Jorge Contreras – Presidential Scholar & Professor of Law | Who Owns Your DNA?

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About The Guest

Jorge L. Contreras is an American legal scholar and attorney who is recognized as a leading global authority on intellectual property law, technical standardization, and the law and policy of human genomics.

Contreras currently holds the rank of Presidential Scholar and Professor of Law at the University of Utah S.J. Quinney College of Law, with an adjunct appointment in the Department of Human Genetics at the University of Utah School of Medicine. 

He also serves as a Senior Policy Fellow at the American University Washington College of Law. He has held prior academic appointments at American University Washington College of Law (2011-13) and Washington University in St. Louis School of Law (2010-11).

Talking Points

  • 00:00 — Intro
  • 02:42 — Jorge Contreras’s origin story
  • 04:09 — Jorge Contreras’s legal background
  • 06:23 — A brief background on patents
  • 08:05 — Can DNA be patented?
  • 11:38 — How can someone patent something that is not man-made?
  • 15:40 — First individual that tried to patent a human gene
  • 16:28 — Why did it take so long for patenting a human gene to be contested?
  • 18:55 — Is patenting a human gene a massive social problem?
  • 26:16 — What was the controversy with the Obama administration regarding this topic?
  • 31:21 — What was the actual outcome of this case?
  • 35:33 — Is there any provision that allows people to study a patented gene?
  • 36:50 — Is Covid directly related to the outcomes of this case?
  • 40:02 — Where does the biotech industry stand on this decision?
  • 42:57 — Will patents like this be a benefit to society?
  • 47:46 — What does Jorge think about patent culture in the future?
  • 51:02 — Where do people connect wIth Jorge Contreras?
  • 53:20 — The biggest challenge of Jorge Contreras’s career
  • 55:40 — Who is the mentor of Jorge Contreras
  • 57:50 — A book or a podcast recommendation by Jorge Contreras
  • 59:25 — What would Jorge tell his 20-year-old self?
  • 1:00:10 — What does success mean to Jorge Contreras?

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Machine Generated Transcript

SUMMARY KEYWORDS

patents, gene, case, people, aclu, book, called, patent office, solicitor general, long, podcast, dna, discovered, company, hear, lawyer, university, brca, polyester, writing

SPEAKERS

Scott D Clary, Jorge Contreras

 

00:00

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Scott D Clary  00:35

Welcome to success story, the most useful podcast in the world. I’m your host Scott D. Clary. The success story podcast is part of the HubSpot podcast network, as well as the blue wire Podcast Network. Now the HubSpot Podcast Network has incredible shows like the martec podcast hosted by Benjamin Shapiro. The mahr tech podcast is all about maximum value in 30 minutes or less. The mahr tech podcast share stories from world class marketers who use technology to generate growth and achieve business and career success on your lunch break. If you like any of these topics, you’re going to love the mahr tech podcast. Some of the topics are zeroing in on the ideal product price point. Identifying loyalty plays for smart marketers, finding the line between sales and marketing and SAS extending the lifetime value of your customer. If these are topics that are interesting to you, go check out the MAR tech podcast hosted by Ben Shapiro wherever you get your podcasts. Today, my guest is Jorge Contreras. Jorge is an American legal scholar and attorney who is recognized as a leading global authority on intellectual property law, technical standardization, and the law and policy of human genomics. Contreras currently holds the rank of presidential scholar and professor of law at the University of Utah with an adjunct appointment in the Department of Human Genetics at the University of Utah School of Medicine. He also serves as a Senior Policy Fellow at the American University Washington College of Law, and has held many esteemed appointments and fellowships as well as positions in a variety of universities across the United States. I brought him on the show because of a very interesting topic that he just wrote about based on a case that he was involved in, and something that he has taken a particular interest in which I don’t think a lot of people understand and pay attention to. Rather, it was the case of the intellectual property concerning human genomes. So can companies put patents on human DNA, and the implications for this could be huge. So he breaks down a lot of points that he has researched, understood, and presented to the public, as almost an alert to what’s going on behind the doors that the public may not be aware of in terms of human genomes, IP patents, private companies, public companies, and what this could mean for the future of us and our health and well being. So let’s jump right into it. This is Jorge Contreras. He is an esteemed American legal scholar and attorney.

 

Jorge Contreras  03:17

Well, thanks so much for having me on the show. So I’m George Contreras, and I’m a law professor. But I wasn’t always a law professor. I started my career as a lawyer, and an intellectual property lawyer. So I’ve got a degree in electrical engineering. I decided, during college when I was getting my degree, I didn’t want to be an electrical engineer for a number of reasons. But I still liked the stuff. I liked the technology. So I went to law school with the goal of becoming a patent lawyer. And that’s a lawyer who deals with technology. different technologies come in the door every day, and you get to help inventors, to figure out how to protect them against competition. And so I did that type of work for a number of years after I graduated from law school, and worked at a big firm in Boston and Washington, DC, I spent a couple of years in London, so all sorts of different industries, from electronics to software to semiconductors and biotech, and pharmaceuticals. And then after a number of years, I decided to turn in my, you know, my barcard and become a law professor, which I did, and that’s where I am now but I’m still interested in these topics I still write about and think about intellectual property law and the bigger picture of how it affects society.

