Judge Robert Sweet, senior federal judge for the Southern District of New York. He ruled against Myriad Genetics in 2010 and invalidated their patents on the BRCA1 and 2 genes in a case that ultimately made it to the Supreme Court.
Sandra Park, senior attorney with the ACLU’s Women’s Rights Project. She’s one of the lead counsels in the Supreme Court case on gene patenting.
Lisbeth Ceriani, one of the plaintiffs in the ACLU lawsuit. In May 2008, she was diagnosed with an aggressive form of breast cancer. Her oncologist noted she was also at high risk for developing ovarian cancer and recommended she get the BRCA genetic test. However, due to patent laws, the test was prohibitively expensive even though she was insured by MassHealth at the time.
In a major victory for women’s health, the Supreme Court has ruled 9-0 that isolated human genes may not be patented. The case concerned the firm Myriad Genetics’ patent on genes linked to higher risks of hereditary breast and ovarian cancer. The firm claimed it had the authority to stop all research on genes it owned patents to — BRCA1, or Breast Cancer One, and a similar gene, BRCA2 — and was the only company that could conduct life-saving tests revealing if women had mutations in those genes — often at a prohibitive cost for most patients. "It’s a very important decision," says our guest Judge Robert Sweet, the senior federal judge for the Southern District of New York who originally invalidated Myriad Genetics’ patents in the case now before the Supreme Court. "The issue of knowledge and freedom of genomic knowledge is something that will be critical in the years to come." We’re also joined by Lisbeth Ceriani, a woman who participated in the lawsuit after her oncologist noted she was at high risk for developing ovarian cancer, only to find out her insurance didn’t cover the BRCA genetic test, and by Sandra Park, a senior attorney with the ACLU’s Women’s Rights Project and a lead counsel on the case. "With the ruling today, we fully expect much better access and much better options for patients, as well as for scientists who want to look at different parts of the genome," Park says. "They no longer now need to deal with patents on the thousands of genes on our genome when they’re engaging in their scientific work."
This is a rush transcript. Copy may not be in its final form.
JUAN GONZÁLEZ: In a major victory for women’s health, the Supreme Court has unanimously ruled that isolated human genes may not be patented. The case concerned the firm Myriad Genetics’ patent on genes linked to higher risks of hereditary breast and ovarian cancer. The firm owned patents to a gene called BRCA1, or Breast Cancer One, and a similar gene called BRCA2, meaning it had the authority to stop all research on those genes and was the only company that could conduct life-saving tests revealing if women had mutations in those genes.
AMY GOODMAN: On Thursday, the Supreme Court sided with the American Civil Liberties Union in saying Myriad Genetics’ discovery of the precise location and sequence of the genes did not constitute a "human-made invention" eligible for patenting. The ACLU and the Public Patent Foundation filed the case four years ago on behalf of 20 plaintiffs, including organizations representing over 150,000 medical professionals, geneticists, breast cancer and women’s health advocacy groups, and patients. They made this video to raise awareness.
ACLU VIDEO: Right now, a private company called Myriad Genetics owns a piece of your body. That’s a really bad idea. It patented two genes: Breast Cancer One and Two, or BRCA1 and 2. Certain mutations on these genes give women a strong chance of getting breast or ovarian cancer. The problem is Myriad Genetics says, because of the patents, it’s the only one allowed to test these genes. That’s more than a bad idea. The law says no one can get a patent on products of nature or laws of nature. But Myriad says, once it removes the genes from your body, it owns them. That’s not how the law works.
JUAN GONZÁLEZ: The issue of genetic testing for inherited health risks gained publicity last month when actress Angelina Jolie revealed she underwent a double mastectomy after finding out she had a roughly 87 percent chance of developing breast cancer. In an op-ed piece for The New York Times, Jolie wrote, quote, "I hope that other women can benefit from my experience. Cancer is still a word that strikes fear into people’s hearts, producing a deep sense of powerlessness. But today it is possible to find out through a blood test whether you are highly susceptible to breast and ovarian cancer, and then take action." Jolie said the cost of testing, at more than $3,000 in the United States, remained an obstacle for many women.
