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Success Story with Scott D. Clary
Lessons - The Supreme Court Battle Over Your Genes | Jorge Contreras - Harvard Law Professor
00:13:40
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- [00:00]
A
In this Lessons episode, examine how gene patenting blurred the line between discovery and invention in modern biology. Discover how isolated DNA sequences were granted exclusive commercial control. Understand how these patents restricted research and diagnostic testing, and uncover why legal challenges reshape the limits of ownership over human genetics.
- [00:27]
B
So walk me through what this actually means. When you say that our genomes are patented. What does that actually mean? What are people actually patenting? What is the thing that they are protecting?
- [00:44]
C
Right, That's a really good question and kind of a head scratcher for most people. So I think people on your show probably know what patents are. In general, they give the owner the exclusive right to exploit whatever the invention is. For a period of 20 years in the United States, and there are corresponding patents all around the world. Patents are issued on inventions. Right. And so the big question in a lot of these cases is, well, what's an invention? And so for, you know, 150 years, we've had case law that says a product of nature, something that you just go out into the forest and you find a new kind of a berry or a mushroom. You know, you're the first one who discovered it, maybe the first one who brought it back to quote, unquote, civilization. That's fine. You should be praised and maybe publish a scientific article about it. But you can't get a patent because you didn't invent it, you just found it. Now, if you make a medication out of the berry or the mushroom that treats whatever skin rashes, then, yes, you can patent that. Right. You found a new use for this thing that no one had known about before. It's patentable. But where you draw the line between what's a product of nature that's not patentable and what's a human application of nature that is patentable. Difficult line to draw.
- [02:07]
B
You would. And that's what. Yeah, no, I was gonna say this is what this is. This is what. This is what they're act. So this is the issue. So they're patenting, like the raw genome. They're patent. Is it correct to say patenting DNA to a. To an extent. Is that. Is that fair? And then. And then all derivatives of that, all derivative works of any sort of medical or advancement or discovery, that's what they feel like they can have control over. And then there's like, obviously like very tangible, like monetary gains. At one point when they do discover something, or I guess there's a new medicine or a new therapy or something like that, then that that particular entity is the only entity that can license that and sell it to the market, correct?
- [02:51]
C
That's exactly right. And not only that, whoever owns that patent can then control all research relating to the genes. And so the judge who heard this case in New York, the district court judge, called this a lawyer's trick, how these patents came about. And when you think about it, it's very clever, right, because human genes were patented as what's called compositions of matter. Right? A composition of matter that's, you know, a new metallic alloy or a new polymer. Right. You're the first one you invent, like polyester or styrene or something. Well, then, you know, anything that's going to be made out of polyester, at least for that 20 year patent period, you control it. Nobody can make something out of polyester without your permission because you invented the material considering a new human gene or a human gene that was just discovered as a new composition of matter. And we can talk about how you could make that leap intellectually. But if you control it as a composition of matter, that means you control everything that's done with the gene, whether testing people to see if they have certain mutations in the gene that might lead to disease, developing a diagnostic kit, developing a drug based on the gene. Even if you just discovered the gene, you're not a drug development company. You have no idea how to make a drug that might target the gene. You still have the exclusive rights to everything relating to the gene. So those composition of matter patents are hugely, hugely valuable and broad.
- [04:34]
B
So how did they make that leap? How do they make that? Because even, even, even, you know, your first example, the. If you patent polyester, than any company that makes any item with polyester has to go through that. Even that is, in my opinion, that seems like that's so reaching. That's so broad, like to, to patent a material to that extent. Now, I'm not a lawyer, but it still seems like it could be something that. How do you patent something that is not, I guess, if you created that material yourself, but if you discovered something that's natural, how do you say that that should ever belong to you?
