Supreme Court Unanimously Rules Human Genes Cannot Be Patented

In an unanimous decision, the Supreme Court justices ruled that a company cannot patent an isolated human gene. To look at the implications of the decisions and its impact for patients and medical research, Judy Woodruff talks to Todd Dickinson of the American Intellectual Property Law Association and Sandra Park of the ACLU.

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    We turn now to the Supreme Court's decision on genes and its impact for patients and medical research.

    The justices unanimously ruled that a company cannot patent an isolated human gene. The case involved Myriad Genetics, a company that holds patents on genes correlated with hereditary breast and ovarian cancer, known as BRCA1 and BRCA2. Myriad sells the genetic tests for those cancers.

    In the majority opinion, Justice Clarence Thomas wrote: "Myriad found the location of the BRCA1 and BRCA2 genes. But that discovery, by itself, doesn't render the BRCA genes patent eligible."

    But the justices also found that firms can patent synthetically created genetic material known as cDNA.

    For a look at the implications, we are now joined by Todd Dickinson. He's the executive director of the American Intellectual Property Law Association. And Sandra Park, she's an attorney with the Women's Rights Project at the ACLU. Their team argued the case against Myriad Genetics.

    Welcome to you both.

    And, Sandra Park, I want to start with you. It was your side that was arguing against Myriad being able to have control or keep this patent. How do you read the justices' ruling?

  • SANDRA PARK, American Civil Liberties Union:

    Well, we were very pleased with the ruling.

    Our fundamental argument all along has been human genes cannot be patented. And the problem with these patents is they gave Myriad the exclusive right to control what testing was done on these genes and even what research could be done on these genes. And so the court's ruling today lifted that barrier to scientific research, to medical innovations.

    And that was what our plaintiffs, who are geneticists, pathologists, as well as patients who need better access to this type of testing, that was our goal, and that is what we got from the Supreme Court today.


    Todd Dickinson, your organization filed a brief supporting the company, Myriad. How do you read the results?

  • TODD DICKINSON, Executive Director, American Intellectual Property Law Association:

    Well, actually, we — our brief didn't support either side in this.

    We were trying to, as we often do, trying to get the law right based on the history of the — and the public policy in this area. I think what Justice Thomas is saying is basically that naturally occurring discoveries in his framing of it are not patentable and that manmade inventions are. He drew a line in this particular case that highlights that.


    And what do you think that will mean for a company, for Myriad Genetics and what it's been able to do?


    Well, short-term, it probably won't have much of an impact. Myriad — these patents expire the year after next, which is kind of an interesting thing, but there are other patents Myriad holds on the cDNA, on synthetic DNA, on methods of using it, how you use these to do the diagnostic testing.

    So, I would guess for the time being, Myriad is still the best test you can get and most people will still want to go there. Insurance covers their test, for example, in many, many cases.


    So, you're saying it won't have much of an impact.

    Sandra Park, you're saying this is good news for patients, for geneticists. What's — how am I hearing this differently?


    Well, I think the problem has been that Myriad has used their patents to have a monopoly on genetic testing. And that has stopped other laboratories, even those that want to offer testing in other — using other methods, or even including the BRCA genes with other greens that are connected to breast and ovarian cancer risk, to provide a more comprehensive picture of a patient's risk.

    And the ruling today allows for all of that. It allows for that competition. And I think we have already heard at least two or three laboratories announcing that they plan to offer genetic testing that includes the BRCA genes within this year.


    If that's the case, Todd Dickinson, why isn't it a setback for the company in that they will not — that — I mean, just to come back to your argument, and what she just said, that it means that Myriad now has competition, that other companies will be able get into …


    That's right. And I think we will have to wait and see how the competition plays out, whether others are able to offer a comparable test.

    Myriad has got many, many years of data, for example, that help normalize the test. I think the bigger question, frankly, is the long-term implication, and whether or not the opinion puts at risk thousands of other patents out there in all sorts of other different contexts in biotechnology.

    We have got plenty of industries that are — to which these patents could be key in terms of encouraging innovation, encouraging the investment in the innovation to bring them to market, from biofuels, to enzymes for clean water, to extractive technologies for finding new antibiotics. It raises lot of questions.


    And what are you saying it means for them?


    Well, I think the question is, will this opinion be expanded to cover all those other patents, which may be at risk at this point? We have issued patents for 30 years in this area. There's thousands and thousands of them that are out there, and it creates some uncertainty.


    Well, before we broaden it too much, though, Sandra Park, I want to come back to you, because we talked with a number of experts in the field, one in particular who was on your side of this argument arguing that Myriad shouldn't be able to patent the gene.

    And one of them said, in essence, agreeing part — with part of the argument that Mr. Dickinson is making. And I just want to read to you what they said. They said: "Myriad still has the proprietary database, which means that even if somebody else, some other company invents a competing test, they're going to have to essentially deal with Myriad's monopoly on information to interpret what those tests mean."


    Well, we agree that is a problem.

    And the patents on the genes allowed Myriad to develop that proprietary database, and that's why it's so important that the court's ruling today invalidated these kinds of patents on human genes, so we don't have the situation in the future with other genes where one company is able to amass that kind of information.

    But I think what we will see going forward is that because there will be competition, because other laboratories will be offering this testing, that kind of information will be much more freely shared. And Myriad's hold on that information won't be able to last the way that they have tried to do so by using the patents to have the monopoly on the testing itself.


    Well, that actually brings up another point and perhaps another concern. The societal bargain that's based on the patent system is that if you disclose your invention completely, we will give you the proprietary right for a limited period of time.

    What happens if you don't have the proprietary rights sometimes is it drives it underground. It causes researchers to keep it secret, not to do so much collaborative research. That could be a downside to this we haven't seen yet.


    Well, I want to come at the very end of this discussion back to the essence here, Sandra Park, and that is, what does this mean for women who may have the — one of the BRCA genes for either breast or ovarian cancer? And what are their prospects for getting the kind of help they need, the kind of treatment that they need? What does this decision mean with regard to them?


    Well, they will have better access to genetic testing of these genes.

    And in fact it well may be that companies will be offering the testing not only of the BRCA genes, but of the many other genes related to breast and ovarian cancer. And that's really important. When a patient gets a genetic test, she doesn't necessarily care only about whether she has a mutation or the BRCA1 or 2 gene. She wants to understand her comprehensive genetic risk for these diseases.

    And so laboratories will be able to offer that testing, which up to now they have not done because of the Myriad patents. There will also be more availability of confirmatory testing or second opinion testing, and that has been an important issue for many patients. And we also think costs will be driven down because of marketplace pressures.


    Very quickly, Todd Dickinson, how do you see the effect on those women we're talking about?


    Well, I think many of those effects might, indeed, occur.

    But that's not really a function of the patent system. The question at the — the basic question is not whether Myriad deserved the patent or not. The question is whether it was patent-eligible. And that's whether court ruled on today. I think many people would believe that this is a very deserving cause and that Myriad is providing a very valuable service and that, as we move forward from here, others will be able to take advantage of that.


    All right, we are going to leave it there.

    Todd Dickinson and Sandra Park, thank you.