Controversy Brews over Patenting Laws of Nature The Supreme Court hears a rare patent case this week. It involves the patenting of a common medical test, and has some asking whether the patent office has gone too far.
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Controversy Brews over Patenting Laws of Nature

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Controversy Brews over Patenting Laws of Nature


Controversy Brews over Patenting Laws of Nature

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You're listening to TALK OF THE NATION: Science Friday. I'm Ira Flatow.

And for the rest of the hour, we're going to look at patent case now before the Supreme Court. It came before the court this week.

And, of course, when you think of patents, I think most of us think about things. You have a widget, a gadget, a light bulb, or even a new drug or a software program.

But what if you discover something that no one has ever known before? Say, why objects fall to the ground when you drop them or why cholesterol is not good for you? Could you patent that knowledge?

Patent law says no, that you can't patent the laws of nature, which is what makes the case before the Supreme Court this week so very interesting. At issue is a patent which says that if you find high levels of a certain amino acid called homocysteine in the body that might mean there's -- homocysteine in the body might mean there's a vitamin B deficiency.

Now, the testing method, the testing method for homocysteine is not in dispute here. Rather, the Supreme Court is considering whether you can patent the thought process, connecting the dots. Do doctors who perform this routine test millions of times a year infringe the patents “merely by thinking about the relationship.”

A testing company called Laboratory Corporation of America argued that the patent went too far, that the patent gave the owners too much control over a basic scientific principle, that high homocysteine levels mean a vitamin B deficiency.

Supreme Court rarely hears patent cases, so this case really stands to have a lasting effect on patent law.

Joining me now to talk more about it is my guest, Robin Feldman. She's professor of law and the director of the Hastings' Law and Bioscience Project at the University of California, Hastings College of Law in San Francisco. She joins us by phone.

Thanks for talking to us today, Professor Feldman.

Dr. ROBIN FELDMAN (University of California Hastings College of Law): Thank you for having me.

FLATOW: Tell us about this patent. Why is this case so interesting?

Dr. FELDMAN: Well, as you mentioned, the Supreme Court rarely takes patent cases. We can go years without seeing a patent case. And this term the Supreme Court has already taken four cases, which suggests that they have a high level of interest in what's happening in patent law.

This case is very interesting because it touches on a fundamental notion of what is something that's an observation of a natural phenomenon, a law of nature that is free to all, owned by none and what is something you can actually control and lock up anybody's right to use for 20 years?

In order to decide this case, the court's going to have to look back at cases from the early 1980s. And that may rethink, reshape, what we talk about that's within the patent law and what's outside the patent law.

One of the most important things about this case is understanding what part of the patent everybody's okay about and what part people are upset about.

FLATOW: Let's go through the patent itself a little bit.


FLATOW: Let's discuss that.

Dr. FELDMAN: Sure. So there is a level of knowledge about, and there was even before these folks came in who patented the invention, a notion that elevated homocysteine levels can suggest that a patient doesn't have enough vitamin C in their body. I'm sorry, a couple of vitamin Bs, B-12 and folic acid.

And if you don't have enough of that, you can have some really serious health effects, cardiovascular disease, cognitive impairment. Pregnant women, if they don't have enough of these vitamin Bs, their babies can be born with spina bifida, neural tube defects.

If you can figure it out, you just give them a vitamin and that heads off all these problems. So it's an important area. We can't test for that directly any more than we can do a blood test and say, oh, you haven't had enough fruits and vegetables today.

But we can look at this other thing called homocysteine because these vitamin B products break down homocysteine. They help break down homocysteine levels in the bodies. So if we see a lot of homocysteine we can make a connection that says, I think maybe my patient needs some vitamin B.

The patent at issue was from a company that invented a test for testing homocysteine levels and correlating that with whether your patient needs vitamin B. And it's the kind of thing we patent. It says, take a sample of tissue. Put it in the following solution. Run it through the following machines. Here's what you do.

That kind of specific test is fine to patent. But they added one more claim. They said, we claim any way of testing for homocysteine levels and making a connection between that and the thought that a patient needs more vitamin B.

And that's what everybody's complaining about, saying that not just their test that they wish to control but they wish to control any way to get at this information. And people who are complaining to the Supreme Court are saying if you allow them to have this last claim, it's the same as locking up a basic natural phenomenon. It's the same as letting them control observing nature. We don't do that in patent law, and we shouldn't do that. That's what at stake in this case.

FLATOW: It sounds to me like, if I could make another analogy, you patent a way of taking your cholesterol level, a certain way. But then we know that a high cholesterol level might be bad for you. So they're trying to lock up that knowledge about the cholesterol, not just the high level, but it also being bad for you and you can't use that.

