Breast Cancer Gene Patents Challenged A landmark lawsuit is challenging the patents Myriad Genetics holds on the so-called breast cancer genes — patents that make Myriad the sole provider of a crucial genetic test. Do patents on genes spur research and innovation, or harm patients? Two experts share their views.
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Breast Cancer Gene Patents Challenged

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Breast Cancer Gene Patents Challenged


Breast Cancer Gene Patents Challenged

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Next up, there are two gene mutations that drastically increase the risk of breast and ovarian cancer in women who have them. They are, of course, the BRCA1 and 2. And how do you know if you have them? There's only one way to find out, and that's pay Myriad Genetics for a test. Myriad owns the patents to the isolated genes, and so they've cornered the market on this pricey test, which can run up to $3,000. Sound unfair? Well, the ACLU thinks so, and so do some disgruntled patients. It has organized a lawsuit again Myriad and the patent office, challenging its right to own that information exclusively.

Joining me now to talk more about its case and who's involved are my guests, two lawyers who are also - well, at least one of them is a scientist, and one of them has a degree in material science.

Kevin Noonan is a patent attorney. He has a Ph.D. in molecular biology, and he's a partner in the law firm of McDonnell, Boehnen, Hulbert & Berghoff in Chicago, and he joins us from WBEZ in Chicago. Thanks for being with us today, Kevin.

Dr. KEVIN NOONAN (Patent Attorney): Hi, Ira, how are you?

FLATOW: You're welcome. Daniel Ravicher is the executive director of Public Patent Foundation. He's also a lecturer in law and associate director of the Intellectual Property Law Program at the Benjamin N. Cardozo School of Law here in New York. He has a degree in material science, and he's co-counsel with ACLU on this case. Thanks for being with us.

Mr. DANIEL RAVICHER (Benjamin N. Cardozo School of Law): My pleasure.

FLATOW: Let's talk a bit about this case. Tell us why the lawsuit was brought.

Mr. RAVICHER: OK. This lawsuit is about whether or not the government has the right to grant exclusive rights to one company over our genes, and over the knowledge that a mutation in those genes could relate to a predisposition for particular types of diseases. We brought this case because these patents are held by a company in Utah named Myriad Genetics, which is asserting them in a way which is cracking down on anyone else doing any research, anyone else doing a second-opinion testing, or providing testing to patients that Myriad themselves refuse to offer the tests for.

CONAN: Your Web site has a sentence describing it that: A gene patent holder has the right to prevent anyone from studying, testing or even looking at a gene.

Mr. RAVICHER: That's right because patent law says once a patent has been granted by the Patent Office, the patent holder is the only party in the United States that's allowed to make any use of the patented thing. And there's no exception from patent law for any type of fair use, as there is in copyright law or research. So there's absolutely conclusive ownership of the gene by the patent holder.

FLATOW: We should note that we did invite Myriad to come on the program, but they declined, considering there's a lawsuit in progress.

Let me go back and ask you for a reaction, Kevin. Would you agree with anything that was said there?

Dr. NOONAN: Well, yeah, Dan is technically correct about that, but let me give you some facts behind it.

FLATOW: Well, what do you mean technically correct?

Dr. NOONAN: He's right that U.S. patent law gives you, gives the patent holder an absolute right. Well, it's actually a right to exclude. Think about it like a fence you can put around your property. People can't come on to your property for 20 years since when you filed the patent application, but after that 20 years is over, it's free to be used by everybody, and that's...

FLATOW: So people not even able to look at the gene?

Dr. NOONAN: Well, let's - now let me get there. Let me get there.


Dr. NOONAN: The National Library of Medicine has a list of most of the major scientific journals in the U.S. and abroad. And last night, I looked and put in BRCA, and there were almost 3,500 papers that have been published about these genes, some as recent as last month.

So I think the idea that people are not doing scientific research on these genes is just wrong. What people are not being able to do, and what some of the named plaintiffs in this lawsuit are trying to do, is provide clinical testing - you know, bring a woman in, do the test, and charge her money. And that's what the patent law is addressed to, not research. It's addressed to if you're going to use the test commercially, and so...

FLATOW: But if Myriad wanted to stop me or anyone from looking at it, they could?

