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Patenting Human Genes
Patient samples are loaded into a machine for testing at Myriad Genetics in Salt Lake City. (AP)

Patient samples are loaded into a machine for testing at Myriad Genetics in Salt Lake City. (AP)

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The human genetic code is a kind of miracle. It’s also a recipe for life.

It’s also widely seen as a giant business opportunity. Corporations, drug companies, are rapidly staking claims.

Twenty percent of the human genome has already been patented — sewn up for research and profit in the emerging field of genetic medicine. And it’s fiercely defended.

Gene patenting is controversial, but it’s the law of the land. A lawsuit headed to court right now would change that.

This hour, On Point: Playing God, pushing research, and patenting the human genome.

Guests:

Joining us from Salt Lake City is Tom Harvey, business reporter at The Salt Lake Tribune, where he’s covering the Myriad Genetics case.

Joining us from New York is Chris Hansen, Senior National Staff Counsel at the American Civil Liberties Union. He is lead attorney in the gene patenting lawsuit that pits the ACLU against the Salt Lake City firm Myriad Genetics and the US Patent and Trademark Office. You can read the ACLU’s complaint here (pdf).

From Washington we’re joined by Hans Sauer, Associate General Counsel for Intellectual Property for the Biotechnology Industry Organization, known as BIO. Its membership includes more than 1,200 biotechnology companies and is aligned with Myriad Genetics in defense of gene patenting.

And from New York we’re joined by Wendy Chung, M.D., Ph.D., director of clinical genetics at Columbia University and a plaintiff in the ACLU v. Myriad Genetics case.

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  • cory

    I can’t see anything good coming from treating the human genome as intellectual property. Must we profit from absolutely everything?

  • http://www.lit.org/author/fritzwilliam F. William Bracy

    I’ve been hearing for at least 35 years that microbiology would be the wave of the future … the technology to dwarf every existing scientific field. Could it be that genetics has turned out to be a bit more complex than we expected?

    The human species is not sufficiently intelligent to be tinkering in this area. We’ve already created “Franken-fish” without even being aware. What we’ve done to seed crops … rice, for example, has already contributed to but one of the many Haitian economic collapses. This will go down as humanity’s greatest disaster.

  • http://silverimagelimited.com Alexander Thompson

    A:I heard some years ago that a major agriculture company ordered some rice farmers in india to cease and desist growing a certain strain of rice because it contained genetic sequences it felt were their property, and the name jasmine was also at issue. The rice growers were growing the variety of Jasmine rice for thousands of years before the theory of genetics.
    B: If I wish to donate any portion of MY personal genome to a research project I defy any legal challenge to my sovereignty over my own blood.

  • http://www.giscell.org Jeremy Baker

    No, naturally occurring materials should not be patentable.
    Rules over the last century have been bent, and it’s is time to reassert patent law.
    Designs of synthetic biology should have to meet a high level of complexity before a patent can be applied.
    I voice my opinion with an education in BS Biology (microbiology, cellular).

  • Debbie

    I’d like to hear Hans Sauer defend the fact that women are prevented from getting a second opinion and defend the cost of a test that could save someone’s life being out of reach of so many potential patients.

  • Jürgen

    I wonder how far we would be if all past scientists would have patented all their discoveries they’ve made?
    I think it can be argued that these very same scientists who seek patents for their DNA discoveries today could not have made those without free access to all the previous science breakthroughs.

    Furthermore, I argue that human DNA is nothing manmade, hence no one should be able to claim ownership to it.

    Otherwise, could NASA have patented the moon?

  • Rex Henry

    Please include Michael Crichton’s book Next in this discussion.

