Lessons - The Supreme Court Battle Over Your Genes | Jorge Contreras - Harvard Law Professor

In this lesson's episode, examine how gene patenting blurred the line between discovery and invention and 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. So walk me through what this actually means. So 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? Right, so that's 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, right? They give the owner the exclusive right to exploit whatever the invention is for a period of 20 years in the United States and they're corresponding patents all around the world. Patents are issued on inventions, right? And so the big question in a lot of these cases, 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 word. You found a new use for this thing that no one had known about before is patentable, but where do 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. You would think that's what yeah, no, this is what this is this is what this is what this is what they're acting. So this is the issue. So they're patenting like the rodging on the patent. Is it correctly patenting DNA to an extent? Is that is that fair? 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 obviously very tangible monetary gains at one point when they do discover something or I guess there's a new medicine or a new a new therapy or something like that. Then that particular entity is the only entity that can license that and sell it to the market, right? That's exactly right. And not only that, they can whoever owns that patent can then control all research relating to the genes. And so, you know, the 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 then when you think about it, it is 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 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 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'll 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 you just discovered the gene, you're not a drug developing 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. So how did they make that leap? How did 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 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? 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 a space shuttle and whatnot. And yeah, they get the full protection, anything, you make coffee pot out of that space shuttle ceramic, you're paying NASA something. But right, your genes are not like a ceramic material or polyester, right? They're, the scientists didn't invent your gene. It was in your body. So how do you consider that composition of matter? So you have to go back and think about like how genes exist in our bodies. So we've got 20,000 genes all, you know, wrapped up in the nuclei of ourselves. They're, they're spread out along a big DNA, 10, 20, we have 23 pairs of chromosomes. And those, 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, like we didn't know where the particular genes were or even what the gene, we thought there were 100,000 genes. And we didn't know where they were or what their DNA sequences were, right? The ATGC, you know, that C3.2 billion A's, T's, G's and C's make up our genome. And discovering that was like pretty hard. It started in the late 80s when the 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, right? It exists along the chromosome, but it's bonded, it's too 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 draws, 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? A new type of baseball bat. Well, yeah, the baseball bat, you, everything came from some natural element, right? There are only whatever, hundreds and some elements in the universe. Everything is made out of them. So just because, you know, the baseball bats 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. And that's, so that was that. So somebody, somebody who first made these discovered, do you know who the first individual that tried to patent a human gene? Do you know who that was? That was in a while back then. The very first one, I mean, again, it only started in the late 80s. And the CFTR gene from University of Michigan is the first one of any significance. And and Francis Collins, whose name you might know, he is now the director of natural incidences 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. Okay, so then, okay, so that is so now we that'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 traction? Yeah, that that's a fascinating sociological question, right? Why was this so? So the the genes that I cover in this book, they're the BRCA one and two genes, right? These are genes that are closely associated with breast cancer and ovarian cancer. And if if a woman has a particular mutation in one of these genes like her risk of getting these cancers in her lifetime is increased like by eight to 10 times, right? So you go from whatever 10, 15% chance of getting one of these diseases to like 80, 90%. It's 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. The University of Utah and a company that spun out of the university called Murriad 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 a 97 started to issue a 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, Yale, 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 like you probably never heard it, right? There's not widespread. It's not widespread. Nice. Thanks for tuning in. If you found this valuable, don't forget to hit that subscribe button so you never miss an episode. And if you want to dive deeper into this conversation, check out the links in the description to watch the full episode. See you in the next one.