AMY GOODMAN: Democracy Now! invited Myriad Genetics to join us on the show, but they declined. When we spoke to company spokesperson Ron Rogers on the phone, he insisted Myriad Genetics offered life-saving genetic testing at an affordable cost.
RON ROGERS: For patients in need, Myriad does provide free testing or financial assistance, depending on the patient’s level of need. So we do have patient assistance programs that patients who are uninsured or who are in financial need can access and to help them get the test. But the vast majority of patients will be able to get this test with no out-of-pocket expense at all. And for those in private insurance plans that are not yet under the umbrella of the Affordable Care Act—and eventually they probably all will be, but for those that are not yet under that umbrella, the average out-of-pocket cost is $92. So, it’s much—it’s far fewer than 1 percent of patients that ever have to pay list price for the test, right? I mean, that’s just not—I mean, it’s not even half of 1 percent of patients that have to do that.
JUAN GONZÁLEZ: That was Ron Rogers, spokesperson for Myriad Genetics.
Well, our next guest had quite a difference experience when she tried to get the gene test through his company. We go now to Boston, where we’re joined by Lisbeth Ceriani. She was one of the plaintiffs in the ACLU lawsuit. In 2008, she was diagnosed with an aggressive form of breast cancer. Her oncologist noted she was also at high risk for developing ovarian cancer, and recommended she get the BRCA genetic test. But due to patent laws, the test was prohibitively expensive even though she was insured by MassHealth at the time.
We’re also joined by Sandra Park, a senior attorney with the ACLU’s Women’s Rights Project. She’s one of the lead counsels in the Supreme Court case on gene patenting.
AMY GOODMAN: And in London, we’re joined by Judge Robert Sweet, senior federal judge for the Southern District of New York. He ruled against Myriad Genetics in 2010 and invalidated their patents on the BRCA1 and 2 genes in this case the Supreme Court just ruled on.
We welcome you all to Democracy Now! Judge Sweet, let’s begin with you. This certainly is a victory, the upholding of your decision. How significant is it, nine to zero?
JUDGE ROBERT SWEET: Well, I think the principle that’s enunciated by Justice Thomas’s opinion is a very powerful one. And I think it will have an immediate effect on people like those represented by the plaintiffs’ groups and so on. But the court itself recognized that the study of genomics is one of the leading areas of research in the United States, and it’s very important to everybody’s health. This decision, I believe, will free up the ability of researchers and others to experiment, to deal with genome—genomes, generally. And that, I think, will expand the area of knowledge and research. So I think it’s a very important decision. It’s one that, frankly, I just feel so delighted that I was able to have a part in it, because I think this issue of knowledge and the freedom of genomic knowledge is something that will be critical in the years to come.
JUAN GONZÁLEZ: And, Judge Sweet, the high court’s decision did make a distinction between the patenting of genes that exist in nature versus ones that are somehow or other altered by a firm in the process of their own scientific experimentation.
JUDGE ROBERT SWEET: Yes. I think it really is a simple but an elegant decision, because the court has made it clear that there are areas in research that can perhaps be patented. That’s for another day, with respect to each one. But that is because they have made a change in the gene. And it’s that change—so, the court has not closed down the ability of people to advance medical research through patents, but at the same time, it has made it clear that the—that no one can patent a genome in itself. So that, I think, will open up a greater ability of people to obtain information on the BRCA1 and 2, and it will also enhance the ability of the researchers to deal with genomic research, which is now, as I understand, not only a question of one genome, but the effect genomes on each other. So that freedom, I think, is very important.
AMY GOODMAN: And BRCA1 and 2 is also pronounced "brack one and two." Lisbeth Ceriani, yours is one of the cases that led to this Supreme Court decision, that first Judge Sweet ruled on, and then the Supreme Court ruled on. Very briefly, if you could tell us your story?
