Wednesday, July 29, 2009
Nearly 20 percent of the human genome is patented by private companies, amounting to thousands of genes. But should what exists in nature be patenting, and what impact will that have on cures for disease?
The next Ethics Center forum "Who Owns Your Genes?" is Wednesday, August 5, 2009, at 5:30 pm, at the Reuben H. Fleet Science Center.
MAUREEN CAVANAUGH (Host): I'm Maureen Cavanaugh. You're listening to These Days on KPBS. When people hear that private companies are allowed to patent DNA sequences in human genes, they are generally astounded. How could it be possible to patent natural biological material? Well, the answer is complex but the United States has been allowing patents on chemical compositions based on human extractions for more than 100 years, after the discovery of adrenaline and insulin. Now, with the mapping of the human genome completed, some research companies have isolated chemical sequences within the DNA structure. In one case, the sequence contained a mutation that indicates a risk for a form of breast cancer. So now, the company that found that mutation has patented the sequence, and everyone who wants to be tested for the presence of that gene has to use the company's test. Some say that's as it should be. Research companies take financial risks to make discoveries and should be able to get compensated. Others say not only is the practice of patenting human genes morally questionable, but doing so actually inhibits research. This morning, we’ll discuss the issue of who owns our genes as part of our monthly series on science and ethics. I’d like to welcome my guests. Kevin Keenan, executive director of the ACLU of San Diego and Imperial Counties. Welcome, Kevin.
KEVIN KEENAN (Executive Director, ACLU, San Diego and Imperial Counties): Welcome. Thanks.
CAVANAUGH: And Stacey Taylor, a law partner with DLA Piper. Stacy, welcome to These Days.
STACY TAYLOR (Attorney): Good morning.
CAVANAUGH: And Dr. Leonard Deftos, professor of medicine at UCSD and a professor of law at Cal Western. And, Len, welcome to the program.
DR. LEONARD DEFTOS (Professor of Medicine & Law): Good morning.
CAVANAUGH: We’d like to invite our listeners to join the conversation. Should a company be allowed to own a human DNA sequence? If ownership is denied, how will private companies be compensated for their research? Give us a call, 1-888-895-5727, that’s 1-888-895-KPBS. Len, I’d like to start with you and I’d like you to be – to remind us, first of all, what does it mean exactly to have something patented? What rights does the patent holder have?
DR. DEFTOS: Yes, Maureen. I think that even referring to owning the genome is a little creepy because a patent right is not a possessory right. You don’t possess the gene or the sequence, certainly as they appear within a human. What you do is possess the right to use the information derived from that chemical sequence in a variety of ways. More importantly, you own – you can stop other individuals from using that information or using that invention, so it’s not a possessory right, and I think that’s an important concept to get across. It’s, in fact, a government enforced monopoly rather than a possessory right. And the rights that a company has is to receive money, to receive royalties, for – from implementing that patent.
CAVANAUGH: Would it be better to say sort of an exclusive right of access?
DR. DEFTOS: Well, yes, you could describe it as an access but it’s an exclusive right of implementation rather than access, of taking that information and converting it into a useful—that’s one of the criteria for an invention—into a useful invention.
CAVANAUGH: Now, the U.S. Patent Office is basing its – the ability to patent these sequences of genes, of DNA, on a couple of recent acts, the BiDole Act, the Chakrabarty case, and I’m wondering if you could tell us a little bit about those?
DR. DEFTOS: Sure. I think actually those cases, especially the BiDole Act, have facilitated and advanced the development of patents by academic institutions and by research institutions, too. But as you said in your original comments, patents for chemicals, which DNA is, have been allowed for hundreds of years, not only in the U.S.A. but in most – in most countries. The BiDole Act allowed universities to benefit from their inventions. Prior to the BiDole Act in 1980, there were many laws, a myriad, if I can use that pun considering it’s a company that we’re discussing, a myriad of different regulations about patents. But what BiDole said was that universities could patent and benefit financially from their inventions.
CAVANAUGH: There is a company named Myriad that does hold exclusive rights…
DR. DEFTOS: Right.
CAVANAUGH: …to the BRCA test and we will be talking about that later. I’m wondering, Len, how does a company end up holding a patent on this gene sequence? The patent is on the chemical compound, is that correct?