Dr. FELDMAN: That's exactly what the argument is about. If you lock up every way to get to that piece of information, we've locked up that piece of information. And, that is supposed to be, within the patent system, that's just, that's an observation of nature, and we don't let individuals control that.

You figure it out, you can win science prizes and the undying gratitude of doctors and patients everywhere, but we aren't going to give you a patent on that.

FLATOW: I compare it to trying to patent the double play in baseball.

Dr. FELDMAN: Well, you know it's interesting you should mention that. Lots of people have something to say about this case. And a lot of these people have nothing to do with pharmaceuticals or biotechnology and medicine at all. So in addition to briefs that have been filed by doctors' organizations and medical organizations, you have some filed by IBM, by American Express, banking industry, by a whole lot of people who have something to say.

And what they're trying to say is that since 1980, when, the early 1980's when the Supreme Court decided a couple of cases about what are the laws of nature and what's something you can patent. It's opened the door for the lower courts to allow patents on all kinds of things, patents on software, you couldn't get that before, patents on business methods, ways of doing something which is very similar to what you just said about the double play.

FLATOW: Right.

Dr. FELDMAN: So I think the one probably your listeners might have heard of the most is the's one-click patent. So they have a patent on, not on the software that will make your site operate to allow one-click shopping, but on the business method, the idea of having someone on your site be able to do one-click shopping instead of having to add it all up at the end.

FLATOW: The whole idea, just the idea of one-click is patented?

Dr. FELDMAN: Exactly. And another of the cases on the Supreme Court docket, they're going to hear that one I think in a couple of weeks, is about eBay. Where someone came to eBay and said, I'm sorry, we own the notion of organizing your website as an on-line auction. And so, therefore, you can't do this unless you're going to pay us a lot of money. These are business method patents and they have been approved by the lower courts.

A number of people are asking the Supreme Court to use this case as a vehicle to move the line back, to say we're not going to let you patent that much.

FLATOW: And is there a perception that the patents have gone wild now?

Dr. FELDMAN: There are a number of people who believe that the lower courts have allowed patenting that's much too broad in a variety of areas, whether you're talking about business method patents or biotech patents. Now there are others who are very concerned about what will happen if you move the line. You want to be very careful that you don't hurt industries that have given a lot to Silicon Valley and certainly the nation.

These early cases we're talking about from the ‘80s really opened the door to the explosion of biotechnology as well as to, it helped in the explosion of computer software as well. So we don't want to slam that door closed. But there are many people who are saying that what we let you control in patenting has gone too far, Supreme Court. Will you please cut back on this?

FLATOW: Right. Is it a question that the overwhelming number of new patent applications has overwhelmed the ability of the patent office to actually make a wise decision on these patents?

Dr. FELDMAN: It is a huge problem. The patent and trademark office does not have the resources to do, to take a careful look at each of these patents. And the information they're looking at is provided by the person who's asking for the patent. We don't let somebody else come in and say, Hey wait a minute PTO, we think this is nonsense, don't let them go that far. It's only an ex parte proceeding, most of the time.

They don't have the resources and they particularly don't have the resources with all of the explosion in computer software and biotech patents. So it's a serious problem.

FLATOW: And so what is the solution here?

Dr. FELDMAN: I think it is very, very good for the patent industry and for science as a whole that the Supreme Court is willing to start looking at these cases. For a long time, there has been concern that the appellate court, right below the federal circuit that hears appeals related to patents, is a very pro-patent holder and really will allow very broad patents, not all the time, but a lot of the time. And that there's no Supreme Court supervision of that, there's nobody to look at that and say, this needs to be cut back.

So the fact that the Supreme Court is willing to hear these cases, and I would predict will take more cases in future court dockets, I think that's very important.

FLATOW: What about modernizing the patent and trademark office?

Dr. FELDMAN: I would love to see modernization in the patent and trademark office, and there have been proposals for that. As a lot of the things in government, one of the issues is money. Meaning, can you really afford to hire a lot more patent and trademark office officials?

There are some changes, there are some small changes you make that might have a big impact. For example, right now, when you have a patent and you go to litigate that in court, there's a presumption that the patent is correct. And some people have argued that one shouldn't be doing that. Given how few the resources are for PTO and how many questionable patents seem to be getting through, we should change that. And we should say, this is information for the court to look at, but if you're going to argue this patent we're not going to give a presumption that it's correct. So that's another way to do it, is to begin to work on the rules.

There are a number of ways in which people move patents through the patent system and they can ask for continuances and they can amend their patents and there's some concern this is a very arcane, archaic process, and that needs to be updated as well.

