The fight to patent genes goes all the way to the Supreme Court : Planet Money Who owns your genes, anyway? For a while, Big Biotech patented 20% of the human genome. Then a lawyer took them to the Supreme Court. | Subscribe to our weekly newsletter here.
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All Your Genes Are Belong To Us

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All Your Genes Are Belong To Us

All Your Genes Are Belong To Us

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UNIDENTIFIED REPORTER, BYLINE: This is PLANET MONEY from NPR.

KAREN DUFFIN, HOST:

For four decades, Chris Hansen worked as a lawyer at the American Civil Liberties Union, the ACLU, arguing big cases on things like Internet censorship and school desegregation.

CHRIS HANSEN: I love to sue people who've done wrong. I love to right wrongs through litigation. Oh, man, that's a good feeling.

ALEXI HOROWITZ-GHAZI, HOST:

Chris' job was to be on the lookout for new kinds of civil rights violations and to figure out a legal strategy to fight back against them.

HANSEN: I used to tell people, I'd go in in the morning and read the paper and see what new outrage was going on around the country.

HOROWITZ-GHAZI: (Laughter).

HANSEN: See if there was a way to deal with it.

DUFFIN: But one day back in the fall of 2005, Chris gets his news hand-delivered. The ACLU science adviser pops her head into his office with an entirely different kind of issue than the kinds he usually deals with. She tells him, I think I found you a new outrage, Chris. Companies are turning DNA, like our genetic material, into intellectual property.

HANSEN: She said to me, do you know that genes are patented? And I said, patronizingly, oh, you mean the methods by which the gene is extracted is patented? She said, no, the human gene itself is patented.

HOROWITZ-GHAZI: Chris is like, wait; you're telling me that the United States government is letting companies claim that my genetic material, everyone's genes are their intellectual property, and then they're making money off of it? Patents are supposed to be for inventions.

DUFFIN: But his coworker is like, I'm telling you, Chris, people are patenting genes.

HANSEN: And I said, well, that's just wrong. Let's sue somebody.

HOROWITZ-GHAZI: Chris starts looking into the world of gene patenting. And the more he sees, the more he's convinced that it has to be stopped. So he starts trying to identify one company that can stand in for all the companies patenting genes. Chris figures if he can convince the right judge that what that company is doing is wrong, he can bring the whole system tumbling down.

DUFFIN: And as he starts calling scientists and patent lawyers, there is one company's name that keeps coming up, Myriad Genetics.

HOROWITZ-GHAZI: Myriad is a biotech company in Utah that had isolated and patented the genes responsible for most types of inherited breast and ovarian cancer. And once Myriad owned these genes, they effectively blocked anyone else from doing comprehensive testing or, in some cases, even doing research on these genes that cause a super deadly disease.

DUFFIN: And when Chris finds out about Myriad, he thinks, this is the company. I found my case.

HANSEN: Myriad was the most perfect poster child for the evil nature of gene patents.

(SOUNDBITE OF LEIGH MCALLISTER GRACIE'S "SMOKE AND MIRRORS")

DUFFIN: Hello, and welcome to PLANET MONEY. I'm Karen Duffin.

HOROWITZ-GHAZI: And I'm Alexi Horowitz-Ghazi. The patent system was set up to reward innovation by giving inventors the right to profit off of their creations.

DUFFIN: That's how we got cotton gins and lightbulbs and gramophones. But somewhere along the way, pieces of our genetic code, the stuff that makes us who we are, also got transformed into a kind of intellectual property.

HOROWITZ-GHAZI: Today on the show, the rise and fall of gene patents - how a generation of scientific prospectors mined the human genome until nearly 20% of our genes had been claimed as private property. It's the story of a company that pushed the limits of patenting power and the lawyer who went all the way to the Supreme Court to free our DNA from the tendrils of big biotech.

(SOUNDBITE OF LEIGH MCALLISTER GRACIE'S "SMOKE AND MIRRORS")

HOROWITZ-GHAZI: The story of gene patenting kind of starts in the 1970s, when scientists figured out how to modify genes in a lab. Until 1980, living things mostly couldn't be patented. But that year, the Supreme Court said, I guess these new modified genes are inventions.

DUFFIN: And pretty soon after that, the patent office started granting patents not just on those modified genes, but even on genes that scientists had just managed to isolate and extract from the body.