DR. DEFTOS: The chemical compound and its implementation into, in this case, a useful diagnostic test. That’s a valid test and that’s novel and not obvious. There are certain criteria. So it’s based on a chemical patent rather than a biological patent. There is a long line of biological patents that have to do with the concept of patenting life, in fact, but the gene patents have taken a different route primarily based on chemical patents.
CAVANAUGH: Stacy Taylor, you represent a – You’re a law partner with DLA Piper, and I wonder why you think it’s important for companies to be able to get patents on this material?
TAYLOR: Well, I think it’s helpful, to put it into context, to understand that a patent is actually a very time-limited right. As Len said, it doesn’t give me the right to own what I have – what is the subject of my patent, it gives me the right to control the idea that is represented by that patent. So if I have a patent to a way of making tires, I don’t own every tire that’s out on the road. I have the right to make, use and sell that tire, and to prevent or license others to do that. Now, that time limit that I am given, at the end of that period of time represented by the patent, then my idea goes into the public domain and becomes free for everyone to use. And so what the Constitution in creating the patent system did was establish a quid pro quo. It says we want to encourage people to innovate. We want them to spend not only their time but also their money and their resources to come up with new ideas that benefit society, and in exchange for that investment of time and effort and money on their part, we will give them a period of exclusivity during which they may choose to allow others to make their invention in exchange for money back or not, or they may choose to keep all of the rights themselves but at the end of their exclusive period, it goes out to the world. Now in the case of a patent to a dog collar, say, and there are plenty of those out there, the amount of investment that went into making the invention is really fairly minimal. But in the case of the kinds of technologies that we’re talking about, the amount of the investment is really staggering and the time it takes to develop and to realize that investment, to develop the technology and make it commercially, is often half or longer the life of the patent. So that if I am working on a new drug, whether it’s based on a gene or whether it’s based on a compound I found in a plant, as many of the breast cancer drugs have been derived from, I have made that chemical compound. It’s not the chemical compound as it exists in your body or my body or in the plant. I have isolated it, I have purified it and now I have to prove to the FDA that it’s safe. I have to prove to the FDA that it works in the way that I intend it to work, whether it’s as a diagnostic or as a drug. That process, from the time I file a patent application, which itself is not inexpensive, the average patent application per country can cost $100,000.00 to obtain. So these are not inexpensive, easy things to do. But from the time that I discover that drug to the time that I actually put it on the market can be more than ten years and hundreds of millions of dollars. So at that point, if a patent runs 20 years, I now have 10 years during which I want to – I – to recoup my investment. I may license my drug to other people, let them make it and pay me some money for it, I may sell it myself, or the drug may fail altogether and I’ll never get any of that money back. So – But at the end of that 20 year period, whether I’ve gotten a dime back out of my investment or not, my invention becomes public property.
CAVANAUGH: Well, Stacy, I think you’ve put the case for patenting, allowing the patents of DNA sequences, very well. And I want to move now to Kevin Keenan, executive director of the ACLU here in San Diego and Imperial Counties and I know the ACLU is challenging the interpretation of the law that the patent office is using to allow these patents to go. And you’re using a case against Myriad, the company that holds the patent on two breast cancer mutations, two genes. So what is this lawsuit about?
KEENAN: Sure. The ACLU national office brought this suit and it’s against not only Myriad Genetics but the U.S. Patent Office for granting the patent on the BRCA1 and 2 genes. Our view is that the patent went too far, that it restricts not only the use of the gene information to develop tests and treatments but the sequence itself and any mutation that’s arrived therefrom. It’s very broad. And whereas the patent system was set up to encourage science and progress, this patent has restricted that and limited scientific inquiry which, at its essence, is part of the First Amendment right to freedom of expression. The – Our clients in the case include scientists who’ve been stopped from looking at the BRCA 1 and 2 genes and doing anything with the BRCA 1 and 2 genes as well as women who can’t afford the $3,000.00 test that Myriad provides and, therefore, have been limited in their ability to find out whether they have a likelihood of breast cancer. So…
CAVANAUGH: Or – or, I hear, get a second opinion because there is no second opinion.