  • Rebecca

    I’m concerned by the way some companies establish legal defenses for their patented genes. I believe it’s true that Monsanto has a patent on a specific corn species. This apparently has meant that when that species cross-pollinates non-Monsanto corn in farmers’ fields, they may not save the leftover seed from one crop to use for growing next year’s crop, as they always have done (from Food, Inc.) Damaging to farmers, would this legal precedent also mean a patented human gene could allow a company to control reproduction in humans, for example? There are so many implications that seem terrible outcomes to Monsanto’s control of corn. Thanks, Becky

  • http://www.giscell.org Jeremy Baker

    Current patent law has made basic research too expensive for under grad and grad students to afford basic wet lab tests.
    I met with a clerk at Burlington VT book store across from University Mall (Barnes n Noble I believe) who changed his doctorate study from molecular biology to patent law. His grad student budget to study a naturally occurring enzyme could not afford the royalty fee for the enzyme. Patent law made his study too expensive. Empirical evidence …
    Peer review is biology. Darwin. Without broad peer review medicine will have unknown side effects.

  • Ann Baker

    The greater point here is that no one will be able to do research using these patented genes without paying the entity that owns it.

  • Russell

    the ACLU is right on this one. Life expressions must remain OPEN SOURCE. The slippery slope is eventually the genome of the entire biosphere will be owned by one corporation or another and citizens will depend on the largess of these firms. Not everyone will be as “generous” as Myriad. Greed is rot here.

  • Dennis Kerr

    In our global era, the patent game is rigged against Americans, in particular the American taxpayer.

    Alot of these patents are created in our Universities at taxpayer expense and effort. Then these patents are licensed to companies who make their products in other countries. Even if the University makes a modest margin, those are jobs Americans should have.

    But more importantly, the genome code is part of our identity. Therefore, it is an inalienable part ourselves.

    Your guest has brought up a bizarre incentive. If only a created product can be patented, not a discovered one, then there is a motivation to risk creating monstrous genome manipulation. That enough is an argument to resist dna patents.

  • Kevin Leach

    The argument that denying patents on the human genome or any genome will stifle innovation or profit is irrelevant. Whether something deserves patent protection depends upon meeting the requirements under patent law.

    The standards of patent law as well as common sense require denial of patent protection.

  • Melanie

    I was wondering why genes are patentable at all. If I find a rock in my backyard, and everyone else has that rock in their backyards, and then I found that this rock was really useful as a fuel source if I process it some way, I can’t patent that rock.

    We all have genes. Companies can patent their knowledge, but we should all be able to do our own research.

    You know why this is? Because Lawyers & Big Biz got together and decided this would be a huge win-win for them. For the rest of us, not so much.

  • Ann Baker

    Please ask the question: ” Will a US patent on these genes prevent research using them from happening in other countries?”

  • http://www.lisaafoster.com lisa

    Tom, please, your mentioning of god in this debate is cringe-worthy.

  • David

    There is also a fundamental fairness issue given that significant expenditures of public money, primarily through NIH/NSF funding, made many new genomics discoveries possible, yet the gains of these discoveries are privatized. BRCA genes in particular were originally identified using genealogical and historical records from the Mormon church.

  • Kerry

    Could both address how clinical trials and patient safety would be affected by the outcome of this case? There are huge costs associated with these absolutely necessary trials – the companies have one model that requires patent protection what is the model without?

  • Nicholas Herold

    There is a fundamental question that is missing from this discussion. Why are natural materials not patentable? It seems that one important reason for that is to ensure that freely available natural substances are necessary for innovation.

    As a society we have interests in property rights, and in the incentive people have in using their property to increase their wealth. Advances in science and technology are good for everyone. But the line seems very clear. Limiting access to naturally-occurring substances is counterproductive.

    The question of whether DNA is a natural material is fatuous. of course it is: even “distilled,” DNA continues to be such. Would Dr. Sauer argue that purified alcohol from fermented corn is a patentable substance?

    Of course it isn’t, but companies that make money from fermented and distilled products seem to do okay. It is the process of making these products which is protected.

  • Malcolm

    Please consider this a second request to comment on Michael Crichton’s book “Next”, thanks.

  • Hana

    Isn’t it against our constitution to assume rights over something created by nature?

    We have seen what happened with plants, seeds. How could we even think about following that path with humane genome?

  • Ellen Bidlack

    The whole point of these patents is to control who does research on them. If you can’t do the research you can’t develop a new drug. Hence if you control the gene you prevent the competition from developing a drug. Don’t be fooled this is designed to prevent innovation.

  • Carolann Najarian

    How would this conversation be different if a foreign country (China?) or foreign corporation held the patents in question?