HOROWITZ-GHAZI: Which started this huge genetic gold rush. Hundreds of new biotech companies popped up. And suddenly, the human genome started to look kind of like an uncharted surveyor's map with hidden treasure worth millions of dollars just lurking out there in the genetic code.

DUFFIN: By the early '90s, one of the biggest genetic treasures was the gene responsible for most cases of inherited breast and ovarian cancer, the BRCA gene. And women with the BRCA gene have up to a 70% chance of getting breast cancer, compared to about just 10% for the general population.

HOROWITZ-GHAZI: There was an enormous international race to find this gene. And when Myriad Genetics was founded in 1991, winning the race to find the BRCA gene was a top priority.

DUFFIN: Geneticist Sean Tavtigian was one of the first people hired at Myriad Genetics.

SEAN TAVTIGIAN: I had never heard of Myriad. In fact, I was roughly employee No. 10.

HOROWITZ-GHAZI: Sean and Myriad hoped that if they could find this gene, they could diagnose people at risk of developing breast and ovarian cancer and create tests and treatments for it.

TAVTIGIAN: That's what we're after in the end - is to add years to the lives of the people who by, you know, unfortunate chance inherited a mutation in one of these genes.

HOROWITZ-GHAZI: The trick to locating this gene is to identify families where breast cancer clusters. And then if you compare the DNA of the people in those families who got cancer versus older people in the family who never got it, it will probably lead you to the gene.

DUFFIN: And in the race to find this gene, Myriad has a huge head start, mostly because of its location in Salt Lake City. Utah has this comprehensive database of anyone who's developed cancer in the state. It is also home to the Mormon church, which famously keeps extensive genealogical records.

HOROWITZ-GHAZI: So their thinking went, if they just cross-referenced those two databases, they'd have themselves a ready-made pool of promising DNA candidates. And then they could get straight to mining for mutations.

DUFFIN: Sean and his team at Myriad get to work. They are working around-the-clock, all hands on deck.

HOROWITZ-GHAZI: How did you guys think about what the stakes were for you guys, you know, in this race for trying to arrive there first?

TAVTIGIAN: Oh, it was merely an existential question for the company.

(LAUGHTER)

TAVTIGIAN: There wasn't any doubt about that. It was like, if we can find this, then the company's going to be successful. And if we don't find it, we're probably going to shrivel up and go away.

DUFFIN: Hundreds of other scientists around the world were also looking for this gene. If Myriad doesn't want to shrivel up and go away, they have to get to it first.

HOROWITZ-GHAZI: After four long years of mining DNA, Myriad finally strikes gold. They find the mutated gene living on chromosome 17 from what is now known to be base pair 43,044,295 to base pair 43,125,364. Myriad extracts and isolates the gene and almost immediately stakes its claim on it by filing a patent. But profiting off of that patent turns out to be a whole other problem.

DUFFIN: There's just no good way to make a drug or a treatment based on this gene. So instead, they focus solely on making a test that would tell people if they have the gene.

HOROWITZ-GHAZI: Though even a test will be hard to make money off of because BRCA isn't like, say, COVID testing, where you might get tested over and over, or a drug that you might take every day.

TAVTIGIAN: You know, the same person will use a particular, you know, patented drug again and again and again and again.

HOROWITZ-GHAZI: Yeah.

TAVTIGIAN: But they get the information that they are a mutations carrier for BRCA1 and 2, they don't need to have that test again. It's done. So the profit situation is different.

DUFFIN: Myriad cooks up a solution to this profit problem. First, they will make the Cadillac of tests, the very best cancer gene test of all time. And they will charge a premium for it.

HOROWITZ-GHAZI: Then Myriad starts using its patent to do what patents do best - to create a monopoly. If anyone else tries to make a comprehensive diagnostic test based on their BRCA genes, including some researchers, Myriad says, kindly cease and desist.

DUFFIN: Last piece of the profit puzzle - they get to work driving up demand. Genetic testing for breast cancer was a relatively new thing. People didn't really know about it yet. So Myriad launched a big marketing campaign aimed mostly at doctors and clinics. But then they tested out something that hadn't really been done before with genetic testing.

(SOUNDBITE OF ARCHIVED RECORDING)

UNIDENTIFIED PERSON #1: Breast cancer runs in my family.

UNIDENTIFIED PERSON #2: My mother.

UNIDENTIFIED PERSON #1: My dad's sisters.

