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Myriad Genetics Inc. Message Board

  • eastcoasttroll eastcoasttroll Nov 1, 2010 4:21 PM Flag

    Q for Twelvetooth

     

    Did you see this release from the DOJ? http://www.fiercebiotech.com/story/bombshell-justice-reverses-stance-gene-patents/2010-11-01?utm_medium=rss&utm_source=rss

    READ the COMMENTS at the end of the article which are helpful in determining the value to MYGN.

    <<By Mr. Gunn | Posted 10:36am | November 1, 2010
    Considering genes to be patentable is not, in fact, necessary for the development of drugs or diagnostic tests. That view is rather bizarre, because it's not the extracted DNA that is the curative element, it's the technology derived therefrom, which the DOJ has explicitly stated IS patentable. A novel isolation method, a novel diagnostic method, drugs derived from an understanding of the role of the gene in a disease process - these are all patentable. What's not patentable is the fact that the gene exists.

    If anyone thinks this change will hurt biotech, they're only displaying their ignorance, not only about basic molecular biology, but in the history of IP in this area. Isolated compounds like EPO are patentable, but that's because the EPO itself is the curative agent, used in a specific formulation, for a specific indication, on a specific population, in a specific fashion. Those specific parameters are what make clinical trials so expensive, not the discovery of the existence of the agent. Not being able to claim exclusive use of a gene for a given indication isn't going to affect any of those costs. The test still has to be developed, the drug still has to be screened for, tested, and put through the whole pipeline. The significant costs incurred in such development and testing is what patents have always been intended to protect and continue to protect. This ruling will do nothing except prevent the DNA equivalent of domain-squatting on the internet.

    I applaud the PTO for finally showing a sign that it understands basic science in this area. Granted, there's still some wrinkles to be worked out, because there remains some murkiness around what it means to have been experimentally altered. For example, if in the process if isolating a sequence you use PCR & the enzyme introduces a mutation, does that count as an experimental alteration or just an impurity, more akin to the mining of ore? Nonetheless, I think the decision is moving in the right direction and there can be no doubt that this will boost innovation and development in this space now that competition is finally possible in the genetic testing space.

    Last but certainly not least, the academic research that makes all this industry possible can now proceed without the worry of some company buying up IP and squatting on it, shutting down their research program.>>

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    • Hello eastcoast. I'm no lawyer and patent matters do make my head spin, so I await the overall outcome of time to tell what's what. As far as I know, MYGN has numerous patents for each of its tests and this protects their IP from duplication. The significant arguments revolve around the methodology that they have devised and don't share. Researchers elsewhere are unable to benefit from these developments and it does retard the pace of overall diagnostic developments, but that is the way of business and not the proclaimed openness of academic research. So be it as Science has become Big Business and IP merits protection in the marketplace....

      Now, what was the question again?

    • From Mr. Gunn's comment:

      "Considering genes to be patentable is not, in fact, necessary for the development of drugs or diagnostic tests. That view is rather bizarre, because it's not the extracted DNA that is the curative element, it's the technology derived therefrom, which the DOJ has explicitly stated IS patentable. A novel isolation method, a novel diagnostic method, drugs derived from an understanding of the role of the gene in a disease process - these are all patentable. [...]

      Nonetheless, I think the decision is moving in the right direction and there can be no doubt that this will boost innovation and development in this space now that competition is finally possible in the genetic testing space."

      Does anyone see the contradiction here? This guy says patent claims to isolated DNA are irrelevant and diagnostic testing is patentable. Then in the next breath he exults in the fact "competition is finally possible in the genetic testing space."

      His analysis is admittedly more nuanced than the drones who reacted in exactly the way DOJ hoped they would (e.g., NY Times, etc.), but he still doesn't know what he's talking about.

 
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