Myriad Mocks Supreme Court's Ruling On Gene Patents; Sues New Competitors Doing Breast Cancer Tests

from the chutzpah dept

Remember how, just a month ago, the Supreme Court had struck down gene patents in the Myriad case? If you don't recall, Myriad claimed, effectively, to have patented the isolated BRCA1 and BRCA2 genes, which are indicators of a likelihood for developing breast cancer. As such, they blocked anyone else from doing tests to find those two genes, and charged a whopping $4,000 or so for anyone who wanted the test. The Supreme Court, thankfully, tossed out those claims, noting that Myriad "did not create or alter any of the genetic information" in those genes, and that if found valid, it would "give it the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes." That's obviously crazy, so it was good that the Supreme Court rejected those claims.

Immediately after that, a few competitors jumped into the space, offering BRCA1 and BRCA2 testing -- for significantly lower prices. And, Myriad wasted very little time in suing them all for patent infringement. Huh? The short version is that Myriad claims that the Supreme Court merely removed five total claims out of its patents, and it still has 515 remaining claims across 24 patents -- and these tests violate those:
As of the morning of June 13, 2013, Plaintiffs collectively had 24 patents containing 520 claims concerning two genes (BRCA1 and BRCA2), and methods of use and synthetic compositions of matter related thereto. On June 13, the Supreme Court of the United States ruled that five patent claims covering isolated naturally occurring DNA were not patent-eligible, thereby reducing the overall patent estate to 24 patents and 515 patent claims. This case involves none of those five rejected claims.
The filing goes on to suggest that the Supreme Court ruling really didn't mean very much at all. In many ways, this really does appear to be Myriad giving the middle finger to the Supreme Court. As Tim Lee notes, if Myriad's interpretation of the Supreme Court ruling is correct, then the Court's ruling is effectively meaningless, because Myriad (and anyone else) can effectively write patents for genes by just changing how they structure the patents:
The patent claims the Supreme Court invalidated last month were “composition of matter” claims, covering the chemical structure of the BRCA genes. But Myriad’s patents also have “method” claims covering processes for diagnosing breast cancer. And while these patents use different language than the composition-of-matter patents the high court invalidated, their practical effect on the genetic testing market could be very similar.

Consider Patent 6,951,721, one of the patents cited by Myriad in its lawsuit against competitor Ambry Genetics. It claims the concept of diagnosing breast cancer by “determining the nucleotide sequence of the BRCA1 gene” from a “female individual” and then checking for mutations at specific points on the gene. The patent isn’t limited to any particular technology for isolating or sequencing the patient’s BRCA1 gene. So while it’s not technically a patent on the BRCA1 gene, it might as well be.
Of course, as you look over the details, it seems like Myriad is still going to be in trouble. Effectively, the claims it's relying on may appear to be more similar to a patent on the diagnostic process itself. But, that's a problem for Myriad, because in the big Prometheus Labs case, which the Supreme Court decided a year ago, and which it relied on in the Myriad case itself, medical diagnostics aren't patentable either.

It seems like Myriad is just trying to squeeze some more money out of these patents before it gets smacked down again. Of course, not everyone agrees. Dennis Crouch seems to think they have a "very strong case," while PubPat's outspoken Dan Ravicher feels otherwise:
PubPat director Dan Ravicher, e-mailing Ars from Beijing, described Myriad's new suits as a way to save face with Wall Street. He said the Supreme Court decision was a "total loss" for Myriad, and the synthetic cDNA they are focused on now is not needed for genetic testing. "I am confident they will lose these cases, too, so long as the defendants have the financial resources and institutional desire to fight," said Ravicher.
Of course, it's that last bit that's the challenge. Any such case will take years and millions of dollars. And, during that time some may just choose to settle, and if lower courts side with Myriad and issue injunctions it can be a big risk for the competitors in the space. The end result may work in Myriad's favor even if these cases are completely bogus: it's likely to scare away competitors, and keep the prices of its breast cancer gene tests very high, making it much more likely people will die. I do wonder how Myriad's execs look at themselves in the mirror. There is no reason for doing what they're doing other than to enrich themselves, while ensuring that more women will die from undetected breast cancer. Sickening.