KEENAN: That’s right. You can only go to Myriad Genetics for this screening test to see if you have what is an 85% likelihood, according to the scientific association, of this gene or gene mutation with breast cancer, and it’s also a very high indicator for cervical cancer. So the system that is mostly set up in a good way to protect and encourage scientific inquiry and invention has gone awry in this case, according to our lawsuit.
CAVANAUGH: And if the lawsuit – if the suit that challenges this ability to patent the DNA sequences, actually if you win it, what will, therefore, be disallowed?
KEENAN: Well, the court could decide a variety of things. It could say that this particular patent shouldn’t have been granted under our standard U.S. patent laws. It could say that the First Amendment is implicated. It could set up a new test to say that we need to look at each and every gene patent to see just how much isolation, purification or other manipulation to it is there and what that really means. So there’s a variety of outcomes that could happen. I do want to make, you know, very clear that the huge amount of investment that goes into this field is not necessarily at stake here. You’re talking just about the patent on the gene sequence itself, not on the – all the tests and the treatments that come out of it, which I, you know, I think is the place where patents should be issued and where discovery and invention should be focused, not on limiting who can actually look at and use the gene and gene sequence itself.
CAVANAUGH: You know, we have some callers that want to get into the conversation but we’re up against a break. Let’s take the break right now and when we come back we will continue our discussion about DNA sequences and the ability to patent those sequences. You’re listening to These Days on KPBS.
CAVANAUGH: Welcome back. I’m Maureen Cavanaugh. You’re listening to These Days on KPBS. We, as part of our monthly series on science and ethics, we’re talking about patenting human gene sequences and whether or not that should continue. My guests are Kevin Keenan. He’s with the ACLU here in San Diego and Imperial Counties. Stacy Taylor, a law partner with DLA Piper, and Dr. Leonard Deftos, who is a professor of medicine at UCSD and a professor of law at Cal Western. And we’re inviting you to participate in the conversation. The number is 1-888-895-5727. And let’s go to the phones and speak with Eric in Coronado. Good morning, Eric, and welcome to These Days.
ERIC (Caller, Coronado): Morning. Thank you. I just wanted to make a quick point and that is this is – understandably, these companies have put in a great deal of money, although that’s, you know, a relative thing. They’ve put in a great deal of money to discover this thing but it has to be understood this is a discovery of an existing thing. If I dis – if I create a process to convert sewage to drinking water, I don’t get to patent sewage. I don’t own exclusive rights to sewage, nobody else is allowed to use it in any way. I can patent my process and then I get to use my process and anybody who infringes on that, I can sue them. Something similar should be established for genomes, for the genome, for a particular gene. This is not something they created, it’s something they found, that we all have.
CAVANAUGH: Well, thank you for that comment, Eric. And, Stacy, I think that that’s brought up a lot when it comes to patenting this material. I know that you say that it’s isolated. I know that you say it’s purified but, essentially, it’s not changed. It’s not a treatment, it’s something that exists in nature.
TAYLOR: Well, very frequently it is changed in the gene patents. And I think the caller’s comment brings up a misconception about not only gene patents, which is a misnomer in and of itself because you’re not really patenting the gene, but the vast majority of materials that we use have some element that is found in nature. Many drugs, vitamins, the first case that you mentioned, the products that are originally found in nature have been allowed to be patented for a hundred years. One of the first cases involving this involved a chemical that was found in a plant. It was isolated, it was purified, and its properties, its potentially therapeutic properties, were discovered by the company called Parke-Davis. The patent was challenged on the basis exactly as the caller said: well, this compound was originally found in nature and all they really did is find it. And it – the courts have consistently, from the 1911 case to when they revisited this in 1980 and, I’m sure, again in this case as well as every time it has come up before congress at all points in between, have said the Constitution is really very clear that it protects discoveries. It doesn’t – Any discovery that is made by man, whether or not it originally existed in nature or not, is potentially patentable. And it helps to understand that I am not patenting the gene as it is ticking away in your body right now. I am patenting a sequence. A gene has a variety of different elements to it. Some of them are active, some of them are not. What I am doing is, I am pulling that gene out of the millions and millions of related components in the human body out. I am finding the one part of it that is active. I am recreating that part and telling the world in my patent application how to recreate that part. I am figuring out how to use that, what it actually does, and how to go from what it does in the body to recreating a use that’s useful to man. So it’s not just a question of picking up a penny off the ground or picking up a cell or a DNA piece out of your body and saying this is mine, give it to – give me a patent on it. There’s much more to that. I’m not patenting what is in your body, I am patenting a chemical compound that is very distinct from what is in your body as we sit here today.
