Bill Seeks to Ban Gene Patents

A bill recently introduced in Congress would ban patenting any and all portions of the human genome. Critics argue gene patents make medical tests more expensive, block innovation, and hurt patient care.

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IRA FLATOW, host:

This is TALK OF THE NATION: SCIENCE FRIDAY. I'm Ira Flatow.

A bit later, we'll be talking about gardening and taking your gardening questions. But first, the writer Michael Crichton caused a stir again last week. No, it didn't have anything to do with global warming. This time Crichton was criticizing the way the U.S. Patent and Trademark Office issues patents. In an op-ed piece in the New York Times, Crichton writes, You or someone you love may die because of a gene patent that should never have been granted in the first place. Crichton goes on to say that gene patents make medical tests more expensive, they block innovation and hurt patient care. And in fact there is a bill being introduced in Congress that limits gene patenting.

Joining me now to talk more about gene patenting is my guest. Robin Feldman is the Herman Phleger Visiting Professor of Law at Stanford Law School, and she joins us by phone from Stanford University. Welcome back to SCIENCE FRIDAY, Professor Feldman.

Professor ROBIN FELDMAN (Stanford University): Thank you for having me.

FLATOW: What do you think of Michael Crichton's op-ed piece?

Prof. FELDMAN: Well, it's a very impassioned plea of support for the bill, and I have a lot of sympathy for the concerns raised in that, and we certainly have some very serious problems in the biotech and genetic patenting area. But some of the criticisms are a little bit out of focus, including some of the proposed solutions. So for example, Mr. Crichton writes, you can't even donate your own breast cancer gene to another scientist without permission. The gene may exist in your body, but it's now private property. And that's not exactly right.

The gene as it exists in your body doesn't belong to anybody. It's only as it exists in an isolated and purified form in a lab in which we are doing something else with it. So if you want to take the - a piece of your cells and donate it to someone, you certainly could. The problem comes that once they start doing their research, then they run into patent rights, and then they have some limitations on what they would be able to do with it. But it's a little different from the notion that someone can own what's in your body at any point.

FLATOW: Well, let's talk about that for a second. Let me give you a hypothetical case.

Prof. FELDMAN: Sure.

FLATOW: Let's say that I discover the gene, if there is one, that causes autism.

Prof. FELDMAN: Yes.

FLATOW: And just for the sake of the argument, can I own that gene or patent it?

Prof. FELDMAN: You can get a patent on that gene, but only in a form that's isolated and purified. So in other words, if you're going to file a patent for that you would have to go through the process of taking some cells and then getting the gene out of the cells, probably going through a process of - most what they do with recombinant DNA, which is to get that into a carrier piece of DNA from a bacteria and getting that into a host cell, and then getting the host cell to do lots of things for you. And once you had all that, then you could go to the patent office and say I'd like a patent on the gene in its form in the lab.

In my view, the problem isn't that we grant rights in these inventions. The problem is how broadly we interpret those rights. So if I may, can I use an example...

FLATOW: Sure.

Prof. FELDMAN: ...that extends the one that you came up with? In 2000, the Patent and Trademark Office granted rights in a gene that produces something called CCR5, and the person who had made the invention of the gene really didn't understand very much about CCR5 or what it did, but got a very broad patent on it. At the same time, AIDS researchers were looking into a substance in the body that was essential for the way that the HIV virus replicates itself. And right after that patent was granted, the other researchers discovered that the thing that they had been working with was actually CCR5, and from that point going forward, everyone who wanted to do basic AIDS research now had to get a license from this inventor who had no idea what it was...

FLATOW: Right.

Prof. FELDMAN: ...that he had at the time he invented it.

FLATOW: Mm-hmm, and so they were stymied from doing the research on it.

Prof. FELDMAN: Well, they had to pay...

FLATOW: Right.

Prof. FELDMAN: ...which interferes with the flow of research. And so I think part of the issue we have to think about is if we are going to grant rights in these kinds of inventions, in an environment in which there are so many things we don't know, how do we limit how far people can reach? How do we keep people from saying I'm here, I get this gene, and even if I don't know what it does or how it does it, I'm going to block everybody out from figuring anything out.

FLATOW: Sure, what's to prevent them from saying I'm going to come up with a competing product and I don't want you to do any research on it, I'm going to put it on the shelf for as long as I want to?

Prof. FELDMAN: And they can certainly do that. That's a problem inherent in our patent system. One of the issues, though, is a question of what do you do about this problem? You know, what - can this bill actually solve the problem? What other approaches can solve that problem? So if you go back to Mr. Crichton's piece and you say, OK, well, we have a problem here and we're going to resolve it by saying nobody can have patents on genes, and then if you want to donate your breast cancer gene somewhere, that's fine and the researchers can work with it and do what they want, because no gene patents.

So the researchers still wouldn't be free to do anything he or she wants because there are lots of other kinds of patents out there - methods patents that say - you know, that would be on how people work with your particular gene. So in other countries that have said we will have no gene patents, there are still a lot of rights to navigate in exactly the same way because people just patent the method.

So you could say, OK, no method patents in the biotech and the genetic area, and no patents at all, everything's free, all research is free. The research is very expensive, so it's hard to imagine you'll get venture capitalists to pour a half a million dollars into researching to create a particular test if you tell them they can't get a return afterwards.

