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The Courts Biotech Medicine Patents

Supreme Court: No Patents For Natural DNA Sequences 214

Posted by timothy
from the finer-distinction-than-I'd-like dept.
ColdWetDog writes "The ongoing story of Myriad Genetics versus the rest of the world has come to an end. In a 9-0 decision, the US Supreme Court has decided that human genes cannot be patented. From a brief Bloomberg article: 'Writing for the court, Justice Clarence Thomas said isolated DNA is a "product of nature and not patent eligible merely because it has been isolated." At the same time, Thomas said synthetic molecules known as complementary DNA, or cDNA, can be patented because they require a significant amount of human manipulation to create.' Seems perfectly sane. Raw genes, the ones you find in nature are, wait for it — natural. Other bits of manipulated DNA / RNA / protein which take skill and time to create are potentially patentable. Oddly, Myriad Genetics stock actually rose on that information." Adds reader the eric conspiracy: "The result for Myriad is that they still have protection for their test, however the decision also allows researchers to work with the DNA sequences that are predecessors to the cDNA used in the test." Here's an AP report on the ruling, as carried by the Washington Post.
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Supreme Court: No Patents For Natural DNA Sequences

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  • Why is it odd? (Score:5, Interesting)

    by Eskarel (565631) on Thursday June 13, 2013 @11:12AM (#43997023)

    The court case is over and the result wasn't actually all that bad. Sure Myriad and their stock holders would much rather have complete patent rights to the whole thing, but they kept the protections on their actual asset and the court case is now final and decided. Hell even if they'd lost completely their stock probably would have gone up because at least the risk was gone.

    • Re:Why is it odd? (Score:5, Insightful)

      by bonehead (6382) on Thursday June 13, 2013 @11:36AM (#43997413)

      The result wasn't that bad, but the real question is "Why the fuck was this ever even an issue in the first place"?

      Patents should be for creations, not discoveries.

      The ONLY people who should be entitled to a patent on my genome is my parents, and even that is questionable.

      Or, I could see a patent on genes being issued to either "God" or "The Universe", depending upon religous beliefs (or lack thereof).

      But this case should have never even been allowed to waste the court's time.

      • by gman003 (1693318) on Thursday June 13, 2013 @12:23PM (#43997985)

        Or, I could see a patent on genes being issued to either "God" or "The Universe", depending upon religous beliefs (or lack thereof).

        Once again, I see people would rather ignore Pastafarianism than accept the objective evidence of its correctness.

        I will note that DNA was obviously made by the Flying Spaghetti Monster, in his image. Why else would the foundation of life be so noodley? Yet more evidence we are correct!

        • Re: (Score:2, Funny)

          by Anonymous Coward

          Once again, I see people would rather ignore Pastafarianism than accept the objective evidence of its correctness.

          I will note that DNA was obviously made by the Flying Spaghetti Monster, in his image. Why else would the foundation of life be so noodley? Yet more evidence we are correct!

          Oh, you religious nuts are all the same, twisting the evidence to reinforce your own nonsensical beliefs. If DNA were really the creation of some mythical Pasta, how do you explain the disparity between the portion of double helical pastas and the portion of double helical DNA? Or more to the point, where are the single helix based lifeforms, modeled in His noodley image?

          No, if the latest findings from the field of theoretical physics are to be considered, the best evidence is for some form of six sided god

        • Re: (Score:3, Funny)

          by Anonymous Coward

          Ramen brother. Ramen.

        • by shentino (1139071)

          Anyone thinking DNA should be patentable has a twisted mind.

      • by cdrudge (68377)

        Patents should be for creations, not discoveries.

        Aren't all creations just discoveries on how to do something a particular way?

        • Re:Why is it odd? (Score:5, Interesting)

          by PRMan (959735) on Thursday June 13, 2013 @12:55PM (#43998271)
          Yes. But you can't patent a new species of plant or animal just because you are the first to find it. Those are "natural" ie found in nature. Taking those building blocks and making a discovery with them (a tungsten wire will glow when electricity is applied to it) is worthy of patent protection, not "hey, I found this new thing called tungsten and nobody else can use it".
        • by c++0xFF (1758032)

          Discovering a new way of putting things together == patentable
          Discovering something that already exists == not patentable

          It doesn't matter if it's nature or prior art: if it already exists, is shouldn't be covered by a patent.

