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Can Genes Be Patented? Ruling Reignites Debate

A federal court this week invalidated patents filed by biotech companies on the human genome, igniting debate on exactly who owns genetic research. Jeffrey Brown gets two points of view on the legal implications of the case.

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    Now to a potentially far-reaching case involving science, medicine and law.

    A major goal of modern health science has been to identify the links between our genes and disease, to assess risk, and to find treatments and cures. Over the last two decades, university researchers and a multibillion dollar biotech industry have expanded the study of the human genome and developed a working blueprint of human DNA that includes hereditary information stored on 23 pairs of chromosomes wrapped as double-helixes.

    Companies have also filed patents on particular genes and the research connected with them. Roughly 40,000 patents are now held on about 20 percent of all human genes. Among those are patents owned by Myriad Genetics, a company based in Salt Lake City, for genes known as BRCA1 and BRCA2, the genes whose mutations have been linked to hereditary breast and ovarian cancers.

    Myriad sells a test costing more than $3,000 that helps assess a woman's risk for cancer. But a group of individuals and organizations challenged those patents in a lawsuit, arguing that, under the law, a so-called product of nature cannot be patented.

    This week, a federal judge agreed with the plaintiffs in a ruling that could have a broad impact on future genetic research.

    Here to discuss the case are Daniel Ravicher, executive director of the Public Patent Foundation at the Benjamin Cardozo School of law. The foundation was one of the plaintiffs in the case against Myriad Genetics. And Ken Chahine, a patent attorney and visiting professor of law at the University of Utah. He's a former CEO of a biotech company, and filed an amicus brief on behalf of Myriad. He joins us from Houston.

    Daniel Ravicher, start with you.

    Explain more about what these patents are and what you see, the problem with them.

    DANIEL RAVICHER, executive director, Public Patent Foundation: All right.

    Well, a patent is the government granting one company the exclusive right to make or use a certain technology. And, in this case, the Patent Office has been granting patents over many genes in our body. And, so, the result means that, if you want to look at your own genes to see whether you have a particular mutation that would increase your predisposition for a certain disease, you can't do that without the permission of the company.

    And, in this case, we sued Myriad Genetics because they were using their patents to foreclose any other lab from offering this genetic screen or from allowing women who couldn't afford to pay Myriad's price to go to someone who might be willing to do that screening for them for free.


    Ken Chahine, from the company's standpoint, the — some process has happened that makes the gene, makes this all patentable; is that correct?

    KENNETH CHAHINE, patent attorney, University of Utah: Yes, I think so.

    First of all, it's we need to be clear that no one actually owns your genes or has patented your genes. And when you isolate a gene, it really is — has been transformed into something different. And we know that intuitively because, now that a gene has been isolated in this particular case, you can — you can tell a woman years, if not decades, before she has any signs or symptoms whether she is going to develop breast cancer.

    And I think that's exactly the type of inventions that the patent system is designed to encourage. And I think it's doing a good job. And I'm concerned that suits like this could actually stymie that progress.


    Daniel Ravicher, this idea of owning a gene, do we — do we agree on that, I mean, because that's a hard concept for people to grab.


    We actually disagree, because, in effect, what these patents are is, you — you want to isolate your gene. And that is a required part of the patent. But to isolate your gene simply means you go to a doctor and they withdraw your blood, and then they want to look at your genes and tell you whether you have a mutation or not.

    So, we do believe — and the judge agreed with us this week — that isolating genes from your body is no different than looking at the gene inside your body. And, in fact, the whole purpose of why isolating your gene is worthwhile is because it is exactly the same as the gene inside your body.

    If when you isolated genes, they were different, and you saw a mutation in that isolated gene, then that wouldn't tell you anything about your own body. It is only useful because it is exactly the same. And that is what we argued, and that's what the judge agreed with.


    So, Ken Chahine, is this — is this a distinction of definition, of science? Or what — what is going on here in not agreeing even on that?


    Well, I think it is a little tricky. And, again, I would say that, when you isolate a DNA molecule, it has transformed.

    And, again, as I said earlier, you know that because you can do something with that piece of DNA that you couldn't do with that same piece of DNA when it's in someone's body. And, so, to me, that really crosses a threshold of being eligible for patent protection, and, again, the type of inventions that we want to encourage. And that is a very important part of it.

    So, perhaps we don't agree on that point, but it is an important one to discuss.


