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Should DNA be Patentable? 257

Posted by Hemos
from the debates-of-our-time dept.
nexex writes: "This story seems brings the patent debate home; specifically, should a company or person be able to 'own' your DNA? Obviously researchers want to profit from their discoveries, thus funding new research. But critics counter they are profitting at the expense of our health, citing restrive screening licenses for things such as breast cancer and Alzheimer's. Citing a figure from a UK activist group, 500,000 gene or gene sequence patents have been applied for worldwide. Another excellent article on this issue from Salon.com was from a couple years ago."
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Should DNA be Patentable?

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  • too late (Score:3, Insightful)

    by dal3 (195148) on Sunday February 03, 2002 @12:17PM (#2946351)
    If someone tries to patent my DNA, shouldn't I be able to provide them with lock of hair as an example of prior art?
  • NO! (Score:2, Insightful)

    by koekepeer (197127)
    DNA should not be patentable. It would be morally wrong, since the discovery of a gene is exactly that: nothing new and unique has been created, it's just finding something that was there already.

    Patents should protect new ideas, not entities that are already present in nature and are waiting to be found.

    However, when you can put a piece of DNA to use in any way, the methodology your technique follows should be patentable. A new method for application of a certain DNA sequence is something that can be new and innovative.
  • by Calle Ballz (238584) on Sunday February 03, 2002 @12:20PM (#2946364) Homepage
    Put a patent and a copyright on the strands that make up diseases like AIDS, Herpes, Malaria & the common cold. I'm tired of catching a cold, and I sure as hell don't want to get any terminal diseases in the near future. If you think about it, DNA is really a kind of software, it is intellectual property that's been unclaimed. Well dammit someone should claim that IP and protect it's right to not be copied unless specifically authorized by the rightful owner and in compliance with the DMCA!
    • Notwithstanding the fact that your point was funny, you give a great example of why it's dangerous and unfortunate that we apply the vocabulary of physical property to the concept of "intellectual property".

      it is intellectual property that's been unclaimed

      ...as if intellectual property is part of a landscape you want to stake your claim to, instead of being part of the creative process. Sigh. If only we could discuss it differently, as a means instead of an end, or a journey more than a destination.
      • As anybody who runs an online forum knows, intellectual property is a two-edged sword. Either the author holds the copyright to his comments, in which case only the author is responsible for its contents, and any law that it infringes (libel, slander), but the board owner may not use those comments in a different context.

        Or the editor (board owner) holds the copyrights, in which case he may do whatever he wants with the contributions, but he is also responsible for any laws that may get violated.

        Shouldn't it be the same in biotech: if a company is stoopid enough to patent the genetic sequence of AIDS, shouldn't it be then forced to also accept legal responsibility for AIDS. I.e. face "wrongful death" lawsuits from each and every victim of AIDS. And if the company maliciously withheld treatment, or sold that treatment too expensively, add blackmail and murder to the list of accusations...

  • by Kjella (173770)
    I do realize medical research is a huge money sink, but depending on the disease, if you get the right patents you can get a limited monopoly in a marked where there are *no* substitute treatment, and that people can't do without (aka they would die). Those together let you set whatever price you want on your drugs/services, and people will just have to pay. Or, your medical insurance would but it'd still be passed on to us as increased premiums. On the other hand, if there's not enough money to find the cure in the first place the entire thing is pretty moot.

    Kjella
    • If and when we get to the point that more people die due to patent issues than would die from lack of publicly developed treatments, then it's time to just junk the idea of a privately held medical research sector. It's not as if it's impossible to do the research on public funding, and then you can even deduct those costs from public health insurance and other society costs.

      The medical industry should be allowed to make money, but not at the cost of human life or human suffering. The companies can benefit society, but they're not irreplacable, and as it is today they're very close to becoming unwelcome parasites.
  • by HEbGb (6544) on Sunday February 03, 2002 @12:22PM (#2946381)
    Two requirements of a patent are the existance of an 'inventive step' and another is 'novelty'.

    Patenting a gene itself (if that's what's done) is nothing more than patenting a transcription of an already-existing structure. It won't hold up - there is no novelty, and no invention - you're just writing down what already exists.

    However, an inventive, novel step could be the application of the knowledge contained in the gene for specific therapies which were developed. These can and are patented, and I don't see anything wrong with this.

    I think there's a common misconception that these companies are patenting genes themselves-I think that with few exception, this isn't the case - they're patenting applications of the knowledge to new therapies, much like someone who has studied the physiology of the body can patent a drug to treat an illness. You're not patenting the mechanism of the body, you're patenting a tool based on that knowledge.
    • So.. Could I patent my process of splicing firefly and baboon genes into human DNA, to make someone's butt glow technicolor-like whenever they're excited?
    • No one patents genes; no one patents life. These people are just silly. More precisely, the research companies are patenting a newly isolated and described chemical compound. It is also possible to patent a method for using such a chemical compound; although it is tough to get therapy patents when there is no record that the therapy usually works. You have to show that you know what to do with a chemical compound before you can patent it.

      In this case, the patented chemical compound is a piece of DNA or RNA which is useful for a number of things. You can use it to detect DNA with a complementary sequnce from a patient's tissue sample. Thus, it is a research tool just as you might patent a clever electronic spectrophotometic tool. The highly indignant researcher from Penn was using a patented research tool which was very expensive to invent and perfect. Myriad and the other research companies have just as valid a right to ask to be paid for its efforts as HP or Lucent's Bell Labs.
      • The highly indignant researcher from Penn was using a patented research tool which was very expensive to invent and perfect.

        See, this is what bugs me so much about scientific discussions on Slashdot- for every expert in the field, there's always one idiot who makes a forceful argument based on a complete lack of understanding.

