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Biotech Medicine Patents The Courts United States

US District Judge Rules Gene Patents Invalid 263

shriphani writes "A US judge has ruled that Myriad Genetics' breast cancer gene patent is invalid. Hopefully this will go a long way in ensuring that patents on genes do not stand in the way of research. From the article: 'Patents on genes associated with hereditary breast and ovarian cancer are invalid, ruled a New York federal court today. The precedent-setting ruling marks the first time a court has found patents on genes unlawful and calls into question the validity of patents now held on approximately 2,000 human genes.'"
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US District Judge Rules Gene Patents Invalid

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  • Wow.... (Score:3, Funny)

    by nog_lorp ( 896553 ) on Monday March 29, 2010 @09:58PM (#31665932)

    I'm glad this is happening. It's a huge weight off my chest.

  • Conversely (Score:5, Insightful)

    by eldavojohn ( 898314 ) * <eldavojohn@gm a i l . com> on Monday March 29, 2010 @09:59PM (#31665936) Journal

    Hopefully this will go a long way in ensuring that patents on genes do not stand in the way of research.

    And let us also hope that financial backers and investors don't pass on the idea of investing in said research without the potential payout of a full term patent.

    As unpopular as the above statement is on Slashdot and as flawed as the patent system is, it still fulfills purposes making this at least a two sided issue. Ignoring either side is nothing but folly.

    You can revise your statement to read: Hopefully it's a net positive for gene research.

    • Re:Conversely (Score:5, Insightful)

      by alex_guy_CA ( 748887 ) <alex@NoSPAm.schoenfeldt.com> on Monday March 29, 2010 @10:02PM (#31665958) Homepage
      However, most research and medical breakthroughs come from publicly funded money, research, and institutions. They only find their way into the corporate portfolio latter.
      • Re:Conversely (Score:4, Insightful)

        by QuantumG ( 50515 ) * <qg@biodome.org> on Monday March 29, 2010 @11:49PM (#31666592) Homepage Journal

        You can do all the research you like, it won't save lives. You can figure out how to make a drug that will cure [insert undesirable disease here] and publish the formula on the Internet.. watch as no-one will pay for the clinical trials to make the drug legal to sell.

        • Re:Conversely (Score:5, Informative)

          by besalope ( 1186101 ) on Tuesday March 30, 2010 @12:02AM (#31666644)

          The drug formulas can still patented.

          The judge just invalidated corporate patents that restricted others from working on trying to cure problems from "patented" genes without paying royalties.

          • Re: (Score:2, Insightful)

            by QuantumG ( 50515 ) *

            So instead of a race to mass produce the unpatentable drug you have a race to produce the drug for the unpatentable gene. Whatever machinery you want to use to create the situation, the cost of clinical trials means drug companies need exclusivity from lab to drug store. The alternative is nationalized drug creation.. not that there's anything wrong with that, but know where your argument is going.. as the trials have become too expensive to expect drug companies to do in a race.

            • Re:Conversely (Score:5, Insightful)

              by AK Marc ( 707885 ) on Tuesday March 30, 2010 @03:41AM (#31667768)
              You can still patent the vaccine for polio (which the inventor could have patented and declined to because he thought it should be free), but you can't patent the genetic sequence of it. You can patent any treatment for breast cancer you want. However, patenting a discovery about a gene linked to breast cancer can't be done. There's nothing at all in this ruling that would jeopardize any actual or potential treatment or cure. The patent was to block research so no one could treat the "disease" as if someone patented polio was was suing anyone else working on a cure for polio.
      • Re: (Score:3, Interesting)

        by BitZtream ( 692029 )

        Check your funding a little closer. Most of that money comes from grants by drug companies that gets donated to the government to be disseminated to research projects.

        Don't get me wrong, we're (public) losing in the deal but its actually not nearly as bad as you think. They occasionally buy us dinner and bring lube with them.