CAVANAUGH: But, Len, in the process of doing that, what you – what some companies are doing are saying that, okay, well, I’ve got an exclusive right to this. No one else can use this. No one else can develop a test. No one else can offer any kind of – can do any research on this particular mutation that I’ve found. And some scientists find that quite disturbing.
DR. DEFTOS: Well, it’s not the companies that are saying it, it’s the law and the way the courts have interpreted the law. The view that patent law somehow inhibits research is not well founded by attempts to look at that question in a non-anecdotal way. For example, the National Association of Science had two studies in 2003, 2005, to try to address that question by actually interviewing scientists and the results of both of those studies were that there were really very, very few instances where scientists themselves felt that the patent law was inhibiting research. So that’s not a well-founded notion. But there are many dramatic and anecdotal episodes where that seems to occur and I think that the breast cancer patents are examples of that. On the other side, it’s also been – it hasn’t been verified by independent studies, that this great amount of money that drug companies hold out is really what’s involved in research. Most independent views of that assert that drug companies are over-emphasizing or at least now expanding the amount of money that it takes to do research and they under – and they don’t acknowledge the fact that much taxpayer money goes into the basic science that allows drug companies to develop patents. And there is no recompense, there’s no royalty system where the government and taxpayers and individuals like you and me can get reimbursed.
CAVANAUGH: We actually have a caller on the line addressing this particular issue. Tom is calling from downtown and good morning, Tom. Welcome to These Days.
TOM (Caller, San Diego): Hello?
TOM: How you doing?
CAVANAUGH: We’re doing great. What’s your question or comment?
TOM: Well, the comment regards what the lawyer had said when she categorized inventing a dog collar versus inventing some genetic-based medicine. She seemed to suggest that that it’s unfortunate that the bio-researchers get less time to bring their invention to fruition. However, I also want to then make a point that with regard to these bio – these medicines, the public invests a lot more of their money to support the universities to do the research, so I think that there’s a give-back that must be recognized. My tax money supports these universities so while the researchers and the companies may think it’s unfair that they get ten less years to bring their product to fruition, they’re failing to recognize that I helped support that research whereas the person who brought the dog collar to the market, I probably didn’t support their research. So I’d like to know how they would respond to that.
CAVANAUGH: Tom, thank you for that question. Stacy.
TAYLOR: Well, I can respond to it very easily. There is a – There certainly are biological discoveries and therapeutic discoveries that are made based on basic science research done in universities but that is not the majority of these inventions. The pi – to the extent that a public comp – a company develops – does drug discovery and develops a drug without any taxpayer participation, whether it’s through paying taxes for a university or, you know, a university having licensed out the technology, I think it would be uncomfortable, definitely, to say that we should have a different patent system for those private companies than we do for publicly developed research. As to the publicly developed research, universities are set up to do basic science. They take the research to a certain point, they license it out, and if it is then commercialized by a private entity, they under – by virtue in part of the BiDole Act that Len mentioned earlier, they do get compensation back, sometimes in excess of the amount of money that the university put into doing the basic science. On the average drug that comes out of the university setting, thirty – if you say $30 million towards the research and development was performed using university resources, the total cost may be $150 million, and the rest is carried by the commercial entity who may never see a realization on that investment. But there’s another point here that I think is very critical. One of the things that universities do, research institutions do, scientists do whether they’re in public entities or not, is research. They help advance the body of human knowledge. And there is, I think, a misconception being put into play here that patents restrict that research or somehow have a chilling effect on that research. As Len mentioned, there’s been a number of studies, including one by the Health & Human Services agency in the last year, particularly with respect to diagnostic tests like the one done for the BRCA gene as to whether or not there really is such a chilling effect on re – basic science research and the answer, frankly, was no. Patents have virtually no effect, on average, on that kind of research and the reason is really twofold and they’re very practical reasons. One, we have a research exemption. As a matter of law, someone doing research, using a patented invention with the idea of eventually, whether they do it or not, but with the idea of eventually going to the Food and Drug Administration for approval of that compound for some use, is exempt from being sued for patent infringement throughout the course of that research. Now if I’m doing the research and I’m not aiming at an FDA approval, then I’m potentially exposed to patent infringement but you have to understand that, as the patent holder, if I’m the commercial entity, I’m looking at upwards of a $2 million or more cost to take someone to trial for patent infringement. Someone who is doing research in a lab at a university that may never see the light of day as a commercial product is not going to be the person I want to spend my $2 million to go after. So the number of cases that actually have resulted in scientists really being either sued for patent infringement or put in legitimate fear of being sued for patent infringement is very small. Those cases do exist. The Myriad case with the BRCA gene may be one of them but we’re talking there about the behavior of the patentee, not the patent system itself.