        Anyway, you need to read up on DNA testing, PCR, gene expression, genome analysis, and gene finding. I'm guessing the genetic test the Penn researcher was doing was for a defective form of a certain gene- could be just a single polymorphism. This could be done from a simple tissue sample, probably, and wouldn't require use of Myriad's "invention" or "perfection". Anyone can get the proper homologous sequences for detection made up with the right amount of money- my university has it's own center for this.

        Secondly, gene finding is more a matter of hard work than of genius or innovation- hardly meeting the "non-obvious" requirement. There are many methods, but right now it could be as simple as this:

        - run a gene-finding program against the raw sequence
        - find matches to suspected genes in protein databases

        and in some cases you can have an almost certain functional identification of the given gene this way- and you can do it all by computer. This isn't like some super-drug that took teams of researchers years to synthesize, it's a natural product that's relatively easy to find and characterize, with a huge probability of multiple independent discovery.

        The real problem is that these genes aren't inventions at all- they are no more than discoveries, however much the biotech corps try to twist definitions. An invention might be something like a human-modified gene that when expressed yields a desireable product. But in this case the protein product would be the better target for a patent.

        This is the real indignity- biotechs aren't coming up with useful products, they're just patenting genes like mad in the hope of coming up with a product later. In the case that someone else independently makes a product, they're besieged by lawyers. Myriad couldn't come up with a use for their patented gene, but they're willing to sue a publically-funded researcher to prevent her from performing a valuable medical service that doesn't even require their data. They're parasites, pure and simple, and the single largest reason why we need projects like the HGP. I think the public research centers should begin patenting every new gene and licensing it free of charge, just to keep companies like Myriad from screwing real scientists.
    • by WillWare (11935) on Sunday February 03, 2002 @01:36PM (#2946664) Homepage Journal
      an inventive, novel step could be the application of the knowledge contained in the gene for specific therapies which were developed. These can and are patented, and I don't see anything wrong with this

      Patenting genes that occur in nature would be an obviously questionable practice, and it worries me that this issue has been kicking around unresolved for at least two years. But the thing you are describing here also worries me: it sounds like you're saying that the genetic information is properly unpatentable, but having sequenced it, I could apply for a patent controlling ANY useful application of that information. I would prefer to see patents limited to controlling a specific application of the information.

      But the obviously worst-case scenario would be where any fool could operate a sequencer for a couple weeks, and patent whatever he gets, regardless of whether an application is apparent at the time of filing.

    • What you describe is the exception, not the rule. Most patents *are* on the expressed sequence of the gene itself (or the amino acid sequence of the protein, which is informationally equivalent in most cases), not on some test kit or therapeutic regimen. The described utility is generally one that has been found through computational homology studies: you screen the gene against a database of knowns, and then declare it to have functionality equivalent to that of the closest match.

      As you pointed out, there's supposed to be some novelty here. The trick is that the expressed sequence isn't how the gene exists in your body: in your body, there are unexpressed intervening sequences (comments, sort of), proteins attached to the strand at various points, and other modifications. Courts have held that since the pure expressed sequence isn't the form found in nature, it's a new compound and is patentable.

      I agree that the specific applications of genetic discoveries should be patentable and patented, but that ain't what we're arguing here.

      Shameless self-promotion: I wrote a primer on gene patents [amsa.org] (PDF format) for the American Medical Student Association about a year ago that goes into a lot more detail on the issue.
    • Two requirements of a patent are the existance of an 'inventive step' and another is 'novelty'

      Well, close. In simple terms, the three requirements of a patent are

      1) Specific Utility
      2) Novel
      3) Non-obvious

      These simple concepts do get complicated (what did you expect - there's lawyers about), but that's the jist of it.

      Now, where the drug companies are paying fast and loose is that they are patenting gene sequences and their expressions (so the DNA and the protein) without any clear idea of what they (the genes and proteins) are doing. Effectively they are ringfencing a gene and trying to control any medicines/drugs/treatments that depend on their effectiveness for that gene. So person A invents a medicine that blocks protein P from doing damage in a cell (and P may well be an expressed cancer gene). Then because company C has a patent on the gene, A has to pay C royalties/licence fees to use the gene/protein.

      The whole problem is that the patents of genes lack specific utility - that are not for something, they are almost the equivalent of land deeds.

      I think there's a common misconception that these companies are patenting genes themselves

      Sadly, it isn't a misconception. The companies are patenting the genes themselves (or, to be more exact, gene sequencies. The genes they are patenting aren't even complete in some cases). The criteria for patentability is that the gene should be capable of being cloned, and their function defined.

      Cloning is straightforward, working out the function is too vague - the function of a gene is make a protein. OK - the patent application says gene Y makes protein X. What does X do? They don't have to know to get the patent.

      I think the idea is wrong - genes and proteins are not, at a fundamental level, useful for the treatment of disease. Sure, you have to know what they are to design drugs to work on them but it is the drug that is the invention, not the protein.

      The drug companies argument is that inventing these drugs is an expensive business, and they need the protection of a patent on the gene so that they will be the only people that can benefit from a drug that works with the protein that is expressed by the gene. Otherwise nobody would take the risk of developing these drugs and society would be worse off.

      The whole question about these patents comes down to this - "Would a company take the risk of trying to develop a specific treatment for a protein if another company could beat them to market with a different treatment?". I think this is called competition, and it so far has worked well - I see no reason to change the rules just because the stakes are increasing.
      • "inventive step" is the phraseology used in the Patent Cooperation Treaty context, and is the better translation for what many countries use. (For instance, Germany, even though Germans don't use English terminology.)

        This reaction was part of Congress' overruling a judge-made "flash of genius" test for patentability. If you work really, really hard, but aren't a genius, you can patent the results of your work, in this country. (It got rid of the distinction of "non-obvious because of intellectual barriers versus non-obvious because nobody wanted to do the 1 billion iterations of a testing and experiment scheme to get the right answer.

        Arguably, inventive step would do a better job of excluding most gene patents than our present concepts of non-obviousness.
        • ...non-obviousness.