    • Re:Conversely (Score:4, Insightful)

      by afidel ( 530433 ) on Monday March 29, 2010 @10:07PM (#31665992)
      Gene patents were always dubious to me, however patents on gene detection methods and kits should be fully capable of obtaining patent protection. It's like copyrights on facts vs collections.
      • Re: (Score:2, Insightful)

        by ArcherB ( 796902 )

        Gene patents were always dubious to me, however patents on gene detection methods and kits should be fully capable of obtaining patent protection. It's like copyrights on facts vs collections.

        I agree. How can you patent something that already exists? It would be like discovering some previously unknown roach and slapping a patent on it. Could you charge everyone whose home gets infested by these things? It's not like you invented it. You simply found it. Genes are in every single cell in our body. You can't patent them.

        Now if you were to discover a gene sequence that does not naturally occur in nature... patent away. That might be pretty cool.

        • Re: (Score:3, Interesting)

          by sjames ( 1099 )

          Evil thought: How about e turn it around. If I claim ownership of a dog, and that dog bites someone, I am liable for the medical bills.

          If a biotech firm claims ownership of a gene and that gene causes cancer, they should be liable for the cancer. Perhaps they would be better off with a narrow patent on a particular method of screening for that gene's presence.

        • Re:Conversely (Score:5, Insightful)

          by oiron ( 697563 ) on Tuesday March 30, 2010 @02:40AM (#31667460) Homepage
          And if someone, purely out of random mutation naturally develops that sequence? Sue them for infringement?
      • by MobyDisk ( 75490 )

        I think the problem is that the hard part is finding the sequence. Once you know the sequence, there's tons of systems in place that can detect it. It's like spending a million dollars to find a number.

        • by afidel ( 530433 )
          Making a test that can cheaply identify a specific gene sequence is still a major goal of biotech firms. Today to get a screening for a handful of known cancer and heart disease risks cost over $1,200, much too expensive to be a routine test for the majority of health insurance customers. Drop that cost by 10x and suddenly you have a much larger market.
      • Re:Conversely (Score:5, Insightful)

        by PitaBred ( 632671 ) <slashdot@pitCOWa ... minus herbivore> on Monday March 29, 2010 @11:06PM (#31666328) Homepage

        The device or a novel process? Yes. But you should not be able to patent the gene which effectively makes your device the only way to detect the disease. That is not what the patent system is for. It is for protecting novel inventions, not for locking up essential, basic knowledge with a toll booth.

      • Re:Conversely (Score:5, Informative)

        by reverseengineer ( 580922 ) on Tuesday March 30, 2010 @12:35AM (#31666818)
        The real issue, in my opinion, with these patents is that Myriad tries to make the information of the gene sequence essential to any detection method for that gene. Take a look at Myriad's patent [freepatentsonline.com] for the breast cancer-related gene BRCA2. Right at the beginning, "Specifically, the present invention relates to methods and materials used to isolate and detect a human breast cancer predisposing gene (BRCA2), some mutant alleles of which cause susceptibility to cancer, in particular breast cancer. More specifically, the invention relates to germline mutations in the BRCA2 gene and their use in the diagnosis of predisposition to breast cancer." So at first glance, you might think that this patent refers to a diagnostic test for BRCA2, which seems to be an acceptable place for a patent for many people. After all, DNA sequences are just molecules, and there are any number of non-contentious patented tests for biological molecules already- think of glucose test strips, for instance. Manufacturers have found ways to patent various advances in testing for blood glucose without actually asserting a patent on glucose itself.

        However, when you test for something like glucose, the test result is going to be a concentration. When you talk about performing a test for BRCA2-based cancer susceptibility, you don't just need to "detect" BRCA2, but be able to isolate it and determine whether it differs from the wild-type BRCA2. So Myriad had the idea that in their patent claims they could define their "methods and materials" to be both the likely molecular bio technique intermediates, and also the molecules that are the theoretical outcomes of any BRCA2 test.