Dr. NOONAN: Well, you know, technically they could but frankly, that's really not a very winning argument. And I don't know any evidence that they did, and in fact, I'd say that 3,500 papers is evidence that they're not.

CONAN: A reaction, Dan?

Mr. RAVICHER: Well, we actually represent researchers at the University of Pennsylvania. We represent research at the Emory University, and we also have assisting our case, researchers at the University of California, Los Angeles, all whom have been sent very nasty letters by Myriad saying we know that you are doing things with these genes that relate to breast and ovarian cancer, and you shall stop or pay us money.

And so this assertion, which they've shut down - there was a lab operating, doing BRCA analysis at the University of Pennsylvania. We represented two medical professors who were in charge of that lab, and they were shut down because of Myriad's patent assertion.

FLATOW: All right, we have to take a break. There's a lot to talk about, of course. You can see we've got a left and right, right and left here. We can discuss - up and down, whichever way you want to phrase it - 1-800-989-8255 is our number, 1-800-989-8255. Also, you can tweet us @scifri, at S-C-I-F-R-I, and also in Second Life, you can join our group and ask a question. So lots to talk about. Stay with us. We'll be right back after this break.

(Soundbite of music)

FLATOW: I'm Ira Flatow. This is SCIENCE FRIDAY from NPR News.

FLATOW: You're listening to SCIENCE FRIDAY from NPR News. I'm Ira Flatow. We're talking about a lawsuit brought by the ACLU against the patenting of the BRCA1 and 2 genes. Those - actually the mutations on those genes is what's really -greatly increases a woman's risk of getting cancer, and the ACLU has brought this case against Myriad Genetics.

Defending, I guess - could I say that correctly, Kevin, defending Myriad Genetics?

Dr. NOONAN: No, I wouldn't say - you know, I'm not going to opine about what Myriad Genetics has done, since we don't represent them, and I don't know how they're enforcing their patents, but I am defending the fact that it would be a mistake for the United States government - whether through the courts, through Congress or through the Patent Office - to not allow genes to be patented.

FLATOW: Because?

Dr. NOONAN: Well, there are consequences. I mean, we can make that decision. We can say we don't want those to be patented. Besides being contrary to 200 years of natural products patenting, the fact is that there are - the consequences would - I should say it a different way. The benefits we get from gene patenting are: one, disclosure; and two, investment.

And the first thing is that, you know, you can't keep something as a trade secret if you are going to patent it. And as I said before, you get a 20-years-from-filing-date term of your exclusive right, and then when that's over, your patent is freely usable by anybody.

So that promotes disclosure of inventions. Secondly, especially in the biotechnology space, investment is critical. Most of the companies that do this are small companies, like Myriad, and unless there's some way for investors, in something that's very high risk and that most of the products fail to get their investment back, you're not going to have investment. And then you don't have the drugs and the diagnostics that the biotechnology industry has developed over the past 25 years. And I think that we're in worse shape if we don't have them.

FLATOW: Well, how do you respond to that, Daniel?

Mr. RAVICHER: Well, we don't have a problem, and in this case we haven't challenged countless other patents that we could have challenged, related to drugs or new methods of isolating a gene or new ways of diagnosing predispositions to diseases.

All we've challenged here are the specific claims that are in just the isolated genes themselves, so the knowledge of what a normal BRCA gene would look like, and the knowledge of what a mutated BRCA gene would look at, just simply those nucleotide sequences.

And then we've also challenged patents purely on the correlation between a mutation in someone's genes and an increased risk for disease. There are valid reasons to have patents on many things, but you can have patents on too many things, and there's a line that's been drawn by the Supreme Court, and we fully believe that these patents land on the wrong side of that line.

FLATOW: But he's arguing that, you know, the patent - by allowing patenting of this, you allow money to be invested, you allow the genes to - people to make useful things out of the gene products. What's wrong with that idea?

Mr. RAVICHER: Well, all patents have both an incentivizing and a chilling effect. So if you grant a patent on anything, even like the law of gravity, that would, you could argue, incentivize people to investigate what is the law of gravity. But the Supreme Court has said that you can't patent some things that are basic laws of nature because that would have such a dramatic countervailing chilling effect on everyone else - all 300 million other Americans and any research that they might do on that subject - that granting a limited monopoly on that one party isn't worthwhile because we have to remember, the patent system's purpose is not to create profit for one company.