 

Scott D Clary  04:44

And as you Okay, so you you know, you stopped practicing, you’re starting to teach. Walk me through why you thought so this, this conversation is gonna be about the book, the genome defense, and we’re going to speak about the implications. This is like a truth. This is a truth story. So walk me through why you wanted to write about this. And of all the different cases that you’ve taken on? Why was this the one thing that stood out and obviously dedicated like a huge portion of your life to it?

 

Jorge Contreras  05:11

Yeah, it. I’ve thought about this case, because this is an amazing case in so many different ways. And we’ll talk more about the details, I’m sure in a little bit, but it’s about a set of patents that were well known in the field, you know, I had been in and around the biotech world venture capital world and pharmaceuticals for a long time. And most everybody in the field knew about the patenting of human genes. And, you know, it was viewed by the industry as pretty normal is like nothing big happening here. And, and then in 2009, when the ACLU filed a lawsuit challenging some of these patents, that was a shock. I n, everybody in the industry, whether patent lawyers or executives and scientists were really surprised, like what’s going on here. And this case unfolded over the years. And the more I looked into it, the more I thought, wow, there’s really something here, like, this isn’t just a fluke, these guys could win. It, you know, again, so this started, I was a lawyer, practicing when the case started, I became a law professor sort of during that time. And, you know, after a few years of watching this happen, I realized this, there are just so many interesting moving pieces here that normal people are just not even aware that these pieces of our government work this way that the law is being affected in this way. And somebody should tell the story. And so I appointed myself as that person.

 

Scott D Clary  06:59

So So walk me through, walk me through what this actually means. So when you when you say that our genomes are our patented, what does that what does that actually mean? What are people actually patenting? What’s the what is the thing that they are protecting?

 

Jorge Contreras  07:17

Right? So that’s, that’s a really good question. And kind of a head scratcher for most people. So 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 their 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 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 published 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, 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?

 

Scott D Clary  08:40

You would feel that’s what yeah, no one’s gonna say this is what this is. This is what this is what they’re after. So this is the issue. So they’re patenting, like, the raw genome, their patent, is it correct, say patenting DNA to a to an extent is that, is that fair, and then, and then all derivatives of that all derivative works have 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 the I guess there’s a new medicine or a new 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?

 

Jorge Contreras  09:24

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 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 we think about it, it is it’s very clever, right? Because human genes were patented is what’s called compositions of matter, right? The 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 at a 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 development company, you have no idea how to make a drug, that my target to 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.

 

Scott D Clary  11:06

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Jorge Contreras  12:51

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 coffee pot out of that space shuttle ceramic, you’re paying NASA something. But right, your jeans 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 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 you know, wrapped up in the nuclei of ourselves, they’re they’re spread out along the big DNA chain 20, we have 23 pairs of chromosomes. And those each of those chromosomes has 1000s of genes on it, right? The genes are sort of like spaced along the chromosomes and an unpredictable kind of way. Back in the 80s, we didn’t know where the particular genes were, or even what the gene becmi At, we thought there were 100,000 genes. And we didn’t know where they were or what their DNA sequences were right to at GC, you know that C 3.2 billion A’s T’s GS and C’s make up our genome, and discovering that was 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 chromosome with 1000, or 2000 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 or write 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 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 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? The new type of baseball bat, well, yeah, the baseball bat you everything came from some natural element right there only whatever 100 and some odd 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 up and made something new, yeah, you can patent it. And so the patent office, agreed that, okay, 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 pay

 

Scott D Clary  16:14

And that’s so that was that. So somebody is somebody who first made these discoveries, you know, who the first individual that tried to patent, a human gene? Do you know who that was? That was been a while back then

 

Jorge Contreras  16:28

the very first one. I mean, again, it only started in the late 80s. Okay, 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 the National Institutes of Health, and has been for the last decade plus, he was a scientist at the University of Michigan and his team with a bunch of other collaborators found that first gene, and there were a lot more to follow.

 

Scott D Clary  17:03

Okay, so then, okay, so that so now we, that’s a very, very interesting how this is sort of how this has sort of manifested over over over time and how this is now. Okay, you have a gene, there has been a successful patent placed 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?

 

Jorge Contreras  17:38

Yeah, that that’s a fascinating sociological question, right? Why was this so? So the the genes in 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 how 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. So 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 sequenced these genes in 1994 and 1995. Their patents, it takes a few years to go through the patent office patents issued in 97, started to issue in 9798, 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, did 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 that, right. There’s not widespread

 

Scott D Clary  19:29

it’s not widespread. Nice. And that’s that’s what it takes to move like, it’s not a small little university lab. It has to be like a massive social problem or injustice that people want to actually get behind.