          But what about non-novelness? Those genes have been in existence for millions, if not billions of years, and have not be created by the self-proclaimed "inventor". If anybody could get a patent on it, it would be God ;-)

          It's akin to some "inventive" software company disassembling the code of XP, and try to get patents on any functions that they disassembled in such a way. Obviously , nobody is doing this, as Micro$oft would sue the shit out of them, and rightfully so...

          Or it's as if Amazon disassembled Netscape and IE, and tried to patent the functions and methods that manage cookies. Oh wait...

  • I've always been confused by this - if I tried to patent my own DNA, couldn't someone use me as an example of prior work?
  • next week:

    * Should the Internet be shut down?

    * Should Open Source be illegal?
    • Open source is a cancer that destroys intellectual property and the Internet is used only by terrorists and pedophiles. Shut it down! Shut it all down!

      - Signed: the people who patented all the DNA - lol :)
  • analogy? (Score:3, Interesting)

    by cowscows (103644) on Sunday February 03, 2002 @12:26PM (#2946400) Journal
    If I discover a new comet, should any astronomer that wants to look at it through a telescope have to pay me royalties?

    It's rediculous. And that's an example of something that doesn't effect human health (Unless the comet is going to smash into earth I guess).

    I cannot see how this could be construed as anything other than choosing money over humanity. It's repulsive.
  • by mindstrm (20013) on Sunday February 03, 2002 @12:27PM (#2946408)
    They do not Patent DNA. They did not invent DNA.

    THey can patent specific genes for a specific purpose.

    So if they discover a gene that permits them to do something interesitng, like grow you a third arm... they can patent that.
    If they discover a gene that will make you smarter... they can patent that.

    They cannot patent genes until they have a use for them.
    • So if they discover a gene that permits them to do something interesitng, like grow you a third arm... they can patent that.

      Unfortunately, very few genetic discoveries thus far enjoy the certainty-of-use you describe. Most gene patents claim a slight correlation to a certain condition (eg, people born with this gene have a 3% greater chance of developing an ulcer), etc. They are far from providing specific applications. What they represent is the protection of a costly process of discovery (ie, the ability to sequence DNA using expensive equipment) and scientific experimentation (eg, when generations of mice are bred without this gene, how do they act?)

      The above process is very expensive, and some would argue that the results arrived at need to be protected, no matter how weak the actual patent claims. As far as I can see, this would be similar to early 20th century atomic researchers "patenting" the heavier elements and their isotopes along with their applications ("this patented Uranium isotope, when struck with a neutron, be made to fission...") Certainly these researchers required enormous resources to detect, isolate, and understand the elements that they were working with. That does not mean that they (or the governments and corporations they worked for) should necessarily enjoy a long-term monopoly on their discoveries simply because they were the first with the right equipment to examine natural processes.

    • by sam_handelman (519767) <skh2003 AT columbia DOT edu> on Sunday February 03, 2002 @01:12PM (#2946585) Homepage Journal
      All of what you say is, or ought to be, true.

      However, Biotech companies are interpreting these patents in a very broad way, as you can see from the article.

      The more sophisticated the biotech you're trying to develop is, the more burdensome these low level, frankly not-very-clever patents become.

      By analogy in software, imagine how difficult it would have been to write Kazaa if quick sort, merge sort and the binary search were all patented. Supposing you needed all of them (and that bubble sort wouldn't do, but stay with me), you'd need to enter into negotations with each of three different parties who hold the patents, and get permission from each of them, before you could finish Kazaa. Now, Kazaa, even though it maps to the set of integers, is a legitimate achievement; the people who wrote it deserve protection of their coding investment. Merge Sort, while a cute idea, is NOT. There is a qualitative difference between the two.

      The biotech patents that are being issued are, likewise, so basic, and generated on such an industrial scale - companies just churn them out as fast as they can - that they are begining to hamper innovation.

      These biotech companies often won't enter into negotations about selling their intellectual property. They're flush with cash, by and large, and if they don't know what their property is worth, why would they sell it?

      When you're trying to develop something really new and sophisticated (the biotech equivalent of a complete piece of software) you may need literally dozens of tiny processes which someone has patented. Even if none of these patents will hold up in court, the risk that not one but several parties could sue you to defend their interests - usually in different jurisdictions! - makes the legal risks of implementing such a procedure prohibitive, even if none of these patents would really stand up in court.

      I have to add that Columbia university, where I am a graduate student, makes more money from patents (in particular one, rather basic, biotechnology patent) than any other University in the world, including the combined patent income of the Universities of California (my BS & BA are from UCSC). That money is what pays my stipend.
      • Biotech companies are interpreting these patents in a very broad way, as you can see from the article.

        Thats quite irrelevant. What is important is how the courts interpret the patents.
        • I hate to be cynical, but it is not irrelevant.

          To a University, which is a very conservative institution, most of the time, the risk of being sued, and losing, is simply untenable. Especially when you consider the staggering damages that might potentially be awarded - how much is something private "worth," if it has been released into the public domain at no profit for the party releasing it?

          The same is true of venture capitalists. If I have a good idea, my ability to get backing is in a lot of danger if there are people waiting in the wings with lawsuits. Backing a biotech venture is pretty risky business anyway - adding in a 5% chance that, even if my method is teneable, it is going to be nuked, or the profits all siphoned off, in the courts, is not helpful; if you take into account the chance of potentially ruinous additional delay is more like one in three, well, it is a serious issue.

          It is very naive to say that only the final decisions which courts reach are relevant.

          • It is very naive to say that only the final decisions which courts reach are relevant.

            Hardly. Patents are litigated all the time. It is not that rare, and lawyers working at companies pay attention to case law. If they try to shake down a deep pocket organization for a patent infringement that is on weak ground, they are risking a countersuit, big time.
            • Hardly. Patents are litigated all the time. It is not that rare, and lawyers working at companies pay attention to case law. If they try to shake down a deep pocket organization for a patent infringement that is on weak ground, they are risking a countersuit, big time.