      • by Anonymous Coward on Thursday June 13, 2013 @12:33PM (#43998063)

        The ONLY people who should be entitled to a patent on my genome is my parents, and even that is questionable.

        It's probably much too late for your parents to claim a patent. If they're anything like my parents you (the invention) were publicly disclosed long before you were even born. The method used for your creation is also widely known, with an entire industry devoted to educational videos documenting many examples of the process and it's variations.

      • by mdmkolbe (944892)

        Patents should be for creations, not discoveries. The ONLY people who should be entitled to a patent on my genome is my parents, and even that is questionable.

        But what if someone created/discovered a gene you have before your parents did? In patent law (unlike copyright), independent creation/discovery is not a defense. All that matters is who was first. This means that protections against DNA patents need to be based on a stronger line of reasoning.

      • what if it's the only way to read it? doesn't this refer that the middle product in the test is patented?

        wouldn't it be more apt that the methods - machinery etc and how they're used - involved in the test was under patent and not some molecyles.

    • Re:Why is it odd? (Score:5, Insightful)

      by Samantha Wright (1324923) on Thursday June 13, 2013 @11:44AM (#43997559) Homepage Journal
      It's disastrous. cDNA is just a direct copy of the most important part of what's in the genome—the actual transcript that gets used to make the final protein. This isn't a victory at all.
      • Re: Why is it odd? (Score:2, Informative)

        by Anonymous Coward

        They said may be patentable. Naturally occuring cDNA falls under the original ruling which stipulated human modification is a requirement for patent eligibility.

        • Re: Why is it odd? (Score:5, Interesting)

          by Samantha Wright (1324923) on Thursday June 13, 2013 @12:32PM (#43998055) Homepage Journal
          The only time cDNA occurs naturally is in the reproduction of a retrovirus or the replication of a retrotransposon. Myriad is still using the natural human sequence in their tests. This is like getting ownership of a quote from a book because you copied it into a Notepad window and then into Google, instead of just pasting it directly into Google in the first place, and then claiming it's a good way to find a certain rare edition of the e-book because it contains a typo made by the original author. It's completely and utterly intellectually dishonest.
      • by Rob Y. (110975) on Thursday June 13, 2013 @12:46PM (#43998155)

        Right. The process for making a cDNA copy of a particular sequence is probably patentable. But I'm betting Myriad didn't invent that process. Whoever did should be able to patent it, and Myriad should have to pay them royalties for applying the process to the BRCA gene. And maybe something as general as cDNA construction should be a FRAND-type patent, so that it's owner can't 'own' all DNA by owning the standard testing methodology. Just like Motorola isn't allowed to own the cellphone industry by virtue of having come up with the standard communications protocol used by cellphones.

        • The core enzyme in question, reverse transcriptase, occurs naturally in humans, and was first isolated in 1970 by two independent teams. The process is something like "put it in hot water with raw materials, your template sequence, and some salt." Even if a patent were awarded for it, it would have expired in the late nineties.
      • Of all the days not to have mod points. Pretty much any genetic research starts by making a cDNA library. It's not that difficult; I think you can probably buy a kit to do it these days.

        It's only a matter of time now until some researcher comes up with a different test for, or treatment of cancer linked to, this particular gene and Myriad's lawyers sue because they "must have" made use of the patented cDNA sequence in their research.

        • Yeah, it's one of the easiest things to kit since it's just an extra step on top of PCR. All of the big vendors supply it.

          Given that the patented sequence is literally a PCR assay for a handful of single-nucleotide mutations, it would be technically impossible to not use the sequence in question, so they can be certain that such a case would go forward. From the patent:

          All four sequence variants are heterozygous and each appears in only one of the kindreds. Kinderd 2082 contains a nonsense mutation in exon 11 (FIG. 9A), Kindred 1910 contains a single nucleoting insertion in exon 20 (FIG. 9B), and Kindred 2099 contains a missense mutation in exon 21, resulting in a Met.fwdarw.Arg substitution. The frameshift and nonsense mutations are likely disruptive to the function of the BRCA1 product.