While the FTC has claimed that it's going to go after patent trolls, this seems like another situation where they, along with the DOJ, should also look into Myriad. While it may not be a traditional "troll," there's certainly a strong argument to be made that the company is abusing patents in a manner this is likely to lead to much higher prices for consumers, especially following the Supreme Court rejecting the very premise that they're now relying on in these new lawsuits -- that no one but Myriad can offer tests for BRCA1 and BRCA2. One hopes that the FTC decides to expand its "investigations" into companies like Myriad.
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Filed Under: brca1, brca2, breast cancer, cancer, gene patents, lawsuits, patents
Companies: myriad genetics


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  • icon
    Ninja (profile), 15 Jul 2013 @ 7:50am

    Jesus people, it's about saving boobs we are talking here! For the sake of the male portion of the population make it... Open source?

    link to this | view in chronology ]

  • identicon
    Anonymous Coward, 15 Jul 2013 @ 9:17am

    Says a lot about a country that large corporations now openly admit to believing they are above the rule of law.

    link to this | view in chronology ]

    • identicon
      Kiwini, 15 Jul 2013 @ 9:27am

      Re:

      "Says a lot about a country that an elected government now openly admits to believing they are above the rule of law."

      Fixed.

      We are supposed to be a nation of laws, but many of those elected to office make a conscious choice not to follow them. The inbred stupidity in our patent system is just one symptom of an on-going lack of leadership.

      link to this | view in chronology ]

    • identicon
      Anonymous Coward, 15 Jul 2013 @ 5:52pm

      Re:

      I never quite understood why American's were so opposed to regulation. Honestly, who do you trust more? Corporations or the government?

      (Yea yea, I know what you're kneejerk reaction is going to be. It's a fair call considering how badly the American gov has been treating civil rights, but let's look past that.)

      link to this | view in chronology ]

  • icon
    artp (profile), 15 Jul 2013 @ 9:20am

    The old double standard

    If I did this, I would end up in jail for fraud, blackmail, antitrust and littering. (Don't underestimate the power of a littering charge. See Arlo Guthrie's Alice's Restaurant! http://www.youtube.com/watch?v=m57gzA2JCcM)

    If a corporation does it, the saga goes on forever............................................................................................. .................................................................................................... .................................................................................................... .................................................................................................... ..............................................................................................

    link to this | view in chronology ]

  • This comment has been flagged by the community. Click here to show it
    identicon
    out_of_the_blue, 15 Jul 2013 @ 9:20am

    "Any such case will take years and millions of dollars."

    Well, IF you let lawyers handle it. My way would be demand speedy trial by jury; explain my view in about a thousand words, most of which point to Myriad as the real criminals, relying on emotional appeal and dislike of lawyers to aid me. It's high risk, yes, but would surprise the plaintiff, besides avoid certain waste of letting lawyers drag it out. -- But I only guess that those options are still available in the corporatized world. Corporations may have "agreed" to limited rights, or are other tricks used. -- Anyway, I'm certain that your "own" lawyers are part of the problem, because actually they owe allegiance to a medieval guild and work for the guild more than for any given client. -- The old catchphrase: No one wins a lawsuit except the lawyers.

    link to this | view in chronology ]

    • icon
      Gothenem (profile), 15 Jul 2013 @ 10:12am

      Re: "Any such case will take years and millions of dollars."

      Not sure why this was flagged as spam, aside from the fact that it posted by someone named "out_of_the_blue". That said, it doesn't have his usual "take a loopy tour of techdirt" signature.

      The argument he posts here does have debatable merit. I would challenge the TechDirt community to not flag a comment that has debatable merit just because it comes from a regular troll.