 

Jorge Contreras  19:40

Yeah, yeah, absolutely. And so there there was a challenge to patents on on genes related to this very serious but rare disease called Canavan disease a few years earlier, and this was a patent held by Miami Children’s hospital. And they were they were also pretty harsh and how they licensed like they didn’t want any other labs to be doing testing for this gene that, you know, this is prenatal testing, right. If the mother gets screened, their parents get screened to see if they’re going to pass along this pretty serious disease to to their kids. Miami Children’s Hospital shut down their lab, other labs are doing this testing for free. That was not an option. Once they got the patent, right, you’re going to have to pay for it. And so there was a very strong patient group in this area. And in fact, the patient group, they were the ones who collected all the DNA from their children with this disease, to camp to the scientist, who then went off and patented the gene when he discovered it. And he was very apologetic, but said, Well, you know, my university, they insist on this, and that was that. And that case, it was it was brought by volunteers by a law professor who was really forward thinking out in Chicago, but you know, they lost the litigation. Litigation is expensive in this country, and just a law school clinic. And some volunteers are not going to do well against a giant hospital system that has a patent that, you know, worth millions and millions of dollars, so they lost. And again, nobody heard about you, you probably didn’t hear about that case, right. I mean, we teach it in bioethics classes. And but but it’s not, it didn’t make national headlines. So it wasn’t until 2005, then that the ACLU got involved, and it was purely by chance, like ACLU has been around for 100 years, never brought a patent case and never even had a scientist on their staff until they started to get a lot of money in donations after the 911 attacks. And, you know, the ACLU was really like a prominent in dealing with civil rights, civil liberty issues after 911 They got a lot of donations, and they doubled the size of their staff at their New York headquarters. And one of the people they hired was a science advisor because they’re all of these issues starting to come up you know, DNA fingerprinting, you know, warehousing of people’s DNA, criminal investigations, you know, tracing people privacy around your your health information, they needed a science advisor. And so, Tanya sim Celli, this young woman is hired out of graduate program in Berkeley, and comes to work for them. And she knows about these cases and the gene patenting stuff. And none of the other ACLU lawyers know, but one of the things this book goes through was how she gradually convinces them that you have this is actually happening, like they don’t even believe her at first. Seems so unlikely, like they have your reaction like that. How could that be possible?

 

Scott D Clary  22:58

But that doesn’t seem right. It doesn’t it doesn’t seem I know, I know, there’s probably a lot of is probably a lot of more more technical, legal, legal arguments, but it does doesn’t seem like an ethically sound process.

 

Jorge Contreras  23:12

It struck a lot of people as just being wrong. This is what Chris Hansen, the very senior litigator at the ACLU thought to when he heard the story and finally believed that Simoncelli like knew what she was talking about, which she did, and they then they had to spend like four years like making this case, moving it through the ACLU, they had to convince the, you know, the leadership, the ACLU that this case was was worth bringing that, that this wasn’t a case that was going to destroy the biotechnology industry, right. They they weren’t concerned, I mean, they cared about health. And, you know, didn’t want to do something that was going to be extremely damaging in the end, but but they did, they did come around to the conclusion that this was just a practice that had gotten out of hand it was it was created by by experts, who who were looking at this in a very narrow way without any perspective on what the broader implications were of this, you know, construction of of a gene that was isolated as being a new composition of matter like polyester.

 

Scott D Clary  24:22

When when the ACLU took on this case, walk me through the walk me through even the the trial. And the argument, was it a was it a complex? Or was this like a slam dunk homerun? It seemed like when it was brought before anybody, it was an easy it was an easy response or an obvious response that this isn’t something that we should continue doing. Well, I guess it went to the Supreme Court. So what it wasn’t that, you know, black and white cut and dry was something that actually was appealed multiple times

 

Jorge Contreras  24:56

this this was a total long shot. Yeah. Which is why I and like everybody else in the community, like, couldn’t believe that this case was being brought. So they filed the case in 2009. Right? It took them four years to figure out if they could even bring this case. And again, remember the patents issued in the late 90s. So we’ve got, like, more than a decade of history with these patents being around, nobody’s challenged him. There’s been plenty of litigation around these patents, right, this company saying, Oh, my patent is the patent that controls this and the other and say, no, no, it’s my patent that really controls it. Plenty of companies were fighting about these patents. But no one had ever argued that we just shouldn’t have these patents at all. Because nobody or no company benefits from that, right? Just like no patent lawyer ever took the position. Except one. Nope, I never took the position that we shouldn’t have these patents because No, every company wanted their patents to be the ones that came out on top. But like losing all the patents, that that would hurt everybody, so and the entire Patent Bar basically was on the side of some company who would gotten these patents. Right, because that’s what you do as a patent lawyer is you get patents, you don’t argue why there shouldn’t be patents, and and even the patent office, it has like 9000 examiner’s who decide whether or not to issue these patents. They’re, they view their job as issuing patents. And they do screen out like the really ridiculous stuff. And they get plenty of spurious applications. But but this was legitimate, right? This is these are real inventions, real discoveries, universities that are prestigious are submitting the application. So it was all happening, complete surprise and a complete long shot of a case.