    • Re: (Score:2, Offtopic)

      by Sarten-X (1102295)

      Wait, you mean the stock market is a complex system that isn't accurately described by a single "good news/bad news" model? But Slashdot has taught me that the easy and simplistic solution is always right!

      Next you'll be telling me that a gold standard won't actually fix economic problems, or that Linux won't immediately replace Windows everywhere once it has $FEATURE... What madness is this?

    • I wonder how much it costs to sue all the way to the Supreme Court. And lose.

    • Re:Why is it odd? (Score:4, Informative)

      by RDW (41497) on Thursday June 13, 2013 @12:29PM (#43998035)

      Sure Myriad and their stock holders would much rather have complete patent rights to the whole thing, but they kept the protections on their actual asset

      If this is the case (and it probably is, hence the increased stock price), then the BRCA genes effectively remain patented in the US. Anyone 'skilled in the art' (like a grad student or junior technician) can trivially create 'artificial derivatives' of a known gene sequence (e.g. cDNA, as mentioned in the decision) just by 'designing' some primers (there's software to automate this), ordering them in (together with the relevant reagent kits), and following some step by step protocols. If this sort of thing is still patentable (as it seems to be), and Myriad is still the only provider allowed to offer a BRCA testing service, then the SC decision will make little practical difference for the moment - Myriad will still 'own' the genes if they are screened by standard methods. However, the decision might be good news for anyone using a 'next generation' sequencing approach, where relevant mutations are pulled out from (e.g.) a whole genome sequence (which isn't much more expensive than Myriad's price for targeted screening, and will be much cheaper in future):

      http://www.genomicslawreport.com/index.php/2010/10/11/a-do-it-yourself-genomic-challenge-to-myriad-the-fda-and-the-future-of-genetic-tests/ [genomicslawreport.com]

      • by rahvin112 (446269)

        Myriad was claiming ownership of the entire Gene, any new tests to identify it using different methods or cDNA would be, according to Myriad, covered by the patent. What the supreme court decisions does is says that Myriad owns the specific cDNA they came up with. It may be even possible that different cDNA that accomplishes the same purpose would not run afoul of the patent and tests that didn't rely on the cDNA would be immune as well. This was an important decision because Myriad's claims had basically s

  • by some old guy (674482) on Thursday June 13, 2013 @11:12AM (#43997027)

    A breath of IP sanity from SCOTUS? And unanimously at that?

    Pinch me. Surely I dream.

    • by mooingyak (720677)

      The unanimous part was the weird bit for me. Partly because they all agreed, and partly because I thought the kind of cases that would have unanimous decisions usually didn't make it to the SCOTUS.

      • by dkleinsc (563838) on Thursday June 13, 2013 @12:13PM (#43997875) Homepage

        Some reasons that you get unanimous SCOTUS decisions:
        1. SCOTUS took the case primarily to send a strong message to current and future courts and legislatures and presidents. A lot of those kinds of decisions get handled at the circuit court level, but in future case law it's one thing to cite that the Ninth Circuit said this or the First Circuit said that, and it's another thing entirely to cite a unanimous decision by a fairly divided Supreme Court.
        2. It can be a judicial smack-down when a circuit court gets something wildly wrong.
        3. It could be that the Chief Justice wants to get everyone to speak with one voice on a particular issue. This usually causes decisions to take a while, as the Chief convinces the 4 holdouts to agree with the majority.

        • by rahvin112 (446269)

          The court is not "fairly divided". Something like 80% of their decisions are unanimous. You only hear press about the 5-4 decisions which are an extremely small proportion (about 10%).

    • by UnknowingFool (672806) on Thursday June 13, 2013 @11:29AM (#43997319)
      No, you're not. And don't call me Shirley.
    • Re: (Score:2, Interesting)

      by Anonymous Coward

      A breath of IP sanity from SCOTUS? And unanimously at that?

      Indeed.

      Even the good recent decisions are uncomfortably often a 5-4 split (meaning that we could be one retirement away from flipping them). That thought disturbs me...

    • by Hatta (162192) on Thursday June 13, 2013 @11:37AM (#43997427) Journal

      This isn't good enough. Creating cDNA is not a creative act. Extract RNA, apply a reverse transcriptase. Now you have cDNA. The sequence of the cDNA(and the protein product it codes for) is 100% determined by the sequence of the RNA, which is a natural product.