      My biggest issue with blue, from what I have seen, is that his comments seem to stem from a black-and-white view of the world. He sees things as either wholly right or wholly wrong, with no grey area. Corporations = bad, Copyright = good, etc.

      While I disagree with that sort of view, there are many who share similar views. His statement here does have a certain validity, and his final line is very appropriate in today's legal system.

      link to this | view in chronology ]

      • identicon
        Anonymous Coward, 15 Jul 2013 @ 10:39am

        Re: Re: "Any such case will take years and millions of dollars."

        I've said this before, but I'll say it again (even though I'll probably be ignored because I'm AC, but I'm cool with that):

        Techdirt shouldn't have a "report" button, as it has some serious problems.

        First, the report button - as far as I can tell - cannot be undone, secondly - also as far as I can tell - it takes very little effort for something to become "reported".

        These problems lead to a situation where perfectly good comments can get slapped with the "reported" label without any way of reversing this. As it stands now - and it pains me to say this - the report button is often used as a beating stick by some parts of the community to be used on someone they disagree with. A quick way to make the a perceived "problem" go "away".

        Also, the report button invites accusations of censorship because the inner workings of the report mechanism aren't clear, which leads to the usual, inevitable and completely pointless "debate" about how Techdirt censors comments.

        The final and last problem (for me, at least, since I use NoScript) the reported comments cannot be seen without unblocking techdirt.com and googleapis.com in NoScript. This is annoying, and I can live with that, but it does discourage me from seeing what is actually under that "reported" label sometimes.



        I think that a better solution is a score system like slashdot or stack overflow and a filter setting to allow you to see only what you want to see.

        Sure, that won't prevent a determined person from modding anyone down into oblivion (or up into...uh...the opposite of oblivion), but it would allow us to "correct" bad downvotes, whilst retaining the positive feedback effect.

        Or perhaps we should do away with the report button entirely.

        link to this | view in chronology ]

        • icon
          Mike Masnick (profile), 15 Jul 2013 @ 10:58am

          Re: Re: Re: "Any such case will take years and millions of dollars."

          First, the report button - as far as I can tell - cannot be undone, secondly - also as far as I can tell - it takes very little effort for something to become "reported".

          Neither point is true. Any vote -- for insightful, funny or report can be "undone" by the person who voted clicking it a second time. What is true is that we don't have a mechanism for admins to "undo" a comment that is reported. I'm sure I could have our tech staff go in and modify the database if we wanted, but it's not like I can just come along and make a comment unreported (nor, for that matter, can I make a comment "reported.").

          Second, it actually is not easy at all to trigger the minimized comments. It requires a fair bit. That some comments get minimized tends to show that a LOT of people don't want to see it.

          These problems lead to a situation where perfectly good comments can get slapped with the "reported" label without any way of reversing this. As it stands now - and it pains me to say this - the report button is often used as a beating stick by some parts of the community to be used on someone they disagree with. A quick way to make the a perceived "problem" go "away".

          To be honest, I've almost never seen this happen. The only cases in which it does seem to happen are in cases, such as here, where a regular commenter who has shown themselves unwilling and unable to disagree constructively time and time again (what some refer to as "trolls") get their comments voted down immediately. The community appears to have decided that those few individuals (the number is less than 5) don't deserve the benefit of the doubt. I may disagree with that, but the comments are for the community.

          On the whole though, I see plenty of constructive criticism that remains visible and find it very rare that a constructive disagreeing comments is minimized.

          Also, the report button invites accusations of censorship because the inner workings of the report mechanism aren't clear, which leads to the usual, inevitable and completely pointless "debate" about how Techdirt censors comments.

          The debate is pointless. We have probably the most open commenting system of any such site online.

          The final and last problem (for me, at least, since I use NoScript) the reported comments cannot be seen without unblocking techdirt.com and googleapis.com in NoScript. This is annoying, and I can live with that, but it does discourage me from seeing what is actually under that "reported" label sometimes.

