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Lessons - The Supreme Court Battle Over Your Genes | Jorge Contreras - Harvard Law Professor · Success Story with Scott Clary

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  In this lesson's episode, examine how gene patenting blurred the line between discovery and
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  invention and modern biology. Discover how isolated DNA sequences were granted exclusive commercial
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  control, understand how these patents restricted research and diagnostic testing and uncover
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  why legal challenges reshape the limits of ownership over human genetics.
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  So walk me through what this actually means. So when you say that our genomes are patented,
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  what does that actually mean? What are people actually patenting? What is the thing that they are
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  protecting? Right, so that's that's a really good question and kind of a head scratcher for most
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  people. So I think people on your show probably know what patents are in general, right? They give
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  the owner the exclusive right to exploit whatever the invention is for a period of 20 years in the
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  United States and they're corresponding patents all around the world. Patents are issued on
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  inventions, right? And so the big question in a lot of these cases, well, what's an invention?
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  And so for, you know, 150 years we've had case law that says a product of nature,
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  something that you just go out into the forest and you find a new kind of a berry or a mushroom,
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  you know, you're the first one who discovered it, maybe the first one who brought it back to
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  quote unquote civilization. That's fine. You should be praised and maybe publish a scientific
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  article about it, but you can't get a patent because you didn't invent it. You just found it.
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  Now, if you make a medication out of the berry or the mushroom that treats whatever skin
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  rashes, then yes, you can patent that word. You found a new use for this thing that no one had
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  known about before is patentable, but where do you draw the line between what's a product of nature
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  that's not patentable and what's a human application of nature that is patentable?
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  Difficult line to draw. You would think that's what yeah, no, this is what this is this is what
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  this is what this is what they're acting. So this is the issue. So they're patenting like the
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  rodging on the patent. Is it correctly patenting DNA to an extent? Is that is that fair? And then
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  all derivatives of that, all derivative works of any sort of medical or advancement or discovery.
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  That's what they feel like they can have control over. And then there's obviously very tangible
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  monetary gains at one point when they do discover something or I guess there's a new medicine
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  or a new a new therapy or something like that. Then that particular entity is the only entity
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  that can license that and sell it to the market, right? That's exactly right. And not only that,
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  they can whoever owns that patent can then control all research relating to the genes.
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  And so, you know, the the judge who heard this case in New York, the district court judge,
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  called this a lawyer's trick how these patents came about. And then when you think about it,
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  it is it's very clever, right? Because human genes were patented as what's called compositions
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  of matter, right? A composition of matter, that's, you know, a new metallic alloy or a new polymer,
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  right? You you're the first one. You invent like polyester or styrene or something. Well then,
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  you know, anything that's going to be made out of polyester, at least for that 20 year patent
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  period, you you control it. Nobody can make something out of polyester without your permission.
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  Because you invented the material, considering a new human gene or a human gene that was just
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  discovered as a new composition of matter. And we'll we can talk about how you could make that
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  leap intellectually. But if you control it as a composition of matter, that means you control
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  everything that's done with the gene, whether testing people to see if they have certain mutations
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  in the gene that might lead to disease, developing a diagnostic kit, developing a drug,
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  based on the gene. Even if you you just discovered the gene, you're not a drug developing company,
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  you have no idea how to make a drug that might target the gene. You still have the exclusive rights
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  to everything relating to the gene. So those composition of matter patents are hugely, hugely
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  valuable and broad. So how did they make that leap? How did they make that? Because even even,
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  even, you know, your first example, the if you patent polyester than any company that makes any
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  item with polyester has to go through that, even that is in my opinion, that seems like that's
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  so reaching. That's so broad like to patent a material to that extent. Now I'm not a lawyer,
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  but it still seems like it could be something that how do you patent something that is not,
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  I guess if you created that material yourself, but if you discovered something that's natural,
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  how do you say that that should ever belong to you? Yeah, no, totally. Well, I mean, the materials,
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  you know, we, people do invent new materials, new carbon graphite fibers and, you know,
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  these ceramic protections like a space shuttle and whatnot. And yeah, they get the full protection,
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  anything, you make coffee pot out of that space shuttle ceramic, you're paying NASA something.
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  But right, your genes are not like a ceramic material or polyester, right? They're,
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  the scientists didn't invent your gene. It was in your body. So how do you consider that
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  composition of matter? So you have to go back and think about like how genes exist in our bodies.
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  So we've got 20,000 genes all, you know, wrapped up in the nuclei of ourselves. They're,
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  they're spread out along a big DNA, 10, 20, we have 23 pairs of chromosomes.