    Well, but explain. Continue on that thought. Why are these patents so important to companies?


    The reason they're important to companies is that, when you have a very basic idea that comes out of a university, which I think is absolutely critical, translating that basic research into a useful clinical diagnostic, as, in this case, Myriad Genetics has done, requires a fair amount of investment.

    And I think that, when are you looking — sitting across the table from a venture capitalist, for example, who wants to invest $10 million or $20 million in a company, they want to have some insurance that there will be exclusivity in order to return — get some return on investment for that money.

    So, I think that is where it really becomes an issue that it is important.


    Did you have to face that yourself?


    I certainly have. And I think there's no question that, in any serious discussion with an investor, they will at some point ask what the intellectual property protection is for the product.

    And, frequently if you don't have that, that could be a point where you are not going to get funding.


    What is the response to that, Daniel Ravicher?


    Ken raises very important issues. We do have to make sure that we have a patent system that promotes progress, as per the Constitution.

    But the Supreme Court has said that patents can have both an incentivizing and a chilling effect. And the line between those kind of patents that we want, having that net incentivizing effect, as well as between those that we don't want is whether or not the patent covers a natural phenomenon or a law of nature.

    And what the Supreme Court has said is the patent has to cover something that is markedly different from what exists in nature. And we argued to the court — and the court agreed with us — that simply removing genes from your body and looking at them is not markedly different from nature.


    But is — but the issue that I think he brought up is the squelching-of-innovation argument for companies, that, if they have done the work, and they get the patent — if they don't have the patent, why would they go ahead with the research?


    Well, we are not challenging any patents on new drugs, new treatments, new ways of finding genes or anything like that. We believe that those kinds of patents should exist and are good for society.

    But we agree with the Supreme Court that patents on things that exist in nature — simply because I have taken gold out of a stream, washed off the dirt and made it shiny doesn't mean that I deserve a patent on gold. I have to actually do something meaningful with it to make it a new invention, not just something that I discovered in nature.


    Ken Chahine, this is one case and it is one judge. And I gather that everyone is pretty sure that there will be an appeal here. But what are the larger stakes, either — I mean both now and if this is upheld down the line?


    Well, certainly, it will be appealed both through the federal circuit and I think ultimately the Supreme Court. This is definitely a landmark case. And I think that the industry needs some clarity from the courts as to whether these inventions are going to be patentable at the — in the long run.

    I guess my long-term concern is really that this is the future of medicine. I think that the vision is to pre — to determine whether someone is predisposed early, before they are sick, and try to prevent that. And anything that is going to deter from that, to me, is very concerning. And I hope that this ruling doesn't do that.


    You would agree, Mr. Ravicher, that this is the long-term future of medicine, right?


    Yes, I agree with Ken completely that the future of medicine is personalized, not one size-fits-all that we have now. When you go into your doctor in the future, they are going to screen your gene and they're going to know exactly which medicines are best for you and which ones would be harmful for you, so they can provide a custom, tailored diagnosis.

    But if we allow patents on genes — and there are 25,000 genes in every human cell — if we allow patents on that, there's going to be a toll booth set up on every inch of our genetic code, and we're never going to be able to realize the promise of personalized medicine.


    Will the research go on, though, if there are not those patents?


    Right. The funny thing is, all the major research in the field of genetics and these genes in particular was done by university researchers who did not want to get patents in a way to exclude others.

    Most gene patents aren't being asserted in a way that's harmful to the public, because they are being widely licensed, and competitors are allowed to do their own individual screening. Women like my client, Lisbeth Ceriani, who is a poor single mother from Massachusetts, who simply wants to know whether or not she is likely to get ovarian cancer, can't afford to pay Myriad's test.

    She wants to go to my client Dr. Harry Ostrer of NYU Medical School, who is willing to do the test for free. Myriad won't let that happen. Most gene patent-holders are more reasonable. We chose Myriad as a defendant in this case because they are being unreasonable in their assertion of these patents.


    And, Mr. Shahine, briefly, your argument is that the research might be stymied from this?


    Well, and it's so much the basic research, because I do agree that basic research needs to continue. And I don't think that there is really a strong observance or enforcement of the patents.

    It's that translation. It really is that translation from that basic research to commercialization that I fear could be stymied by these actions.


    All right, Ken Chahine and Daniel Ravicher, thank you both very much.




    Thank you so much.

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