          For the most part, the reason people have reported those comments is because there's little to no value there.

          link to this | view in chronology ]

          • identicon
            Chris Brand, 15 Jul 2013 @ 12:05pm

            Re: Re: Re: Re: "Any such case will take years and millions of dollars."

            You might consider allowing people to do the opposite of "report" if we're reading a comment that has reached this threshold where that seems unreasonable.

            link to this | view in chronology ]

        • icon
          John Fenderson (profile), 15 Jul 2013 @ 11:02am

          Re: Re: Re: "Any such case will take years and millions of dollars."

          First, the report button - as far as I can tell - cannot be undone


          Yes, it can. If you "report" a comment, clicking the report button a second time will "unreport" it.

          As it stands now - and it pains me to say this - the report button is often used as a beating stick by some parts of the community to be used on someone they disagree with.


          While I see this occasionally (and I notice because it irks me), I wouldn't say this happens "often". But there may be some overlap here that causes confusion.

          For example, I will "report" comments that include ad-homs or gratuitous insults, even if that comment also contains a valid point. It's not that I disagree with the point, it's the ad-homs and insults that I'm reporting. The trolls, however, always seem to assume that it's because of the point they're making rather than because they're acting like dicks.

          I do think a slashdot-like mechanism would be better, but the report button is better than nothing.

          link to this | view in chronology ]

        • identicon
          Anonymous Coward, 15 Jul 2013 @ 11:13am

          Re: Re: Re: "Any such case will take years and millions of dollars."

          In practice the score function works almost exactly like an 'up/down' voting system with unpopular sentiments getting caught up with genuinely puerile. Ask yourself though, if OOTB doesn't even have a tracked account and his posts are frequently reported based on his name alone why then would he go through the extra trouble to post under that name by manually adding it each time?. The answer is that the reputation he has built is exactly the one he's shooting for. The report button didn't do anything really, it was all a design of his own making.

          link to this | view in chronology ]

  • identicon
    Anonymous Coward, 15 Jul 2013 @ 9:21am

    In a common sense world, the Supreme Court would just issue a statement clarifying their ruling today and save everyone a lot of time and money.

    link to this | view in chronology ]

    • identicon
      Anonymous Coward, 15 Jul 2013 @ 11:41am

      Re:

      The supreme court ruling was stocked up with medically wrong definitions and terminology with several of them disturbing the meaning. The basic premise seems to have been that DNA was not patent eligible, but cDNA (if that was actually what they meant?) was not in itself ineligible for patenting. I think Myriad has a case here since the supreme court ruling was so limited in scope and hard to read for anyone including microbiological scientists and lawyers.

      link to this | view in chronology ]

      • identicon
        Anonymous Coward, 15 Jul 2013 @ 3:57pm

        Re: Re:

        When the Supreme Court issues such a limited ruling what they are doing is inviting additional court action and suits to be discussed in a lower court concerning other parts of the issue.

        link to this | view in chronology ]

  • identicon
    Anonymous Coward, 15 Jul 2013 @ 9:24am

    Seems to me Myriad, is trying to bankrupt their competition by dragging them through frivolous and expensive court battles.

    I guess this is just another example of patents, and the patent holders, fully willing to accept the deaths of millions of people, all in the name of 'maximizing profits' by exploiting the sick and dying.

    link to this | view in chronology ]

  • identicon
    Anonymous Coward, 15 Jul 2013 @ 9:25am

    Think someone has made a big boob on this.

    link to this | view in chronology ]

  • identicon
    Anonymous Coward, 15 Jul 2013 @ 9:38am

    We impede health care, and brag about it!

    "The public interest is advanced by more patients receiving tests from Myriad because of Myriad's exclusive access to its proprietary and extensive database of known genetic variants when making a comparison with a patient test sample. Ford Decl., ? 6. This database allows Myriad to report definitive findings to over 97% of its patients. Id., ? 7. Ambry, in contrast, can do this only 70-75% of the time. Id., ? 19. Thus, Ambry will inform 25-30% of patients tested that they have a genetic variant, but will give them no further information about the clinical implications of that variant. Because insurance will not reimburse for a second, repetitive test, most patients will not be able to be tested again."

