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Supreme Court Tackles Case of Patent Law, Human Genetics

April 15, 2013 at 12:00 AM EDT
The Supreme Court heard arguments in a case on whether a biotech company can patent a gene associated with cancer. Jeffrey Brown gets details from National Law Journal's Marcia Coyle, plus viewpoints from Ellen Matloff of Yale Cancer Center, a plaintiff in the case, and Kevin Noonan, an intellectual property attorney.
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JEFFREY BROWN: We will continue to follow developments in Boston, but for now to another story.

Today, the Supreme Court heard arguments in a case at the intersection of law and science, specifically, genetic research, one that may well have major consequences for the future of medicine. The question, can human genes be patented?

We turn, as always, to Marcia Coyle of the National Law Journal, who was in the courtroom today and is back with us tonight.

Marcia, first, some background on this case.

MARCIA COYLE, National Law Journal: OK.

Myriad is a Utah-based genetic research company. And Myriad holds patents on two genes with mutations that are linked to a very high risk of breast and/or ovarian cancer. Its patents also give it exclusive control over diagnostic testing for those genes.

About four years ago, a group of scientists, researchers, civil rights organizations, women’s health organizations decided to challenge Myriad’s patents in federal court. They filed a lawsuit. They lost. Two courts, two lower courts have upheld Myriad’s patents. Today, they brought — the challengers brought the case to the Supreme Court.

JEFFREY BROWN: OK. So the legal issue here is, what can be patented?

Now, we made a graphic of patent law just to help you out here.

MARCIA COYLE: OK. All right.

JEFFREY BROWN: We will put that up.

Tell us — tell us what the law says. And then we can go into this case.

MARCIA COYLE: OK.

Well, the law says that you can get a patent for any new and useful process, machine, manufacture, and composition of matter or any new and useful improvements on that invention. But what you can’t get a patent for is the application of a product of nature or natural phenomenon.

And I think Justice Breyer today put the case in context in explaining the law by saying, if you develop a process for extracting sap from a plant in the Amazon, you can get a patent for the process. If you take the sap and you manipulate it and you come up with a new use, you can get a patent on the use. But what you can’t get a patent on is the sap itself.

JEFFREY BROWN: So the justices reaching for an analogy, I guess, to help them understand it.

MARCIA COYLE: Right. Exactly.

JEFFREY BROWN: So what happened in these arguments? What kind of questions were they pursuing?

MARCIA COYLE: Well, the question for the court is whether these genes are products of nature or a human-made invention.

And so first up at the lectern today was the attorney for the challengers, Chris Hansen of the American Civil Liberties Union. And he said, basically, Myriad has invented nothing here. He said Myriad deserves credit for unlocking the secrets of these two genes. But the isolation of these genes from a strand of DNA is something that is routine and done all across the country.

But the genes themselves, how they work, what they do, what they fail to do, those are decisions made by nature. And while Myriad deserves credit for unlocking the secrets, it doesn’t deserve patents.

JEFFREY BROWN: And what reaction did that get from the justices?

MARCIA COYLE: The justices are concerned about the inherent tension in patent cases.

And that is, on the one hand, we want to encourage investment in research and invention. Myriad, for example, spent roughly $500 million dollars until it found these two genes. And then, on the other hand, you don’t want to lock up that invention for years to prevent further research and new uses.

So the justices were asking Mr. Hansen, well, what incentive will Myriad have to do this or any company have to do this kind of research? And he said there are lots of researchers who want these genes in order to do research. And also, he said, Myriad and other companies can issue licenses to researchers to do that kind of work.

JEFFREY BROWN: And the attorney for Myriad was able to make those arguments himself, I guess, about why it is important for the company to have the patent.

MARCIA COYLE: Absolutely.

Myriad’s attorney was Gregory Castanias. And he told the court that the human invention here is — was in Myriad’s identifying and isolating these genes from the strand of DNA. And he gave as an analogy of a baseball bat. He said a bat doesn’t exist until it’s isolated from a tree. But the invention is in deciding where to begin the bat and where to end the bat.

But he faced skeptical questions from Chief Justice Roberts, who said, well, now, wait a minute. What’s involved here is snipping this strand of DNA. You cut here, you cut there, and you have got the genes. But a bat is different. You don’t — you have to invent the bat. You don’t look at a tree branch and say, if I cut here and cut there, I have a baseball bat.

JEFFREY BROWN: And what is the feeling among the interested parties — because a lot of people joined into this — about the implications here for the outcome beyond this case, right?

MARCIA COYLE: This case has really pitted biotechnology, agricultural, a whole slew of research organizations against civil rights groups, individual scientists.

They’re all concerned about how broadly the court might rule here. Lots of genes have been patented. And what the court says in terms of this type of gene vs. maybe a more narrow decision will have many implications for how research is done in the future, as well as for individualized medicine.

JEFFREY BROWN: Marcia Coyle, thank you, as always.

MARCIA COYLE: My pleasure, Jeff.

JEFFREY BROWN: And we continue our look at this case and the larger implications with Ellen Matloff, director of cancer genetic counseling at Yale — Yale Cancer Center — excuse me. She’s a plaintiff in today’s case. And Kevin Noonan, an intellectual property attorney and founder of the blog PatentDocs.org.

Ellen Matloff, you heard Marcia talk about the legal arguments. As someone involved in genetic counseling and research, what’s the essence of this case for you? What’s at stake?

ELLEN MATLOFF, Yale Cancer Center: Well, I have really seen from the ground floor what this has done to patient care over the last 15 years.

And keep in mind that when these genes were cloned, many laboratories were offering this testing. There was nothing novel here, no invention, no special process, no special machine. We were doing this testing in our laboratory at Yale. And then, when the patents became — when they clamped down on the patents, our labs and all others were shut down.