 

Scott D Clary  26:50

Yeah. And I just want to touch on one more point, while this while a ACLU took on this case, was arguable prep for four years to even make a case then argue that what was the the controversy with the Obama administration about this same topic was that in tandem, when the ACLU was arguing this case?

 

Jorge Contreras  27:10

This is one of the most fascinating pieces of this whole story. So we think about litigation, you know, you’ve got two parties, we’ve got the ACLU and all the plaintiffs that it assembled on its side, and you’ve got the company who has the patents on the other side, but there’s another party to it’s the government. So the patent office issued these patents, and they were pretty proud of these patents, right. And so when a party brings a lawsuit that involves the government or some government agency, if the government can intervene, right, they can say, you know, we want to appear in court, we want to make arguments is generally in support of this, of this set of patents. And the Patent Office wanted to do that, which which it often does, right, this is pretty normal. But to do that, the patent office doesn’t act on its own right, in the executive branch of government, all the agencies have to run their litigation matters through the Department of Justice. And sitting at the top of that chain, of course, as the attorney general, but the Solicitor General, who is the number three lawyer in the United States and Solicitor General is the lawyer for the United States government. Right. When the United States has case at the Supreme Court, the Solicitor General argues it and all of the 1000s of cases involving government agencies around the country, like the Solicitor General, obviously doesn’t argue them all. But somebody either from the Solicitor General’s office or they dole that out to somebody else in the Department of Justice, right. The solicitor general’s office controls all of that. So the patent office, in this case approaches the Solicitor General and says, Look, this crazy, ACLU, people, they’re challenging. These patents. We’ve the patent office had been issuing the patents on genes for 20 years, well established precedent, the entire industry agrees the biotech industry is built on this, we’ve got to step in and defend these patents. And the Solicitor General. And again, I’m sorry about that. I’m oversimplifying a little long process here. The solicitor general says, Well, you know, let’s think about that. And they try to get a consensus among other agencies, whether this is the right position. And believe it or not, the answer turns out to be well, maybe not so much. Because other agencies are opposed to the gene patents and the agency that as most opposed to them and most vocally opposed is the National Institutes of Health being run by Francis Collins. Right. who himself has his name on gene patents. The difference is when the University of Michigan discovered the cystic fibrosis gene, and patented it, they let anybody who wants it to operate under that patent right for a fairly nominal fee, through their hundreds of labs who can contest for CFTR. And no one ever considered that patent to be a problem, the BRCA gene. So as I said that one company Mariette, they shut down the entire rest of the industry, and they charged a very high price for their tests that many people couldn’t afford, Medicaid didn’t cover it. This led to a lot of social problems in this case. So NIH and a bunch of other agencies, the Office of Science and Technology at the White House, you know, the National Economic Council, led by Larry Summers, a lot of really a prominent people in the administration, got behind the NIH s position and opposed these patents. And ultimately, the Solicitor General took their view over the patent office, right. I mean, and this is crazy, at least from the view of the patent office, because the Department of Justice is supposed to be there lawyers supposed to be representing them as a government agency. And instead, it appears in court, after the Supreme Court, the Solicitor General of the United States himself argues that these patents should be invalidated, which is completely shocking. But But tapping was really important.

 

Scott D Clary  31:18

There. So that obviously, that obviously had a massive impact on I’m assuming some not massive, but some sort of impact on the outcome of the case. It could this is a normal, this is not normal, that this would have happened.

 

Jorge Contreras  31:31

It is totally not I mean, usually, even in patent cases, the Solicitor General supports the patent office. Yeah, so this was totally unusual. And, and the Solicitor General won the case, right. I mean, there were three sets of arguments before the Supreme Court, the ACLU, Mariette and the Solicitor General, and they picked the Solicitor General’s argument as the winner, basically.

 

Scott D Clary  31:57

So what was the well, so obviously, we know, we know the outcome. So the outcome was, and what was it? What was the the the more specific outcome? So was it just that no companies can ever patent genes? Any ever again? Or what was the actual outcome? Or was it was, I just wanna understand that because I want to understand what some of the impacts that outcome has had in the since since I guess, when was that case decided? 2013. So since 2013, what was some of the impacts that has had that this has had on the industry? And then on the MediCal, the medical industry, in general? So what was that outcome?