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  And those, each of those chromosomes has thousands of genes on it, right? The genes are sort of like
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  spaced along the chromosomes in an unpredictable kind of way. Back in the 80s, like we didn't know
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  where the particular genes were or even what the gene, we thought there were 100,000 genes.
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  And we didn't know where they were or what their DNA sequences were, right? The ATGC, you know,
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  that C3.2 billion A's, T's, G's and C's make up our genome. And discovering that was like
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  pretty hard. It started in the late 80s when the University of Michigan and other research labs
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  like figured out where the exact gene that related to cystic fibrosis was located,
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  and what its exact sequence was. And to do that, they have to extract it from the chromosome.
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  So that gene CFTR sitting along a chromosome with 1,000 or 2,000 other genes, they have to break
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  it out of the chromosome, isolate it and purify it, like make millions of copies of it so that our
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  instruments can read it, right? The DNA is just far, you can't look at it with a microscope,
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  right? You need to multiply it by millions of times so that we can detect it. So they did that,
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  that isolated and purified gene broken away from the chromosome, like that doesn't exist in the
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  human body, right? It exists along the chromosome, but it's bonded, it's too ends to like the
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  rest of the chromosome material. It's got all these other molecules attached to it. When it's
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  isolated outside of the body, it was considered to be a new thing, a new composition of matter.
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  And the analogy draws, well, okay, so you've got a tree with a branch, the tree branch,
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  it's a product of nature. You can't patent a tree branch, but you chop off the branch,
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  and then you carve it into a new baseball bat, right? A new type of baseball bat. Well,
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  yeah, the baseball bat, you, everything came from some natural element, right? There are only
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  whatever, hundreds and some elements in the universe. Everything is made out of them. So just because,
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  you know, the baseball bats made out of wood, you couldn't patent the wood when it was in the tree,
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  but when you broke it out and made something new, yeah, you can patent it. And so the patent
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  office agreed that, okay, that this gene, when it's taken out of the body and purified,
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  now it's like the baseball bat, as opposed to the branch, and you can patent. And that's,
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  so that was that. So somebody, somebody who first made these discovered, do you know who the first
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  individual that tried to patent a human gene? Do you know who that was? That was in a while back then.
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  The very first one, I mean, again, it only started in the late 80s. And the CFTR gene from
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  University of Michigan is the first one of any significance. And and Francis Collins, whose name
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  you might know, he is now the director of natural incidences of health and has been for the last
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  decade plus. He was a scientist at University of Michigan and his team with a bunch of other
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  collaborators found that first gene. And there were a lot more to follow. Okay, so then, okay,
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  so that is so now we that's a very very interesting how this is sort of how this is sort of
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  manifested over over over time. And how this is now, okay, you have a gene. There has been a
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  successful patent place on this gene. Now there's precedent set. So at what point
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  why has why did it take so long for this to be contested? Was nobody interested or was it
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  contested before? And it never actually got any traction? Yeah, that that's a fascinating sociological
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  question, right? Why was this so? So the the genes that I cover in this book, they're the BRCA one
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  and two genes, right? These are genes that are closely associated with breast cancer and ovarian
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  cancer. And if if a woman has a particular mutation in one of these genes like her risk of getting
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  these cancers in her lifetime is increased like by eight to 10 times, right? So you go from whatever
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  10, 15% chance of getting one of these diseases to like 80, 90%. It's it's huge. It's almost a
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  certainty. So super important information to know. These are the genes that were patented by the
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  University of Utah, which happens to be where I work now did not when I started this project.
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  The University of Utah and a company that spun out of the university called Murriad Genetics.
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  They made the discovery. They they sequenced these genes in 1994 and 1995. They're patents. It
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  takes a few years to go through the patent office. Patents issued a 97 started to issue a 97, 98
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  and so forth. And at that point, once the patents issued, they started to shut down all the labs
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  around the country that were performing tests for these BRCA gene mutations. Mostly universities,
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  right? University clinics, Pennsylvania, Yale, Georgetown, NYU. You name it. Some some fertility
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  clinics were doing testing. Everybody else in the country gets shut down. So by 2000, they're the
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  only game in town. And there's a lot of, you know, there's criticism in the academic community
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  among, you know, cancer advocacy groups, but it's not like you probably never heard it, right?
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  There's not widespread. It's not widespread. Nice. Thanks for tuning in. If you found this valuable,
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  don't forget to hit that subscribe button so you never miss an episode. And if you want to dive
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  deeper into this conversation, check out the links in the description to watch the full episode.
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  See you in the next one.