DNA model

On Monday, the U.S. Supreme Court is set to hear a case that could decide whether genes can be patented. The ACLU, cancer patients, scientists and others sued Myriad Genetics — which owns the exclusive rights for two genes tied to breast and ovarian cancers — arguing the company limits patients’ access to affordable and accurate testing. But supporters say gene patents are necessary to incentivize research. What could the Court’s decision mean for scientists, patients and corporations?

Lauren Sommer, science and environment reporter for KQED Public Radio
Karuna Jaggar, executive director of Breast Cancer Action, an education and advocacy network for breast cancer patients and their supporters, and one of the groups suing Myriad Genetics
Jeffrey Lefstin, professor at UC Hastings College of Law and former molecular biologist
David Koepsell, author of "Who Owns You: The Corporate Gold Rush to Patent Your Genes," lawyer and philosophy professor at Delft University of Technology in the Netherlands

  • A patent that gives DNA ownership could be a financial if not sociological or medical disaster, should it happen that cures cannot be developed by real innovators, because some company is sitting on a patent and doing nothing with it. There would need to be further laws to govern myriad nuances to control over that DNA and numerous exploitations and liberties, it would become a ludicrous process.

    People should not have to face the possibility of ending up in court because they used their own DNA for a sole purpose. If miscellaneous company A, B, C sue because of some patent, copyright, or legal restriction it could stall research progress.

    In a dire scenario of ever compounding legislation, I can imagine how far of a step is it to escalate justifiable ownership to other components of a human body, all the way to owning an entire human. No one should own DNA; not now, not ever, not even metaphorically!

  • geraldfnord

    Corporations—potentially immortal (undead?) persons often equipped with lawyers more numerous and more fearsome than we can muster—do not stand level with us, the living. If they are allowed to own one bit of us they will end owning all of us.

  • Guest

    Henrietta Lacks’ cells were “stolen” in 1951. The HeLa cells were sold for many years and her family didn’t receive money. Is this the same issue?

    • Robert Sachs


  • Chemist150

    The US leads in medical research and drug development. The reason is because of the money that can be made from it. In some cases, the patent life may not be long enough to recoup the cost of development. Without the process, the research would be nearly non-existent and dependent on the government through a few pennies at it. Think of the $100 million Obama wants for brain research. A small company can burn $50 million a year and fail.

    The average drug costs $700-$900 million to develop. Wrap in the failures and those that the FDA does not approve, it costs $4-5 billion per drug. If you take away the patent life, the company would have no incentive to develop a drug. This easily puts out orphan diseases.

    When something is available and it’s wrapped up in patents for 7-15 years, it’s frustrating but if you consider without the patents, we would not be nearly as far along as we are.

  • James Ivey

    Why isn’t this more of a patent misuse case rather than statutory patent eligibility? Why isn’t compulsory licensing a satisfying remedy?

    Years ago, my classmate, Mark Lemley, wrote pretty extensively about the intersection of patent misuse and antitrust.

    • Robert Sachs

      It’s not clear how misuse would apply. Assuming you mean misused based on an antitrust, attempt to monopolize, you would have define the relevant market, etc. and establish a host of legal and factual requirements to meet the misuse requirements. Further, even if granted, it would only render these patents unenforceable. That does would not achieve the public policy goal of the ACLU, etc. which is to get rid of all such DNA patents. By attacking on patent eligibility grounds, they can (and I think likely will) reach that goal.

  • Melanie Topp

    I am a 40 year old woman whose biological mother died of premenopausal breast cancer at age 46. At age 23 I had a “scare” and again at age 30 had a benign lump removed. My doctors recommended MRIs every 6 months (excessive, in my opinion) and finally I connected with a genetic counselor with Kaiser after my daughter was born at age 36. I was actually shocked that per Kaiser’s “protocol” I qualified to receive the testing for BRCA I and II gene mutations. The genetic counselor explained to me at the time that there was only one company in the US that performed the test, and it would cost me between about $3k if I were to request it as an individual or if my medical insurance was with a traditional PPO or HMO. So in a rare moment of the health care system working FOR me (or so I thought), I paid very little out of pocket for the test. The rub: Because I had no living first degree female relative who had been diagnosed with breast cancer and subsequently survived (and my mother was deceased) the result of my test was inconclusive. The result was quite literally “indeterminate significance”. So, while it wasn’t positive, it also was not definitively negative. At the time (2009) I assumed this was due to limitations in the science, and understand it partly was, but the test cost my insurance company a goodly sum and had I been a patient in a different system I would have been extremely irritated with this inconclusive result had I paid out of pocket for the test. I realize this show is about the politics of patenting genes, but the topic goes far beyond that interesting concept. Patients. How can we best serve the patients?