        Paraphrasing some of their claims: -We claim the isolated normal BRCA2 sequence, and any isolated subset of that sequence comprised of at least 15 contiguous nucleotides.
        -We claim the isolated major mutant sequence of BRCA2 known to be involved in susceptibility to cancer, and any isolated subset of that sequence comprised of at least 15 contiguous nucleotides.
        -We claim nearly 40 different variants of the major mutant sequence.
        -We claim any sort of cloning vector, expression vector, recombinant cell line, or PCR primer involving an at least 15 contiguous nucleotide stretch of any of the above sequences.

        So Myriad was trying to claim that the invention was a diagnostic method, just that any molecule corresponding to the nucleotide sequences they claimed were an intrinsic part of the "method." What's interesting about the "15 contiguous nucleotides" mention that keeps cropping up is that BRCA2 is over 11000 nucleotides long, producing a protein 3400 amino acids long, such that Myriad laid claim to tiny fragments of the gene which would have had no BRCA2 function on their own.
    • Re:Conversely (Score:5, Insightful)

      by Anonymous Coward on Monday March 29, 2010 @10:24PM (#31666092)

      There is absolutely no way we can grant monopolies on certain aspects of life, to anyone. Whether it is a good business proposal to found science or not, it is not correct at all.

      Patents like this come with the power to hold people ransom on existential needs. That cannot, ever, be right.

      Another reason, Gene's are nature's "programming language". Once you can read some of it, reasonable efforts will help you to understand more of it.
       
        But, there is no point or fairness in granting anyone who finds out "something" first the right to, for many years, control its use. Things will be found out because people NEED to figure them out, even without prospect to get money from patents. This is also why you don't need to patent software - just because someone needed a selectable button and did it first, that does not mean they should be able to patent it and henceforth control all selectable buttons - someone will absolutely, positively need the exact same thing and would have figured it out themselves anyways, with a reasonable degree of certainty.

    • Re:Conversely (Score:5, Insightful)

      by Burdell ( 228580 ) on Monday March 29, 2010 @10:32PM (#31666144)

      Do you think that an astronomer should be able to patent a planet because they saw it first? How about the particle physicists working on the LHC patenting the Higgs bosun if they find it (sorry, no gravity without a license!)? Why should someone be able to patent a naturally occurring gene, just because they found it first? If they find something original, such as an easy way to detect the presence or absence of a gene that can lead to illness, or a way to use that knowledge to treat the condition caused by the gene, patent away, but nobody should be able to patent something that has existed in thousands or millions of people for decades or centuries just because they were the first to track it down. They didn't invent or create anything.

    • Re:Conversely (Score:5, Insightful)

      by robotkid ( 681905 ) <[alanc2052] [at] [yahoo.com]> on Monday March 29, 2010 @10:43PM (#31666226)

      As unpopular as the above statement is on Slashdot and as flawed as the patent system is, it still fulfills purposes making this at least a two sided issue. Ignoring either side is nothing but folly. You can revise your statement to read: Hopefully it's a net positive for gene research.

      Good thought, especially for more tricky examples like patient-derived cell lines or naturally occurring therapeutic molecules, but in this case such worry is not warranted. Treatments, cures, diagnostics, etc are all still patentable, and they are what the investors were looking to make their money from in the first place.

      The central issue at stake was whether the discovery of a gene in and of itself, which is just a snipped of biological information, was patentable, and all the resulting technology that utilized that information would be rendered derivative works. Think about that for a moment, if someone went out and discovered a new type of fish, maybe they'd get to name it but they certainly can't claim to own all future profits made by anyone else catching and selling that fish. More to the point, if someone then discovered that the fish produced a chemical that cured some disease, they original discoverer of the fish would not have the ability to sue and say that was reverse engineering of his patented intellectual property. Discovering a gene is not terribly different - it already existed all over the world long before we had to tools to identify and study it. Discovering is different than inventing, and in the case of genes discovery by itself is a far cry from understanding how it works, much less how to manipulate it to fix a disease.

