Patent Pending with Prof. Jorge Contreras | Crooked Media
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December 14, 2021
America Dissected
Patent Pending with Prof. Jorge Contreras

In This Episode

Imagine someone could patent your arm, or your mouth. Well, for a long time, someone could patent a part of the human body, a DNA sequence. That all ended in 2013 with a landmark supreme court case. But it illustrates how science, business, and law intersect—in ways that shape our health today. Abdul speaks with Prof. Jose Contreras, Law Professor and Author of the new book, The Genome Defense.

 

 

Transcript

 

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Dr. Abdul El-Sayed: New data from Pfizer shows that a third dose of their COVID-19 vaccine elicited the same antibody response to Omicron as two doses do to garden-variety SARS-CoV-2. Meanwhile, Delta is surging across the Upper Midwest, hitting pandemic-level highs in cases and hospitalizations, and taking us past the grim milestone of 800,000 COVID-19 deaths. New Zealand moves to ban cigarette purchases for the next generation entirely. This is America Dissected. I’m your host, Dr. Abdul El-Sayed. I remember hearing about this, sitting in my high school biology class:

 

[clip of President Clinton] Today the world is joining us here in the East Room to behold a map of even greater significance. We are here to celebrate the completion of the first survey of the entire human genome. Without a doubt, this is the most important, most wondrous map ever produced by humankind.

 

Dr. Abdul El-Sayed: The sequencing of the human genome led to some really high-profile and really important discoveries. Discoveries like the genes TNF or TP53, which are critical in the pathways for cancer. But more than anything, the Human Genome Project showed us that genetics are anything but simple. Most of the serious diseases we deal with aren’t what we call Mendelian. They don’t follow the simple genetic rules that you might have learned about in high school, where there’s a dominant and recessive gene, and your phenotype is a function of the mix of what you inherited from your parents. Unlike, say, cystic fibrosis, a rare but devastating genetic lung disease, or sickle cell disease, a debilitating genetic blood disorder, most genetic diseases are the result of a vast array of interactions between various genes and the environment in which you grew up. There’s another side of this. The rush to reprogram those genes left us ignoring the obvious things we as a society can do to promote good health. Cystic fibrosis, for example, is a terrible lung disease, but childhood asthma affects vastly more children. And while we understand now that some children may have genetic predisposition to asthma, so much more of whether or not a child may experience an asthma exacerbation is about the air they breathe day-in and day-out. Children who live in heavily-polluted communities are more likely to have more persistent and more severe asthma. That sounds obvious when I say it, but considering how much money and time has been spent researching and trying to block the genetics of asthma, compared to doing the obvious work of reducing air pollution and protecting our kids from breathing, what may be obvious to you and I has been obfuscated by our obsession with genetic explanations for disease. Here’s the difference though: you can make a lot more money discovering a biological treatment for asthma than you can reducing air pollution. In genetics, the pharmaceutical industry found a whole new goldmine, and they’ve been mining it ever since. Don’t get me wrong, I think our understanding of the human genome is an amazing breakthrough. But what’s new isn’t necessarily what’s always most valuable. Take COVID-19 vaccines, for example. It is a medical marvel that we were able to sequence the virus’s genome, create mRNA strands that match its spike protein and turn it into a safe and effective vaccine within less than a year of the virus’s discovery. And as someone who’s been triple vaxxed, I benefit from that science every single day. And yet, the very same country where the vaccine was researched, developed, and deployed has suffered one of the worst rates of COVID-19 mortality in the world. Why? Because we didn’t do basic things like quarantine travelers, test or contact trace effectively. The issue isn’t with genetics. It’s science, after all, and y’all know that science always wins. My issue is with the way that capitalism has exploited genetics to make us believe that the key to our health lives inside our bodies, rather than in the environments in which our bodies live. All to sell us something. Today, we’ll explore the edge of that greed that left companies trying to patent those genes to claim monopolies over parts of our body. A patent is, after all, a government-sanctioned monopoly, which gives the discoverer or developer of a new product the exclusive right to exploit that thing on the market. But when the thing is a human gene, something inside all of us, it gives a single company complete rights to own every single diagnostic test or medical treatment that targets it. Take BRCA genes for example. Women who inherit certain mutations on the BRCA 1 or 2 genes have upwards of 70% chances of developing breast cancer during their lifetimes. But until the ACLU sued, a single company, Myriad genetics, held the patent on those genes and the rights to sell a genetic test that could tell millions of women their risk of breast cancer. Today, we speak with Professor Jorge Contreras, law professor and author of the new book about the legal battle over genetic patents, The Genome Defense, after this break.

