Whose DNA?

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What happens when you can't get tested for a genetic disease because the company that makes the test doesn't have enough money to pay the company that owns the patent on the gene in question? Okay, this hasn't happened yet, but it's likely to become an issue soon.

"Fortunately, it doesn't appear that we're in a lot of danger," Stone said. "We've (been) doing this for a year and have not encountered a problem. But not encountering a problem in a year doesn't mean there will be no problems forever. Even a single problem that would require legal representation is just incredibly expensive for a completely non-moneymaking operation."

The ultimate answer, Stone believes, is to amend the Rare Diseases Act of 2002 to include patent freedom for nonprofit organizations that want to provide gene-testing services to patients with or at risk for rare diseases.

The law currently gives financial incentives to pharmaceutical companies to develop drugs for diseases that affect fewer than 200,000 people in the United States and would not otherwise make much revenue. But the law does not address genetic testing.

This is just another example of how unfit the system of patent and copyright is to new developments in science and technology.

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  1. I find it hard to believe that a patent would be granted on a human gene. Maybe it?s just wishful thinking, but it seems obvious to me that it?s something in the public domain.

    You can?t patent something that?s clearly owned by everyone. At least that?s my hope. And it seems easy enough to challenge in court.

  2. kmw,

    I would have found it hard that a patent could have been awarded on one-click web ordering, or riding a swing an uncommon way (thanks, KentInDC). As far as I know, the Patent and Trademark Office has a mandate to award patents unless there is an obvious duplicate and let the courts sort them out. Seems like a great deal for the lawyers.

  3. “…would have found it hard to believe that a patent…”

    Oops.

  4. “I find it hard to believe that a patent would be granted on a human gene. Maybe it?s just wishful thinking, but it seems obvious to me that it?s something in the public domain.”

    That’s what I would have initially thought too. However, as we get to the point where we can create new genes, designed to correct a genetic problem or enhance the existing genome, and plug them into our chromosomes, the question of IP and the proprietary secrets of the designs is bound to come up.

  5. Patenting human genes has been clearly legal for years. Here’s a Wired News article from January 2001 about it.

    After responding to more than a dozen such comments, the Patent Office said the law clearly allowed for genes to be patented, so long as those genes have been “cloned” or reproduced in the laboratory and their function defined.

    The Patent Office said the practice of patenting bits and pieces of nature was not new. “For example, Louis Pasteur received U.S. Patent 141,072 in 1873, claiming ‘yeast, free from organic germs of disease, as an article of manufacture’,” it said. “Another example is an early patent for adrenaline.”

    Companies have asked for patents on tens of thousands of human genes. Human Genome Sciences says it holds 159 patents on full-length genes, for example, and has filed applications on more than 16,000 genes.

    But I’m with you, KMW, I think it’s obvious that naturally occurring genes should be in the public domain.

  6. Hanah Metchis,

    Actually, you can’t patent the gene per se, what gets patented is the process or resulting product of processing the gene. The gene itself, the sequence of nucleic acids that code a protein. is a facet of nature and thus unpatentable. (Wholly artificial genes, ones that never existed in nature, are patentable)

    The legal/technological problem is that due to the way DNA works, there maybe only one specific matching RNA or protein that can be used to latch on to a specific gene. It’s like each gene is a lock that will only open with a key of a very specific shape. What is getting patented is the shape of the key, not the lock. No amount of technological ingenuity will let you make a differently shaped key. The first person to patent the key can effectively control access to the gene for the life of the patent.

    I think the way out of this is to define both the gene and RNA or protein key as existing natural facets and just let inventors patent process above that level.

  7. Hanah Metchis,

    Actually, you can’t patent the gene per se, what gets patented is the process or resulting product of processing the gene. The gene itself, the sequence of nucleic acids that code a protein. is a facet of nature and thus unpatentable. (Wholly artificial genes, ones that never existed in nature, are patentable)

    The legal/technological problem is that due to the way DNA works, there maybe only one specific matching RNA or protein that can be used to latch on to a specific gene. It’s like each gene is a lock that will only open with a key of a very specific shape. What is getting patented is the shape of the key, not the lock. No amount of technological ingenuity will let you make a differently shaped key. The first person to patent the key can effectively control access to the gene for the life of the patent.

    I think the way out of this is to define both the gene and RNA or protein key as existing natural facets and just let inventors patent process above that level.

  8. “As far as I know, the Patent and Trademark Office has a mandate to award patents unless there is an obvious duplicate and let the courts sort them out.”

    And they earn their operating revenue by issuing patents and collecting the related fees.

  9. How could a administrating a genetic test infringe on a patent, unless the test itself is what is patented? The way this is worded implies that in analogy if someone put a patent on spanish flu, a doctor could not diagnose you and therefore treat you. This does not seem a correct conclusion.

  10. No, it’s an example of how government subsidization of politicians’ current pet business endeavors always has unintended (and usually negative) consequences.

  11. This strikes me as a non-issue for any lengthy period. If there is any significant market for the items covered by the patent there is going to be a licensee for both the test and the patented data. Pricing yourself out of business ruins the entire reason for pursuing patents in the first place.

    Further on, these test are dropping in the cost of development and manufacture at quite a good clip for a product that is still something of a novelty for existing at all. When those costs drop sufficiently the potential for a mass market will force the patent holders to reconsider their business model in favor of the one that makes them real money.

  12. “…now might be a good time to argue that the Christian god holds a prior art claim on DNA and all component genes. ”

    Shhhhhh…. Not so loud! You want to give them ideas?

  13. The good thing about patents is their short life span; twenty years and they turn to dust.

  14. You know, with creationism gaining ground in official circles, including the Bush administration itself, now might be a good time to argue that the Christian god holds a prior art claim on DNA and all component genes.

    Since the currentr president would argue that the world and all plants and creatures in it, including humans, were created some 5800 years ago, any patents would have expired over well 5700 years ago, putting all genes firmly in the public domain.

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