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Patents Medicine

Doctors Fight Patent On Medical Knowledge 205

Posted by kdawson
from the no-not-patent-medicine dept.
I Don't Believe in Imaginary Property writes "Doctor's groups, including the AMA and too many others to list, are supporting the Mayo Clinic in the case Prometheus v. Mayo. The Mayo Clinic alleges that the patents in question merely recite a natural phenomenon: the simple fact that the level of metabolites of a drug in a person's body can tell you how a patient is responding to that drug. The particular metabolites in this case are those of thiopurine drugs and the tests are covered by Prometheus Lab's 6,355,623 and 6,680,302 patents. But these aren't the only 'observational' patents in medicine — they're part of a trend where patents are sought to cover any test using the fact that gene XYZ is an indicator for some disease, or that certain chemicals in a blood sample indicate something about a patient's condition. There are even allegations that certain labs have gone so far as to send blood samples to a university lab, order testing for patented indicators, then sue that university for infringement. Naturally, Prometheus Labs sees this whole story differently, arguing that the Mayo Clinic will profit from treating patients with knowledge patented by them. They have their own supporters, too, such as the American Intellectual Property Law Association." Prometheus doesn't seem to be a classic patent troll; they actually perform the tests for which they have obtained patents.
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Doctors Fight Patent On Medical Knowledge

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  • by Tubal-Cain (1289912) on Tuesday July 21, 2009 @01:22PM (#28772807) Journal
    Patenting chicken soup and lots of liquids for treating colds?
    • by psicop (229507) on Tuesday July 21, 2009 @01:28PM (#28772881)

      A patent on the observation of cessation electrical activity in the heart, resulting in a pulse as a precursor to an eventual absence of a pulse.

      In other words...He's dead, Jim.

      • by Mordok-DestroyerOfWo (1000167) on Tuesday July 21, 2009 @02:23PM (#28773509)
        Dammit psicop, I'm a doctor not a patent lawyer!
    • Ironically, while that would either be shot down by prior art(if filed today) or expired(if patented on invention), it would actually be a much more suitable patent than the one in question.

      If they wanted to patent a particular means of testing for the metabolite, that'd be fine(assuming it was non-obvious, and they invented it, and so forth); but the notion of metabolite testing is, at best, something that would once have been patentable and is now common obvious knowledge.
  • by ArcherB (796902) on Tuesday July 21, 2009 @01:24PM (#28772829) Journal

    Does this mean I can patent the method the body uses to convert O2 to C02 and then sue everyone?

    I understand the need for patents, but I don't feel discoveries should be patented. If they were to devise a method to test for their discovery, patent that, but not the discovery itself.

    • by AliasMarlowe (1042386) on Tuesday July 21, 2009 @01:45PM (#28773077) Journal

      I understand the need for patents, but I don't feel discoveries should be patented.

      A discovery cannot be patented by itself. To be patentable, there is an explicit requirement under US law for an "inventive step" to be taken. A discovery might cover the requirement for non-obviousness, and perhaps the requirement for usefulness, but a discovery is not an invention.
      In the case of the cited patents (6,355,623 and 6,680,302), I think the non-obviousness part is severely lacking. Rephrased, their independent claims are for the combination of (i) treating condition X with drug Y, in which (ii) the dose of drug Y is adjusted based on the inferred level of drug Y in the bloodstream. Given that treating condition X with drug Y was already known, the step of adjusting the dose would be obvious to one of ordinary skill in that art (gastro-intestinal medicine). The method of inference is the "discovery" in question.
      Both patents suck, but for other reasons.

      • Rephrased, their independent claims are for the combination of (i) treating condition X with drug Y, in which (ii) the dose of drug Y is adjusted based on the inferred level of drug Y in the bloodstream. Given that treating condition X with drug Y was already known, the step of adjusting the dose would be obvious to one of ordinary skill in that art (gastro-intestinal medicine).

        I would imagine this sort of information isn't just obvious to someone of ordinary skill in gastrointestinal medicine, but I would hope "What factors (list 5) could affect a recommended drug dosage?" would be a entry-level med school question, and "levels of the drug in the patient's bloodstream" seems like one of the more obvious answers (after weight, age, side effects, etc, so maybe not in the top 5).

      • A discovery cannot be patented by itself. To be patentable, there is an explicit requirement under US law for an "inventive step" to be taken.

        While I usually cringe when thinking of responding to patent related topics here, the fact that this got modded up to "4, Informative" made me cringe more.. 35 USC 101 is the key to what can and cannot be patented in the US, and it starts: "Whoever invents or discovers any new and useful..." so, yeah "discoveries" can be patented. If you "discover" a new rock mineral that cures cancer, you are entitled to a patent on the mineral itself (given you can prove it's "usefulness", i.e. actually curing cancer).

        • by hedwards (940851)

          35 USC 101 is the key to what can and cannot be patented in the US, and it starts: "Whoever invents or discovers any new and useful..." so, yeah "discoveries" can be patented. If you "discover" a new rock mineral that cures cancer, you are entitled to a patent on the mineral itself (given you can prove it's "usefulness", i.e. actually curing cancer).

          That reminds me of something a Spaniard once said, "You keep using that word. I do not think it means what you think it means."

          Discovering the rock would not entitle you to a patent, using the rock to cure cancer is also not likely to qualify. Conveniently you chopped off that sentence right before a set of significant qualifiers. It's sort of like defining rape and neglecting the portion of that statute that defines what consent is. You'll not the portion of the sentence that says "composition of matter

    • by mea37 (1201159) on Tuesday July 21, 2009 @01:47PM (#28773107)

      "Does this mean I can patent the method the body uses to convert O2 to C02 and then sue everyone?"