 

Jorge Contreras  32:37

Yeah, yeah. So so the Solicitor General, because the patent office was very upset that this was going down. This way they, they did try to come up with a compromise solution. Right. So the ACLU argued that all of these patents should be invalid. Myriad argued, they should all be upheld. The solicitor general’s argument was, well, some of each, so the petals that covered the sequence of DNA, the at GC, whatever, as it appears in our bodies, right, that exact sequence, those are not valid, because that’s a product of nature. You can’t patent that, but the way DNA works, we’re gonna have to have a slight science detour here than we do. You know, the ATG see there are about 80,000 of those letters in the BRCA one gene. Of those 80,000, only about 6000 do what’s called coding the protein. Right? So the BRCA genes, they create these proteins that are tumor suppressors, right, when there’s a flaw in the gene, then the protein doesn’t get coded properly. And that’s why tumors grow. I mean, they’re obviously like lots of other reasons that tumors grow, but but you’re much more likely to get cancer if you do not have these tumor suppressors, like working for you every day in your body. And so only 6000 of those bases code, those tumor suppressing proteins. So if in the lab, you sort of took only those 6000, coding bases, right, and strung them together into a smaller thing, not the 80,000 bases long gene, but a 6000 bases long what we call, you know, exons you know, or what the court called a C DNA a complementary DNA that’s made up just that small coding region the DNA, well then that might be patentable because that doesn’t exist in the body, brain in the body. Those 6000 coding bases, they’re spread out along the 80,000 long length Have gene. And you know, we’ve got molecules called RNA that figure out which are the coding ones, and they reproduce, you know, the the coding elements to create the protein. But those 6000 aren’t just like stacked up neatly together in the body, like they would be in the lab. So a few in the lab create one of these cDNA constructs artificially. And because it doesn’t exist in the body that wouldn’t be patentable. And some of Marriott’s patent claims covered that. Now, myriad, didn’t create cDNA constructs, that those are not used in the diagnostics business. Because they for for a number of reasons, MariaDB was not helped at all, really, by this decision, or by the compromise, but it might have helped, you know, companies and other areas that like manufacture proteins and things, artificial antibodies, and and a lot of the biotech community had been concerned about that. So they were happy about the compromise.

 

Scott D Clary  36:10

So if they if there is a compromise now, if somebody else wants to study these, is it? Is there any, is there any part of that compromise, it allows a new scientist or a new institution to come in and build out works on on something that has already been patented? There’s just you just have to pay a fee to be able to access this, like, was there any sort of because you know, the original gene patenting, there was a nominal fee to get access to this, to create derivative works and to create additional studies on it. So that’s, that’s sort of like in good faith for you know, the betterment of humankind is the best way to put it. But is there any provision that allows people to at some sort of subsidy go in on a patented gene and to study it? Or is that not allowed?

 

Jorge Contreras  36:56

Well, well, so the ACLU basically won this case. So after 2013 Yeah, those patents on the G on the full genes, those are no longer valid. They’re, they’re effectively gone. I mean, they may still be lingering out there on the books, but they can’t be enforced, right? This did knock them all down. So anybody can go conduct research on a human gene. And there’s no patent that can stop them.

 

Scott D Clary  37:25

And then okay, so then walk me through. Because I know that in the book, you reference some of the the impacts that this had on more recent diseases, pandemics. You mentioned SARS, h one and one, I’m assuming there has been some, some positive impact in terms of like COVID, and the creation of a COVID vaccine. So what what were the things that we are able to do now, that allowed us to deal with SARS? H one, n one, and what we’re trying to figure out with COVID. Now, are these are these directly related to the outcome of this case? Said differently? If we didn’t have this case? would COVID-19 be a much different situation?

 

Jorge Contreras  38:09

Yeah, no, this is this is a great question, because this case, I think, did have an impact here and is has an impact that we’re feeling right now. So pre 2013 SARS, h one n one, you know, those viral RNA sequences, right? They like viruses have genomic sequence two. And the way a virus infects us is it’s, it gets into our body, and it inserts its DNA into us in certain ways, it makes us sick. Um, there were patents that were filed like immediately when you know, those outbreaks happened as soon as the viral agent is discovered. It sequences and patents were obtained very early on in those processes that then made other researchers who were trying to look at the virus and how to combat it, have to go get permission in order to in order to, to study it, and certainly to make any kind of vaccine or therapeutic with COVID-19. Right, the SARS cov. Two virus, that viral sequence was put up in public databases as soon as it was discovered. Within a week, and I don’t know if you’ve, you’ve probably spoken with people or read a number of the new books that are out about how the vaccines were developed, you know, the people at the different companies, whether it was moderna or biotech, you know, they were able to get immediate access to those viral RNA sequences from these public databases. And, again, the viruses mutate some other Hundreds of 1000s of mutations of the SARS cov. To sequence and those are all public, no one has gotten patents on those. And, and so labs don’t have to worry about paying something, they don’t have to worry about signing a agreement, you know, in order to want to do research, they’re able to just go in immediately and start to do that. And I do think this contributed to the speed. I mean, there are lots of factors. And it’s an incredibly impressive job that these researchers did in getting these vaccines out. But I think this was a contributor. And I do think it sped up the process.