    My case rests……

    Carolann Najarian, M.D.

  • Kate

    Why the all or nothing model? Why not mimic the licensing model that artists use to sell their ideas? I come up with a great idea and then I sell licenses to those who want to use the image. This model could be applied to the genes—the company who found it should get money for all their time and research and yet it opens it all up for more users and more discoveries.

  • http://www.studentvision.org Hing

    gene patenting is only good for lawyers.

    Gene patenting prevents invention to be useful for innovation.

  • Melanie

    Something similar is being done with Lyme. The majority of MDs on the ISDA for Lyme have patents on some aspect of the disease (testing, vaccines, etc). This is one reason why they deny the existence long-term Lyme, they deny that long term antibiotics work, and they actually go after doctos who successfully treat very sick patients with long term antibitics.

  • Cara

    Maybe I’m just being a knee-jerk feminist here, but I am particularly struck by the irony that biomed companies are allowed to patent and profit off portions of the genome that influence one’s risk of breast cancer, but the rights of women to terminate a pregnancy continue to be threatened in this country. . .if we can’t fully own our own bodies, how can a corporation own what makes us human? I think it is reasonable to allow a company to patent therapies or drugs that are developed as a result of their research, but it is not reasonable to allow them to own portions of the human genome.

  • Steve T

    When they start to make People they will have to have ownership. What’s the point, if you can’t have legal control over what you make?

    We’ve given away every thing else why not give ourselves away too?

  • Dolores Wagner

    That insurers will not pay for testing for some people who may benefit from some patented testing is not a good argument against patenting. This complaint more legitimately is an argument against the U.S. health care system. Insurers have been the designated gatekeepers of health care, after all.

  • Jeremy Baker

    If genes can be patented, then apply the rules: A specific blueprint for a specific design defined by a rigid form.
    For example, Ford has a patent on a design for a car, a specific design. Ford does not have the patent for the reduced elements of a chassis, power plant, with wheels. If Ford could reduce the fundamental elements of a car and patent these elements, violations of the patent would include motorcycles, airplanes, trucks, etc because all these designs include a chassis, power plant, and wheels.
    Onco mouse, Du Pont patented this animal, a mouse, but argues that it qualifies for any eukaryotic cell, not just mice but all animals, and amounts to a series of genes that have been rendered useless that are known to repair DNA, hence, the cell often develops cancer and is used in cancer research, making a 10 cent mouse a 10 dollar mouse, and if a lab test requires 10,000 mice, drug development gets expensive and medicine gets expensive. There are probably thousands of ways to render these genes useless. How can a single patent claim so many designs?
    If a gene has an imagined 5000 nucleotides, and certain sections must appear in specific positions, or areas must not include alien genes, and a scientist can mutate any one of these nucleotides to render the gene useless (over simplifying complex problem…), there are millions of designs to achieve the same down stream effect, hence, millions of patents can be applied. If Du Pont has a patent for switching nucleotides 4 and 5, to render the gene useless, another lab can patent the design that switches out 7 and 8, another design. Two blueprints, each different from the other, and both share the same down stream effect, much like two different companies each with their own patent for their own car, regardless if the cars share the same down stream effect.
    ANother problem, patenting genes without knowledge of their part in the cellular pathway under varied environments… such as a cell stressed by cold that promotes or inhibits another protein that repairs damage which involves numerous cellular systems, genes tweaking histone tails to pack or unpack other genes, so to patent a gene may inhibit peer review to study how the gene behaves under varied environmental conditions. Some scientists study the natural world, to understand the real world around us, why things work they way they do, blaa blaa, not to bang a buck out of a sick person ready to sell their home for a few extra days of life.
    What if a gene amounts to only one nucleotide, how can a scientist engineer around this patent? Patent law argues that patents stimulate innovation, but some cellular mechanics are too small to engineer “around”.
    Sick people buy medicine, drug companies will sell medicine, getting rid of gene patents will stimulate less expensive drug development, more companies will ship drugs…
    These drug companies are right, patents do stimulate research and innovation in their own labs.
    Education: we are teaching young students with less than clear and honest science, lacking details (teacher can’t explain the secret formula, or experiments are limited to those that can be afforded or don’t violate a patent) using materials and systems from the 60s.

