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IRA FLATOW, host:

Up next, imagine going in for a checkup and having your doctor recommend a test for a genetic mutation known to increase your risk for a certain disease. Now that test might otherwise cost, let's say, $100, but you're going to pay $300 because the company that developed the test has a patent on a procedure. And anyone who wants to use that test must pay royalties. Does that sound fair to you?

Well how about this one. You're at the doctor's again and this time your doctor uses a test to measure the level of an amino acid called homocysteine in your body. Now if the level is higher than normal your doctor concludes that you may be deficient in vitamin B. And then your doctor then gets sued for patent infringement, not for performing the test, mm-hmm, but for merely thinking about the connection between homocysteine and vitamin B deficiency.

Sound crazy? Well my next guest, says it's not as unusual as you think because more and more patents are being awarded for basic biological processes, the building blocks of science. And she says this trend stifles inquiry and threatens to impede scientific progress.

And she states her case in an article in today's issue of the Journal of Science. And she joins us now to talk about patents in scientific progress.

Lori Andrews is a distinguished professor of law, director of the Institute for Science, Law, and Technology at the Chicago-Kent College of Law. She joins us today from Chicago.

Welcome back to the program, Dr. Andrews.

Professor LORI ANDREWS (Chicago-Kent College of Law): Oh, my pleasure.

FLATOW: Any case stick out for you now where this is a better example than I've mentioned?

Prof. ANDREWS: Oh there are so many startling and troubling cases. For example, not all drugs work on all people. Maybe an asthma drug will work on three out of 10 people for whom the physician prescribes it.

But through genetic testing we can tell who the three are that the drug will be efficient for and not harmful. In one instance a company that makes the asthma drug has actually patented the genetic sequence that let's people know whether they are at risk for the drug or will be benefited.

And the patent holder says that it will not develop the test or let anybody else develop that test because, of course, it would cut down on its market if it couldn't sell seven out of 10 of the drugs to people for whom it is not useful at all.

So what we're seeing is that in contrast to the purposes of patent law, people are getting patents on basic products of nature like genes and principles of nature like you mentioned the correlation between an amino acid and a disease. And it's getting in the way of healthcare and scientific research.

FLATOW: So they're able to patent the knowledge of the genetic sequence that...

Prof. ANDREWS: The sequence itself, even though it occurs in all of our bodies, and so one professor at MIT said, well, he could take his, you know, blood down to a homeless shelter and use his insulin gene to make insulin for diabetics. But he's not allowed to do so because someone has a patent on the insulin gene.

I got a call from a biotech company that wants to do really inexpensive hepatitis C screening. The holder of the patent, though, on the hepatitis C genome is preventing it. So now you actually have companies and researchers owning whole diseases and not letting other people work on them.

FLATOW: Wow. That's amazing.

Prof. ANDREWS: Yeah. It goes against, you know, and it's a perfect contrast to your guest that you just had on who talked about how sharing information and access to the bones they found allowed other researchers to find things that the original researcher had missed. And I think we're losing out. And in fact, in countries where genes have not been patented, like the hemacromatosis gene, the Alzheimer's gene, breast cancer gene, they actually have better testing, because they have discovered mutations we haven't here. Because if one company owns something like the breast cancer gene, nobody else is allowed to test for it. And so unlike a situation where you have a lot of researchers doing the tests, you might not find out about mutations in the gene that they didn't think to look for.

FLATOW: So how did it get to be this way? And why does it stay this way?

Prof. ANDES: Well, I think in part - it's funny. There are actual incentives within the patent office to grant patents. I learned that patent examiners get a bonus if they close a file. So one way to close a file on an examiner is to grant the patent; then I get my bonus. If I deny the patent, it's appealed and my bonus is not given to me right away. I can't get a whole bunch of bonuses because I'm working on the appeal of that file.

And in fact, at one point, a few years ago, they had t-shirts at the patent office that said this is the patent office, not the rejection office. So they have moved away from the - doing things like granting patents on actual inventions, like a patent on a mousetrap, to patenting concepts, like the concept of trapping mice. And I think I'm starting to see now a tendency on the part of the U.S. Supreme Court to start taking more patent cases, possibly to slap down the patent office and the federal circuit, which is the court that hears all of the patent appeals, because they've moved away from basic Supreme Court jurisprudence.

And it's very common to look at the patent system as a three-way give and take. You've got the Patent Office, Congress and the Supreme Court. And so often patents are granted, like Samuel Morris got a patent on - in the late 1800s -on all use of electromagnetic waves to write at a distance. And despite the fact that he got that patent, the U.S. Supreme Court said no, he can't patent a concept, electromagnetic waves; he can only patent his particular invention. And the Supreme Court has also said you can't patent formulas, like E=MC2, or products of nature, like a new plant found in the wild. So hopefully, we will start seeing some of these cases go to the Supreme Court and making it easier for scientists to get access to the basic building blocks of science.

FLATOW: In fact, there is a very interesting patent case that was - that's argued this week in the Supreme Court. It's what I call the Tinker to Evers to Chance case. You know, that famous double play theme. They were Chicago Cubs. You may appreciate the analogy, being from Chicago. You know, there was a famous poem written about this double play, and I call it the Supreme Court's case, that, because the case centers on whether obvious inventions could be granted patents like the double play. Hey, you know. Why get one out at second base when we can get - throw to first and get two outs at second base? And it appears in today patenting climate, as you say; it sounds like the double play could have been patented.