 

Scott D Clary  40:39

And then just just update update us on where the biotech industry stands, because the last part of this book focuses on the fact that they’re campaigning to reverse this decision. Now, I’m not a lawyer. I don’t know how easy it is to reverse a Supreme Court decision. I’m sure not that easy. But this is something that they’re actively campaigning for. And where do they stand right now?

 

Jorge Contreras  41:02

Yeah, you’re totally right. Well, I mean, since 2013, like the biotech industry was very unhappy with this decision from the day it came out. And so there’s been a pretty steady effort to overturn it. Now, a Supreme Court decision is pretty binding. And the courts, the courts, all the courts in the country have to obey it. But the way our tripartite system of government works is that Congress can pass laws to reverse the effects of Supreme Court decisions as long as they’re not doing something unconstitutional. Right. And so this, this doesn’t really implicate constitutional rights in that way. And so in the patent area, the Congress has the authority to amend the Patent Act. And in 2019, a bill was introduced, that would explain Atlas that explicitly said the Supreme Court’s jurisprudence on product of nature are abrogated, meaning like, they’re gone. And we’re back to you can patent anything, whether it’s a product of nature, or not, as long as you’re the first one to discover it. And and that would put us right back to where we were right before this case was brought. And so that 2019, that that legislation didn’t advance, and the pandemic started, and things were sidelined, for for a couple of years. But just this summer, at the urging of the same senators who proposed that legislation back in 2019, the patent office issued a public call for comments, asking the industry, please tell us how you’ve been affected by these cases. And and, of course, you know, the stories that you’re hearing are, well, you know, we can’t get patents, and this is really damaging our business, and they got 140 responses to that call for comments. They’re still sorting through what everybody said, they’re publicly available on the PTOs website. If anybody’s curious, I’ve got somebody, one of my research assistants is sorting through them right now, trying to figure out what everybody said. But clearly, you know, this exercise is going on as background for legislation that would potentially limit the scope of the Supreme Court opinions again, in the next term.

 

Scott D Clary  43:31

It’s very interesting. And I just want to I want to get your opinion on this, because this whole this whole story and what’s and how this has evolved. To me, I’m from a tech background, it seems like very similar to the open source versus, like private IP for software companies. And the arguments always made like, well, if you open source something, then you’re gonna have more contributors. But there’s always less money, less energy and less effort put behind something, if it’s free, right. So do you think that do you think that just opening and removing patents will be a benefit to society to humanity? Or do you believe that there has to be financial incentive, and it has to be private, not privatized, but patented, so that these huge large organizations that do have significant revenue can invest in the best and the brightest researchers and they can focus on these genes and on they will only focus on them because they’re patented?

 

Jorge Contreras  44:31

Yeah, so So I am not against patents. Right. And I do think we need patents in the system, and especially in the biopharma area where r&d is extremely expensive. I think I think they’re necessary may not be the greatest, you know, mechanism, but they’re pretty good mechanism and they generally work okay. But that doesn’t mean that you should be able to patent everything under the sun. Right. So I mean, the way I view it is that basic research tools and basic information about how the world works and how the human body works, that should be available to everyone to access and research without having to pay a toll and without having someone be able to coordinate off exclusively. But past that stage, there’s plenty of room to get patents, right. So with COVID-19, I have no objection to the companies that obtained patents on all of the various delivery mechanisms and their, you know, the mRNA vaccine technology, that’s, that’s fine. You know, they should go ahead and get those patents, and there are all these different competing technologies that work fine. You know, and there are some issues around access in the developing world and international law that the whole other conference, that’s a different podcast, I’m happy to come back for that one. But in general, I think the issuing those patents is is fine. It’s just at the basic research tool level, everybody should have access to it. And that will, that will lead to the most innovation, right? Ring fencing, a human gene and all of its uses, like you would with polyester or a new like super strong steel product. That that limits the number of companies who can use it. What happened with the BRCA gene. So Mary is a diagnostics company, they weren’t making drugs, yet they their patent covered to use, you know, making drugs targeted to BRCA one and two, also, they knew they weren’t going to make a drug. They licensed those rights to Eli Lilly, one company, who paid them several million dollars for this and that, actually, they, they they licensed this, this was a futures deal, right? They they licensed those rights to Lilly before they even discovered the gene. And it was at Lilly money that actually helped them win the race, right, because they had more sequencers and equipment and other academic labs, you didn’t have that kind of corporate backing. So the money did help. But Lily had them the exclusive rights before the gene was ever even discovered, to exploit it. For any kind of therapeutic they wanted to, they never did. They just didn’t find it useful, and they had other priorities. So nobody else could look at it either. Right? No other drugs like maybe Pfizer, maybe Novartis, maybe somebody else would have come up with a tumor targeting agent that could have used BRCA one or two, we’ll never know. I mean, well, now it’s off patent. Right. But and it turns out that the BRCA genes just didn’t turn out to be good targets for drugs. They’re very, like loose genes that move around all the time, and are very difficult to work with. But like we didn’t know that at the time. So locking up the basic research tools, I think is is the problem. I think beyond the basic research tools, there’s plenty of space for patenting, and for every company, you know, to get its rights, but will have the most innovation and the most discoveries that benefit our health. If the field is open, and sort of that basic research level.