UNIDENTIFIED PERSON #3: I wondered if it would be inevitable.

DUFFIN: They tried marketing their test directly to consumers.

(SOUNDBITE OF ARCHIVED RECORDING)

UNIDENTIFIED PERSON #4: Talk to your doctor or visit bracnow.com.

HOROWITZ-GHAZI: Myriad says they invested around $500 million to develop and market the test and that they didn't even turn a profit until 2008. And Sean says patenting the gene was the key. That's the only way Myriad could get the time and money needed to create what they deemed one of the most sophisticated genetic tests to date, a test that gave more than a million people information about their risk for breast and ovarian cancer.

DUFFIN: But as you may remember, not everyone saw Myriad's business model in the same positive light. First of all, that direct marketing to a broad swath of consumers - less than 10% of women are even good candidates for this test. So there were concerns that Myriad was encouraging all of these people to try to get a test that most of them don't even need that costs thousands of dollars before insurance.

HOROWITZ-GHAZI: And back at the ACLU, that lawyer, Chris Hansen - by the mid-2000s, he'd spent a few years learning all about gene patenting and looking into the ways Myriad was doing business. And he had a few concerns of his own.

DUFFIN: For example, Chris says, people who did take Myriad's test might have been getting a false sense of security because Myriad's Cadillac of tests - the original version of that test did not screen for several dangerous mutations in the gene which came to light after they'd gone to market.

HANSEN: So that even if you got a result back from Myriad saying you're fine, you weren't necessarily fine.

HOROWITZ-GHAZI: Which, you know, science is a process of learning. But once Myriad realized its mistake and fixed the test, if customers wanted to take their new and improved test that identifies all the scary mutations, that was going to cost extra.

DUFFIN: And, Chris says, Myriad policed its gene patent so aggressively that no other comprehensive BRCA test was available. So if you were worried that Myriad had missed something, there was no way to get a second opinion.

HANSEN: Myriad Genetics was the only place in the country you could go if you wanted to be tested. Other labs could do BRCA - could technically do BRCA screening but were not allowed to do so because of Myriad's patent.

DUFFIN: Myriad told us, look; we only actually filed two lawsuits against our patent. But scientists we spoke with told us that Myriad also sent out a ton of letters that threatened legal action, which had basically the same effect of shutting down testing efforts.

HOROWITZ-GHAZI: And many scientists were already frustrated with Myriad because the race to find these genes in the first place had been largely collaborative among scientists around the world. And, yes, Myriad had found the gene first, but they'd done it with the help of everyone else's published work. And then they used their patent rights to essentially claim testing for it all to themselves.

DUFFIN: And because really only Myriad could test for these genes, only they could gather certain kinds of really valuable new data about inherited breast cancer. They collected years and years of data, most of which they also didn't share with the rest of the breast cancer research community.

HANSEN: They had this gigantic database of BRCA1 genes and the various variations of the BRCA genes. Myriad refused to share that database with the scientific community.

HOROWITZ-GHAZI: We spoke to the folks at Myriad, and they told us that they didn't want to share their genetic database with the broader scientific community out of a concern for patient privacy. They say the pricing of their tests has always been proportionate to the costs of developing and bringing them to market. And they say their patent strategy was in line with others in the industry.

DUFFIN: But Chris' concerns went far beyond Myriad's business model, far beyond how Myriad used its gene patents. For him, Myriad was just a symptom of a much more fundamental issue. The real problem to Chris was that genes could even be patented at all.

HANSEN: The notion that some private company can own a part of my body and that I can't look at it without paying a royalty to some private company seemed, to me, blindingly obviously a civil liberties issue.

HOROWITZ-GHAZI: And when Chris Hansen sees a civil liberties issue, he knows what to do. Take them to court. That's coming up after the break.

(SOUNDBITE OF AARON WALDBERG AND BRUNO HUNGER SONG, "COSMIC COWBOY")

DUFFIN: Chris Hansen filed his lawsuit against Myriad in 2009. And over the course of four years, the case made its way from district court to appeals court to, finally, in 2013, the Supreme Court of the United States.

HOROWITZ-GHAZI: By the time Chris arrived at the courthouse for oral arguments that April morning, the case had gained a ton of national attention. Chris made his way to the courtroom past journalists, government officials, scientists, protesters.

HANSEN: There was a huge crowd, and it was hard to get in. I had a bunch of relatives come to Washington to watch me argue the case. Most didn't get in.