    A web site with more material arguing in favor of patent reform.
    http://www.giscell.org

  • http://www.actokine.com Richard

    We have discovered AK-1 for anti-aging and AK-2 for protecting cells against infection by a broad spectrum of viruses.

    We have not yet filed patents because we want to share our data and master control genes inducible by AK-1 & AK-2 with students, postdoc & scientists around the world.

    Gene patenting is not good for any scientists who are working from their hearts.

  • Todd

    “Tom, please, your mentioning of god in this debate is cringe-worthy.”
    Posted by lisa

    @ lisa:
    FYI, the ‘P’ in NPR stands for Public, not pagan. If you can’t tolerate listening to an alternate perspective, then you’re not really debating. Your ignorance is “cringe-worthy.”

  • Andrew Margenot

    Todd, Lisa has a point. I too cringed at Tom’s reference to the “playing God” argument, though perhaps for a different reason. “Playing God” is an oft-used and little-examined argument with historically anti-scientific theological roots. In “Protocells,” a collection of essays on synthetic biology published by MIT Press, Joachim Schummer points out that the playing God argument would not have made sense to pre-1900s scientists, ethicists, theologians, and the general public due to the acceptance of spontaneous generation. Human design and creation of life forms was unobjectionable, as the creation of life was thought to be a mundane occurrence (e.g., flies arising from rotting meat). Only with the encroachment of science on realms under the explanatory rule of religion following the Enlightenment and its Scientific Revolution (most notably, the dismissal of spontaneous generation) did some theologically-minded cook up the playing God argument. This intensified with the development of evolutionary science.

    My point is that we should reconsider the playing God argument. I do think it contains something of worth, as it hints at a deeper argument against human intervention in the natural world; hence why even secular scientists and atheists acknowledge it metaphorically. Perhaps we should abandon the metaphor to sharpen the underlying argument(s) and shed the troublesome theological baggage. (By troublesome I mean the conflation of a distinctly theological argument and a non-theological argument(s)). Another danger is our complacent acceptance of cliches when we hear them; “playing God” is one that sounds especially deep and serious. In these debates we almost expect it, almost as a formalism (in this sense I suppose we can’t blame Tom for bringing it up), just to assure ourselves that there is some ‘deep,’ however unexamined, objection to X technology/scientific practice.

    We should diversify and sharpen objections to biotechnology beyond the stale “playing God,” (not so much an argument as an accusation, knee-jerk even) which includes non-theological ethical arguments.

  • Gene Gunn

    Myriad Genetics and every overpriced diagnostic test that they run will be redundant and dead soon. $3000 to test 2 genes for mutations and polymorphisms associated with breast cancer risk? Getting the sequence of our ENTIRE GENOME will cost less than that soon.

  • Ray Grifftih

    Is it possible to have a patent that has a sunset clause? i.e. Myriad gets a patent for a period of time in order to recoup the costs of research without profit?

  • Brett

    Thanks for the show, “On Point.” There was a fair representation of both sides in this mostly ‘point-counterpoint’ program. It is a debate that has been going on for some time.

    The more Hans Sauer spoke, the more he simply sounded like a corporate shill, replete with all manner of scare tactics if companies like Myriad weren’t allowed to proceed unfettered in their beneficent pursuits. Chris Hansen’s points were much more compelling and prompted me to continue my agreement with his side.

    The private sector always claims that innovation will be stifled and consumers will suffer if their corporations have regulatory limitations imposed on them. Which, in reality, conversely, both will suffer if those same corporations continue in their present mode of operation. In this case, it’s even worse! Corporations such as Myriad are claiming the same unfortunate fate will befall new breakthroughs in technology if they aren’t allowed to have a monopoly on the genetic material they use.

    Sauer downplayed the potential for abuse, too, essentially saying it hasn’t happened yet, therefore it won’t happen…that’s not good enough for me!