CAVANAUGH: I don’t want our audience to get the idea that we’re only talking about the BRCA gene because there are other patents on genes, Kevin, that are out there that have doctors and scientists concerned. There’s one for QT syndrome, which can lead to heart arrhythmias and sudden death. The HFE gene, which is linked to a blood disorder than can cause organ damage. And do you see this as a growing trend? Is that one of the reasons that the ACLU is interested in this lawsuit?
KEENAN: Well, we’re interested in this lawsuit because it affects real people’s lives. If this were, you know, a patent on either a drug or a dog collar, we wouldn’t be in this. But this is impacting real people’s lives. And I don’t know myself, but I accept what the other two panelists said, that mostly the biotech industry who holds gene patents have been very good about sharing and licensing. But the power to not behave well is granted with this gene patent license and, in our case, for example, one of our clients is Professor Haig Kazazian of the University of Pennsylvania School of Medicine. He had his work at the genetic diagnostic laboratory interrupted by a cease and desist letter from Myriad Genetics and that was because his research included a routine test for BRCA1 and 2 genes, which the Myriad company holds the patent to, and he had to abruptly stop his scientific inquiry as a result of that. Even if the law firm that represents BRCA1 and 2 wasn’t going to, you know, go forward with the $2 million necessary to pursue that, if you’re the recipient of that cease and desist letter and you’re anticipating having to defend that, there’s going to be a chilling effect on what research you’re going to do. So both for the scientific inquiry aspect and the fact that this is vitally important to real people’s lives, in this case women mostly, that’s why we’re in this.
CAVANAUGH: I want to take another call. We are taking your calls, I want to remind you, at 1-888-895-5727, that’s 1-888-895-KPBS. And Tracy is calling us from Crest. Good morning, Tracy. Welcome to These Days.
TRACY (Caller, Crest): Good morning. I’m calling regarding the pharmaceutical patents. I’m not sure what the term is but this 20 year patent seems awfully long to have the privilege to blocking anybody else to use a test or formulate a test for a particular gene. So I’m curious about the time period of how they spend 20 years versus what I thought the average pharmaceutical patent was like seven.
TAYLOR: No, that’s not true. All patents throughout the world now are 20 years. The U.S. used to have a system of 17 years from the date of a patent actually issued, which effectively gave you a much longer period of patent protection, and that’s for all patents regardless of the type of technology that is involved. Now we have harmonized our system with systems throughout the world where your patent period is 20 years from the date that you filed the application. So that if I file the application the day I made the discovery and it takes me ten years to develop a product and get it approved for marketing through the FDA, I have ten years of my patent life left.
CAVANAUGH: But how frequently are those patents renewed?
TAYLOR: They are – there is no such thing as patent renewal. When it is over, it is over. And with – That is, again, to go back, that is the quid pro quo. If we did not have a patent system – Let me give you a real life example. Louis Pasteur, who is responsible for many of the groundbreaking vaccines in using biological materials that were first developed in the world, was not allowed, by virtue of a French law, to obtain patents on many of those vaccines so what the Pasteur Institute, formed by Louis Pasteur, did was keep them as a trade secret. Unlike patents, trade secrets go on forever. As long as you keep them secret, you don’t have to tell anybody what is in that vaccine, you know, subject, of course, to regulatory requirements, or teach anyone else how to do it. In the patent system, we are obligating people who discover inventions to teach the world how to do it. One of the requirements for getting a patent is that I actually teach someone else how to reproduce it. And at the end of my patent life, my rights are over and it becomes in the public domain and I have taught everyone else how to do what I once did.