DUFFIN: At long last, Chris stands before the judges to argue his case. And, you know, a few years before all of this, Chris didn't even know the difference between DNA and a chromosome. And now he has to explain it expertly and compellingly with the brightest scientific and legal minds watching and the freedom of the human genome on the line.

(SOUNDBITE OF ARCHIVED RECORDING)

JOHN ROBERTS: We'll hear argument first this morning in case 12-398, Association for Molecular Pathology v. Myriad Genetics. Mr. Hansen.

HANSEN: Mr. Chief Justice, and may it please the court. One way to address the question presented by this case is what exactly did Myriad invent?

HOROWITZ-GHAZI: That is Chris talking to the nine justices of the Supreme Court, laying out what is basically the fundamental question in this case - not, is Myriad's business model shady, not, should they have played nicer with other scientists. The question at the Supreme Court is a kind of philosophical one. Was this thing that Myriad had done - isolate the BRCA genes - was that an act of invention?

DUFFIN: Because the whole point of the patent system is to give people an incentive to innovate. You come up with a new mousetrap, you can file a patent, and then you get to control who sells and earns money off of that mousetrap.

HOROWITZ-GHAZI: Chris told the justices that Myriad hadn't invented a mousetrap at all. What they did, Chris said, wasn't make something so much as just find something that already existed in nature.

(SOUNDBITE OF ARCHIVED RECORDING)

HANSEN: For example, this court has used the example of gold. You can't patent gold because it's a natural product.

HOROWITZ-GHAZI: A gene, Chris tells the court, just exists, like gold exists in a mountain. The fact that you find the gold and dig it up doesn't mean you invented it. You'd have to actually do something to change that gold.

(SOUNDBITE OF ARCHIVED RECORDING)

HANSEN: For example, if you find a new way of using gold to make earrings or if you find a new way of using DNA to do something, you may be entitled to a patent on that.

DUFFIN: And then, when it's Myriad's turn, their lawyer stands up and tells the justices, yes, we did use natural material. But you should think of it like we're sculptors. When we chose where to carve out the specific BRCA gene from the human chromosome, that was a creation.

(SOUNDBITE OF ARCHIVED RECORDING)

GREGORY A CASTANIAS: A baseball bat doesn't exist until it's isolated from a tree. But that's still the product of human invention to decide where to begin the bat and where to end the bat.

DUFFIN: Like, yes, the baseball bat is made of wood, which is a natural product, but the wood didn't just show up like that. You had to carve it into a baseball bat, something that is patentable. Myriad's lawyer tells the justices, that is what we did.

(SOUNDBITE OF ARCHIVED RECORDING)

CASTANIAS: What Myriad inventors created in this circumstance was a new molecule that had never before been known to the world.

HOROWITZ-GHAZI: This thing they're debating - is a gene more like a plain old raw material, like wood or gold, or, because Myriad had isolated the gene, is that gene more like a baseball bat sculpted from a tree? This is the philosophical heart of the case, but it also raises a pretty major practical question that the justices start to wrestle with.

DUFFIN: See, the patent system incentivizes the thing you actually create, the invention, like making earrings out of the gold. But how do you incentivize the step before the invention? How do you get people to look for the gold or, say, look for a gene so that you can create a test for it?

HOROWITZ-GHAZI: If the highest court in the land declares genes to be just another raw material, like gold, the justices start wondering, will people still be motivated to do the hard and expensive work of finding new genes? Here's Justice Kagan.

(SOUNDBITE OF ARCHIVED RECORDING)

ELENA KAGAN: Mr. Hansen, could you tell me what you think the incentives are for a company to do what Myriad did? Why shouldn't we worry that Myriad or companies like it will just say, well, you know, we're not going to do this work anymore?

DUFFIN: It is a very difficult line to define. Like, what is the exact moment when something stops being a raw material and starts being an invention, a patentable invention?

HOROWITZ-GHAZI: At some point, the arguments in the Supreme Court of the United States start to sound a little bit like they're floating around the purple haze of a sophomore college dorm room. Myriad's lawyer's like, what is a gene anyway, man?

(SOUNDBITE OF ARCHIVED RECORDING)

CASTANIAS: Now, remember; genes are themselves human constructs.

HOROWITZ-GHAZI: That's some heady stuff, man.