  • Chemist150

    And those that are doing “research” without the patent laws, which I want that woman to be more specific about, are doing research based on the literature coming out the industrialized nations leading research with patent laws.

  • Is there a possible middle ground in this argument — perhaps easily accessible gene patent pools could serve as a happy medium?

  • Michael Joseph

    A therapy for opiate drug addicts was discovered by a government research program because corporate drug companies didn’t think there was enough money in treating addicts. Don’t worry if companies can’t make money off these patents. There is a place for government agencies funding science for the public good and these agencies need to be able to help ill people who aren’t in a lucrative market for corporations.

    • Chemist150

      There is a role for government funding but it cannot replace the pace of research in the private sectors. While I do not know specifically about these patents, patents are important for driving real research.

      In the case of being barred from a patent process, companies can adopt the policies that very large companies often adopt and that is not to patent at all and keep key parts secret. For example, there is a very well developed catalytic system for producing nylon cheaply but the catalyst is not public information. They have not patented it because they can make more money over time keeping the secret. If they had disclosed it, others could be using these catalysts.

      Another issue like that comes up with fracking, they don’t tell the exact process and claim intellectual protection when the SEC or government asks. The reason is that they’re doing chemistry on a global scale injecting phase transfer catalysts, CO2 and water to reseed the process and produce “natural gas” faster at a site. The knowledge could go global and we could start recycling CO2 on a global with every company within a couple decades if they had patented the process but they’ll keep it a secret instead.
      Secrets can hurt more than holding intellectual rights for a few years. The governments science investment is miniscule compared to the private sector and denouncing patents as you have is short sighted.

    • Chemist150

      Oh, and maybe you should look up “goofballs” and ask why the government developed programs for addicts.

  • Robert Sachs

    There are many interesting points here, but there is a lot of confusion about the issues.

    First, there are underlying assumptions here that what is patented is exactly what exists in the body, and there is nothing ‘inventive” in identifying these genes. Both assumptions are false. First, the common misperception is that when we say the “genes for” something like BRCA1, there is some bit of DNA that is sitting there all neat and pretty and scientists need only look around and find it, like finding an undiscovered flower growing in the wild, and we only need spot it and pluck it. That is not the case. Genes are not like bones, or organs, or cells: we know where a bone or muscle or organ begins and ends. Nature does not put out sign posts that say “Here is where BRCA1 starts and here is where it ends.” That is because the notion of a “gene” is simply a handle use to talk about some bits of DNA that we believe are related to a specific biological function. Thus the discovery where the DNA sequences are is the “invention” and the Constitution says that “discoveries” are to be protected.

    Second, even once the DNA sequence is identified, what is patented is not the DNA sequence itself as it exists in the body. Rather it is an essentially artificial version of that sequence, as it would exist only in the laboratory, and only in combination with a test, treatment or other human engineered process or product. In short, the patents do not cover something found exactly in nature.

    Companies in this field do not “sit on a patent” and do nothing with it, while blocking the “real innovators.” (Who would they be?) The companies that make investments in this research, and patent the products of such research, are in fact the “real innovators,” and they are doing this in support of providing diagnoses or treatments. Second, there is zero chance of a person being sued by a company with a gene patent on the grounds that the company owns the person’s genes. That’s simply nonsense. We have had these types of patents for more the 20 years, a never has an individual been sued (nor could that even happen) and the so called sociological or medical disaster has not occurred.