    Monsanto and their genetic engineering of seeds were mentioned, briefly, by an emotional caller, and sort of dismissed by another. But, it is a good example of how far a corporation will go to protect its”intellectual property” and maintain its proprietary exclusivity. Monsanto dictates what happens in corporate farming to the point of overtly stamping out any innovation coming from other areas. They also use very much the same tactics that Robber Barons used (Pinkerton thug-like oversight) in the early-20th century in maintaining their “intellectual property.”

    I wonder–and I didn’t hear any mention of this–how long the patents last?

  • http://www.lisaafoster.com lisa

    Todd,
    Neither is it National Pulpit Radio.

    Andrew,
    Thank you for expanding on my point.

    Lisa, the Humanist not Pagan.

  • Amir Jaima

    Patenting DNA for economic reasons is like arguing for the perpetuation of slavery because slave labor is an essential component of the economy. Economic motivations are not the only (nor the primary) considerations for action.

  • Don Dunklee

    If these companies, making a profit from my genes, follow patent law, if I get cancer from their “patented product” , can I receive compensation for a “defective product” under product liability laws? After all, they are claiming they “own” the gene? “Owning” this gene also means “owning” all liability so connected. My heirs should therefore be equally compensated for perpetuity. This may be more expensive than their illegal claim to my body for their financial gain.
    Don Dunklee

    • Katie79222000

      A patent does not give the right to “OWN” – See the Patent Act. Patenting something confers no positive legal rights to the thing you patent, it merely allows you to exclude others from using, making, or selling the claimed invention.

  • Q. Ajaqer

    What I can not understand is if the Constitution prohibits any one in the USOFA from owning a whole person how come a corporation can own a part of person?
    Why is this only framed as a patent law issue??

  • http://curehunter.com Alex

    The patent system in general needs to undergo a huge cost-benefit re-assessment.

    The current patent system (legal system?) is turning otherwise sensible healthy companies into defensive litigious patent-squatters.

  • http://dnapatents.georgetown.edu Doris Goldstein

    For more information on DNA patenting, please check out our website, especially this resources page:
    http://dnapatents.georgetown.edu/resources/index.htm

    The DNA Patent Database hosted at Georgetown now has more than 52,000 granted U.S. patents and 77,000 applications.

    You can search for literature on all ethical, legal and social implications of genetics research and practice at:
    http://genethx.georgetown.edu

  • http://www.viaflavia.net Flavia

    Horrific and outrageous – NO, NO,NO – absolutely NO patenting of “nature’s works”, no genes (human or other) and in fact I’m also totally against patenting of any other naturally occurring substances (plant, mineral, etc).
    Patents should ONLY be allowed for PROCESSES: you create a product, a solution to a problem, a cure to a disease via a drug that requires a combination of ingredients and process of delivery, and the like – then its ok but also for a reasonable amount of time: i.e.: 20 years NOT 50 years or longer as some are claiming.

    There HAVE to be limits to capitalism, particularly in areas where human life and well being is critically involved. ALSO let us not forget that “we the people” DO contribute quite a bit of money to basic research in the form of direct research grants as well as subsidies to universities and the education of scientists!!

  • ruth housman

    I tuned into this program and found it very interesting to hear this exploration of the ethical issues that do adhere to scientific inquiry and the patents that result from this work, often arduous, and often spurred by the need to discover something that will help mankind. We have come a long way in this discovery process, and it wasn’t so long ago, that we did not have the information that is about this language of life, the DNA of it all.

    Now that genetics has reached another stage of discovery, through the cloning of the human genome, and ongoing discovery that has far reaching potential in terms of such implications, we hit more ethical dilemmas. Who profits from this research? How much profit is unconscionable? Is it right for those who made a discovery about something that is within us all, to patent that knowledge, which is an elucidation by way of a picture, of what we all have known, in differing ways? is it right for one group to hold a monopoly over such discoveries that then stops others from moving forward in ways that could help mankind?

    The issues are real and there is a debate that has ongoing right on both sides of this equation. It seems that resolution has got to be reasonable, in that we all want discovery to continue and we all want equal access to research, because we do all build on the past, in terms of the accretion of knowledge. Monopoly is an old game. We have all played this, but the game is changing, and we must look at ethical issues at every turn in the road. Whose turn is it now? Who gets to reap the benefit of this research and how do we do business in the commerce of human health, in the business of knowledge, and what is this notion of working together and sharing?