      • by OG (15008)
        I think it's a bit more complicated than that. Blindly creating cDNA is one thing. Identifying particular cDNA that can be used for therapeutic purposes is a whole other thing and requires a lot of research. I can understand protections for the first researcher/group to identify a particular sequence that can be used for gene therapies. It's fair to address exactly what those protections should be. We need protections from people who want to patent sequences willy-nilly. There needs to be a strong reason fo
        • by afidel (530433) on Thursday June 13, 2013 @12:06PM (#43997803)

          Perhaps a form of copyright may be more appropriate there than patent.

          Oh hell no! Since copyright is DeFacto forever thanks to the MickyMouse Copyright Extension Act it would be MUCH worse if they could be granted a copyright on genes.

          • by OG (15008)
            Which is why I said a form of copyright. I don't think this type of innovation falls cleanly under either patent or copyright law, but I think a case can be made for some time-limited protection for the work.
        • by Hatta (162192)

          Identifying particular cDNA that can be used for therapeutic purposes is a whole other thing and requires a lot of research.

          Identifying a particular gene or piece of mRNA that can be used for theraputic purposes requires a lot of research too. This has nothing to do with whether that gene, mRNA, or cDNA is a "natural product" or not.

          • by OG (15008)
            If the researchers do isolate a particular strand of cDNA that does not occur in that particular form, by which I mean you're not going to find that piece of cDNA existing as a standalone entity within a cell and that particular sequence as a stand-alone provides functional, therapeutic effects, I think that's a gray area.
            • by Hatta (162192)

              The "particular form" is irrelevant. It's the same sequence whether it's mRNA or cDNA. You might as well allow people to copyright public domain works by doing a ROT13 transformation.

              • by OG (15008)
                I don't think it is irrelevant. If someone found a unique splicing from three different areas of a gene, a splicing that is not produced by the body, it's not "natural". The body doesn't produce that particular variant, even though it's composed completely of coding regions from a gene. The researches constructed that sequence from bits of an existing gene. They created that particular sequence. To go to the extreme end, one could say that any sequence is going to be an alternative splicing of individual ba
      • by tpjunkie (911544) on Thursday June 13, 2013 @11:56AM (#43997699) Journal
        Assuming that you're targeting processed mRNA. I feel the same way as you however. I believe that producing cDNA of a naturally occurring protein (whether wild type or novel mutation) is not "creation" per se, so much as translation (well, reverse translation followed by reverse transcription if you want to be anal) of an existing, natural item. Are translations patentable? Perhaps copyright is more appropriate, although the existing copyright laws might actually be worse than patent law.
      • > Creating cDNA is not a creative act.

        Umm your sentence is self-contradictory.

    • Mostly Unanimous. Justice Scalia wrote a brief concurrence that, depending on how it read, suggests he doesn't believe in molecular biology. I am giving him the benefit of the doubt and assuming he is just trying to say that SCOTUS should avoid pronouncing scientific facts in binding legal opinions.

      JUSTICE SCALIA, concurring in part and concurring in the judgment. I join the judgment of the Court, and all of its opinion except Part I–A and some portions of the rest of the opinion going into fine details of molecular biology. I am unable to affirm those details on my own knowledge or even my own belief. It suffices for me to affirm, having studied the opinions below and the expert briefs presented here, that the portion of DNA isolated from its natural state sought to be patented is identical to that portion of the DNA in its natural state; and that complementary DNA (cDNA) is a synthetic creation not normally present in
      nature.

  • by sjbe (173966) on Thursday June 13, 2013 @11:15AM (#43997079)

    Oddly, Myriad Genetics stock actually rose on that information.

    That's not really surprising. All that means is that the market expected the news to be worse than it actually was. Once the ruling was handed down and the uncertainty removed, the stock rebounds based on the new information. You'll see this all the time where a company has a terrible quarter and their stock price goes up because while it was indeed terrible, it wasn't as terrible as expected.

    • Ah yes. Thanks. I keep trying to apply rationality to the stock market.

      You'd think I would have learned by now.