CAVANAUGH: I see. So – But, Kevin, when you think about that, when you think about the idea of changing this into a trade secret rather than a patent, would it even – would sequencing a bit of DNA even qualify as a trade secret?
KEENAN: Well, the other panelists might be more qualified to answer that but, you know, we’re not talking about vaccines or applications or tests or drugs, we’re talking about the thing itself. I think it’s a fair discussion whether purifying the gene is sufficient to have it be so different from this thing that exists in nature. We argue that it’s not. I think analogies are only of limited use but, you know, if you isolate gold from all the junk that’s around it, it’s no less a thing, a product that exists in nature. But, you know, there is, I think, a continuum of this sort of close to nature that needs to be analyzed and is not – has not sufficiently been part of the legal reasoning since the patenting of genes has been allowed. And we would argue that the, for example in the BRCA1 and 2, that merely removing the junk DNA introns and purifying it does not sufficiently remove it or take it away from something that exists in all our bodies to merit a patent.
CAVANAUGH: And if I may, because I really do think that this is the heart of the ethical argument, what Kevin just said, the – Australia is going through this very same discussion and the head of the Australian National University Genetic Sequence Right Project has said this: ‘I think we should have it very clear that isolated biological materials that are identical or substantially identical to those that exist in nature should not be the subject of a patent. That doesn’t mean if you can find a way of using that material in a truly inventive way that you can’t get a patent.’ And I think it’s that dichotomy, the being able to actually patent the – virtually the natural sequence as opposed to patenting an invention based upon that sequence that is the heart of the ethical dilemma. And, unfortunately, I have to leave that sort of hanging. But we will be back, taking your calls and talking to the guests here on These Days on KPBS in just a few moments.
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CAVANAUGH: Welcome back. I'm Maureen Cavanaugh. You're listening to These Days on KPBS. Some research companies have isolated chemical sequences within the DNA structure and have patented those sequences, and that’s what we’re talking about. Our discussion is with Dr. Leonard Deftos. He’s professor of medicine at UCSD and professor of law at Cal Western. Stacy Taylor, who is a law partner with DLA Piper, and Kevin Keenan, executive director of the San Diego and Imperial County ACLU. And we are taking your calls on this subject, 1-888-895-5727. And since I ended the last segment talking about Australia, I want to ask you, Len, how do U.S. patent law regarding genes and higher life forms differ from that of other countries, like the European Union, Canada?
DR. DEFTOS: Yes. There is a very important distinction in European patent law that is not an element of European patent law that is not present in American patent law, and that’s referred to as a morality clause. There is a – One can oppose a patent. It’s easier to do in European law. One can oppose a patent by claiming that it is against the public order. That cannot be done in United States patent law, so that’s an important element of European law that’s different. In addition, countries like Canada, for example, have different standards for patents than – that seem to be higher than the United States does. For example, Canada does not allow mammals to be animals, transgenic animals, animals that have a foreign gene inserted in them, does not allow them to be patented although the United States has allowed that for a very long time. So there are distinctions between United States patent law, which is based primarily on British patent law, and European patent law. And, finally, there are some third world countries who don’t allow any patents at all. They call – On biological materials, they refer to it as bio-piracy rather than patent law.
CAVANAUGH: Now if other countries have a different take on the use of these DNA sequences and the patent rights involved, what does that mean? That a company is Europe could use genes patented in the U.S.? Or how does that work?