The patent system's purpose is to advance the state of the art available to the public, and there needs to be an out-of-bounds area of laws of nature and natural phenomenon that are not to be captured by patents.

In-bound things like drugs, new testing methods, innovations like that, perfectly acceptable. But patents on genes or correlation knowledge, not patentable.

FLATOW: Kevin, if I wanted to do research on these genes, and I had a way to cure cancer, I would not be able to do that, would I?

Dr. NOONAN: Well, I wouldn't go that far. If you could do research on the genes, and at the end of the day, you came up with a cure for cancer - let's say a drug - then you probably would, and I'll give you an example.

When researchers at the University of Rochester found that there in fact is a second enzyme that is - that can be inhibited to prevent pain but not have the effects of being inhibited in your stomach to cause ulcers, they patented that gene. And when companies made drugs that, in fact, did exactly that, those patents were not allowed to be asserted against those companies, they lost in court, because they hadn't come up with the drugs.

So if you come with a drug, and then the patentee hasn't come up with that drug, then you can patent that drug. And if that drug cures cancer, well, that'd be great.

FLATOW: And what do I owe, then, the holder of the patent?

Dr. NOONAN: Well, in that case, you owe them nothing. I think that the question here would be - there would be a question of whether you practiced the invention in such a way that in finding that cure for cancer, you would have infringed their patent. But you know, there's a lot of fact-specific questions here, and I don't think we should assume that you necessarily would if you did that.

FLATOW: Well, if I were - let's say just technically, just to pull a name out of a hat - let's say I were Bill Gates, and I wanted to take the gene, and I wanted to patent it, and I would - I wanted to use it to cure, to find a cure - let's say a genetic engineering cure. I could take the gene, I could change it, and I could put it back in women and then cure them of this cancer. And I would give it to everybody because I'm rich enough, I can give this whole thing away. Would there be anything wrong with that? Would the company want to stop me from doing that?

Dr. NOONAN: Well, first of all, it would depend in how you did it because you might be able to do that with just a piece of the gene. And one of the things about these gene claims is that they're very limited. They're not exactly - they do not cover the gene as it is in a cell, and so you might be able to do exactly that without using the whole gene, and you wouldn't. And I think that we could spin hypotheticals here all day, but it gets down very, very, very much to what exactly is it that you're doing. And if you isolate the gene and use it, then you would be infringing, that's right. And whether or not that would be something that would be - you'd be sued for infringement, would depend on the circumstances.

FLATOW: It would depend on whether they want to sue me or not.

Dr. NOONAN: Well, that's part of it. I think that certainly, there - I could imagine - go ahead.

FLATOW: They could just decide they wanted to for whatever arbitrary reason, because they have the right to do that, according to patent law.

Dr. NOONAN: Well, except that Rule 11 of the Federal Rules of Civil Procedure says you can't just do something for any arbitrary reason. You have to have a good-faith belief that somebody's infringed your patent.

Mr. RAVICHER: The unfortunate thing is Rule 11, while it's a screening for lawsuits, is not the same screening that applies to sending nasty letters. And unfortunately, a lot of researchers, they're either at universities that have very skittish university counsel offices, or they're small businesses themselves, and they could never afford to defend themselves. So merely the threat of a lawsuit, just through a letter, which doesn't have to meet Rule 11, often chills conduct that most reasonable people would agree would never be covered by valid claim of any patent.

FLATOW: Now, I'm reading the lawsuit here, and there are letters cited in the suit, and some of them are very veiled threats in these letters.

Mr. RAVICHER: Right.

FLATOW: They're not really - they just, they use terminology. It doesn't say, I'm going to sue you. It's sort of, I'm going to look at what you're doing.

Mr. RAVICHER: And there's a very justified reason for that veiled threat. Because there's a law that says if someone threatens to sue you, you can actually preemptively sue them in the home court that you want to choose. But if they just simply let you know that they have certain rights, then the courts have said, well, that may not provide you standing to preemptively sue them.