 

Scott D Clary  48:22

I want to I want to pivot and just ask a couple rapid fire questions to pull out from your experiences I’d like to do with every show. But before I do that, of course, I think like I think we know like your stance on where you would like the industry to go. But your background is in law, you’ve been in this field for a while. Where do you think, even though there’s like the best possible scenario, where do you think this will end up in the next five years? Because now it’s being put in front of Congress? Again, do you think we’re going to revert to where we were before, based on your past experience of maybe similar cases or similar, similar campaigning from large industries that may have looked at like tobacco or energy or other other other other you know, like huge industries that lots of money to to solicit government, or do you feel like that this decision will carry going forward?

 

Jorge Contreras  49:21

Yes. So there’s a lot of criticism of of the patent system right now. And these bills would would cover a lot of different issues. I think some patent reform legislation will probably come into effect in the next five years. But I think I mean, my my hope, and my prediction is that this case in this particular issue, won’t get changed. And that is because when the ACLU picked up this case, that got public interest started, right. And so organizations like breast cancer action, who hadn’t really been looking at genetics issues before this or patent issues now Oh is on the alert as the ACLU, you know, they’ve continued to monitor these issues. And so they submitted comments to Congress and the patent office in response to that PTO call for comments. And they’ve been very active in sort of marshalling patient groups and medical groups, you know, in, in this way. And so I think that that, that you need a public advocate, because you’re right, I mean, before this, it, this was just the land of experts like industry lobbyists, patent lawyers, you know, and company representatives, they were the only ones who were even paying attention. So of course, this is what’s going to shape the rules, if there aren’t that many public advocates and public watchdogs out there to cover all of these complex scientific issues, but but this one is now being watched. And I think by very vocal and articulate and smart organizations that, you know, again, I see what they do, and I think I think they will be effective. So there may be some patent reform, but I’m hopeful I’ve got my fingers crossed that this one, this this case won’t fall.

 

Scott D Clary  51:11

Very good. No, I’m very, very interested. Thank you for thank you for giving us a rundown on that. i The second. The second, I saw what the book was about, I’m like, we have to talk. We have to chat. Like this is something that I like, I’m probably like, most people like I didn’t realize this was a thing, until you start to sort of dive into it. You’re like, like, you know, excuse my French like, holy shit. This is like, a pretty significant issue.

 

Jorge Contreras  51:33

Yeah, I agree. Yeah.

 

Scott D Clary  51:37

Yeah. So okay, so I also want to get some information from you. So if people want to go get this book, if they want to connect with you, where should they go? Is it social? You have a website? What’s the best spot?

 

Jorge Contreras  51:49

Yeah, so the book that can buy anywhere? Generally, it’s, it’s a book book. It’s also, you know, there’s an ebook format, there’s an audio book. And these days, yeah, I listened to a half of the books I read are on audio. So you know, audible and Amazon, your local bookseller, I do have a website, which I’m not I’m not selling the book, right. But it has links to all of the book, The bookstore sites, it’s called Genome defense.org. Right, just one word, the book is the genome defense. And so genome defense.org, and I mentioned the website, um, because it’s got a lot of other material on it. So again, depending on how interested you are, if your listeners or law students are just really curious about what a lawsuit like this looks like, I’ve got all of the documents or they’re probably 1000s of dockets, I’ve got all of the important documents from the case are up on the website. So if anybody wants to see like, what did that patent actually look like? I’ve never seen a patent before. You can go see what a patent looked like on a gene, all the patents that were challenged what or and the demand letters, like Mary had sent cease and desist letters to all these universities and clinics, all of the demand letters I could get my hands on are up there on the website and the transcripts, you know, from the oral arguments, like if you want to hear what a really good argument at the Supreme Court sounds like you know, read this transcript. So there’s a lot of fun stuff for for the real law geeks out there. And it’s all there. It’s all free and it’s organized on the website.

 

Scott D Clary  53:29

Amazing. Not, that’s awesome. Thank you. I appreciate it. I’ll link that below in the show notes too. Okay. I like to do a couple rapid fire career questions, just life questions, because you’ve had a great career obviously, having a life practicing law writing a book, teaching law, that’s no small feat. So I like to split some insights people that are earlier on in their career or later on and just want to learn from somebody who’s done it before. So the biggest challenge that you’ve had to overcome in your entire career could be personal or professional. What was that and how did you overcome it?