TAYLOR: That is always true. Patents are on a country by country basis. So if I patent something in the United States, it has no impact at all on what is done outside in the rest of the world. And even within Europe, as Len mentioned, there’s a policy at the European Union level that doesn’t necessarily bind or apply to each one of the European countries so that the U.K., for example, has a much more liberal patent policy than what Len elucidated for the European level. But I think what’s important to bear in mind, that whichever system you’re looking at patents tend to be – patent systems tend to be self-correcting whether it’s a gene patent, whether it’s a software patent, whatever the new technology is and whatever patent system that you’re looking at it in, when that first technology is first developed, you tend to see patent claims come out that are of somewhat sweeping breadth. So in the early stages of genetic engineering, you tend to just see patents come out that were – covered genes and all variations on those genes based on the discovery of one sequence. Over time, as the technology becomes more routine, the outcomes become more predictable. The patent office begins to sharply restrict the breadth of the kind of patent claims and control over your inventions that you can obtain through the patent. For example, the process of being able to pull a gene out and know what it does and isolated (sic) it back in the 1980s was a very difficult process. Now it’s arguably considered to be routine. And due to that change in the technology as well as recent changes in the U.S. patent law that make it easier for the patent office to say that something is an obvious result of a routine use of technology, it is much more difficult to obtain these patents than it used to be. And so going forward, the system is sort of self-correcting.
CAVANAUGH: It’s interesting. I – And I think it’s only fair to point out there is at least one success story in allowing the patent on a DNA sequence and that is for the company that holds the patent on the CFTR gene, the gene linked to cystic fibrosis. Apparently that company has been very forthcoming in allowing research on that gene and it has led to a number of breakthroughs in the – for cystic fibrosis patients. So perhaps it really, Kevin, it really depends on how the company views the use of its own patent.
KEENAN: Well, it’s good that that is more common but it shouldn’t be built into law that there’s the power to abuse that. And I think that the ACLU national office case is attempting to rein in where the patent office and Myriad Genetics have gone too far. So maybe we’re a part of that self-correcting mechanism.
CAVANAUGH: The tightening up that Stacy was just talking about. You know, when I was doing research on this and I read that 20% of the human genome now has a patent sort of pending on it, it’s really, I think, rather disturbing to the general public and I wonder how – how do you translate that, Len, into something that makes sense? Because I think that just generally hearing that, that’s rather disturbing.
DR. DEFTOS: It is a little frightening when stated in those terms. But, again, it’s important to keep in mind that patent rights are not possessory, so although the – about 20% of the entire human genome does seem to be under some patent or pending patent, that doesn’t mean that our genes are owned or in any way manipulatable in our bodies by those companies.
CAVANAUGH: Do you buy that, Kevin?
KEENAN: Well, I have a sincere question because I’m not as expert in this but doesn’t it mean that the company that owns the patent can restrict you, others, from even looking at the gene?
DR. DEFTOS: Well, it depends on what you mean by looking. As Stacy said, there is an experimental exception to using another company’s patent. And there are instances where companies, in fact, have taken the position of putting their information, the genetic information that they discover into the public domain. There are consortiums whose purpose is to put genetic information to the public domain which means that it cannot be patented. So there are countervailing forces. It’s not – But people – I just think, again, as I said earlier, it’s a little creepy to say that companies own our genes. They really don’t own our genes. They own the chemical representation of those genes outside of our body.
CAVANAUGH: Right. And Stacy.
TAYLOR: And you have to bear in mind, too, that a lot of the gene patents that we’re talking about, these 20%, many of those aren’t issued, by the way, they’re just applications which means they don’t give anyone the right to do anything with respect to what’s described in them. But many of them were filed on and looked at prior to the completion of the Human Genome Project. The Human Genome Project created a map to the sequence of every gene in the human body and has had a dramatic effect on the ability to get genes to any particular sequence. The Human Genome Project doesn’t tell you what those genes do and so there is still a tremendous amount of research to be done in that area and innovation to be performed in that area. But, you know, again, the technology tends to be self-correcting and when it is not, when you have a patentee who, you know, it – I don’t know that I would characterize Myriad Genetics’ desire to make money on its product as being abuse rather than simple capitalism but it – when you do have a patentee who is abusing a patent right or somehow affecting the public health, we already have mechanisms in place to address that without throwing the entire patent system out. The – For example, when the – during the anthrax scare, the Department of Health and Human Services, there is a procedure by which you can ask them to step in and require a patentee to license or make a product available to be made by persons other than the licensee and even to lower the price of it. And during the anthrax scare, they did that to the Bayer Corporation to make ciprofloxacin antibiotic more available. We do it with flu vaccines every year. Plus, if the research was publicly funded, the government retains what are called margin rights. They can, for any reason or no reason at all, come in and take the technology back.