So these letters are purposefully drafted in a way to not expressly threaten people. But everyone knows that that's exactly what they are meant to do.

Dr. NOONAN: Well, except - I'm sorry, Ira.

FLATOW: Go ahead, no, go ahead.

Dr. NOONAN: Sometimes you send those letters because you want to invite somebody to come in and sit down with you and figure out whether what they're doing isn't infringing, because you don't always have all the information.

FLATOW: Do they specifically say that in the letter, come in and sit down; let's talk this over?

Dr. NOONAN: I don't know. Dan, what do they say in the letters?

(Soundbite of laughter)

Mr. RAVICHER: Sometimes, there is offers to discuss and sometimes, they're not so genuine. But I just want to step back a minute and go back to - the really interesting thing here is the word "isolated."

I think most reasonable people would agree that if the patents were just on the BRCA genes, that would not be valid because that is - that exists in our body. The genes exist in our body. It's that these patents say an isolated gene.

In the Patent Office, just an administrative agency, under a previous administration - which was a very pro-business, pro-patent administration -said that well, if you've isolated the gene, then that's patentable. And we just think that's incorrect. That's like saying I can go out into nature, I can dig up some gold, I can isolate it from the mountain and well, now I deserve a patent on gold. And that's just not the law.

Dr. NOONAN Well, that's - wait a second. Let's just step back from that, Dan. As you well know, there are plenty of natural products - there are antibiotics that are made by bacteria. Taxol is an anti-cancer drug that's in the bark of a yew tree, and we can sit here and make lots of examples where perfectly patentable by isolating something from nature in that way. And frankly, the way these genes are isolated, and the way these genes are chemically manipulated, A, they're not identical to what's in the chromosome; B, they're not in the chromosome anymore; and C, they are much more converted, changed, as the Supreme Court would say, by the hand of man, than what's in Taxol from the yew tree.

So if you're going to use the traditional standards of what is - what you have to do to change something that's found in nature to make it patentable, these genes satisfy that criteria hands down.

Mr. RAVICHER: I think Kevin does an excellent job at presenting our opponents' point of view, with which we disagree. Those - all those isolated natural product claims have never been upheld by the Supreme Court, and we think they would be invalid under binding precedent.

FLATOW: All right, 1-800-989-8255. Sheila(ph) in Macomb, Michigan, hi.

SHEILA (Caller): Hi there.

FLATOW: Hi there.

SHEILA: It sounds like you've already headed off a bit in the direction that I was going. I'm calling because I'm a breast cancer survivor. I was diagnosed just last year and, of course, I was interested in getting the BRCA testing to find out what my risk of elevated - or my elevated risk for ovarian cancer is, too. I am not in a high risk-enough group to have the test covered by insurance, and I don't have $3,000 in my back pocket to pay for it myself.

However, having said all that, I have to say that I can't fault the company Myriad because they are the holders of a patent that was granted to them legally. And so, I don't see any point in any lawsuits against them or complaints against them. I do see quite a bit of validity in complaints or suits against the U.S. Patent Office because, as you've been discussing, perhaps the patent of the isolated gene itself is what should be at question, and also maybe the question of the profitability from this testing - or the prohibition of having other companies do studies on the same isolated genes.

FLATOW: So you see�

FEMALE: So I think that the direction that the ACLU is going is perhaps a little bit off, although I do agree with the actual, you know, what they're saying.

FLATOW: Well, the patent�

FEMALE: And I'll take any comments off the air.

FLATOW: OK. Thank you. The Patent Office is mentioned right at the top.

Mr. RAVICHER: The Patent Office is also a defendant. We have sued them. But I would just - I'm, first of all, very happy to hear that she's a survivor. I'm very sad to hear that she's not able to access the test, which we think is her civil liberty that she has a right to.

But I would disagree when she concedes that these patents are legal. There are many things done on our pervious administration that were not legal. Just because the Patent Office has granted a patent doesn't mean it's actually valid. In fact, about half of the patents granted by the Patent Office that are later litigated in court are found to be invalid. They were wrongly granted by the Patent Office. That's because the Patent Office has been created to be a pure patent-issuing office under previous administrations. Under the new administration, we expect that to change. So I would not concede that these patents are valid just because they were granted.