 

Jorge Contreras  54:03

So you know, it’s it’s it’s, it’s it’s hard to say I mean, I so I I was always like in elementary school middle school high school, I was always like pretty creative kid. I was always really like the most into creative writing assignments and projects and like I directed a play that I wrote on was really creative stuff um, but But you know, that I, I was good at math and science and I went into him an engineer and, and one of the reasons I left engineering was I couldn’t be creative in the way that I wanted to be there and then you might think well go to law school is a pretty stupid choice. And I liked law school a lot. You know, if students are thinking about law school, it actually is like an intellectually like amazing place to be But then when I came out, and I started to be a lawyer, and I did negotiations and transactions, like drafting these agreements around intellectual property, I liked it, and it was detailed and careful, but I found myself, I, this just isn’t very creative, you know, in this way. And I, I, you know, got kind of unhappy about that and really wondering, What can I do, you know, am I stuck here, you know, doing a job that will I can do very well and efficiently and effectively, but I’m not going to exercise that much creativity and, and that is what, after a very long road led me to become a law professor where you can, greatest job in the world, you can do literally anything you want to no one’s checking you, no one’s don’t get a boss really. And I decided I’m gonna write this book, like to try to explain, you know, in kind of a journalistic, literary creative way, how something really complicated works in the real world. And, and took me a long time to get here. But but that like, challenge, the challenge is figuring out how to do what I really enjoyed in a series of different jobs that weren’t exactly the right fit, but but helped me a lot along the way.

 

Scott D Clary  56:16

I love that, if you had to choose one person who was very impactful in your life, and there probably has been many, but you have to pick one, who was that person? And what did they teach you?

 

Jorge Contreras  56:26

So, so I’ll go, I mean, obviously, you know, my wife, I cannot avoid mentioning mentioning her because she’s helped me very much along the way, does a molecular biology background and helped me a lot in writing this book. And we both know many of the people in the book, but but for you know, sort of a more professional thing going to go back to high school. Because, you know, I was this kid I went to high school, big public high school in outside of Dallas, Texas. And, and, you know, I had, I was interested in in writing, but I was also this kind of Math Science Kid. But my English teacher in 11th grade, Janet arbury, I, she’s no longer with us. But this long time ago, I was in high school, she she actually, you know, thought that I was a good writer and believed in me as as a kid who like, you know, could could express himself in in writing and, and put me on the high schools expository competition composition team, which was called Ready writing at that time, and, and we competed and like, unbelievably, you know, we competed and I went up through the ranks, I ultimately won the Texas State Championship in this, you know, competition of ready writing. And, and I, I was I was just so grateful to her, right, because I previously the previous year, like, the teacher didn’t nominate me for this team. It was kind of bummed out that this teacher, she took a chance, you know, and, you know, saw something in what I could do and, and I just, I really grabbed it, and I ran with it. And that was again, that was a long, long time ago. It was my senior year in high school. But AI is really one of my proudest moments, you know, when I won that competition,

 

Scott D Clary  58:23

amazing. That’s good. A favorite favorite source to learn and grow could be a book podcast that you’d recommend people go check out.

 

Jorge Contreras  58:33

Oh, boy, ay, ay, ay. I take inputs from so many sources. You know, you had so many

 

Scott D Clary  58:41

fair Yeah, and it doesn’t have to be like a business, anything anything. Like if the you that you’ve read recently or that in the past that you just thought was a good? Some good, something that people like if it had to be business at all, or law be anything?

 

Jorge Contreras  58:55

Yeah, yeah. Well, so, you know, this may be totally inappropriate, but but there’s a, I’m gonna start to listen to your podcast. But the planet money podcast is, is one that it’s got these short, like 15 minute things. They they actually had a segment on gene patenting a year or a year and a half ago, before this book came out. And I was I was bummed that they didn’t know about my book, and I’m hoping they’re going to do a follow up. But um, you know, but but they periodically they do segments that cover law and they cover they have a few really good segments that cover patents, crazy things. One of my favorites is a segment of theirs called Can you patent a steak? Like Ste AK and the answer, believe it or not, is yes. And so for people who don’t know who aren’t experts, it’s got just a lot of really good economic tidbits and information that that shows us how the real world works and you know, it, it’s it’s a good one

 

Scott D Clary  1:00:00

You’re interesting. If you could tell your 20 year old self one thing, what would it be?

 

Jorge Contreras  1:00:06

I would, I would say to my 20 year old self, you know, go get into academia sooner, don’t wait. Don’t spend many years as a go with what you really love. As soon as you can. You know, we all have debts, and I had to pay off debts, also from college and law school, and you’ve got to work and make some money before that. But once you’re done with that, don’t don’t let the golden handcuffs bind you longer than they absolutely have to, you know, follow your passion as soon as you’re financially able to do it, and maybe

 

Scott D Clary  1:00:45

very good advice. Very good advice. Last question, what does success mean to you?

 

Jorge Contreras  1:00:52

You know, to me, I think success is having people recognize what you’ve done and making a contribution, you know, making a real contribution of some kind to society. I mean, I’m not a scientist. I’m not a doctor. But you know, my contribution, I hope is explaining complicated things to people in a way that they can understand so that they, they learn something more about our crazy system of government and laws.

 

 

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