DUFFIN: Then one by one, the justices start picking their own metaphors to try to make sense of all of this. Justice Sotomayor pulls this hot take out of the oven. She chimes in with chocolate chip cookies. Like - I don't know - aren't genes just like ingredients?

(SOUNDBITE OF ARCHIVED RECORDING)

SONIA SOTOMAYOR: I can bake a chocolate chip cookie using natural ingredients. 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 salt, flour and eggs.

HOROWITZ-GHAZI: Justice Alito is like, OK, OK, OK. What if the human genome is like a plant you find in the jungle?

(SOUNDBITE OF ARCHIVED RECORDING)

SAMUEL ALITO: Now suppose there is a chemical, a molecule in the leaves of a plant that grows in the Amazon, and it's discovered that this has tremendous medicinal purposes, let's say.

HOROWITZ-GHAZI: Medicinals - he said medicinals. The highest court in the land is starting to sound like the highest court in the land.

DUFFIN: (Laughter) Yes. But as the smoke clears, what starts to become obvious...

(SOUNDBITE OF ARCHIVED RECORDING)

ALITO: I mean, that's actually what's bothering me.

DUFFIN: ...Is that the justices are starting to lose patience with this philosophical argument.

(SOUNDBITE OF ARCHIVED RECORDING)

KAGAN: The isolation itself is not valuable.

ALITO: That's the problem.

SOTOMAYOR: You're not suggesting if you cut off a piece of the kidney that that somehow makes that piece patentable?

CASTANIAS: No, absolutely not. It is the...

SOTOMAYOR: So what's the difference?

DUFFIN: And after just over an hour, the oral arguments close.

(SOUNDBITE OF ARCHIVED RECORDING)

ROBERTS: Thank you, counsel. The case is submitted.

HOROWITZ-GHAZI: And with that, after more than 30 years of gene patenting and four years of court hearings, it was in the hands of the nine justices to decide whether the stuff that makes us who we are should count as property.

DUFFIN: The day after the oral arguments, Chris fully retired from the law. This was his final case. And then he went back to his house in the burbs to wait for the opinion and, as he put it, sit around for the rest of his life. And two months later...

HANSEN: I was sitting at home one morning, and I'm sort of - I don't know - playing video games or, you know, something. I opened up my email, and there was an email that I had been copied on in which one ACLU lawyer was saying to another ACLU lawyer, did you see that Chris just won his case? It was the most anticlimactic notice of a victory that I can possibly imagine.

HOROWITZ-GHAZI: And one of the best cc's on an email I can ever imagine getting.

HANSEN: Well, that's also true, yes.

HOROWITZ-GHAZI: The ruling was unanimous. The court said, quote, "Myriad did not create anything. Separating a gene from its surrounding genetic material is not an act of invention," end quote.

DUFFIN: The court did make an exception for something called CDNA, which is a synthetic version of a gene. But human genes that had merely been isolated - those could no longer be patented and privately owned. And with that, thousands of gene patents that had been granted over three decades, including Myriad's claims on the isolated breast cancer genes, were invalidated and set free.

HOROWITZ-GHAZI: And these days, any scientist or company who wants to is free to do testing and research on the BRCA genes. Many BRCA tests now cost thousands of dollars less than they did when Myriad held its monopoly.

DUFFIN: We have made some tools for educators to use PLANET MONEY in the classroom. You can find those at npr.org/teachplanetmoney. That is npr.org/teachplanetmoney. And if you want to email us, we are at planetmoney@npr.org. You can also find us on Facebook, Twitter, Instagram and TikTok. We are @planetmoney.

HOROWITZ-GHAZI: Today's show was produced by James Sneed, with help from Irena Hwang and Gilly Moon. And it was edited by Keith Romer.

DUFFIN: Alex Goldmark is our supervising producer. Bryant Urstadt is the show's editor.

HOROWITZ-GHAZI: Special thanks today to the team at Myriad Genetics who spoke with us. Also, huge thank-you to Shobita Parthasarathy and Mary-Claire King. If you want to hear more stories about science, technology and public policy, check out Shobita's podcast, "The Received Wisdom Podcast."

I'm Alexi Horowitz-Ghazi.

DUFFIN: And I'm Karen Duffin. This is NPR. Thanks for listening.

(SOUNDBITE OF MARC FERRARI AND MICHAEL GOLDWASSER SONG, "JAMROCK WE A COME FROM")

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