 

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Dr. Abdul El-Sayed: All right, can you introduce yourself for the tape?

 

Jorge Contreras: I’m Jorge Contreras and I am a professor of law at the University of Utah SJ Quinney College of Law.

 

Dr. Abdul El-Sayed, narrating: You may wonder, why are we speaking to an attorney about genetics? Well, because this conversation is about who gets to own those genetics, because, well, capitalism.

 

Dr. Abdul El-Sayed: Professor Contreras, thank you so much for taking the time to join us here today. We’re really excited to chat with you because I thought your book was really a thoughtful engagement with an area of the space where science meets public policy meets our health that I think few of us know to pay attention to, but, you know, is increasingly hot right now, particularly given a lot of the science that has come out with the pandemic. And so I want to just step back. This is a bit of a new topic for a lot of our audience. Can you give us a primer on the history of DNA patenting?

 

Jorge Contreras: Sure, sure. So the history doesn’t go back that long. It goes back to the 1970s, and this is when researchers were first able to create genetically modified organisms—bacteria, not even at the human stage yet. And in the ’70s, a researcher at General Electric produced a new bacterium, a bacterium that was genetically modified so that it would break down petrochemicals, right, oil spills. This is the kind of bacterium that when there’s an oil spill in the Gulf, you see helicopters fly over it and they spray this stuff onto the oil, and it actually does help break down the oil. So this was new. He took a existing form of bacterium, modified its genome so that it was more attracted to oil, and he tried to get a patent on it. And at that time, you, you know, there had never been a patent on a living organism like this. Plants, yes, there was a whole separate area of protecting plants, but not this, not this type of thing. And the Supreme Court eventually heard that case in 1980, and there was a split decision, a five-four decision. There was a lot of opposition, a lot of public commentary, but they decided that if this thing, living organism or not, didn’t exist in nature before then it could be patented, because it was the new thing, a new substance created by people. And so it could be patented. So as you can imagine, it didn’t take many more logical steps to get to patenting human DNA after this bacterium. And so by the late 1980s, researchers were discovering different human genes and determining what their DNA sequences were. And those were also viewed as compositions of matter, like the bacterium—not because they had been changed by the researchers, but because the researchers pulled them out of the much longer chromosome that the genes existed on. All right, we’ve got 23 chromosomes, each one of thousands of genes on it. They’re all strung together like beads in a necklace but each individual gene has a specific function. It’s hard to figure out where one gene starts and ends and the next gene starts, but when you do that and figure out the sequence of the gene and pull it out of the larger chromosome, well, then you’ve got something that didn’t exist in nature before, right? Because in our bodies, in ourselves, the genes are all strung together on the chromosome. In the lab when it’s isolated and multiplied millions of times, it’s something new. And the patent office agreed with the lawyers who filed these patent applications and said, Yeah, you’re right, this is a new composition of matter, didn’t exist before, and so you can patent it. And they did, in large amounts.

 

Dr. Abdul El-Sayed: Wow. So even though these strings of DNA exist independently inside you and I, the fact that somebody had isolated them and can reproduce them meant that they could then hold the patents on those strings of DNA.

 

Jorge Contreras: That is what happened. That was the theory. Yep, absolutely.

 

Dr. Abdul El-Sayed: So going back, right, you think about the history of patenting, and I think that’s that’s kind of important here, right? What is the argument that people give for the existence of a patent to begin with?

 

Jorge Contreras: So patents have been around for a long time. They’re actually written into the Constitution of the United States so since the very earliest days of the United States we’ve had a patent system. And why is that? Well, it’s to encourage invention. So a patent—this has varied over the years—but today you get a patent and whatever your invention is, you get 20 years in which you’re the only one who can make, use, or sell that invention in the United States. I mean, that’s a pretty powerful right. For 20 years no one else can copy your invention. So that gives you—and it takes a few years to get the patent, so you probably have 17 or 16 years that when you’re the only one selling that thing in the U.S., and as a result, you can charge what you will, what the market will bear without competition. And the theory of allowing some to do that is that that helps to recoup your costs of R&D, and it encourages you to make inventions. Because if you could make a great invention and then the next day, someone else could just go copy it and sell it in competition with you, you would have much less incentive to make the invention. You’d be much better off being the copier than the inventor.