LISBETH CERIANI: Sure. I had difficulty obtaining the BRCA analysis test because I was told by the genetic counselor that they wouldn’t accept my insurance, that my insurance wouldn’t cover it, actually. When I contacted my insurer, they said they would cover it if it was provided by a contracted lab. And I contacted Myriad and said, "Please contract with my insurance." And that wasn’t happening. They chose not to contract with my insurance, which was at the time Massachusetts MassHealth. And, you know, that was within their right, but, as you know, the test was extremely expensive, so it did take over a year and a half for me to finally access the test through a grant, luckily.
JUAN GONZÁLEZ: Well, you heard the spokesman for Myriad say that very few people actually have to pay list price. And he, Ron Rogers, yesterday insisted his company made the gene test highly accessible.
RON ROGERS: Let’s take a step back and talk about access to the test. The BRCA analysis test for hereditary breast and ovarian cancer is very widely accessible. In fact, essentially all private insurance companies, Medicare and Medicaid provide reimbursement for at-risk patients for BRCA analysis. And also, because of the Affordable Care Act—some people refer to it as "Obamacare"—under the preventive care provisions of the Affordable Care Act, patients can actually get the BRCA analysis test without any out-of-pocket cost, meaning no copayment, no deductible. So they can get the test with no cost at all. For the private insurance plans—and there’s still a small percentage of the private insurance plans that are not yet under the umbrella of the Affordable Care Act—for those private insurance plans, the average out-of-pocket cost for the patient is $92, so it’s less than $100.
JUAN GONZÁLEZ: Could you respond to that?
LISBETH CERIANI: In my case, it would have been close to $4,000 for me to access the test in 2009. They were—Myriad was choosing not to contract with Massachusetts Medicaid at the time. And many negotiations went back and forth between the contracting people with MassHealth and the contracting people at Myriad. So, in my case, it would have been close to $4,000. And apparently, they weren’t allowed to offer me any financial—financial deals on the price, because I did have MassHealth, so they were prohibited from offering me any financial discounts. So that was just prohibitive for me to pay at that time. So, luckily, I was able to access a grant in enough time to get the information I needed in order to assess whether I had an increased risk of developing ovarian cancer. And in my case, it turned out I did have a rare mutation, so it was lucky I was able to access the test when I did, but it did take over a year and a half for me, actively working on it like a part-time job. And I just knew that there were other women, who—definitely other women in Massachusetts with the same issues.
AMY GOODMAN: Sandra Park, you were a part of the team that argued this before the Supreme Court. The significance of this victory?
SANDRA PARK: It’s a huge victory. I think that what we had up to this point is a company that monopolized two human genes—genes that we all have in our bodies—and with that monopoly, dictated the terms of testing. So what you’ve heard from Lisbeth is they decide what the price was, with absolutely no competition. And they also decide which mutations that are looked for. They decide the quality of the test.
And what we now know is that there are many laboratories that are fully capable of offering this kind of testing, that would offer it in very different ways, so that they would be looking at the many genes that are connected with breast and ovarian cancer, and not just screening two. And so, with the ruling today, we fully expect much better access and much better options for patients, as well as for scientists who want to look at different parts of the genome. They no longer now need to deal with patents on the thousands of genes on our genome when they’re engaging in their scientific work.
JUAN GONZÁLEZ: And the direct impact immediately of this decision in terms of the availability of testing, not only for this, because this obviously has ramifications beyond these two particular genes, in terms of what’s going to happen in the industry?
SANDRA PARK: Right. Well, with these two genes, we’ve already heard two or three different laboratories have announced they plan to offer testing on the BRCA genes within the year. So it’s already had that immediate effect. But you’re absolutely right, the patent office has issued patents on thousands of human genes connected with diseases like muscular dystrophy, colon cancer. And so, what we expect to see is that patents on those genes will—are seriously under question with the ruling, and more options will become available.
AMY GOODMAN: I wanted to turn to Myriad Genetics’ lawyer, Gregory Castanias, tried to suggest patenting a gene is much like patenting a baseball bat. This is during oral arguments. He said a baseball bat doesn’t exist unless it’s isolated from a tree, but it’s still a product of human invention. Chief Justice Roberts took issue with the argument.