              Which is fine.. so long as you're a deep pocket organization. What about the smaller universities?
          • To a University, which is a very conservative institution, most of the time, the risk of being sued, and losing, is simply untenable

            Unless you have deep pockets being even being sued and winning can be a problem.
    • THey can patent specific genes for a specific purpose.

      That's part of the problem. Allowing patenting the gene as opposed to only patenting the doing something with the gene. Whilst the DNA sequence itself remains in the public domain

      So if they discover a gene that permits them to do something interesitng, like grow you a third arm... they can patent that

      Such genes are likely to actually be fairly "general purpose", but only useful in combination with other genes
      Someone patenting genes which enable extra limbs could well affect using some (or all) of the same genes in something like improving healing of injuries.
  • by Baldrson (78598) on Sunday February 03, 2002 @12:28PM (#2946413) Homepage Journal
    Properties of nature are not patentable. Specific applications of properties of nature are patentable.

    Patents that attempt to cover general applicability of properties of nature are invalid and the courts that uphold such patents in error.

  • For shame (Score:3, Insightful)

    by Digitalia (127982) on Sunday February 03, 2002 @12:31PM (#2946432) Homepage
    I always assumed that a patent was intended to cover a new or uniquely contrived object. Were these geneticists to be patenting recombinant DNA, I would be alright. When they begin to patent DNA that they discover, it becomes a travesty of science. Not only do they have no rights to that DNA, but it impedes scientific progress. Of course, most modern geneticists aren't working for the benefit of man. Some work for their own good first and last, Monsanto, while others work for their own good first but hope to benefit civilization in the process. Even academic research is beginning to fall under the latter category. In both examples, progress is stifled by greed and gluttony.
  • The article makes the point towards the end:
    "It's not just the patents themselves. It's how these patents are being enforced," said Michael Watson
    Information may or may not want to be free, but it costs a lot of money to do this kind of research. Patenting gene sequences and describing their function as intellectual property offers a way to recoup the high cost of R&D.

    The problem is, some (not all) biotech companies are enforcing their IP like some (not all) software companies do - sue first and ask questions later.

    Now, I'm sure I'll get flamed by the Slahdot crowd that thinks everything should be "Open Source", but there are fundamental differences between computer science and genetic science.
    • Now, I'm sure I'll get flamed by the Slahdot crowd that thinks everything should be "Open Source", but there are fundamental differences between computer science and genetic science.

      I don't think "everything" should be open source; hell, I don't even think all software should be. I do, however, think it's contemptible to allow the patenting of DNA. I mean, I really don't give a damn about the cost-effectiveness of the R&D department of a large biotech firm. If it costs too much to find new genes, then don't; the Universities, government, and non-profit groups will eventually get to it, even if it takes a little longer.
  • Knowing my luck, one day my doctor will tell me "I'm sorry, but we just noticed the DNA for your mitochondria is patented. I've been told that the patent holder is filing under the DMCA that you've illegally been copying their intellectual property since conception and you must either cease operations immediately or remove all offending material."

    *sigh*
  • My position (Score:3, Insightful)

    by MarkusQ (450076) on Sunday February 03, 2002 @12:37PM (#2946460) Journal
    Digital information should not be patentable, period.

    The space of all-possible-digital-information maps directly onto the space of integers. Asking for a patent on a chunk of digital information (DNA, object code, what have you) is the same as asking for a patent on an integer. The claim that "oh, but it's a very large integer" is specious. Patents are for inventions not facts-of-math.

    Copyright is only slightly more reasonable.

    -- MarkusQ

  • Open Source (Score:4, Funny)

    by DeadBugs (546475) on Sunday February 03, 2002 @12:40PM (#2946472) Homepage
    I am releasing my DNA under the GPL license.
  • by TekkonKinkreet (237518) on Sunday February 03, 2002 @12:42PM (#2946480) Homepage
    Caveats:
    a) I know nothing about genetics or law myself. I learned all this from the genetics law expert I sat next to on a plane last week.
    b)The duration of the explanation was part of a flight from Salt Lake to Seattle
    c) I had a first class upgrade and took full advantage of the free Heinekens. That is to say, I hope I'm remembering this right.

    Goes like this. It's illegal to patent an object, right? But a sequence of DNA in addition to containing the gene you're interested in, is always full of random and irrelevant pairs. So what they want to patent is not the gene as it naturally occurs, with all the junk DNA in it, but a cleaned-up version containing only those bits which are relevant to the patent. This is not a naturally occuring sequence, and so is patentable. So to answer the fellow who says "wait, I have that gene, every cell of me is prior art," no, you don't have that exact gene, yours contains different randomness. Yes, this sounds like a legalistic dodge to me too, and the expert acknowleged the point, but there it is.

    A further wrinkle is that they patent the transcriptase necessary to make the cleaned-up gene, not the gene itself, though I had a sufficient buzz by that point in the conversation that I was ready to talk about football. :)
    • wait, I have that gene, every cell of me is prior art," no, you don't have that exact gene, yours contains different randomness.

      Shouldn't that actually cut both ways? What if a compteting company based a therapy not on that exact gene, but a slight variation thereof? If those patent lawyers were in any way consisten with themselves, they should grant the comptetitor that permission, as he would actually not be using that exact gene that was patented, but one containing "different randomness" instead. Oh, and while we're at it, why not extend this to other kinds of intellectual property? Just flip one bit in Windows XP (for instance, in an error message), and presto, you'd have a copy free of copyright!

      Basically, being too picky about what is, and what is not prior art will (or rather: should) actually make their patent much weaker, because the same arguments could be turned against them by any infringer...