      • by Sique (173459)
        I don't see any sanity in your reasoning. Everyone knew this case was at the SCOTUS, and everyone knew that patenting something that occurs naturally was not what patent law was supposed to do. Thus the stock had been tanking already at the time when the lawsuit became known. Stocks usually move at new information, not at confirmation of old information.
        • Everyone knew this case was at the SCOTUS, and everyone knew that patenting something that occurs naturally was not what patent law was supposed to do.

          There is NEVER certainty regarding a SCOTUS ruling. Expectations cover a spectrum and not everyone makes the same bet. SCOTUS could have ruled in such a way that this company lost their patent protection altogether which appears to not have happened. Just because what you outlined is the most likely outcome does not mean it is the only possible outcome. Some people were clearly betting on other, more pessimistic, outcomes than the one that actually occurred. It's pretty much the same thing as betting o

      • by sjbe (173966) on Thursday June 13, 2013 @12:06PM (#43997807)

        Ah yes. Thanks. I keep trying to apply rationality to the stock market.

        It is extremely rational behavior. Think of it like playing a poker hand. You have imperfect information so you make your bets based on the likelihoods of various results. Some results are more likely that others and you play accordingly. As more information becomes available your betting strategy may change. That is exactly what is happening here.

        One has to understand what is driving prices for the stock market to make any sense. Information about company performance is at the core but it is NOT what drives prices. There is no direct link between a company's financial performance and their stock price. What drives prices is peoples expectations and in some cases people's expectations about other people's expectations. (and even expectations about expectations about expectations... you can keep going) If you invest in the stock market you are placing a bet not so much on what a company will do but on what other people will think about the company. When you buy IBM stock you are saying in essence "I expect more people to find this valuable in the future". Any secondary market (stocks, baseball cards, tulips, real estate, etc) works this way. It's shockingly rational (with some exceptions) but highly chaotic and thus hard to predict.

        • by rahvin112 (446269)

          Absent a large shareholder making a major move in position you can't know what is driving the market on any day. It's an irrational and unpredictable well of emotion. Anyone that tells you differently is an idiot or trying to sell you something. The market and what drives it is a black box of emotion, those news stories that claim that X event is driving Y change are complete speculation.

          Absent direct polling of all players in the market no one has any idea what is driving the market. That isn't to say you

      • by PRMan (959735)
        Apply raw animal emotion to the stock market and then do the opposite. That should be the same as "buy low", "sell high".
    • by stanlyb (1839382)
      They asked for $100, they got $50, and they expected to have $1...So, win-win.
    • It was actually good news for Myriad, not just non-terrible news. While they did lose some parts of their patent, the core test is still protected.

      In addition the way the decision was stated settles the entire field of biotech patents in such a way as to give certainty that there will be lots of opportunity for patentable inventions in the field, AND that R&D activities on isolated human DNA will be able to continue without threat of patent suits.

      It isn't just Myriad stock that is up today. The stock ma

  • by pablo_max (626328) on Thursday June 13, 2013 @11:15AM (#43997099)

    I am actually surprised by the ruling. I fully expected the courts to say you can patent anything, so long as you are first to file. Glad to hear it nonetheless.

    • I am actually surprised by the ruling. I fully expected the courts to say you can patent anything, so long as you are first to file. Glad to hear it nonetheless.

      I'd assume that you can, in fact, apply to patent anything; but one would hope that "Prior art older than human civilization, quite possibly older than humanity, depending on the DNA involved" would cause you problems...

    • by rubycodez (864176)

      I suspect the mega-corporation with our government in their pockets have already thought this through. They will use big pharmy and gene therapy to get artificial dna sequences into your genome. Then they own your genetic ass anyway.

      Laugh now, and just wait about 10 years....

      • by riverat1 (1048260)

        Oh, so that's what GMO organisms are for, so big business can own our ass (even more than they already do).

  • by LF11 (18760) on Thursday June 13, 2013 @11:25AM (#43997233) Homepage

    This is definitely call-everybody-I-know newsworthy! Holy cow! Gonna mark this day and celebrate it next year! I can't believe this is happening!

