocolate chip cookies using salt, flour, butter, eggs and sugar - all natural products - she might get a patent on her special cookies, but she couldn't get a patent on the natural ingredients.

Justice Scalia: You haven't created a new gene that doesn't exist in the body. Lawyer Castanias analogized the isolation of the genes to the creation of a baseball bat made up of the natural substance of wood.

Chief Justice Roberts: What Myriad did was to snip out the genes from other genetic material. The baseball bat is quite different. You don't look at a tree and say, well, I've cut the branch here and cut it here, and all of a sudden I've got a baseball bat. You have to invent it.

Justice Kagan: Do you think the first person who isolated a chromosome could have gotten a patent on it? Answer: In theory, it's possible. Justice Kagan: How about the first person who found a liver?

Castanias drew the line there, maintaining that livers, kidneys, gallbladders are the same when taken out of the body as when in it, whereas the genes isolated by Myriad give patients a new thing they didn't have before. Justice Kennedy: That would have been true with atomic energy and electricity, but they were laws of nature and were not patentable.

Justice Breyer: The patent law is filled with uneasy compromises. On the one hand, we do want people to invent. On the other hand, we're very worried about them tying up a thing that itself could be used for further advance.

So if you get a new process to extract sap from a plant in the Amazon that can cure cancer, of course, you can patent the process. But what you can't do is to patent the sap itself. Nina Totenberg, NPR News, Washington. Transcript provided by NPR, Copyright NPR.