      A further wrinkle is that they patent the transcriptase necessary to make the cleaned-up gene, not the gene itself, though I had a sufficient buzz by that point in the conversation that I was ready to talk about football. :)

      If they patented the transcriptase, wouldn't competitors still be able to use konwledge of the gene itself, if they gained it without using that transcriptase?

      To take a computer analogy: let's consider a company specialized in forensic data recovery (reading back data from crasshed disks). They may very well have some patented tools to read data from disks in such bad condition. But that doesn't automatically give them intellectual property rights to data that they recover using their patented tools.

  • by erroneus (253617) on Sunday February 03, 2002 @12:53PM (#2946526) Homepage
    I think at some point, an international summit for "Things that belong to mankind" should be held and agreed upon.

    Profit at the expense of public health has always been considered "wrong." But this is generally when it's a company unwilling to keep the air, water or land clean and safe for human habitation. But in cases such as patented AIDS drugs being suppressed when a far greater good could be served?

    When mankind cannot 'afford' to be healthy or to survive, there is something very BROKEN in the way we are thinking. I'm not a communist, but get real... should one person DIE simply because he can't afford to live? It's all around us and no one is willing to say I'm wrong about that. But who is willing to actually step up to the plate and actually give to mankind rather than profit from its needs?
    • The fundamental problem with arguments such as yours is that they miss a major point that motivates innovation:

      The Motive for Profit (aka greed, being a meanie, etc).

      Drug companies will tell you how hard it is to research, develop, implement, test, study, test, study, and finally sell a drug. It is a vastly expensive operation - usually returns on new drugs are measured over the period of 10-20 years or more.

      If a drug company spends billions to create a new drug, and then that drug is approriated by third-world nations, the US government, or other governments, it often results in that drug being a net financial loss for the corporation.

      Everynow and then most big companies can afford a loss - but how many losses does it take to really hurt a company?

      The answer to your question is prickly: if every life-saving drug was appropriated, reproduced by some other company, and given or vastly subsidized in price, what would the net, long term effect be?

      I think we are already seeing that result today. These days you see drug companies promoting heart-burn medicine, anti-allergy pills, and other "quality-of-life" drugs. Why? Because - the money - and the motive - for the next "big score" isn't there.

      Whats the solution?

      I have no idea. I'd say government funding except that the government is a terrible researcher and very bad at coming up with new things. I'd say government subsidizes but that doesnt make sense in third-world nations. I'd say that the corporations should simply give the drugs away but I know that it would seriously lower the chances that the next big drug would be discovered. Its a pretty bad problem.

      My best guess? Keep it going kinda how it is - with maybe some government benefits for doing "The Right" thing. Right now rich nations, like the US and Canada, pay very high-prices for certain drugs. We in effect subsidize drug development and distribution for many third-world nations. Maybe we could do something like "waive your international patents and you pay no federal taxes" for the drug companies. Something, anything, to create perceived value for "doing the right thing".
      • The fundamental problem with arguments such as yours is that they miss a major point that motivates innovation:

        The Motive for Profit (aka greed, being a meanie, etc).


        And the fundamental problem with your argument is that profit has absolutely no connection to making people healthy.

        Which is more profitable, a single pill that cures Parkinson's disease, or a chemical cocktail that Parkinson's disease sufferers have to take for the rest of their lives? Never assume that pharmaceutical companies are in the business of curing disease. They're in the business of making us take pills - if it happens to cure a disease or two along the way, well that's great.

        Drug companies will tell you how hard it is to research, develop, implement, test, study, test, study, and finally sell a drug. It is a vastly expensive operation - usually returns on new drugs are measured over the period of 10-20 years or more.

        Which is interesting considering that there's a few studies out there showing that the big Pharmacomps spend as much or more money on both marketing and administration as opposed to R&D.

        I'd say government funding except that the government is a terrible researcher and very bad at coming up with new things.

        Does it? You have facts for this or is it just the prevailing opinion? Even if it is, it certainly doesn't have to be. After all, it's not the management and marketing sections of a corporation that produce the drugs, it's the R&D people. If you assume the same benefits, pay, and penalties if nothing productive is come up with, how will an R&D person working for the government be any less effective than that same R&D person working for a corporation?

        In addition, the government doesn't have a need (though it usually does, I'll admit) to provide things like lavish CEO perks or bribes/donations to politicians for things like patent rights.

        Maybe we could do something like "waive your international patents and you pay no federal taxes" for the drug companies.

        Unfortunately, most Pharmacomps pay no taxes anyway. It's all written off long before the feds get to them.
        • And the fundamental problem with your argument is that profit has absolutely no connection to making people healthy.
          I agree. I do not dispute that. However, if making people healthy is a side-effect of getting the profit, then it is related casually. This is the whole idea behind the "pharamacorps" - (btw, I really like that term! i will be using it from now on).

          I do not dispute that drug companies are not in business strictly to help people. That is just a side-effect of the pill-popping. I bring them up simply because they are the only other groups doing disease research outside the government/government funded projects.

          About marketing and research: I also agree. They probably do spend so much more non-R&D than on actual R&D. Why? I think the trend started long ago. This is why today we get Viagra, Allegra, and other heavily marketed drugs. The countries that might appropriate life-saving drugs will just ignore these - because their starving dying masses don't really worry about allergies - they worry about malnurtion, AIDs, and basics like infections, gangrene, etc. So we get these "quality-of-life drugs" that only the rich IP obeying countries buy.

          Next, the government does stink at research. It is both the general opinion of researchers and empiracly clear. But lets assume it is true, just for this argument. There are just a few things that really motivate innovation in any field. The first is need. The second is money. We all know about the money one. About need, we see this alot during total war - think of the scientific progress achieved during WWII. It was truely motivated by necessity. The point? Right now niether condition is met by the government. We are not in a state of all out war or national need. As a whole, the rate of diseased death that is unpreventable (ie, heart attacks not included) is acceptable for us.