  • by SpaceManFlip (2720507) on Thursday June 13, 2013 @11:34AM (#43997387)
    Reading the book "Next" by Michael Crichton awhile back alerted me to the nonsense going on with gene patents. There's even a scene in the book where a guy with a rare genetic mutation is chased by the equivalent of bail bondsmen for a company holding a patent on his genes. They want to capture him and bring him in for running around with "their" genes in his body or something like that.

    Good job, SCOTUS

  • A thought experiment (Score:5, Interesting)

    by wbr1 (2538558) on Thursday June 13, 2013 @11:37AM (#43997447)
    What if a company makes and patents a cDNA that is later found to also exist naturally?

    Have we sequenced every variant of every species?

    Case in point, Monsato make GM crops that resist herbicides. What if the parts they are patenting, have analouges in some other plant in the wild?

    • by Nutria (679911) on Thursday June 13, 2013 @11:43AM (#43997549)

      Then presumably they'd be overturned by prior art.

    • by stanlyb (1839382)
      They will sue the "Nature", and rape her...
    • Realistically, it goes back to court.

    • by ankhank (756164) * on Thursday June 13, 2013 @12:10PM (#43997853) Journal

      ! yep

      We already know that's the case for antibiotics. And we know plants compete with one another by suppressing competitors' growth.

      Seems to me Thomas's comment is intended to add a loophole -- "we created this cDNA and patented it, so we have the patent, so if you claim you found the exact same thing out there in nature somewhere, it must be you stole it from us." Betcha.

      http://www.nejm.org/doi/full/10.1056/NEJMp1215093 [nejm.org]
      The Future of Antibiotics and Resistance
      Brad Spellberg, M.D., John G. Bartlett, M.D., and David N. Gilbert, M.D.
      N Engl J Med 2013; 368:299-302January 24, 2013DOI: 10.1056/NEJMp1215093
      ----------------
      "... after billions of years of evolution, microbes have most likely invented antibiotics against every biochemical target that can be attacked — and, of necessity, developed resistance mechanisms to protect all those biochemical targets. Indeed, widespread antibiotic resistance was recently discovered among bacteria found in underground caves that had been geologically isolated from the surface of the planet for 4 million years.2 Remarkably, resistance was found even to synthetic antibiotics that did not exist on earth until the 20th century. These results underscore a critical reality: antibiotic resistance already exists, widely disseminated in nature, to drugs we have not yet invented.

      "Thus, from the microbial perspective, all antibiotic targets are “old” targets...."
      -----------------

    • If you find it you can use the natural form.

    • What if a company makes and patents a cDNA that is later found to also exist naturally?

      Have we sequenced every variant of every species?

      Case in point, Monsato make GM crops that resist herbicides. What if the parts they are patenting, have analouges in some other plant in the wild?

      Monsanto is, in part, doing exactly what you suggested. The genetic element that grants their crops resistance to glyphosate (Round-Up) was discovered in microbes growing in waste runoff containing glyphosate [nih.gov]. The patent is on the plants that have been transformed / engineered to contain this naturally occurring resistance gene in their genome and express it to garner resistance to the herbicide.

      The cDNA argument is much worse to ludicrous. The only thing one could imagine is patentable surrounding the issu

  • by the eric conspiracy (20178) on Thursday June 13, 2013 @11:40AM (#43997489)

    This is really a great decision that benefits everyone, in the following ways.

    1. Isolated DNA is not patentable. This allows R&D on DNA to proceed unencumbered.

    2. Commercial development of technologies using synthetic DNA derivatives for useful products is encouraged by allowing patent coverage.

  • SCOTUS agrees unanimously on something? *Looks at the calendar* It's not April 1st... Am I being punked??

  • I was planning to patent Sunshine.

  • Isn't cDNA just same DNA but written a bit differently? That is, it contains same information. And it looks like this ruling allows one to patent that information! The very same information that is used to produce proteins in YOUR body. This ruling sounds like - we cannot allow you to patent your record in MP3 format, but if you transcode it to FLAC - go ahead and patent it. Doesn't make any sense.
  • Could we please use this same logic to say that the human desire to openly and freely share thoughts and ideas is natural and therefore ineligible for legal protection? Thanks.
  • Naturally-occurring human genes is a narrowly defined set that isn't patentable, but still this will save many lives by allowing cheap genetic testing for things such as breast cancer susceptibility.

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