 

Dr. Abdul El-Sayed: So the idea here is that if people don’t get the monopoly on the use of their invention, then they really won’t have an incentive to invent. And so in some respect, the idea of a patent, even though it does impose a certain monopoly, is that it itself incentivizes a certain kind of inventiveness that is good for all of us. Now the interesting question is whether or not that would apply in DNA, right? Because there’s only a limited amount that people have, and once it’s all patented, you sort of seal the thing up. There’s not really all that much innovation happening here. I want to ask you, right, did that kind of logic, did that get engaged with at all as these early decisions around DNA patenting was made, whether or not, you know, patenting DNA would be good for the promotion of science or bad for it?

 

Jorge Contreras: Yeah, yeah. There was a lot of debate over this entire issue. You know, on the one hand, you’ve got this incentives argument, as you just said. You know, are people going to take the effort to invent something if you don’t have patents? With DNA, it’s a little bit of a weird argument because they didn’t actually invent the DNA, right? The DNA existed already, but they did have to take some effort to find it. And back, you know, in the late ’80s, in the early ’90s, it was hard, right? This took years to find a particular gene. And so there were a lot of arguments that, you know, people wouldn’t be incentivized to do this unless they had that carrot at the end of the path, which was the patent.

 

Dr. Abdul El-Sayed: And I want to jump into the book here. It’s a fantastic book, and I highly recommend folks read it. It’s called The Genome Defense. Can you tell us about, you know, what got you interested in this particular case that is the cornerstone of the book, and why did you decide to write a book about it?

 

Jorge Contreras: So, the book, it’s about it’s about gene patenting broadly, but it’s also about a specific case that relates to a challenge to the patents on these two genes, BRCA 1 and 2, which are related to breast cancer. So these patents were famous in this narrow field of patent experts who look at genetics. People have known about these patents and had concerns about them since they were issued in the late ’90s. And I was a lawyer, I have represented biotech companies and consortia of pharmaceutical companies in private practice, and then I became an academic in 2010 and continued to be interested in these issues. And again, these patents had been around for a while and had generated controversy for a lot of reasons—which some of which I think we’ll get to—but it had been a long time that they were out there and nobody challenged them, right? It wasn’t until 2009 that the patents were challenged in this lawsuit, and everybody in the field, for the most part thought, Oh, you know, this is, these patents are a problem, they’re causing these issues about access to health care and impeding scientific research but you know, this has been the patent office’s policy for so long, I guess that’s just how things are. And then when this lawsuit was brought, it was amazing, right? For the first time, somebody decided to challenge these patents, and that was just fascinating. It was fascinating to watch as it developed over the years. And I knew that, you know, the story was so interesting. I knew that short news stories and like academic articles just weren’t getting the message across to a large audience. And so I set out to write a book about it.

 

Dr. Abdul El-Sayed: So walk us through the case. Who was the plaintiff, who was the defendant, what was the argument that was made in the suit?

 

Jorge Contreras: Right. So the case was brought by the American Civil Liberties Union, the ACLU, and another nonprofit called the Public Patent Foundation. They were the lawyers for the case, and it was their idea. It germinated back in 2005 at the ACLU, when lawyers there started to realize what was going on with gene patenting. It took them four years to gather the facts that they needed and to bring the case. And the plaintiffs that they found to represent in the case were a whole assortment of people who they argued had been injured by these patents on the BRCA gene. So they were associations of geneticists and genetic pathologists, right—people who do diagnostic testing—they were health organizations, breast cancer activists like Breast Cancer Action, individual doctors and geneticists, genetic counselors, and six individual patients—women who had these BRCA mutations but because the test was expensive weren’t able to afford it, didn’t have insurance that would cover it and, you know, suffered some health consequences as a result.

 

Dr. Abdul El-Sayed: And what was the defense’s case? What were they arguing?