          It is the third world nations that really need the breakthroughs - nations were AIDs is spread without rest. Nations that have no infrastructure for medical services, education, or other support. In the US most people get AIDs from unsafe sex - in fact thats about the only way to get it right now. In other nations, children are born with AIDs, it is spread because of the vast ignorance and mal-education, and the inability to reach the infected for even basic treatment. In the US, AIDs is treated with a 15k a year barrage of pills and shots. A vaccine would be useful and save many lives, but by far, a nation like Sudan (by 2010 they will have an infection rate of 40%) could literally be saved from destruction.

          So the question still remains: how can the needed medicines and technology be developed? Is it best to trust in government or corporations? The answer is probably neither. The government has no incentive, no pressing need and corporations also have little incentive - knowing that anything they develop will likely be sold at loss for longer than they can exclusively own it (7 years).

          The bottom line is that neither government nor private industry is well suited to do the job right now.

          Final note, Pharmacomps pay vast amounts of taxes. Thanks to shows like Dateline, et all people think these companies pay no tax. Several big companies pay no income tax thanks to rebates, credits, and whatnot. But there are plenty of other taxes - AMT, property, sales, export, etc. For example, Glaxo-Wellcome payed no income taxes but paid out $750M to the US government in various other taxes and tariffs last fiscal year. That is nothing to shake a stick at.
  • Then presumably we want companies to research such techniques. But companies will only research them if they're profitable. If the product of the research is easily reverse-engineered and copied companies won't be motivated to do GE research unless they are protected by patent. So I guess the original question boils down to "Do you want the products of genetic engineering?"
    • If the product of the research is easily reverse-engineered and copied companies won't be motivated to do GE research unless they are protected by patent.

      If the product of the research is a complete organism then copying is very much taken for granted. A mitosis inhibited bacterium isn't that much use. Problem is that when patents were though up the idea of a self replicating "product". Also organisms tend to swap their genes around. Bacteria use plasmids. Many organisms (including those which biotech companies are often interested in) use meiosos and sexual reproduction to increase the genetic diversity of the species.
      Existing laws already lead to utter daftness where farmers who's crops are contaminated by GM crops are treated as stealing "IP". When the plants are just doing what comes naturally. In many cases the required crop is either a fruit or seed (sometimes a flower), so mess around with the plant's reproductive system and you don't have anything worth growing for agriculture in the first place.
    • That's an interesting point.

      Will _people_ research techniques to save their own lives of the lives of their loved ones for altruistic reasons, or simply reasons other than cash profit motive?

      Why is it always 'well, companies will'?

      If companies are not capable of the full range of motives and drives that humans have, despite having the same rights (or more) under the law, then maybe the problem is with the companies, not with humans or with the law.

  • You are not allowed to patent fact, in my small understanding. For example, c^2=a^2+b^2 can not be patented, since it is taken as fact. Another more simple example is you can't patent the fact that we see the sky is blue. In the case of DNA, it too is fact. You can patent the process to finding DNA, but that should be all. Clinton opened the flood gates when he allowed the patenting of DNA. It was like opening up the west to homesteaders. All of a sudden this relm of fact could now be patented, though only a small area of it.

    Some conspiracy theorists see this as a move by the US, which holds much of the capability to find DNA combinations, to try and corner the lucrative market of owning this fact. The US holds a lot of power with its patent office and most of the world regards it as the gate keeper as well as fear the Patent Office since the US holds a big stick to protect it's patent system.

    The patenting of fact looks much like the DMCA when held up to the light.
  • patentable only if (Score:4, Insightful)

    by Alien54 (180860) on Sunday February 03, 2002 @01:29PM (#2946641) Journal
    DNA should be patentable only if

    they can document the functionality down to the level that computer code is now

    The functionality is one that is not previously existing or discovered in nature.

    a unique combination of features where the majority of the code is new work. The thought here is that Ford company probably could not patent a new engine unless they owned the patents on the component parts and technologies. But there are an indefinite number of ways to build car engines.

    Thus one probably could not patent a fire breathing dragon, but could patent the various implementations of the various subsystems.

    patenting huge random chunks of DNA, hoping that something practical will come out of it is not the way to go.

    • Thus one probably could not patent a fire breathing dragon, but could patent the various implementations of the various subsystems.

      Just as well Anne McCaffrey didn't invent a Pern patent office :)
  • by Alik (81811) on Sunday February 03, 2002 @01:55PM (#2946753)
    There's a primer on gene patents [amsa.org] (PDF file) that I wrote about a year ago. It explains the generally-accepted patent criteria and how genetic material has been interpreted to meet those criteria. The arguments for and against patentability of genes are presented, although the bias is against strict patentability; my personal viewpoint is that applications of genetic information are fair game, but the raw sequence itself should be off-limits.
  • The law allows for "inventions" to be patented, but you cannot patent a "discovery".

    Thus if you find that a particular gene exists in the human body, you have not "invented" anything. One the other hand, if you take a piece of DNA and use it in a particlar process that is not naturally occuring, then you can patent the novel aspects of the process. DNA is just a chemical , and it is protected in exactly the same way as less complex chemicals.

    This is exactly the same as patents for chemical reagents. You cannot patent phosphorus, but if you find a novel way to combine it with other elements to make something new, then you can patent that. For example, if you combine it with a piece of DNA that allows you to "mark" the DNA in certain ways, then you can patent that process if nobody has done it before.

    If that happens to be the only way to diagnose a human disease, then you can and should reap a big financial reward from your patent.

    Now, it very well be that the PTO is granting patents that aren't legally valid. We knew that already and it has nothing to do with the biological arena, it has a lot to do with complete incompetence and a political process that is broken.
    • One the other hand, if you take a piece of DNA and use it in a particlar process that is not naturally occuring, then you can patent the novel aspects of the process. DNA is just a chemical , and it is protected in exactly the same way as less complex chemicals.