      Also, for context, the only real reason one would want to patent a gene is some sort of exclusivity clause (i.e. I discovered this breast cancer gene so now only I can work on a cure for it) or for patent trolling (now lets sue all the other folks working on breast cancer cures). Both scenarios would effectively destroy the ability for competing companies to work on the same disease, and lead to a massive gene-squatting free for all. IAAB (I am a biochemist), and I honestly can't think of any scenarios where being able to patent a naturally occurring gene would be good for either society as a whole or even just letting the market do what it does best.

      • Re: (Score:2, Flamebait)

        by eldavojohn ( 898314 ) *

        Also, for context, the only real reason one would want to patent a gene is some sort of exclusivity clause (i.e. I discovered this breast cancer gene so now only I can work on a cure for it) or for patent trolling (now lets sue all the other folks working on breast cancer cures). Both scenarios would effectively destroy the ability for competing companies to work on the same disease, and lead to a massive gene-squatting free for all. IAAB (I am a biochemist), and I honestly can't think of any scenarios where being able to patent a naturally occurring gene would be good for either society as a whole or even just letting the market do what it does best.

        I am not a biochemist so I must ask some questions about your particular example with breast cancer genes. I'm lead to believe that 'discovering a breast cancer gene' is extremely difficult. Doesn't the number of sets of DNA one must collect coupled with the accuracy of those collections coupled with the willingness of the volunteers coupled with the number of potential snippets of DNA that could be the gene coupled with all sorts of other complications and permutations make finding such a gene like findi

        • Re: (Score:3, Insightful)

          by Anonymous Coward

          It's ironic that we can even call this newer thinking "science." The whole point of the scientific method is to allow for peer review and improvement. For centuries, mathematicians and inventors have been building upon one another's work without compensation expectations --they were already schooled and rich enough to be in their advantaged positions. How can Galileo patent finding moons with his telescope, therefore keeping others from legally verifying there is a moon there at all? Now that everyone is ed

    • I dunno. What constitutes infringement of such a gene patent?

      I think it's fiarly obvious that exclusive rights to genes, read literally, would be stupid. After all, that would allow the pharmaceutical company to go around suing breast cancer patients for patent infringement on the theory that they probably have the patented genes. If these are not provided for in statute specificaly, I don't think they should be subject to patent.

      The closest thing I can think of are plant patents, but they are surprising

    • by Nethead ( 1563 )

      eldavojohn: Most insightful. The one day I don't have mods.

  • by paper tape ( 724398 ) on Monday March 29, 2010 @10:01PM (#31665954)
    Well of course its invalid...

    God could claim Prior Art.

    ;)
    • but then he'd have to provide an address for service, and there goes Christianity.

      • by Cryacin ( 657549 ) on Monday March 29, 2010 @10:21PM (#31666076)
        Come on, if God was such a freaking fantastic engineer, why the hell did he put a sewage outlet right in the middle of a recreational zone?
        • Re: (Score:2, Funny)

          by Anonymous Coward

          Hey! New Jersey was created by the British, not God!

        • Come on, if God was such a freaking fantastic engineer, why the hell did he put a sewage outlet right in the middle of a recreational zone?

          A recent (non-scientific) sampling I made of the cultural practices depicted in a certain category of popular films would suggest that for many, both are recreational and the placement is considered a feature. Then, of course, there's the Germans.

          As for the article, if you think patenting genes is outrageous, consider the patenting of turmeric [wikipedia.org].

  • It'll be overturned on appeal.

  • by pecosdave ( 536896 ) * on Monday March 29, 2010 @10:02PM (#31665960) Homepage Journal

    Seriously, all this groping around in my genes and telling me that they owned anything they found. Fucking lawyers.

    • Re: (Score:3, Insightful)

      by JustShootMe ( 122551 ) *

      Yeah. that's not lawyers! That's a wife!