    In other words, we have information that would help people get better test results, but we keep that stuff a secret!

    link to this | view in chronology ]

    • identicon
      anonymous, 15 Jul 2013 @ 2:51pm

      Re: We impede health care, and brag about it!

      How would Myriad Know what Ambry does or does not have? In fact I looked at Ambry's website and they are nearly the same detection rate as Myriad.

      link to this | view in chronology ]

  • identicon
    Just a guy who actually knows what he is talking a, 15 Jul 2013 @ 10:10am

    Thanks for obfuscating

    There are no middle fingers, there is no rejection of the rule of law, there is no chicanery at work. Everything is functioning as it is legally obliged to.

    What is not functioning is the commentariat's understanding of patent law. Perhaps I'm naive, but I wish to believe there was a time when some inkling of research and context would go into a piece before it was published. Based on everything I've seen in patents about the news in the past 5 years, I'm convinced this "research" thing is out of style, and that today's bloggers-masquerading-as-professionals are merely indulging their prejudices and pandering red meat to the uninformed to rack up pageviews.

    I don't suppose this will change, so all I can say is "Reader beware, you're getting what you pay for".

    link to this | view in chronology ]

    • icon
      Gothenem (profile), 15 Jul 2013 @ 10:15am

      Re: Thanks for obfuscating

      Perhaps if you gave examples or cited sources? Otherwise, it is you who is obfuscating.

      link to this | view in chronology ]

    • identicon
      PRMan, 15 Jul 2013 @ 10:17am

      Re: Thanks for obfuscating

      And your understanding is better because...?

      link to this | view in chronology ]

    • icon
      Mike Masnick (profile), 15 Jul 2013 @ 10:24am

      Re: Thanks for obfuscating

      Rule of thumb for how you know someone is bullshitting: they say "you don't understand, I do" and provide not a single verifiable or debatable point, other than "I know and you don't."

      Seems like you're the one obfuscating here.

      link to this | view in chronology ]

    • icon
      John Fenderson (profile), 15 Jul 2013 @ 10:37am

      Re: Thanks for obfuscating

      Too verbose. I was waiting for you to make an actual argument of some sort, to no avail. You could have said exactly the same thing with two words: "Techdirt SUCKS!!!!!1!"

      Assuming this is just an oversight on your part, here's a second chance.

      There are no middle fingers, there is no rejection of the rule of law, there is no chicanery at work. Everything is functioning as it is legally obliged to.


      Please explain.

      link to this | view in chronology ]

    • icon
      Josh in CharlotteNC (profile), 15 Jul 2013 @ 11:46am

      Re: Thanks for obfuscating

      What is not functioning is the commentariat's understanding of patent law.

      You don't need to know the intracacies of organic chemistry to be able to tell when someone's shit stinks.

      And certainly this lawsuit by Myriad stinks.

      Maybe I'm the naive one, in thinking that the whole point of patents were to encourage new discoveries and inventions. I'm pretty sure that you won't find any supporting documentation by the writers of the Constitution or the various patent laws that say that patents should be for lawyers and corporations to use to parasitize money from those who are trying to make those discoveries. And I don't think you'll find anything saying that patents should be used to prevent people from getting the medical care they desperately need. And yet that's all that patents seem to be used for now.

      link to this | view in chronology ]

  • identicon
    Anonymous Coward, 15 Jul 2013 @ 10:32am

    there are so many systems in the USA now that are totally fucked up, what do you expect? if someone can see a way of making money off of someone else, especially if it's someone else misery, they will do it. the only way to change all this is to scrap the lot and start again! however, the last ones you want to have any say in it are members of Congress. they are the reason it's so screwed anyway!

    link to this | view in chronology ]

  • icon
    Hephaestus (profile), 15 Jul 2013 @ 10:33am

    As Dan Ravicher speculated, the lawsuits are nothing more than trying to save face with investors, and stave off competition to eek out a few more dollars. Simple as that.