FLATOW: Yeah, but what --

Dr. FELDMAN: But I really think -- oh, I'm sorry.

FLATOW: No, go ahead.

Dr. FELDMAN: I really think the issues, I really don't think it's so much tinkering. I really think it takes the kind of fundamental overview that the Supreme Court is able to do, to say, what are we doing here? What do we want to grant rights in, and what do we want to say really should be available to all scientists everywhere? To think about, to work with, to develop inventions from, where should that line be drawn?

FLATOW: We're talking about patents for the rest of the hour on TALK OF THE NATION: Science Friday from NPR News.

We're talking with Robin Feldman, professor of law and director of the Hastings Law and Bioscience Project at the University of California, Hastings College of Law in San Francisco.

Our number, 1-800-989-8255.

Do you think that these four cases, are they cohesive cases or do they cover all different areas of patent law?

Dr. FELDMAN: I don't think they're cohesive cases. There are some very different issues at stake.

One was really a patent anti-trust case that had to do with what you need to prove in a case where you're trying to bring an anti-trust claim. You have this case, which looks at the question of what's a law of nature and what's not. The next case they're going to hear is the eBay case, and that, you know, hidden in the eBay case is concern about the question that business method patents have gone too far. But that's not the question before the Supreme Court. The question before the Supreme Court is should you be able to avoid injunctions in certain cases?

And so, I don't see these as coherent. But the one thing that pulls all these cases together, and its why I think you'll see more cases, is an increasing interest on the part of the Supreme Court in looking at the patents and looking at what the lower courts are doing. So I don't think, I think this is the beginning but not the end of what they are doing.

FLATOW: Because people thought they had no recourse until now. Take it all the way up to the court.

Dr. FELDMAN: And you really just never saw the Supreme Court taking these kinds of patent cases, and in fact in this case, when the LabCorp case was filed, the Supreme Court turned to the government, the Solicitor General, and said, what do you think? Should we take this case? And the government said, don't touch this case!

And I think that maybe, there's so many people who have such, you know, it's a very important and could be a very volatile area. But the Supreme Court ignored that advice and they took the case anyway, which suggests they have something to say to us.

FLATOW: Now that has, this occurred after the two new justices?

Dr. FELDMAN: This was before the two new justices, so this was last fall. And one of the new justices has recused himself, because I believe his firm represented one of the parties. So, only --

FLATOW: Which one was that?

Dr. FELDMAN: That was Justice Roberts.

FLATOW: Right.

Dr. FELDMAN: So he's not hearing this case. We only have eight justices on it. Justice Alito, however, is new to this case, and there was some disagreement or some potential disagreement during the Supreme Court arguments. Some of the Supreme Court Justices, I think a couple of them, focused on the government's argument about, maybe we shouldn't be deciding this. Maybe we should say the parties need to argue that below, and they didn't do enough arguing below. We'll send it back or we'll say, you know, they didn't preserve their issues.

But a number of the Justices hammered very hard on this notion. What is it that man has contributed? What is it that nature has contributed? And are we giving away things that we shouldn't be?

FLATOW: Are you a handicapper, Dr. Feldman?

Dr. FELDMAN: (Laughs) Well I thank you for the title. I'm only a professor.

If I were a handicapper, I would say the Supreme Court will not send this back, that they actually will make a decision. I think they will make a decision saying that in this last claim the patent goes too far. But you know, its very dangerous for law professors to try to offer crystal balls.

FLATOW: Especially in Washington.

Dr. FELDMAN: Yeah, oh, that is absolutely right.

FLATOW: Yeah. So, but you expect more of these, a little momentum here now that these cases have made it to the Supreme Court?

Dr. FELDMAN: I think it's absolutely true. And I think it's an awareness both on the Supreme Court's part and on the public's part about the role that patents play in our lives and how they can get in the way of things that we took for granted.

FLATOW: Take the BlackBerry case!

Dr. FELDMAN: Perfect example. Everybody was running around wondering if their BlackBerrys were going to get shut off any minute.

FLATOW: Right. Right.

Dr. FELDMAN: And nothing brings home patent law that way than if you, something you depend on is about to be turned off.

FLATOW: The old two-by-four. I want to thank you very much, Professor Feldman, for taking time to be with us, and explaining some really rough law here, to we science folks.

Dr. FELDMAN: Thank you for having me.

FLATOW: Have a good weekend.

Dr. FELDMAN: All right.

FLATOW: Robin Feldman is a professor of law and the director of the Hastings Law and Bioscience Project at the University of California, Hastings College of Law in San Francisco.

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