 

Jorge Contreras: So the company which was backed up by the US patent office and the entire biotech industry, their argument was This is legal, right, we didn’t do anything wrong. We, you know, we got these patents from the United States government, the U.S. Patent Office has for 25 years by this point been issuing patents on DNA, and this is perfectly legal. What you want is to change the law. And it’s always a lot more difficult to change a law that’s been in effect for, you know, a quarter century than to simply say, Look, we’re just following the law. And they made all of the policy arguments that you’ve mentioned that, you know, we put a lot of money into this discovery, you want to incentivize innovation, you don’t want to destroy the biotech industry in the United States, so leave the patents alone.

 

Dr. Abdul El-Sayed, narrating: We’ll be back for more with Professor Jorge Contreras after this break.

 

[ad break]

 

Dr. Abdul El-Sayed, narrating: We’re back with more of my conversation with Jorge Contreras.

 

Dr. Abdul El-Sayed: And it’s interesting, right, because this case wasn’t one that you would have assumed the Supreme Court might hear, and when they picked it up, they were ruling on a really broad question. Can you walk us through the Supreme Court’s logic in hearing the case then, and what ultimately they decided?

 

Jorge Contreras: Absolutely. Right. So, so the case, it goes on for several years, right, and there are reversals and, you know, changes and so forth in the lower courts. It does get to the Supreme Court finally, but it was far from certain that it would. The Supreme Court only hears about 5% of the cases that are appealed to it. And nobody knows whether the Supreme Court is going to even hear such a case. If the Supreme Court hadn’t heard it, the law would not have changed, right? The lower court, the appeals court had ruled in favor of the patents for the most part. But there was a lot of pressure for the Supreme Court to hear this case. And the ACLU was very smart in how they brought this case. They were opposed to patenting human genes. And so they could have picked any of thousands of genes that were patented at that time, but they picked genes that related to breast cancer and ovarian cancer—two very serious diseases that affect a huge number of people in the United States, either directly or because all of us know a relative or friend who has been afflicted by these diseases. So there was a lot of public sentiment around this case and a lot of public interest. And there was also interest within the administration. So a lot of really weird and unprecedented things happened in this case. One of them was that the government intervened, but not to support the patent office. Right? So the patent office, of course, was very much in favor of these patents. It issued the patents following its own practice for many, many years. They wanted the government, the Department of Justice, to intervene in the case to support them, to say, Yeah, you know, the patent office is just doing what it’s supposed to do. But interestingly, that’s not what happened, because there were agencies in the federal government that thought gene patents were a bad idea, namely the National Institutes of Health. And by coincidence, the director of the NIH at that time, Francis Collins—who’s still the director, just announced his resignation—he had been on one of the scientific teams back in the ’80s and ’90s who had been looking for the BRCA genes, at the University of Michigan.

 

Dr. Abdul El-Sayed: Go Blue.

 

Jorge Contreras: Exactly. And he and many others in the administration were very suspicious of the practice of patenting human genes, and eventually assembled a coalition within the White House and the executive branch to oppose the patents. And the solicitor general sided with them and argued in the case at the Supreme Court in opposition to the patents. Which again is really surprising.

 

Dr. Abdul El-Sayed: And how did the Supreme Court rule? You know, what was the question at hand, the ultimate, the nugget of legal question on which they had to rule, and how did they decide?

 