    Consilience, a word that EO Wilson used in his book, is about the merging of disciplines and in fact, we see this happening in every possible way, around the Globe, in whatever endeavor we choose to examine.

    It’s an old idea, but the idea of LOVE is one that I think needs to permeate our thinking, because we are all of us drawing from the same Source, and I think the movement HAS got to be towards recognizing we’re all in this together. I think the new prophets of this time have to look at this notion of profit, who profits unreasonably, and why. And yes, we need to reimburse people for their hard work, but this notion of EGO, of this is MINE. well that’s got to change. It’s not yours, it’s OURS, the ours in the very word, yours.

    We either do this together, or we don’t. But I am saying, when I hear, that Conan O’Brien leaves his program with a sum of money equal to more than a third of what Obama has pledged for Haiti, I am saying we’ve got a Seismic problem here, a SIZE MIC problem. So let’s hand that MIC to those who are singing about the music, and let’s realize this is about concerted effort, and we need to sing in concert, and lose that ego along the way. Just lose it!

    Do what’s fair and realize there are old parables about these situations and then reach not only for a middle ground, but reach higher, for humanity, in thinking about the real reasons for discovery, that has to do with kind and, mankind.

  • L.M.

    I have participated in various clinical trials in which blood samples were taken. I have had to sign consent forms which always state that the pharmaceutical company that is going to use the blood and it’s products for experiementation, will not share any profits with the test subject for any future discoveries. Of course I am usually also told that I can request that testing or research on the blood and it’s products can be stopped anytime I change my mind and the blood and it’s products will be destroyed. There is something I don’t fully get about how certain scientists or pharmaceutical companies can patent the human genome. It seems that the genome has to have been gotten from a certain persons or various persons. I know that a lot of people whom have died long ago before the biomedical research of today had existed have had their bodies exhumed and experiemented on; and perhaps biological material had been taken from many long-dead bodies of mummies, human bones and shrunken heads and there was one case in which researchers visited a tribal village took blood and medical samples from the primitive-living people and then many years later the biological material from one of the tribal women was being sold on the internet defining the biological material as being from a young woman of a certain race, and indigenous culture and a legal controversy ensued about whether someone’s genetic or biological material obtained years back and for which no consent form or contract was ever signed, and which somehow made it’s way via test tube into the culture of biological merchandicing via the internet, can be bought or sold or traded among scientists or doctors or researchers for the “good reason” of benefitting medical research even if the person whom the biological material was obtained from never gave consent.
    However, since all this is unprecedented in human history, biological research on human biological products is underregulated and somehow law-makers and human rights advocates will have to enact legislation to protect the rights of people whom do not consent to be experiemental material, especially after they are dead.

  • Tommy

    Lisa, this is a debate about the basics of life. You should fully expect that there are those that have a theological concern. Todd was absolutely correct, your “Cringe” comment was ignorant and unnecessary.

    And Andrew, if you really are interested in the science terminology then you should welcome the ‘playing God’ crowd into the debate instead of cringing as well. People fear the unknown and a fair and balanced debate showing both sides of an argument is the best way to remove any such ‘knee-jerk’ reactions.

    -Tommy (The Agnostic from Chicago)

  • http://www.genome.duke.edu Robert Cook-Deegan

    For those interested in more background and details on genetic testing for inherited predisposition to cancer, including the BRCA genes associated with breast and ovarian cancer, see a wonderful case study of Myriad Genetics done by E. Richard Gold and Julia Carbone at:
    http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1260098

    And the Secretary’s Advisory Committee on Genetics, Health and Society is working on an entire report on the impact of patenting and licensing practices on clinical access to genetic testing. See their website at: http://oba.od.nih.gov/SACGHS/sacghs_focus_patents.html

    And a case study comparing testing for BRCA to inherited risk of colorectal cancer is temporarily off-line at that site, but should be public again soon.

    A fairly detailed blog on the case that is not on one side or the other:
    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2799099/

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