Prof. ANDREWS: Oh, totally. There's already a New York law firm that's advising sports figures to patent their moves. So if you have a particular style of dunking, no one else would be able to use it...

FLATOW: Is that right?

Prof. ANDREWS: ...against you. And there are patents that have been granted on certain tax shelters and so forth. There's even a patent on the comb-over for baldness. So you know, so I think all of us may be in the position of having to pay, you know, royalties on just going about our daily life.

Flatow: And the case before the Supreme Court is about the design of an adjustable brake pedal, is it not?

Prof. ANDREWS: Yes. And I think what's happened and one of the reasons the U.S. Patent and Trademark Office has run amuck is that they've been more concerned with making things easy for patent examiners than with this purpose underlying the patent system to encourage innovation. So the patent office puts a lot of stock on what they consider to be prior art, a prior writing in the literature that sets forth the invention, and you can't get a patent if someone else has, you know, written about it over a year before someone else has patented it.

And so they look for these writings. But sometimes a patent or an invention would be obvious, but nobody's written down the fact it would be obvious. And so someone else is allowed to get a patent on just a slight change. It would be like I patented a red ball and you made a blue ball. Well, that would have been obvious to make a blue ball, but nobody has written in the literature of sports that you could use a different color. You might get a patent, and then things are kept from the public for a long time, because I might have my 20 year monopoly on the red one and you have then the next 20 years after that on the blue and it never gets into the public domain.

I think, you know, we're seeing a lot that happening. We're also seeing, because of that focus on the prior written art, some really out there patents being granted, like one on a space vehicle, you know, for time travel that...

Flatow: They allowed a patent on...

Prof. ANDREWS: And it's been granted because the patent examiner looked and nobody had written about it before. And so...

Flatow: So it doesn't have to actually work?

Prof. Andrews: No. Nobody - and that's a real issue with the gene patents, too. It's not like going to the Food and Drug Administration. I could file a patent on a genetic sequence and I could write in my patent, you know, this will tell you if your teenager will get a high grade on the SAT scores. And that may not be in fact be true, and you know, parents might pay me to give that DNA test to folks, and nobody, you know, double checks.

And I have found in some instances that in patents about actual diseases the patent applicant has exaggerated the prevalence of the disease in order to sort of scare more people into getting these tests. And nobody - not only are they not required to prove it in advance, but by holding the patent on the genetic sequence, they can prevent anybody from doing the epidemiological studies to find out the actual prevalence. And half of gene patent holders will not allow their gene to be used without permission in epidemiological studies.

FLATOW: Wow.

Prof. ANDREWS: Some refuse permission altogether.

FLATOW: Wow. Talking with Lori Andrews on TALK OF THE NATION: SCIENCE FRIDAY from NPR News about what's going on our patenting system. Is there any way to reverse this trend?

Prof. ANDREWS: You know, I think so, because cases have not made it up to the Supreme Court. And I think that would be a way to think about it. And we've had some reversals by Congress as well.

One thing that happened in the mid-'90s was doctors started patenting their surgical procedures in great numbers. One doctor sued another for doing cataract surgery in his patented fashion. And the American Medical Association stepped in and said that can't be good for patients. I mean, imagine if someone had a patent on appendectomies. I go to a doctor who doesn't have a license for that patent, would he do something dangerous like take out my appendix through my nose? You know, we don't want people to have this sort of monopoly over something that's so important to people's health.

And so Congress did adopt a statute that said doctors can use patented medical and surgical procedures without having to pay royalties. So we could have something like that that doctors could get access to the genetic sequences without having to pay royalties, or we could mount a challenge and bring some of these crazy patents before the Supreme Court to allow scientists to have access once again to the basic scientific building blocks.

FLATOW: And is it a fact that the patent office has a backlog of tens of thousands of applications?

Prof. ANDREWS: Yes. And part of it has been the possibility of patenting these basic building blocks of science and gene sequences. Because some people have filed patents on tens of thousands of gene sequences, not whole genes but snippets of genes that might be important developing pharmaceutical projects and so forth, so part of it is the vast expansion.

And the federal circuit is at fault too, the appellate court, because they, you know, said that even though there's a Supreme Court precedent, you can't patent laws of nature. They would allow patents on laws of nature if the law produced a useful, concrete and tangible result. But that's the definition of laws of nature itself - I mean the law of gravity. All these laws that the Supreme Court has said, you know, you can't patent would meet that test.

So it's really the federal circuit that's out of line. And we saw that this week in, you know, the Supreme Court oral arguments about an instance that you were talking about with the brake pedal, that - where the Supreme Court just thought that federal circuit's test was, you know, confusing and ill-placed, at least it seemed that way from what of the questioning of the justices.

FLATOW: Well, I want to thank you for sharing this shocking news with us.

Prof. ANDREWS: You better tap into that USPTO database before you go home and see if you're doing anything, you know, that violates a patent.

FLATOW: I've got to go. Yeah, you know.

Prof. ANDREWS: (Unintelligible) you know, questioning a guest on a talk show.

FLATOW: I could be throwing, you know, a curve ball following a slider. I got that sequence patented. You can't do that.

Prof. ANDREWS: Oh, man.

FLATOW: You know? You can't throw three strikes - three sliders in a row, but not a curve ball and - wow. Thank you, Lori, for taking a time to talk with us.

Prof. ANDREWS: Great to talk to you.

FLATOW: Lori Andrews, a distinguished professor of law and the director of the Institute for Science, Law and Technology at the Chicago-Kent College of Law.

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