Great story on legal battle over gene patents

You might have heard that a Federal court invalidated seven patents on BRCA1 and BRCA2, collectively known as "the breast cancer genes", earlier this week. It is, to quote our Vice President, a big fucking deal.

A couple of years ago, I wrote a story for about women who were faced with the decision to be tested for faulty versions of those two genes. If tests showed the women had mutations that were likely to lead to breast cancer, the decisions became even more complicated. Everyone handled it differently, but they were all happy to have the choice. Unfortunately, that choice was very expensive, one expert told me, largely because Myriad Genetics owned patents on the naturally occurring genes and, effectively, had a monopoly on testing. The monopoly also meant women couldn't get a second opinion, so to speak, because there was only one lab doing the tests.

Patents like this are nothing new. But, according to United States District Court Judge Robert W. Sweet ...

the patents were "improperly granted" because they involved a "law of nature." He said that many critics of gene patents considered the idea that isolating a gene made it patentable "a 'lawyer's trick' that circumvents the prohibition on the direct patenting of the DNA in our bodies but which, in practice, reaches the same result."

That's from a fabulous story by New York Times' reporters John Schwartz and Andrew Pollack. If you want to understand what's at stake in this case, why Monday's decision was so unexpected and what's up with the legal history on gene patents, this story is a great jumping-off point.


  1. My wife had a very aggressive form of breast cancer at 30. Everyone assumed that given her age, health, and family history that she must have had a genetic predisposition to breast cancer. The one thing that was the deciding factor in not losing both her breasts was this test coming back negative. It was God-awful expensive but we felt it was worth it.
    Still, I am usually pretty pro-patent but Myriad really did go to far with this one. Yes, they discovered these genes however their patent does enforce bad science/medicine in that you can’t retry or retest your results ie second opinion.
    My one concern with the whole matter is I know that it cost quite a lot of money to find these genes so I can fully understand why Myriad went for payday at the end of the patent trail. Genetically engineering something and patenting it is one thing, but patenting a scientific fact is really another.

  2. There’s an excellent writeup over at Ars Technica as well, with a much better explanation of the arguments presented by the judge.

    To quote an interesting bit:

    Chemically, [Judge Sweet] notes, DNA is rather inert, and the process of testing performed by Myriad doesn’t really rely on any chemical properties that are distinct to the BRCA genes. (…) Instead, the BRCA patents rely on the second aspect of what the decision terms the “dual nature” of DNA: its role as a carrier of information.

  3. I’m glad to see this decision as I think it set a dangerous pattern, but at the same time I can understand Myriad’s perspective. Developing these technologies is incredibly expensive so in the absence of a pharma-style model of patent protection (as for new drugs), how do we provide incentives for private-sector participation in this type of research? If we’re going to rely on publicly funded research for everything so that we get open data, we’re going to need a bigger boat of cash.

    1. What’s so expensive about it?
      Do some expression profiling (the hard part is getting enough samples from different patients), look for genes that seem to be unusually up- or downregulated in breast cancer samples. Look for variants of those. Develop some cheap way of determining which variant exists in a given single sample. (Something involving fluorescent proteins and well-selected markers, I would assume – shame I’m not at work so I can ask the biologists.)

      Sure, it’s not trivial … but compared to pharmaceutical development and testing, it really is peanuts.

      And yes, I do work with people who do this sort of thing. Finding SNPs that are correlated to increased risk is the kind of you see students doing for their degrees, and developing tests for a specific variant is so daring and innovative that you can get custom test arrays for a set of them made by filling out a web form.

      Put another way, Myriad jumped onto something a large number of labs would have found fairly soon anyway (and on nonprofit research budgets), then patented testing for it. I have absolutely no respect for them.

      [1]Single Nucleotide Polymorphisms – many genes have a number of variants separated by which base they have in one, or a few, sites.

  4. @jenjen “If we’re going to rely on publicly funded research for everything so that we get open data, we’re going to need a bigger boat of cash.”

    By my very rough back-of-the-envelope calculations (~120 new drugs approved every year, $1B in costs from conception to FDA approval per drug, 135M US tax returns filed each year), each US taxpaying household would see their taxes go up by nearly $1000 per year to cover the costs of new drug development – most for drugs they would never need. I imagine a similar figure for medical devices. Try selling that to the US public.

    1. First off, we’re paying it anyway. That moneys comes from either our taxes, our insurance premiums, or our medical bills.

      If we choose the former, we also get control over which diseases we try to make drugs for. We can choose the ones we care about and that matter, rather than the ones that provide the greatest opportunity for profit. Oh, and we could then require that purchase prices be set by the cost of production, rather than the cost of development.

      1. “If we choose the former, we also get control over which diseases we try to make drugs for.”

        Because we have so much choice about where our tax dollars go now? Even just in terms of health research – when was the last time you told the NIH what you wanted your tax dollars spent on?