FLATOW: Hmm. Mm-hmm. If they - Kevin, $3,000 for a test. Isn't there something ethically, morally wrong with not allowing someone to come up with a cheaper test that potentially, cancer patients can afford?

Mr. NOONAN: Well, I think that that's - I mean, that points to the problem with our health-care system, that there are people who can't afford things that we have.

I don't know that anybody has shown any evidence that Myriad is the most profitable company in the country, or that what they're charging is excessive. I don't know, I've seen bills from doctors and from hospitals for friends and loved ones that I thought were pretty excessive. But the fact of the matter is that this is a number that the company has come up with for a reason. And if they were making money hand over fist, and were on Forbes's front cover as the most profitable biotechnology company, maybe you'd have an argument. But I have no evidence that they're doing anything more that making whatever the profit they need to justify the investment to have the test in the first place.

FLATOW: This is SCIENCE FRIDAY from NPR News. I'm Ira Flatow, talking with Kevin Noonan and Daniel Ravicher. Dan, any comment on that? I mean, it - it doesn't matter what the company is - how much money the company is making if you still can't afford $3,000.

Mr. RAVICHER: No. And I'm as a big a conservative as you'll find anywhere, especially here in New York City. I'm from the South. And I just don't believe in big government granting exclusive rights to companies.

Now, I don't have a problem with Myriad staying in business and being the most successful BRCA tester. I just have a problem with them having exclusive rights over the knowledge, which is our genetic sequences and those correlations. If they have patents on new tests, they can do that better and they can compete in the marketplace and be the most successful company in the world, God bless them. I'm happy for them.

So this isn't a case about taking down Myriad. This is a case about protecting the right of all Americans to access knowledge about their body and their health.

FLATOW: Mary(ph) in Providence. Hi. Welcome to SCIENCE FRIDAY.

MARY (Caller): Hi. How are you? Thanks for having me on.

FLATOW: Mm-hmm.

MARY: You've covered the issue that I initially called about a little bit, and so I have a comment and a question. The first comment is that, you know, you asked if, you know, ethical - the ethical, moral considerations that a gene patenting company might have. And I have to say that I think there's ample evidence that moral and ethical issues have become so secondary to the considerations of research science that it's shameful, and that science has become so profit-driven that ethics - I don't even see ethics. I would like there to be ethics, but I don't even think that's a consideration. So I just wanted to make that comment.

Second of all, I'm still a little unclear on this isolating of the gene. I have the gene, right? It's in me. And so they've isolated it, but I have the gene, right? So why don't I have the patent on the gene or can't - why can't I sue Myriad in that, you know�

FLATOW: They're using your gene�

MARY: Sort of an argument, you know - based on something that's in my body.

Mr. NOONAN: No, no.

FLATOW: It's in your body. OK. Let me - Mary, before I go to break, let me get an answer from Kevin, who's going to try to make light of this question.

Mr. NOONAN: Ira, come on. No, I will. I'm not going to make light of the question. That's, in fact, the emotional crux of the ACLU lawsuit. They have buttons they're giving people that say, don't patent my genes. We're not patenting your gene. The gene probably came from a blood cell, from a donor who is perfectly happy with it.

The fact that they have this gene, it has no relevance to you as a human being except insofar as you want to have a doctor perform a test that will tell you whether or not you have this mutation. So the fact that they've isolated a gene is irrelevant to your use of the gene and your body or anything else. It's not your property right because they haven't infringed on your property right, and nobody is going to knock on your door, like Michael Crichton said in a New York Times editorial a few years ago, and give you a bill for using your gene. That's just - it's great, it gets people all excited and all upset, but it's just - frankly, at the end of the day, it's a lie.

FLATOW: But you can't use my gene to do research on.

Mr. NOONAN: Well, the fact of the matter is, is that you can't isolate any human gene from anybody if somebody has a patent on it. And the fact that it's in your body, as long as you keep it there, nobody cares.

FLATOW: I guess that's a yes.

Mr. NOONAN: Yes.