    The concerns of patients are important, but should be addressed not with regards to deciding what can be patented, but rather with more targeted solutions regarding funding, exemptions, mandatory licensing, and the like. These are policy concerns best decided by Congress–not the Supreme Court who’s job is to decide the scope of law. The decision of the Court is going to apply not just to Myriad’s patents, but will be applied to all kinds of patents, and so concerns that are specific to women patients in this case (or perhaps children in some other case), while important, should not drive the general rules applicable to all technology.

    The rules of what kinds of things are patent eligible must be open ended: we cannot know what the future will bring, what inventions can be made. If we narrow the definition to exclude various types inventions, we have no idea what inventions will not be made, and what loss there will be to society. What if in the1800’s the Court decided that anything using electricity could not be patented because electrical is “natural.” Edison, Westinghouse, Bell, and many others specifically pursued their inventions because they depended on patent protection for their investments.

    Without the benefit of patent protection, many advances in medicine simply would not have been made or would have been made years later at best. Yes, if Myriad had not identified the gene it would have been identified by others, but perhaps not for years later. You have to consider both sides of the equation. Indeed, it’s likely that no one has died of breast cancer *because* of Myriad’s patent, we know many have been saved, and we can be certain that some *would have died* for lack of a test had the discovery been made not by Myriad but later by another company.

  • Myriad is welcome to own the test. They can even own the material they create with the test. But they shouldn’t be able to own the gene or the mutation of the gene which inherently belongs to the individual. There are new ways to competitively identify the gene and the mutations using whole genome sequencing. A whole genome identifies all your genes and mutations. Granted we don’t know what those billions of genes and mutations all do. However… Following Myriad logic to an absurd level. If a whole genome sequencing company “discovers” a unique whole genome sequence (and every person on the planet has one) by running your genetic material through their device, they could legally patent that unique sequence of genes and variations known as (fill in your name here). In essence every person who has their whole genome sequence done could have their unique gene sequence added to the company’s portfolio of patents because they used their unique technology to generate enough of your genetic material to run it through their machines and map it out for you. You can’t patent a place on a map or the map itself. You might copyright the presentation of the information, but you can’t patent it. It would be like google patenting my house because they found a way to zoom in on it. Myriad should not be able to own for any period of time my genes or their mutations. They are welcome to own their way of finding it.

    • Robert Sachs

      Kristen, your reply is thoughtful, and passionate, but reflects some common misunderstandings about patents.

      Neither Myriad nor any other company would or could patent the unique genetic sequence of an individual. That’s not how patents work. In the same way that the specific sequence of musical notes that make up a song is not patentable, so too is the unique sequence of DNA that make you you not patentable.

      And that’s a key difference with genes for diseases: they are *not* uniquely yours, any more so then the “genes” for your blue eyes are “yours.” These genes existed well before you born (indeed, hundreds of thousand of year ago) and will continue to exist well after you die. Genes such as these are shared by millions of individuals, so it makes no sense to say they are “your genes.” Ok you say, if the are shared by millions and have been around for thousands of years and will continue, how can Myriad or other patent them? Because they do not patent the gene per se, but instead they patent a test for a disease or the creation of treatment, or the gene as isolated in the laboratory and not in your body. In short, just because a patent claim mentions a particular gene, that does not make it a patent “on the gene.”

      When I say a “patent claim” I’m referring to the specific legal description that defines an invention. A patent claim on an airplane wing would list say nuts and bolts, but that does not mean the patent is on the nuts and bolts–it is a patent on the wing as a whole. Similarly, a patent claim on a test for a genetic disease would identify the gene associated with the disease, but that does not make patent “on” the gene or the disease. The patent is on the test.

      The point is that you have to look carefully at what is patented, because the details matter. Read http://holmansbiotechipblog.blogspot.com/2011/08/will-gene-patents-impede-whole-genome.html for an analysis showing the errors made by researchers who claim that 20% of all human genes are patented.

  • menloman

    Those who opposed restrictions on stem cell research did so on the basis that these discoveries would lead to cures. Some of these same people now want restrictions on cellular discoveries. Progressives seem to want less progress.

  • This is very interesting.

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