    • It's unclear to me why the lawyers are the ones you blame and not, say, the executives at Myriad. Or the Congress men and women who worship at the feet of the IP industry.

    • Attacking lawyers completely misses the point. You should be attacking the greedy medical researchers and doctors who decided to patent a gene. Lawyers are just middlemen. If the doctor-inventors weren't greedy SOBSs, they wouldn't have patented the genes to they could extort a higher amount from women trying to not die of breast cancer.

  • Monsanto (Score:5, Interesting)

    by Anarki2004 ( 1652007 ) on Monday March 29, 2010 @10:03PM (#31665962) Homepage Journal
    I would like to see something similar happen to Monsanto's patents.
    • by Manfre ( 631065 )

      Sadly, not going to happen. Monsanto's will hold up a lot better because their patented material was created through selective breeding.

      • Re:Monsanto (Score:5, Interesting)

        by Bruha ( 412869 ) on Monday March 29, 2010 @10:21PM (#31666068) Homepage Journal

        I think it should be illegal though. If you have a farm next door to a patented crop, bees cross polinate, and then monsanto is knocking on your door.

        In essence their patent is viral in nature.

        • It would be one thing if the farmer were complaining he couldn't sell his crop because it was contaminated. Instead he was found to be using the features of the Monsanto crop (Roundup resistance).

          If the crop just blew over and he still grew it as normal it'd be one thing, but instead he knew it was genetically modified and he was using that feature of it to make his growing easier.

      • fine, but wouldn't that make the patent for the method of selective breeding that led to their GM plants?

        claiming to have a patent on the process of pollination is a bit much, IMHO.

    • Monsanto is a culprit but the issue much larger than just this one company. We need to help governments pull their collective heads out of their collective you know whats. This link sums up a lot of the impacts that can be seen and forecast due to various Countries' Seed Acts. http://www.zcommunications.org/the-indian-seed-act-and-patent-act-by-vandana2-shiva [zcommunications.org]
  • I'm glad and all... (Score:5, Interesting)

    by JorDan Clock ( 664877 ) <jordanclock@gmail.com> on Monday March 29, 2010 @10:03PM (#31665970)
    But I'm kind of upset that we live in a society that we have to tell someone "No, you cannot have exclusive rights to a natural occurrence." Worse yet, this "patent" prevented anyone from even looking at the gene, whether it was for diagnostic or research purposes.
  • Natural Resource (Score:5, Insightful)

    by LightPhoenix7 ( 1070028 ) on Monday March 29, 2010 @10:09PM (#31666006)
    You can't patent coal, or wood, so why should you be able to patent a natural resource like DNA? If they create something new from it, like a new allele or treatment, I'd say that's fair game. In the end, this is an extremely important ruling, but unfortunately it's probably not the end. It will probably require the Supreme Court to make a ruling. I don't see anyone involved giving up that easily.
    • by robbyjo ( 315601 )

      Even for a new allele, say a SNP, its combination is only A, C, T, or G. Unless they can show that it is highly unlikely that the patented modification would occur naturally, any new alleles should be patent free. And heck, they can't compare the chance with pure random chance since we know that mutations / gene modifications do not occur randomly either. Claiming so would be very hard.

      New treatment may or may not be patentable as well. If the treatment involves a naturally occurring sequence from other peo

      • I'm pretty sure this case isn't all that far reaching.

        Certainly the treatment, even if its naturally occurring, would still be patentable. Sure, they wouldn't likely be able to win a lawsuit against a guy whose body was producing their treatment (ala Monsanto), but they could definitely win against another pharma producing and selling their patented treatment in vats. Which is what they want the patent for anyways.

        The allele thing is probably similar. They could still patent the assembly of the pieces in

  • by Anonymous Coward

    Back in my day, genes were supposed to help give you the rugged looks of a cowboy or an outdoorsman, not of a greasy 19-year old kid on the make at the disco with his obnoxious friends. Patent genes! What will they think of next!!