- [05:11]
A
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- [07:57]
C
Yeah, no, totally. Well, I mean, the materials, you know, we. People do invent new materials, new carbon graphite fibers and, you know, these ceramic protections like the space shuttle and whatnot. And yeah, they get the full protection. Anything you make a coffee pot out of that space shuttle, ceramic. You're paying NASA something. Yeah, but. Right. Your genes are not like a ceramic material or polyester. Right there. The scientists didn't invent your gene. It was in your body. So how do you consider it a composition of matter? So you have to go back and think about, like, how genes exist in our body. So we've got 20,000 genes all wrapped up in the nuclei of our cells. They're spread out along big DNA. We have 23 pairs of chromosomes, and each of those chromosomes has thousands of genes on it. Right. The genes are sort of like spaced along the chromosomes in an unpredictable kind of way. Back in the 80s, we didn't know where the particular genes were or even what the gene. Back in the 80s, we thought there were a hundred thousand genes and we didn't know where they were or what their DNA sequences were. Right. The A, T, G, C. You know, that 3.2 billion as Ts, GS and Cs make up our genome. And discovering that was pretty hard. It started in the late 80s when University of Michigan and other research labs, like, figured out where the exact gene that related to cystic fibrosis was located and what its exact sequence was. And to do that, they have to extract it from the chromosome. So that gene CFTR, sitting along a chromosome with 1,000 or 2,000 other genes, they have to break it out of the chromosome, isolate it and purify it, like, make millions of copies of it so that our instruments can read it. Right. The DNA is just far. You can't look at it with a microscope. Right. You need to multiply it by millions of times so that we can detect it. So they did that. That isolated and purified gene broken away from the chromosome, like, that doesn't exist in the human body. It exists along the chromosome, but it's bonded at its two ends to, like, the rest of the chromosome material. It's got all these other molecules attached to it. When it's isolated outside of the body, it was considered to be a new thing, a new composition of matter. And the analogy you draw is, well, okay, so you've got a tree With a branch, the tree branch. It's a product of nature. You can't patent a tree branch, but you chop off the branch and then you carve it into a new baseball bat. Right, the new type of baseball bat. Well, yeah, the baseball bat. You. Everything came from some natural element, right? There are only whatever 100 and some odd elements in the universe. Everything is out of them. So just because, you know the baseball bat's made out of wood, you couldn't patent the wood when it was in the tree, but when you broke it out and made something new. Yeah, you can patent it. And so the patent office agreed that, okay, that this gene, when it's taken out of the body and purified, now it's like the baseball bat as opposed to the branch and you can patent.
- [11:22]
B
And that's. So that was that. So somebody, somebody who first made these discovery. Do you know who. The first individual that tried to patent a human gene. Do you know who that was? That would have been a while back.
- [11:34]
C
Then, the very first one. I mean, again, it only started in the late 80s.
- [11:39]
B
Okay.
- [11:40]
C
And the CFTR gene from University of Michigan is the first one of any significance. And Francis Collins, whose name you might know, he is now the director of the National Institutes of Health and has been for the last decade plus, he was a scientist at University of Michigan and his team with a bunch of other collaborators found that first gene and there were a lot more to follow.
- [12:09]
B
Okay, so then. Okay, so that, so now we. It's a very, very interesting how this is sort of, how this is sort of manifested over, over, over time and how this is now. Okay, you have a gene. There has been a successful patent place on this gene. Now there's precedent set. So at what point. Why has. Why did it take so long for this to be contested? Was nobody interested or was it contested before? And it never actually got any. Got any traction.
- [12:45]
C
Yeah, that. That's a fascinating sociological question, right? Why was this? So, so the genes in that I cover in this book, they're the BRCA1 and 2 genes, right? These are genes that are closely associated with breast cancer and ovarian cancer. And if a woman has a particular mutation in one of these genes, like her risk of getting these cancers in her lifetime is increased by 8 to 10 times, right? So you go from whatever, 10, 15% chance of getting one of these diseases to 80, 90%. It's huge. It's almost a certainty. So super important information to know. These are the genes that were patented by the University of Utah, which happens to be where I work now did not. When I started this project, University of Utah and a company that spun out of the university called Myriad Genetics, they made the discovery they, they sequenced these genes in 1994 and 1995. They're patents. It takes a few years to go through the patent office. Patents issued in 97 started to issue in 97, 98 and so forth. And at that point, once the patents issued, they started to shut down all the labs around the country that were performing tests for these BRCA gene mutations. Mostly universities, right? University clinics, Pennsylvania, at Yale, at Georgetown, nyu, you name it. Some, some fertility clinics were doing testing. Everybody else in the country gets shut down. So by 2000, they're the only game in town. And there's a lot of, you know, there's criticism in the academic community among, you know, cancer advocacy groups, but it's not. You probably never heard of it, right? This is not widespread.
- [14:35]
B
It's not widespread. No.
- [14:37]
A
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