CHIEF JUSTICE JOHN ROBERTS: My understanding is that here what’s involved—obviously, through scientific processes, but we’re not talking about process—here what’s involved is snipping. You’ve got the thing there, and you snip—snip off the top, and you snip off the bottom, and there you’ve got it. The baseball bat is quite different. You don’t look at a tree and say, "Well, I’ll cut the branch here and cut it here, and all of a sudden I’ve got a baseball bat." You have to invent it, if you will. You don’t have to invent the particular segment of the strand; you just have to cut it off.
AMY GOODMAN: During the hearing, Justice Sonia Sotomayor questioned Myriad Genetics’ lawyer. She compared patenting a gene to someone trying to patent the ingredients used to make chocolate chip cookies, such as sugar and flour.
JUSTICE SONIA SOTOMAYOR: I can bake a chocolate chip cookie using natural ingredients—salt, flour, eggs, butter. And I create my chocolate chip cookie. And if I combust those in some new way, I can get a patent on that. But I can’t imagine getting a patent simply on the basic items of salt, flour and eggs, simply because I’ve created a new use or a new product from those ingredients.
GREGORY CASTANIAS: And that’s—
JUSTICE SONIA SOTOMAYOR: Explain to me—
GREGORY CASTANIAS: Sure.
JUSTICE SONIA SOTOMAYOR: —why gene sequences, whether in the actual numbers, why gene sequences are not those basic products that you can’t patent.
GREGORY CASTANIAS: OK. I’ll start by showing you how this is actually a different structure. It actually has an entirely different chemical name when you give it the C—
JUSTICE SONIA SOTOMAYOR: That’s the cDNA.
GREGORY CASTANIAS: No, no, no. That’s absolutely true with regard—
JUSTICE SONIA SOTOMAYOR: Oh, only if your—
GREGORY CASTANIAS: —to the isolated molecule, as well, because if you were to write it out in those interminable chemical equations that you had to do in high school—
JUSTICE SONIA SOTOMAYOR: So, I put—
GREGORY CASTANIAS: —it’s a "C" very different, "H" very different.
JUSTICE SONIA SOTOMAYOR: I put salt in flour, and that’s different?
GREGORY CASTANIAS: Well, that is—
JUSTICE SONIA SOTOMAYOR: That’s—
GREGORY CASTANIAS: That is a combination, yes, of two different things. And that’s sort of like—that’s sort of like—
JUSTICE SONIA SOTOMAYOR: So if I take them apart, now you can get a patent on the salt, and now you can get a patent on the flour?
GREGORY CASTANIAS: Well, they were apart before, and they—but they were both old. That’s the problem with using the really simplistic analogies, with all due respect, Your Honor.
AMY GOODMAN: That was Justice Sonia Sotomayor questioning Myriad Genetics’ lawyer. Judge Sweet, your response on the significance of this ruling?
JUDGE ROBERT SWEET: Well, what the fundamental issue was—the issue was: Can you patent something that is a product of nature? Can you patent gold, and—for example? And what this decision has affirmed is that there are things in nature that cannot be patented. And one of those things in nature is your genome. It is a peculiar development that is natural. It is not the product of any outside influence. It is your genome, and that can’t be patented.
So the issue really is the extent to which your genome can be, if you will, grasped for some other purpose. And I think the court—I attended the argument. The justices were marvelously attentive. And I think the simple, direct and powerful nine-to-nothing decision indicates that they believe the genome is something that is important to be, if you will—not using it in a legal sense—but free. And it will make a difference, I believe, both in terms of availability for those who want the tests and also in terms of research. So, my view of it is that it is quite an—well, I know it’s an important and long-range decision. And—
AMY GOODMAN: Judge Robert Sweet, we’re going to have to leave it—we’re going to leave it there, and I thank you so much for being with us. Also, I know your clerks just got together and celebrated your 90th birthday. Happy birthday, Judge Robert Sweet. Also, thanks so much to Sandra Park and Lisbeth Ceriani.
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