    (after whispered exchange)

    Ohhhhh. Um. Never mind!

  • by BlueBoxSW.com ( 745855 ) on Monday March 29, 2010 @10:33PM (#31666154) Homepage

    See the difference?

  • mother fucking nature

    greedy douchebags

  • Don't forget GMOs (Score:5, Informative)

    by JumboMessiah ( 316083 ) on Monday March 29, 2010 @10:41PM (#31666210)

    Gene patents are also big in the agriculture industry [twnside.org.sg]. And they actively sue [iastate.edu] to keep it that way.

  • Hopefully this will go a long way in ensuring that patents on genes do not stand in the way of research.

    If you look at the empirical data [umd.edu], gene patents don't interfere with research. In a survey of 414 biomedical researchers at universities, government, and nonprofit institutions, none of the 381 respondents reported abandoning a line of research due to patents and only five delayed completion of an experiment for more than one month. Only one respondent reported paying for access to research materials co

    • Re: (Score:3, Insightful)

      by Chris Burke ( 6130 )

      So gene patents are both ethically wrong since they're patenting a discovery instead of an invention, and useless for the patent holder as well. Good to know.

    • Only one respondent reported paying for access to research materials covered by a patent

      sounds to me like 1 out of 381 research labs were using patented genes. either the patented genes aren't all that interesting (possible) or the researchers are actively choosing not to research those genes to avoid the patent issues.

  • by pearl298 ( 1585049 ) <mikewatersaz@NosPaM.gmail.com> on Monday March 29, 2010 @10:48PM (#31666254)
    The US Supreme Court ruling used the term "anything under the sun that is made by man".

    The essence of this lawsuit is that the natural genes were "discovered" not "made by man".

    In other words these patents were invalid under existing law. Nothing new here, bad patents have been around since King James (the gay King of England and Scotland).
    • They were not made by man. They were made by woman (a.k.a. your mom).
    • Hmm, so if I'm a Platonist, then...everything already exists in Forms, thus everything is discovered, never invented, thus...no patents?

  • Well, I suppose it's nice that someone finally ruled you can't patent the genetic code itself, but the net change will be practically nothing.

    If they can still patent every single technique and tool involved in examining, testing, or isolating the gene then who gives a crap if they pretend they own the code? We'll still end up reinventing the wheel every time we'd like to look at any known gene; either that or we'll pay thousands of dollars in patent fees per procedure. I suppose it's nice that some distr
  • I'm still waiting on my patent on fire to go through.

  • Henrietta Lacks (Score:2, Informative)

    by blaster151 ( 874280 )
    It was so surreal to see this as the most recent headline on Slashdot - two minutes before, I'd finished listening to the audio version of "The Immortal Life of Henrietta Lacks," which touches on issues surrounding genetic research and the unfortunate incursion of capitalism into tissue storage and research. The book itself is a fascinating mix of science and history, but the Afterword is all about the commercialism of genetic research and the obstacles it's introducing to scientific progress. Who owns hu
  • Patents, even of genes, may not be a bad thing. Here's the point of patents: you have to reveal how it works. Why? to advance the state of the science. Not to create a monopoly, but rather to prevent them. I know this is counter intuitive. But it creates a a situation where the next research group can come along, study the patent and then say "Aha! Now we know the next step to take". And as long as they can show a substantial improvement, they can patent their work as well, even *before* the previous patent

  • It occurred to me that capturing genetic code as a database is somewhat (albeit remotely) like taking a photograph of something that already exists in nature. If patents are there to protect invention (ie, to encourage invention by making it profitable), why is literary work not patentable? If a sci-fi writer invents a new scientific concept and builds a story around it, he may be able to patent that scientific concept, but there's nothing to stop other writers from stealing his invention in writing, is th
  • I mean, who wants to have to pay royalties whenever they get cancer? ;-)

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