CAVANAUGH: You know, we’ve been talking a lot about legalities here and for good reason because that’s – this whole question stems from, really, a lawsuit from the ACLU. But I’m wondering if there isn’t a larger question here about whether or not there are some things that are beyond commercialization, that there are some parts of us that are beyond simply capitalism. And I’m wondering, this whole venture into the human DNA is so new and there’s so much to be discovered, is this really the right time to be giving some companies, some commercial companies, exclusive access to the chemical compounds that make up human DNA? Len.
DR. DEFTOS: Well, I don’t know if it’s the right time but that’s what our current patent law says, and I think we are a country of laws and I think we have to abide by those laws. There have been periodic attempts to change patent laws and, in fact, one of the bills introduced several years ago was to ban patents based on genes. That, I think, passed the House, in fact, but it never got through the Senate. So there are periodic attempts. There is the recent Genetic Privacy Act that was made – that was created, I think, in response to the fear that the public has about the use of genetic information, and that prevents discrimination from employment and health insurance, notably not life insurance…
DR. DEFTOS: …which is probably one of the more important aspects of this. So there are attempts at correcting the mechanism but I think that they – and I’m pleased, personally, that the ACLU is doing what they’re doing because I think it will raise a lot of important questions. But I think, fundamentally, we have to keep in mind that we are a country of laws and the patent laws have been developed over centuries. Attempts to change them, in my view, would be best benefited by trying to insert a morality clause in United States patent laws, and I think that that could be used to address some of the issues that lie at the ethical intersection of patents and commercialism.
CAVANAUGH: As I say, Kevin, this is – this whole subject is so new and so rife with so many unknowns. Do you think that a morality clause would be a good thing to insert into our patent law?
KEENAN: I do. I think that this case has many concerns that would be impacted by an ethical look at the whole balance in our patent system. And like I said, I think that the Constitution and our patent laws generally strike a pretty good balance promoting science by giving some restricted rights, limiting those rights to inventors and scientists. And I think this is a case where the patent office has gone too far. It affects real women’s lives, women who can’t get access to vital information about their own bodies because of the patent that Myriad Genetics holds. That’s a real problem. I think legally we’re asserting a First Amendment interest when the patent laws aren’t doing the self-correcting that they should be. We’re asserting that because scientists do need a range of expression and right to inquiry to research basic things that exist in nature. So I, too, am optimistic that this will raise interesting questions and, hopefully, resolve them in a way that’s helpful for the patent system and for science.
CAVANAUGH: And, Stacy, even though what you’ve been talking to us, and very eloquently, about is how these companies are well within their rights legally. Do you see that there may be this continuing problem of balancing scientific discovery with the rights of public access and public health and – and the ethical question at the heart of this debate.
TAYLOR: That’s always true. And, as I say, there are already mechanisms in place apart from challenging the constitutionality of the patent system as a whole for addressing when the public good should override a patent right to anything. And, you know, in terms of changing the law or introducing new concepts into the law, fundamentally, I think, that’s the function of congress. It’s a little disturbing to see that kind of effort being undertaken in the courts on a court-by-court basis because it’s a very complex question. If we say that all materials that were naturally occurring at some point can’t be patented, then we’re creating, I think, some very unintended results. Some of these same patients, the breast cancer patients, might no longer have the drugs that are used to treat them. Many – One of which, one of the most common drugs used to treat breast cancer was derived from a plant. That was a naturally occurring compound. If the drug company that developed that didn’t have the proper incentives to put that drug on the market, that might not be available.
CAVANAUGH: We’re going to have to end it there. I thank you very much for a very interesting discussion. Dr. Leonard Deftos, professor of medicine at UCSD, professor of law at Cal Western, thank you. And thank you Stacy Taylor, law partner with DLA Piper. And Kevin Keenan, executive director of the ACLU of San Diego and Imperial Counties. I want everyone to know the next Ethics Center forum “Who Owns Your Genes?” is next Wednesday, August 5th, at 5:30 at the Reuben H. Fleet Science Center. The forum is free and open to the public. For more information, you can go to KPBS.org/TheseDays. And we encourage you to post your comments about this issue online at KPBS.org/TheseDays. Stay with us. The second hour of These Days is just ahead here on KPBS.