JEFFREY BROWN: Well, Kevin Noonan, same question to you. As someone involved in the patent world and research, what do you think is the essence of this?

KEVIN NOONAN, PatentDocs.org: Well, I think that that is true, that you’re looking at what is going to enable the technology to get to the most patients the quickest and the most reliably.

And, frankly, Myriad has done a great job of doing that because there are more people who have gotten this test than I think would have gotten it otherwise more consistently and more reliably than if it had been scattered among hundreds of thousands of individual research labs.

JEFFREY BROWN: Well, Ellen Matloff, address that specifically, because that claim has been put out there, that scholarly work has hardly been stopped. There’s been plenty of research done — I mean, studies of the research done on this.

ELLEN MATLOFF: Yes. I think those of us in the know will tell you that this has had a chilling effect on research, and not as much research has been able to be done.

One company has had a monopoly on this testing. And so for companies and laboratories that wanted to find better ways to look for mutations, faster ways, less expensive ways, they have been stopped. And, yes, Myriad has done a great job of marketing this test to a lot of people because they have a huge financial incentive.

But many patients who really didn’t need the tests were frightened into thinking they did by Myriad’s marketing. And insurance companies clamped down on who could have the test. And it’s made it difficult for some of my patients who need the test to actually get it.

JEFFREY BROWN: Well, so, Kevin Noonan, where should the line be drawn that Marcia Coyle just raised and the justices clearly raised today between allowing the company to reap a reward from its investment and getting the information out to those who need it?

KEVIN NOONAN: Well, I think what you have to realize is what happens in these instances is that, if you don’t permit people to patent, which is something that will end up with full disclosure of what the invention is so that when the patents expire, which will happen in about two years, everybody gets to use the invention, if you don’t do that, for most genes, for most diseases, it won’t be as simple or straightforward as it with the BRCA genes, and what will happen is that people won’t disclose it.

And then they will hide it. They will figure out ways that they can do this testing without disclosing what the basis is. And if they did that, then the monopoly, if you will, would last for a much longer time.

One thing I will say is that there have been more than 10,000 basic research papers that have been published since the Myriad patents were issued, and — in about 12 or 15 years. That sounds like a lot to me. I think basic research is being done. What’s not being done is clinical work charging patients for the tests in the face of Myriad’s patents.

JEFFREY BROWN: What about that, Ellen Matloff, I mean, about the argument that the work might not get done if the patent isn’t given?

ELLEN MATLOFF: I think those of us who work in genetics know that that just isn’t true.

Before BRCA1 and 2, there were hundreds and hundreds of genes discovered, and patents on many of those genes. None of them were used in this way.

Testing was available for all of those genes. This is just a company that has done something unprecedented in the way they have clamped down on this patent.

And, quite frankly, there is no invention here. They didn’t invent anything.

JEFFREY BROWN: Staying with you, Ellen Matloff, if you go beyond this case, where else in the world of research and testing would this have consequences?

ELLEN MATLOFF: Huge consequences.

We have really come to a fork in the road here. And moving forward, we’re going to be able to do whole genome sequencing on one DNA sample, a tiny tube of blood. We’re going to be able to look at 30,000 genes. And people are estimating that that might even cost $1,000 dollars to look at 30,000 genes.

With Myriad and their monopoly, they’re charging $4,000 dollars per patient for two genes. Imagine if every one of those genes was patented. Think about the cost of this testing. It wouldn’t reach the average consumer. It wouldn’t reach anyone.

JEFFREY BROWN: Kevin Noonan, what about that?

KEVIN NOONAN: First of all, that’s probably not going to be the case.

Secondly, the whole genome sequencing wouldn’t infringe the patents at issue here. In fact, the sad thing is that the genes — the gene claims at issue, even if the Supreme Court were to rule in its entirety that the petitioners win, if a doctor were to or if Yale started to do this testing the day after that decision, Myriad has lots of other patents with lots of other claims that are directed not to the genes, but to the methods themselves, and things that the court seemed not to think were a problem.

And they would be able to sue them for those — on those patents. So the problem is that the answer you get, that our genes are patentable or not, are really not — is really not going to impact the issue that’s been raised about whether patients will get care.

JEFFREY BROWN: Kevin Noonan, just to stay with you, one of the issues, questions I have seen raised is whether the pace of change in the field of genetic research is outstripping the law. How relevant is a case like this?

You watch these developments. What is your answer to that?

KEVIN NOONAN: Well, I would say that the case is about 30 years too late.

JEFFREY BROWN: Thirty years?

KEVIN NOONAN: Yes, because that’s when genes were first patented. It was 1980 or so.

And so, right now, if you look at just the procedural aspects of patent law, a patent is granted with a term of 20 years from when the application was filed. Most of the gene patents that are out there, most of the new ones, were filed around the turn of the century. So, by 2020, they will all expire just by the nature of the way that the patent system works.

And so many of the — for these claims, many — or these types of claims, many of the putative problems, many of the things that people are afraid of just won’t come to pass.

JEFFREY BROWN: A brief last word from you, Ellen Matloff, on that very issue, whether the science is outstripping the law.

ELLEN MATLOFF: I think we’re finding new ways around things like isolated DNA, but moving forward, this is a bigger issue.

Are we going to let people patent things that occur in the human body that they didn’t invent, because, if we do, do that, it’s going to hinder the future of personalized medicine? I don’t think we want that.

JEFFREY BROWN: Ellen Matloff and Kevin Noonan, thank you both very much.

ELLEN MATLOFF: Thank you.

KEVIN NOONAN: Thanks very much.