FLATOW: I see one of the problems as being locking up the research altogether if you have a patent on it, preventing other people from doing the research because you want to make a competitive product.

Prof. FELDMAN: Well, that is an issue that's inherent in the patent system, which is that we do tell people that in exchange for telling us all about this wonderful invention that you've made and making it available to the public after 20 years, for that 20 years you can exploit it in the way that you would like.

FLATOW: But Dr. Feldman, this is the difference. If I patent a doorknob, the only thing that's going to do is make it harder for me to open a door. But if I patent a gene for autism, that's not - that's going to prevent possibly the cure for millions of people around the world.

Prof. FELDMAN: I agree with you, and I would take your hypothetical and put it even farther. We've got all these doctrines within law that are based on mechanical inventions like your doorknob. And with a doorknob, we understand all the parts so, you know, we know what the doorknob is and the shaft that fits into the wall and the door, and we don't have any hints that the doorknob may be integrating with the door in ways we've never thought of or that there may be hidden parts we haven't heard of. When you take all those old doctrines and you put them and graft them onto biotechnology, you get an extraordinary reach of rights to people that can lock up all kinds of things, and we can't simply continue saying we'll take all of the ways that we used to think about mechanical inventions and will now apply them freely in biotech.

I guess my concern about this particular bill is that it's a little like taking a sledgehammer to go after a swarm of ants. You could end up creating a lot of damage, and you could still miss a lot of the ants.

FLATOW: So what would you, in your sage knowledge...

(Soundbite of laughter)

FLATOW: ...what would you suggest as the way out of this, that allows the research for sick people to be done, protects it, but doesn't stifle, you know, innovation?

Prof. FELDMAN: I think there are two kinds of approaches that are very, very important, and one is to limit inventors much more closely to what they actually did, what they actually knew about, and what they contributed. You could cut back significantly on rights if Congress or the courts were willing to do that. And second is that we really need to have a meaningful exemption for basic research in this country. We have something that's called an experimental use exception, but the courts have essentially read it to say it means nothing.

There's a very famous recent case called Madey vs. Duke in which the court looked at the question of a university professor. Suppose we just have someone at a university who's got a class doing research on something. They're not trying to produce a product, they're just trying to learn about this. Is that an experimental use? Can those people operate without the patent system? And the court said, nope, the university is a business and it gets students as part of its business and anything that makes it look better is a business purpose. Essentially, there is no experimentation that you can do outside the patent system. And there are other countries who do this very differently, and I think we need a meaningful way for people to do basic research and testing.

FLATOW: Wherever health issues are involved.

Prof. FELDMAN: I actually - I think that I would look more broadly than that. I think, you know, within the patent field, in a variety of areas, you should be able to engage in basic research without having to interact with the patent system at such an early point.

FLATOW: Could be quantum mechanics.

Prof. FELDMAN: Yes.

FLATOW: Do that sort of thing.

Prof. FELDMAN: Yes.

FLATOW: You should be allowed to take the research wherever it leads you without worrying about somebody clamping down on you.

Prof. FELDMAN: Yeah, and you can later on, when products are commercialized, begin to interact with the patent system. The United Kingdom has a much broader experimental use exception than we have. There are models out there in other countries that we could follow.

FLATOW: So if you want to do that research, you can now go to Great Britain.

Prof. FELDMAN: That is true, and there are companies who choose some of these routes to try to find a way around what our patent laws can restrict.

FLATOW: Is this on the radar screen in this country?

Prof. FELDMAN: I think there is a growing awareness that we have problems with how broadly we're granting rights in the healthcare field and how broadly we're granting rights to genetic and related inventions. I think you saw this last year on a case that you and I spoke about on this program, which is the LabCorp vs. Metabolite case. The Supreme Court took the case and then heard oral argument and then didn't rule, dismissed it as improvidently granted.

But within the argument, you heard the Supreme Court talking about things that are essentially creations of nature. How is that we are locking up things in ways that are quite so broad? So I think there is a growing awareness that we have to think of how to address this problem.

FLATOW: Do you think it just takes the right case to come before the court?

Prof. FELDMAN: Well, I think there was a problem, a procedural problem with that case.

FLATOW: Yeah, I remember that.

Prof. FELDMAN: And I think that was the problem. I think it's the right case to come before the court. I also think the court has taken a number of patent cases last term and this term, and it's part of the court beginning to orient itself towards what are these problems, how are they playing out in the cases, and what can we do to get some coherent theory as a whole that will take care of the problem?

FLATOW: And we won't even get into this time about the ability of the patent office to handle all these different kinds of...

Prof. FELDMAN: I think that the - you know, there are more things than the patent office has the resources to handle, but I also think that questions are broader. These really some fundamental, theoretical questions...

FLATOW: Yeah.

Prof. FELDMAN: ...that we have to ask. We can't just let a regulatory agency decide that.

FLATOW: Dr. Feldman, thank you for taking the time to be with us.

Prof. FELDMAN: Thank you for inviting me.

FLATOW: We'll have you back. Robin Feldman, visiting professor of law at Sanford Law School in Stanford University.

We're going to take a quick break and come back and talk about gardening. So you have your gardening, your green thumb polished, seed catalogs in the mail? Stay with us. You can ask any kind of question about gardening that you desire. We'll be right back.

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