      The parts which make up DNA are not especially complex chemicals. They can be made fairly easily.
      DNA has the unusual property that it can be copied, duplicating the entire molecule. Also a slightly different type of copying of DNA creates mRNA.
      Stick DNA in the appropriate part of a biological organism and it will automatically be copied. This is the problem with attempting to apply patent laws to genetically modified organisms they simply don't make sense.
  • The whole idea of patenting anything should be re-thought from the ground up. It was designed before DNA, code, and the internet and is long out of date. You can't expect a civilisation to grow, if their own laws prohibit it and give ownership of technology to single individuals. Its one thing for a company to sue another for copying an idea for profit, but when you start leveraging royalties from people for breathing because you have a patent on "oxygen hemoglobin transfer" you have issues.
    • You can't expect a civilisation to grow, if their own laws prohibit it and give ownership of technology to single individuals.

      Patents were developed as a concept in law because companies who discovered technology were keeping it secret. Granting a limited exclusive right to a technology is far better than having it kept totally secret.

      Its one thing for a company to sue another for copying an idea for profit, but when you start leveraging royalties from people for breathing because you have a patent on "oxygen hemoglobin transfer" you have issues.

      Now you are making up stuff. No person has ever been sued for engaging in normal body functions as a violation of patent law, and none ever will be.
  • 35 USCS 101 governing issuance of patents does not embrace every discovery, nor is it without limit, laws of nature, physical phenomena and abstract ideas are not patentable; discoveries that are manifestations of nature free to all men and reserved exclusively to none are not patentable. Diamond v Chakrabarty (1980) [101, n 38]

    Most of the patents are for use of DNA sequences in diagnotics assays. A general assay procedure itself might be patentable, but I'd think the hybridization of DNA or it's related biological functions would be considered manifestations of nature.

    If a company invents a treatment they should patent that.

    Someone needs to take these greedheads to court.
  • Sue first and ask questions later? That leads to the impasse defined in the third couplet of my 1992 poem:

    http://www.magicdragon.com/EmeraldCity/Poetry/DN A. html

    THE TWILIGHT OF GENETIC ENGINEERING
    by
    JONATHAN VOS POST

    Jungle-floor bacteria devour helicopters after war;
    ripped human corpses thaw, screaming, in battle zone

    Smog-sucking moss evolves to grow on auto bumpers;
    gas-tank tapeworm writhes: blind premium dreams

    Heavy weaponry of corporate wars, intractable
    ultimatum when lawyers subpoena their own DNA

    Cockroaches skitter: dust of broken televisions;
    lay phosphorescent eggs between commercials

    Reunification pressures force abandonment of immortality;
    death substitutes for taxes: final cost of doing business

    Skinned headless lizard throbs, shoved into your chest:
    replicant replaces your broken-once-too-often heart

    Time & nucleotide
    wait for no man

    2300-2320
    15 Sep 1992
  • by gotan (60103) on Sunday February 03, 2002 @02:20PM (#2946853) Homepage
    Patenting genes seems to be common business practice in agriculture. Patented rice and grain seeds with special properties (like resistance to a specific herbicide) are sold all over the world already to Farmers more or less licensing the stuff. There are some problems with this aproach:

    How can we be sure that the patented genes really came out of some laboratory, and were not found in some countries where people already knew about the specific properties of the stuff (maybe because they cultivated it over thousands of years). Some corporations are accused of doing just that with rice varieteys in 3rd world countries (where the farmers probably couldn't even pay the flight to USA, when dragged before a court there). We haven't even begun to catalog all species on earth, let alone their genetic diversifications, but maybe there should be a puplicly accessible database of genetic material from particularly successful or common crop sorts all over the world that are not yet patented, to be able to prove prior art.

    Another problem is, that unlike music, films, books, software and whatnot life has it's own builtin copy-mechanism, in fact, once it's out it's sometimes hard to stop it from replicating or crossing borders. I remember a case, where a Farmer had to pay license fees, because grain from seeds his neighbour (who had planted patented stuff) blew on his fields and grew there. How could that man have prevented that, short of burning down his own corn? We already know to what ends the rights holders struggle for getting each and every use of IP paid led us in the case of copyrights. What will we see now? Genes with builtin DRM schemes (like if you don't spray your crop with a specific shortlived virus it won't survive the next month)?
    --
    • Another problem is, that unlike music, films, books, software and whatnot life has it's own builtin copy-mechanism, in fact, once it's out it's sometimes hard to stop it from replicating or crossing borders.

      Also remember that with quite a lot of crops the bit of the plant which is important is tied up with the plant's reproduction. All cereals are seeds, for example.

      What will we see now? Genes with builtin DRM schemes (like if you don't spray your crop with a specific shortlived virus it won't survive the next month)?

      They's have a tough time patenting this technique, Jurassic Park would qualify as "prior art".
      Also all this would do is mean that any plant which mutated not to need the virus symbiote would do well at spreading it's genes around.
  • ... are the people who hold the patent going to pay me royalties? Probably not.
  • DNA patents (Score:2, Insightful)

    by o0oo (556237)
    Pre-existing DNA sequences are not like software. Software is an algorithm developed to perform a specific function or to solve a problem. DNA is more like a computer language. Even then, the computer language was developed by someone or a group of people, unlike DNA which existed before people discovered it. Software is more like a process for producing something. However though it processes data, or produces information, it is not likely to produce anything physical. Software is an intellectual or artistic work and can be protected by copyrights. The Technology/process used to produce or develop software may be patented. You can patent a Process or Invention, not discoveries.