        Regarding insurance premiums and medical bills – the people who need more drugs (generally) pay more in premiums and bills. Someone with HIV, for example, is going to pay more than someone who only needs a multivitamin and a yearly flu shot.

        If we socialize the costs of development, of course purchase prices will be set by the cost of production. That’s essentially the generics model, after patents expire.

      2. Agree with you on this. The history of early chemotherapy:
        relates a times when the government was doing it, and got a lot of it right. Right now there is a lot of our “brain trust” focused on tweaking dosages/mixtures to get a new patent/more money rather than patient benefit.
        The boatloads of cash everyones talking about are currently sitting in the bank accounts of CEO’s of pharmaceutical and managed care companies. It was funnelled out of our premiums. It did cost us a billion dollar for every new drug, and we’ve paid for it in premiums/copays and then whatevers left when the insurance runs out and the hospital/drug companies take whatever money is left. If the bulk was paid by only the sick, then there’d be no sense in having health insurance.

  5. This is a disaster for the consumer.

    I used to work in a biotech company on diagnostics, but am now back in academia with no conflicts of interests on this question.

    Companies will not try to discover biomarkers or format clinically practical assays for them where there is no prospect of a period of exclusivity in which to recoup the costs of development of this assay (and some fraction of the many other expensive avenues of research and development that never come to fruition because this is just the reality of research science).

    So the existing assays will get cheaper (great!), and these may be the last innovative gene-based diagnostic assays we ever see (not so great).

  6. Thank heavens for this.

    Now, on to Monsanto and it’s evil green* empire.

    *Note: not “green” as in agriculturally-sustainable, but “green” as in plants.

  7. Speaking as someone who has acquired a few US and some international patents, I do have to wonder how it’s even possible to acquire a patent in the US for something that exists in nature. While I do not have specific experience in the Group Art Unit that handles gene patents, all US patents are supposed to demonstrate an “inventive step” or meet other non-obviousness requirements.

    Seeing patents on natural occuring genes to me seems odd, like patenting the boiling point of water or the wheel.

  8. Finally some good news on this front. How can ANYone even begin to defend the logic of patenting a GENE? And if the only incentive people have for scientific research is to make a shitload of cash, the problem lies not in intellectual property court but in our culture’s philosophical backbone. Fix THAT problem and you’ll see how easily the money will get reshuffled to the right places- schools, science labs, the arts… you know, shit we could actually USE.

  9. I do wonder…

    If patentable matter must involve the invention of

    -Something new (that does not exist in nature or previously)

    -Something well-described and specific (you cannot patent the throwing of projectiles over long distances, but maybe you could patent the trebuchet or the mangonel, with diagrams and descriptions)

    -Something non-obvious

    How could these people patent the isolation of a piece of naturally occurring DNA? Did they invent a novel method, a very specific method to isolate those genes? If not, what claim is there for them to make on using another’s work? Sure it is that they have not produced a new, artificial piece of DNA.

    Did they patent a very specific test, well-described and specific as an approach to the problem at hand, so it cannot pre-empt a different approach to solving the same problem by a competitor?

    The other benefit of patent law is to force competitors to try a different approach to the same problem and force technological diversity. W.L. Gore has an honest patent on Gore-Tex, and it is good and proper that competitors produced alternatives that were cheaper, if not more efficient. Imagine if W.L. Gore had patented the very idea of breathable-waterproof fabrics that solve the problem of keeping you dry from sweat and rain.

    To me, it seems Myriad patented the idea of solving a problem.

    Under such standards you would claim authorship over the concept of demonstrating a theorem, then, rather than over a demonstration. A non-contribution, and certainly not worthy of recognition, much less exclusivity

  10. Several years ago I attended a biotech ethics conference at MIT. I learned that the basis for patenting naturally-occuring objects rested on a case in which a company sought to patent a oil-eating bacteria (name: Jacobaria, I think) which the company found (surprise!) in the middle of an oil spill. The judge in this case said that since the bacteria looks to the naked eye more like a chemical compound (which is patentable) than an animal (which is not patentable), then the company should be allowed to patent it. That opened the doors, and patents on naturally-occurring phenomena have been pouring in ever since.
    My favorite moment of the conference was during a discussion of an attempt to patent tungsten. A lawer representing some patent-holding firms made the case that the patent would only be in effect for seven years, after wich the entire world would be free to use the discovery. In response, a white-haired professor in the audience said, “Yes, but oxygen is just a few squares away on the periodic table, and seven years is quite a long time to hold one’s breath.”
    This is the best news I’ve heard in a long time, and props to the ACLU for bringing the suit that got the patent overturned.

  11. I think this is wonderful news. Bottom line, existing genes in our bodies are acts of nature and nobody has a right to own them except the people that have them in their bodies. Plain and simple.

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