    link to this | view in chronology ]

  • icon
    Rich Fiscus (profile), 15 Jul 2013 @ 10:59am

    For anyone who isn't familiar with the major problem the Myriad testing monopoly causes, I can explain based on first hand experience. Mutations of the BRCA1 and BRCA2 have been identified as the single most reliable indicator that a woman is at risk for breast cancer. Although recommendations for when and how early the general population should be tested, there is almost unanimous agreement that women who have those mutations begin regular testing at an earlier age and supplement mammograms with MRIs.

    A few years ago my sister in-law was diagnosed with breast cancer at an unusually young age. She had excellent insurance so it was pretty much automatic that she would be tested for the BRCA mutations. When that came back positive she was then told she should recommend that her parents and siblings - both female and male - be tested as well. My wife could not get the test because Myriad charges $4000 and after her (relatively good) insurance the out of pocket cost to us would still have been significantly more than we could afford.

    Right now we know for sure that her other sister and father both have the mutations. Unless she either has access to a less expensive test or gets one of Myriad's charity awards to defray the expense we won't know if she does or not. For the moment we have to assume she does.

    link to this | view in chronology ]

    • identicon
      J, 15 Jul 2013 @ 9:05pm

      Re:

      Not true. If there is a known mutation in the family, the test is $400, not $4000.

      link to this | view in chronology ]

  • icon
    Lab Spider (profile), 15 Jul 2013 @ 11:53am

    Patent "My" Body.... I don't think so.

    Patent the human heart, and prevent me from getting a physial exam from my doc because he is unable to listen to my heart without paying the patent holder first...'
    Or Patent my eyes, and prevent me from getting glasses unless the glasses are made and overcharged for by the patent holder....
    No... patenting pieces of the human body, the sacred temple created by each holder's mother and father, is not something which a company can patent.
    They can patent the test which they have developed which diagnososes a particular condition, illness, or the potential to get that illness in the future, but they can't stop others from developing their own tests to diagnose ailments or characteristic which may lead to preventing the onset of a disease or cancer, whether hereditarily linked or not.
    Even though I leve in Utah, where Myriad Genetics employs many Utahns, I must take issue with their desire to charge anyone $4000 for their BRAC1 or BRAC2 test, just because they hold the patent to the genes, and can prevent competition in this area. This goes against the very foundation of what made the USA a leader in many medical areas of research and cures. Patents were never designed to stop fair market competition, just the theft or use of technologies which were "man-made", and not naturally created.
    Sure, this decision by the supreme court places all gene patents at risk of becoming invalid, but that's a precident I can get behind and support.
    Let them patent what they have created, not what I, or my parents, created. 'Nuff said.

    link to this | view in chronology ]

  • identicon
    Anonymous Coward, 15 Jul 2013 @ 11:59am

    That's because Dennis Crouch is the son of Satan.

    I hope they try to sue me for everything I'm not worth.

    link to this | view in chronology ]

  • identicon
    Anonymous Coward, 15 Jul 2013 @ 12:26pm

    The chutzpah is unreal!

    link to this | view in chronology ]

  • icon
    Sheogorath (profile), 18 Jul 2013 @ 11:27am

    Did I help update patent law?

    On June 13, the Supreme Court of the United States ruled that five patent claims covering isolated naturally occurring DNA were not patent-eligible, thereby reducing the overall patent estate to 24 patents and 515 patent claims.
    Because of the above statement, I'm wondering if some of the judges read my story about gene patenting on AO3. Or maybe they just read Next by Michael Crichton.

    link to this | view in chronology ]

  • identicon
    Deborah, 10 Jan 2014 @ 9:25am

    Wow, they're really doing this?

    I can't believe this, people doing Breast Cancer research and treatment are trying to HELP people - and Myriad is pulling this stuff? I'm sorry, this is just VERY upsetting to me....

    link to this | view in chronology ]


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