(Soundbite of laughter)

FLATOW: 1-800 - I love talking to lawyers. 1-800-989 - hey, got two of them here - 1-800-989-8255 is our number. But you see, people, when they hear about this, they really get upset. Hearing everything about isolating, whatever, they think this is - part of my body, and you shouldn't have exclusive rights to do whatever you want, then make something and charge me an outrageous price of $3,000 using the research you did on my�

Mr. RAVICHER: Well, this is an overarching problem with our patent system, which is most people, they hear the word patent system, their eyes glaze over and they get bored to tears. They think it's irrelevant to them. They don't realize how the patent system has a direct impact on their daily life, their access to technologies, research and development, their health, their financial well-being.

And that's one of the reasons why I started the Public Patent Foundation - we're co-counsel with the ACLU in this lawsuit, that ACLU and PubPat are both co-counsel on the lawsuit - is because the public needs to be aware of how the patent system is impacting them.

FLATOW: Right.

Mr. RAVICHER: And this case is a great example of that.

FLATOW: Is it too late for me to get the patent on the double play, I'll give you the sacrifice fly? We can work�

Mr. RAVICHER: Yeah. I don't think anybody would care about that.

FLATOW: Oh, well, every time it's used, I get a royalty. What are you talking about?

Mr. NOONAN: Actually, there was�

Mr. RAVICHER: �I think.

(Soundbite of laughter)

FLATOW: They didn't think about it early enough. We're going to take a break. We'll be right back: 1-800-989-8255, here with Kevin Noonan and Daniel Ravicher. So stay with us; don't go away.

FLATOW: I'm Ira Flatow. This is SCIENCE FRIDAY from NPR News.

(Soundbite of music)

FLATOW: You're listening to SCIENCE FRIDAY from NPR News. I'm Ira Flatow. We're talking this hour about patenting genes with Kevin Noonan, who is a patent attorney, and Daniel Ravicher, executive director of the Public Patent Foundation. Our number: 1-800-989-8255. Let me go to the phones because there's an interesting question from Rachel(ph) in D.C. Hi, Rachel.

RACHEL (Caller): Hi. How are you?

FLATOW: Fine. Go ahead.

RACHEL: Well - are you there?


RACHEL: This test and an alert doctor saved my life. But nevertheless, I have a comment, which is that the recommendation, typically, for women who test positive for the BRCA gene is to have a double mastectomy and their ovaries removed.

FLATOW: Mm-hmm.

RACHEL: And it's troubling that you can do this and you can't get - really get a second opinion. There is no other company you can go to to get this test done before you have this very radical, life-changing surgery. The other thing I want - point I'd like to make about patenting genes is that - or patenting scientific information of this type that's so critical to life is that, for example, there's a lot of research being done now on nicotine and vaccinations that will prevent nicotine addiction. Well, if I was big tobacco, I would be doing that research big time so that I could then patent that and prevent people from being immune to nicotine.

FLATOW: Mm-hmm. All right, Rachel, we're running out of time, but I want to thank you for bringing those points up. Let me see if I can get an answer. Kevin, does this mean I can't get a second opinion if I have a positive diagnosis?

Mr. NOONAN: Well, the only thing I know is that - spoken with some people at Myriad who say that nobody ever asks them for the second diagnostic. Nobody has ever come to them and said, if a woman has had the first test and has paid you for that first test and wants to come to us for a second opinion, can we make a deal about that? And so, the second opinion option is one that may still be out there, but so far nobody has actually done it.


Mr. RAVICHER: I've actually written a letter to Myriad on behalf of my client, who has already paid them their money and just wants a second opinion because there is evidence that despite how hard they work, Myriad still gets it wrong sometimes. And having a second opinion before you have your breasts and ovaries removed would be a desirable thing. And they refused to grant our client in this lawsuit the right to get a second opinion. So I'm glad to hear that they told Kevin something more positive, but what they've told me and my client is, no, they can't do that.

Mr. NOONAN: Was that after you filed the lawsuit?


FLATOW: Let me see if I understand this. So I'm told that - I get a test, I'm told I have the gene mutation and that, as she said, that most people get a radical mastectomy. And I want to go back and have a second opinion. And according to what you say, filing with Myriad, they've denied this.


FLATOW: You can't get a second opinion with someone else?

Mr. RAVICHER: You may not. That is illegal. You would be violating the law. And the doctor who did that for you would be violating the law and subject to expensive damages.