    If they were to follow the patenting of discoveries to its logical conclusion, then I could patent air, the sun, stars, the moon, gravity, ... as things I discovered, just like the research labs, doctors, and lawyers are doing when they discover gene combinations. Even though this is obviously wrong, it is being done because of an interpretation of a ruling that allows scientists, reseach labs, laweres, or just about anyone, to patent viruses and bateria that they create to do specific things such as using bacteria to produce insulin, or using a modified virus for injecting an immune system into infants born without one. The patent office concluded that the only way to protect the bacteria and viruses that they had been created was to patent the DNA, and I agree to some extent; however, we are talking about patenting the invention which happens to be the DNA sequence that was probably discovered for the immune system, and was combined with an existing DNA sequence--in my example, the basic virus or bacteria.

    As far as intellectual property goes, there are a plethora of things that fall under common knowledge, such as "for loops" or sorting routines, that can't be copyrighted.

    Finally there is the idea that somethings will do or currently does the world so much good that it can't be copyrighted with the intent of making money, or impeding its use. This would include "air-bags", and vaccines for such things as polio. We see this in the software field with "Open Source" or "Copy Lefted" copyrights.

    Patents are for thing that may contain DNA, or for DNA sequences which are original works. The problem with "original works", is of course proving it, thus giving more weight to the argument of excluding DNA from Copyrighting/Patenting.
  • Almost all DNA tests use completely standard and widely known technology. Furthermore, the genetic sequence associated with a disease is a simple fact of nature. Patenting genetic tests is therefore not much different from if we were to allow patenting diagnosis of a disease, say, from the visual appearance of a rash that's examined with a magnifying glass or Wood's light. The argument that DNA tests take time and money to develop doesn't hold much either: reliable diagnosis from any kind of symptom requires extensive experience and, ultimately, scientific studies.
  • patenting DNA (Score:2, Interesting)

    by pmineiro (556272)
    there are several things to note here.

    the quid-quo-pro of the patent system is disclosure for _limited time_ monopoly. by offering patents, we incentive people to discover and reveal literally life-saving things about them in exchange for being able to solely exploit this knowledge for 20 years. 20 years later, anyone can exploit the knowledge.

    it is unfortunate if strict licensing agreements prohibit some people from affording detection of breast cancer, but this must be balanced against the alternative that without the promise of patent protection, the knowledge underlying the screen might still be unknown.

    prior art of the form "my cell contains this" is not relevant here. the patents most people are shooting are "composition of matter" patents, which are relevant to natural products that are purified or isolated from their natural state. in other words, public policy recognizes that finding a needle in a natural haystack and understanding the functional importance of the needle constitutes a genuine advance in the state of human knowledge. otherwise many things (industrial chemicals, drugs, etc.) which can be found in nature _if you know where to look_, would not be patentable.

    finally, many of the early patents on genes were actually patents on cDNA, which is an image of the gene as cleaned up by the cell (think of it as an executable that has had strip run on it). these patents are neither considered very strong or very valuable, and companies (e.g. incyte) that pursued a patent heavy strategy are now struggling to find the value and are invariably moving towards more interesting achievements (aka advancing up the drug development chain). to some degree, the patent system is GIGO.

    are there some harms associated with granting patent monopolies? yes. are there goods associated with granting patent monopolies? yes. the patent is a compromise.
  • What does DNA have to do with it? If someone finds a new sequence (the information) that does something cool, why shouldn't they be able to patent it? On the other hand, they have quite a lot of prior art to contend with. So if they can come up with a truely unique arrangement of DNA, they should have the rights. However, this excludes patenting sequences present in a living being that they merely 'discovered'.
  • If someone gets a patent on genes, I want the patent on Oak Trees and Duckbill Platypuses, because I can look at thier genes and remove any irrelevant pairs, and say that the sequence does not occur in nature. Of course, I wouldn't do this because I feel it it just plain wrong to try to patent a fundamental piece of nature. But someone thinks otherwise...
  • A lot of people are arguing that DNA should not be patentable because it is a natural object, and has existed longer than humanity, and therefore cannot be an invention.

    This is definitely the crux of the issue, but I think it's slightly more complicated. Imagine that the patent system had been invented before the discovery of the lever (ok, just for the sake of argument). Should a person be able to patent the lever? Did they discover the lever, or invent it?

    Given the laws of physics, there is the potential for the existence of a lever, and lever-like objects can exist even if human hands did not make them. Therefore, it might be argued that the lever was discovered, not invented.

    On the other hand, you can also argue physically that levers in general cannot exist without intelligent design. In order to really be a "lever," an object must not only have lever-like characteristics, but there must also be a source of input force, and an object to which the output force is transferred. Thermodynamically, this combination is highly unlikely, and you might argue that a lever-like object is not a lever unless an intelligent being uses it as such. Therefore, the lever was invented, not discovered.

    Now, look at DNA. You can claim that since DNA existed before humans, it cannot be patented since it was not discovered. But you can also argue that, pre-humanity, DNA had no actual "purpose," since only humans create "purpose" and lower forms of life do not (this is a controversial statement). Therefore, by finding new "purposes" for DNA, such as the curing of diseases and other non-natural uses, we are "inventing," in a way. Therefore perhaps DNA can be patentable.

    To boil it down to an archetypal example: suppose a team of scientists discover a gene in a rare species of dung beetle that can be spliced into human DNA to give increased resitance to ultraviolet radiation. Should the team of scientists be able to patent this use of the gene? Note that this is a patent for a specific "use" of the gene, not the gene itself.

    I think that if a team of people has put in the effort, time, and frustration to discover something like that, they should be allowed to benefit from their research. As long as DNA patents are patents on "uses" and not the genes themselves, it doesn't bother me much.

  • We'd better get all IP on our own DNA quick.

    And you better not get any DNA treatments without checking the fine print.

    Coz if you ever have kids, some corporation may sue you for unauthorised reproduction of their "intellectual property".

    There shouldn't be such a thing as intellectual property. Because if you try to scale, it can end up this way:

    "I own this thought, so you can't think of it without my permission".

    Because in a possible future, thoughts, brains, machines, computers could be intertwined.

    That said, lying is still wrong: e.g. saying "I thought of this first" when you didn't. This rule scales.

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