Jorge Contreras: So the exact question that was appealed to the Supreme Court, that they agreed to hear, was “Are human genes patentable?” Four words. Probably the shortest question presented to the Supreme Court of all time. And that’s what they decided to hear. There were other ancillary issues in the case that they didn’t decide to hear, but that was the big one. And how did they decide? They, basically the Solicitor General won the case. So Myriad made its arguments in favor of the patents. The ACLU made its arguments against the patents. But the Solicitor General, after getting input from both the patent office and also all of the executive agencies, made kind of a compromise proposal, right? And the compromise was this: that the DNA sequence as it exists in the human body should not be patentable, but if you in the laboratory look at the gene—and a little bit of biology here, so the BRCA 1 gene is something like 80,000 bases longer, right, at A T G C, 80,000 of those in order. But the gene’s purpose, or at least the purpose that we know of, is to create a protein that is a tumor suppressor, right? When the gene malfunctions, it doesn’t carry that tumor suppressor, which is why people get cancer when they’ve got these mutations in the gene. The parts of the gene that create that tumor suppressor, that’s only about 6,000 bases, right? Those are called the coding region of the gene. The 6,000 are interspersed among that 80,000 bases of the gene in, you know, kind of random places. If in the laboratory, you just pick out the 6,000 coding elements of the gene and make a string of DNA with just that, well that’s something that doesn’t exist in nature, right? In nature the gene has the 80,000 with the 6m000 interspersed along. If you just pull out of 6,000 and make a little chain of DNA that’s 6,000 bases long that just as the coding regions, that should be patentable. That’s called a cDNA, or a complementary DNA construct. And the Solicitor General argued that because it doesn’t exist in nature, then it shouldn’t be subject to this product of nature exception in the patent laws, and you should be able to patent it. And the Supreme Court agreed. So it said that DNA as it exists in your body, the sequence in your body, the 80,000 bases in the gene not patentable. But if you create one of these cDNA constructs, it is patentable.

 

Dr. Abdul El-Sayed: And what have the implications been for the way that science has progressed in the decades since?

 

Jorge Contreras: So the results of this case have, in my opinion, been pretty positive. There is obviously, you know, genetic science and technology are advancing really rapidly. Today we have the ability to test, you know, hundreds of genes simultaneously to look for diseases or health effects that are caused by combinations of genes. When you can patent individual genes, you couldn’t do that. Those tests, those panels would have been far too expensive. But without patents on individual genes, you can do these multi-gene tests, these panels very efficiently and quickly. And that’s helpful. In the area of COVID-19, right, which we are all suffering through right now, back in December of 2019, when the sequence of the SARS-CoV-2 virus was first sequenced, it was not patented. Those researchers put it out there into public databases like, immediately, the week after they found it. That is not what happened in previous outbreaks. With H1N1, with SARS patents were filed on the basic viral RNA sequence—its RNA, not DNA, in a virus—but same thing, patents were filed and that was causing problems. Researchers, you know, needed to get permission and, you know, do exchange agreements in order to get access to the sequence. COVID-19, whatever you might think about patents on other parts of the vaccines and so forth, the research to discover those vaccines happened incredibly fast, faster than we’ve ever seen before. And part of it is that there weren’t patents getting in the way of the basic research. So I think that was a really good thing.

 

Dr. Abdul El-Sayed: So in some respects, the fact that we have multiple safe and effective vaccines and we had them as fast as we did, it is a function of the Supreme Court’s decision in this particular case, the fact that, you know, nobody could patent the genome of SARS-CoV-2, which left that genome out in public space, which then allowed several teams of scientists to work on mRNA vaccines that we could deliver to the public quickly. And you know, it’s interesting, right, because we don’t really think about the broader implications of this in a moment, simply because nobody really knows what direction science is going to go. But once science goes in that direction, you can look backwards and say, Oh, this was a really important case in the path-dependency of what science was allowed to do. And we forget that that matters. And, you know, in some respects, one of the issues that we talk a lot about on the show is the role that corporations have in gatekeeping science and therefore being able to maintain and sometimes even grow huge disparities in access to you name the thing, whether it’s a certain medication or its health care itself or its dental care as we talked about last week. And in this case, there was a public interest goal in preventing corporations from being able to patent part of our bodies, which is which is what DNA is. And you know, the absurdity of it is to say, look, imagine someone could say, well, the first time we characterized this thing as an arm, right, somebody could patent that and therefore you couldn’t leverage that in your science-making. I want to, I want to just sort of as we part ways here, I want to think a little bit about where the next frontier is in this legal space. Are there future cases or current cases that are being considered around the role of patenting and that could have implications for the flow of science in the future?