FLATOW: Could you go outside the country?

Mr. RAVICHER: Yes. You can fly outside the country because these gene patents are not allowed in most other countries in the world.

FLATOW: So it's like the old abortion days, before - when abortion was illegal nationally, you had to go to another state or you had to go outside the country if you wanted to have one. And you still - you now have to do this with the gene patent.

Mr. RAVICHER: We've seen another analogy which was - respect to patents on human embryonic stem cells in this country, which were granted but not granted in other countries. And many researchers actually had to move their labs to foreign countries like Singapore because the patents didn't exist there, and the patents that were granted here in the United States were being used to shut down any competitors.

Mr. NOONAN: Well, wait a second, Dan, you know as well as I do that the reason those labs moved offshore was the Bush administration's restriction on cell lines. In fact, Wharph(ph), who holds those patents extensively, made an agreement with the NIH and those - the cell lines they had, and more cell lines would have been disseminated except for the Bush administration's prohibition of using federal funds for human embryonic stem cells. So�

FLATOW: But Kevin, you have�

Mr. NOONAN: �not exactly right.

FLATOW: �you have no problem with the idea that you have to go out of the country to get a second opinion?

Mr. NOONAN: Well, I think that that's one of the options, and we certainly - Dan is right. Other countries have been free-riding on American innovation for 25 years.

FLATOW: Well, you call free-riding a woman who wants a second opinion about getting a mastectomy?

Mr. NOONAN: No, I mean - do you think they're going to do it for free? If somebody�

FLATOW: What if she was willing to pay any amount of money?

Mr. NOONAN: Then, why doesn't she pay Myriad?

FLATOW: Well, he's already written to Myriad, and Myriad has said no.

Mr. NOONAN: No, but they could get another opinion from Myriad because frankly, do you think another lab is going to give you a different result? The idea would be that there�

FLATOW: Are you prejudging what the lab - that's the whole idea of what a second opinion is, isn't it? You go to one doctor, you say, well that's your opinion. You go to another doctor, you get a second opinion.

Mr. NOONAN: It is actually - there are different methods of screening genes, and it's known that the different methods which are used, and it's debated in the literature which ones are best for what purposes. And there is evidence that Myriad was not doing the best testing possible through several periods of its existence.

FLATOW: Where do you think this - how far up on the judicial ladder is this case going?

Mr. NOONAN: Right now, we're still at the district court stage, where we filed the lawsuit back in May. The defendants, both the Patent Office and Myriad, made motions to dismiss our case, saying we had no right to bring it. We survived those motions to dismiss. Now, we have made our own affirmative motion to the judge, saying there's no need for trial. It's absolutely clear that we win. And the defendants have their time to respond within the next few weeks. We'll have a hearing on that in January, and then the judge will decide.

FLATOW: And it could go up higher than...

Mr. RAVICHER: We fully expect that this will get appealed at least to the Court of Appeals, if not ultimately the Supreme Court.

FLATOW: Would you agree with that, Kevin?

Mr. NOONAN: Oh, absolutely. It doesn't matter who loses. It will go to the appellate court and then - 'cause the Supreme Court doesn't have to take every case, they will decide whether they'll take the case depending upon what the district court judge decides and how the appellate court treats that decision.

FLATOW: All right. We've run out of time. I want to thank you both for representing your side very well. Kevin Noonan is a patent attorney, and he is a partner in McDonnell, Boehnen, Hulbert & Berghoff.

Mr. NOONAN: Hulbert.

FLATOW: Thank you. Hulbert.

Mr. NOONAN: That's OK.

(Soundbite of laughter)

Mr. NOONAN: It's usually the Boehnen that has - they have the problem with Boehnen, not Hulbert.

FLATOW: No, you're now officially part of SCIENCE FRIDAY when I screw up your name. And Hulbert & Berghoff in Chicago, Illinois. And Daniel Ravicher is the executive director of the Public Patent Foundation. Also�

Mr. RAVICHER: Ira, can I add one more thing?

FLATOW: �associated - well, no, we've run out of time.

(Soundbite of laughter)

Mr. RAVICHER: Too bad. OK. Thank you.

(Soundbite of laughter)

FLATOW: Thank you both for joining us.

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