 

Jorge Contreras: Yeah, absolutely. I mean, as you can imagine, there were many in the biotech industry who were not happy with this court decision, and there have been pretty consistent efforts since 2013 to get this case reversed. It hasn’t been reversed in the courts. In fact, as the courts have done a pretty good job of upholding it. But in our three, you know, tri-cameral system of government, what the courts say can always be overturned by Congress and as long as Congress doesn’t pass a law that’s unconstitutional, they can override judicial decisions. And so there has been an effort to overturn this case and other cases that the Supreme Court has issued around patents, through legislation. And that happened in 2019. There was a bill that was introduced by a couple of senators that basically would have just explicitly abolished all of the Supreme Court jurisprudence in this area with one stroke of the pen. That legislation kind of got derailed and then we had COVID and obviously other big health issues emerged that Congress had to deal with, but it’s coming back. Just this summer, the patent office—at the request of a couple of senators—the patent office issued a public call for comments on what effect the Supreme Court decisions were having on the industry. And of course, lots of players in the industry responded. They got 140 different responses to this request. Many of what—we’re studying these responses right now. The deadline was, I think, just October to submit admit them, but many of them say, Yeah, these Supreme Court decisions are terrible, we should have legislation to reverse them because of the innovation issue, because of investment, because we don’t want the US to fall behind other countries in biotechnology science. And so this is undoubtedly coming down the pike next term or sometime soon.

 

Dr. Abdul El-Sayed: Well, the fight continues. And you know, it’d be interesting just to simply map out how much corporate PAC funding from Big Pharma those particular senators may have received. And it’s a reminder that corporations do have a lot of money to spend on protecting their interests, which sometimes comes in the face of the public interest and the well-being of the rest of us. Professor Contreras, thank you so much for taking the time to join us. That was Professor Jorge Contreras, he’s the author of the new book, “The Genome Defense” and a professor at the University of Utah. And thank you again for your time.

 

Jorge Contreras: Thanks so much. Real pleasure.

 

Dr. Abdul El-Sayed, narrating: As usual, here’s what I’m watching right now. Two studies this week suggest that a third dose of Pfizer’s vaccine could offer sound protection against Omicron. The first study from teams of scientists in South Africa looked at antibody neutralization in two different versions of the virus, omicron and garden variety, among two different groups. Group one had two shots of Pfizer, and Group two had two shots of Pfizer and had been previously infected. They found that everyone had less antibody response to Omicron predictably, a 41-fold decline on average. Importantly, though, folks who’d been previously infected had high responses to Omicron. This makes sense. If you ever bought a new iPhone that unlocks with, let’s say, facial recognition, it makes you show it multiple views of your face: some straight on, some from the top, some from the bottom. Priming your immune system works in a really similar way. The more looks your body has of the virus, the better the immune response. Obviously, getting COVID is no way to prevent COVID, so another booster is the next best thing. That’s where Pfizer’s study comes in. They looked at antibody responses to garden variety COVID, Delta, and Omicron, in people with two or three doses of their vaccine. They found that people who’d had three doses had a similar response to Omicron as people who had had two doses did to garden variety COVID-19. But Omicron isn’t even our biggest COVID threat right now. Delta is. It’s raging in parts of the Upper Midwest, like in my home state of Michigan, where case and hospitalization rates are setting pandemic records right now. And the winter is just getting started. Which reminds me to tell you, don’t sleep on this. If you’re not boosted yet, what are you even doing? And whatever the mask policy is in your local community, make a good decision. If you’re in a public indoor setting, it’s always safer to mask up. Oh, and don’t forget to get your flu shot. Meanwhile, in New Zealand, which has had one of the world’s best COVID responses, they’re thinking ahead. Lawmakers have proposed a law banning sales of cigarettes to anyone born after 2008. They literally want to make cigarettes a thing of the past. Honestly, I’m here for it, because I want young people to be here for it, too. Smoking kills, folks. That’s it for today. On your way out, if you haven’t already rated, reviewed, and shared our show, please do. And if you’re looking for a great gift for that special science-loving someone or even yourself, I hope you’ll drop by the Crooked store for some America Dissected drip. We’ve got our logo mugs and T-shirts, our Science Always Wins T-shirts and sweatshirts and dad caps, and our Safe and Effective tees.

 

Dr. Abdul El-Sayed: America Dissected is a product of Crooked Media. Our producer is Austin Fisher. Our Associate producer is Olivia Martinez. Veronica Simonetti mixes and masters the show. Production support from Tara Terpstra, Lyra Smith, and Ari Schwartz. The theme song is by Taka Yasuzawa and Alex Sugiura. Our Executive are Sarah Geismer, Sandy Girard, Michael Martinez, and me: Dr. Abdul El-Sayed, your host. Thanks for listening.