      No, and I don't see the connection. The patent doesn't cover a natural process of the body; it covers the procedure of looking at the results of that natural process.

      It doesn't look to my (admittedly untrained) eyes like a valid patent, but that's because it appears obvious. It essentially seems to say, "Want to know if there's too much or too little of a drug in the patient's system? Then check!" My attitude would vary if there's some sophisticated, non-obvious mechanism behind taking the reading of how much drug is in the system, and they invented that method, and that method is spelled out in the patent...

      That the patent "recites a natural phenomenon" is a non-issue to me. Every patent can be boiled down to observations about nature. Every patent is an observation about a useful application of natural laws of physics, chemistry, etc.

      • by AigariusDebian (721386) <.gro.naibed. .ta. .suiragia.> on Tuesday July 21, 2009 @02:02PM (#28773277) Homepage

        Patenting knowledge is absurd. Patents are there to allow patenting of novel and non-obvious *devices* that can not be easily reverse-engineered. The society has agreed to grant a limited monopoly on creation of a novel and non-obvious device, if its inventor describes how it is made and how it works to enough detail that anyone skilled in the arts could replicate it. That is a patent.

        If a device is simple enough that it can be reverse-engineered once it hits the market, there is no insetive for the society to ever grant a patent on such device.

        Nowadays we can reverse-engineer almost anything, thus patents are obsolete, it just remains to change the law to reflect this simple fact of life.

        • by Red Flayer (890720) on Tuesday July 21, 2009 @02:17PM (#28773433) Journal
          You've got it backwards. Patents exist *precisely* to protect inventions that can be easily reverse-engineered.

          If an invention cannot easily be reverse-engineered, then it does not need the protection of a patent. QED.

          "Novel and non-obvious" does not mean "difficult to reverse-engineer".

          The cotton gin is a great example. Easily reverse-engineered, but protected by patent nonetheless.

          We know it was easily reverse-engineered because several people did just that. Never mind all the claims that Whitney's "invention" was simply the result of reverse-engineering gins in Europe/England.
          • by causality (777677)

            If an invention cannot easily be reverse-engineered, then it does not need the protection of a patent. QED.

            I'm not nearly so quick to pronounce quod erat demonstrandum on this one.

            "Cannot easily be reverse-engineered" is not the same thing as "utterly hopelessly impossible to reverse-engineer." You can have many devices or inventions where the reverse-engineering, however difficult, is a single one-time event. One person may go to great lengths to perform this reverse-engineering, after which many oth

        • by Miseph (979059)

          "If a device is simple enough that it can be reverse-engineered once it hits the market, there is no insetive for the society to ever grant a patent on such device."

          Only if you don't count "rewarding ingenuity so that it might be repeated" as an incentive. There are all sorts of non-obvious devices out there which are trivial to reverse engineer, and it is absolutely of benefit to society that the people who invented them be rewarded for their effort. If the best and most reasonable benefit we can give them

      • by scribblej (195445)

        "Does this mean I can patent the method the body uses to convert O2 to C02 and then sue everyone?"

        No, and I don't see the connection. The patent doesn't cover a natural process of the body; it covers the procedure of looking at the results of that natural process.

        So he could patent the process of checking to see whether someone is breathing to determine if they're still alive and then sue anyone who's ever done that?

    • Re: (Score:3, Insightful)

      by adonoman (624929)
      No, but maybe you could patent reading the percentage of CO2 in the air exhaled by the body as an indicator that the person is indeed using the O2 being breathed in.
      • by Tmack (593755)

        No, but maybe you could patent reading the percentage of CO2 in the air exhaled by the body as an indicator that the person is indeed using the O2 being breathed in.

        Or, more relevantly, patent the process of observing the color of the patient's skin in shades of violet as an indicator for the amount of O2 being administered as a treatment against hypoxia.

        -Tm

  • by eldavojohn (898314) * <eldavojohn AT gmail DOT com> on Tuesday July 21, 2009 @01:25PM (#28772835) Journal

    Naturally, Prometheus Labs sees this whole story differently, arguing that the Mayo Clinic will profit from treating patients with knowledge patented by them.

    I think I recall a part in the book Jurassic Park where the man behind the dinosaur research explains why he used Cray computers to read dinosaur DNA and not cure AIDS. Simply put, he could charge whatever he wanted for entrance to a dinosaur park but would probably be lauded as a money hungry monster to charge that same amount to treat AIDS patients. Being that millions of AIDS patients would not be able to afford it.

    So we're all going to jump on Prometheus Labs and talk about the scenario in which the Mayo Clinic informs a patient they may have disease X and that they have the ability to test for it, they just can't unless the patient pays $200 to Prometheus Labs or some such surcharge.

    On the other hand, the research surrounding statistical analysis of correlation between diseases and body diagnostics will surely skyrocket as people race to patent these things. So, while I'd argue in favor of the Mayo Clinic, I have to admit that I'd rather have the ability to test myself for a disease for $X than to not be able to test for it no matter what the cost.

    I guess it's the classic argument for patents. I'd be interested in hearing Prometheus Labs' pricing scheme. A modest one time fee per hospital? A once per use fee? Covered by insurance? What motive do they have to pour over this data and draw these correlations statistically without a monetary incentive of some sort to keep them going/make money?

    • by bugnuts (94678) on Tuesday July 21, 2009 @01:36PM (#28772975) Journal

      Although I appreciate the distaste of making money off sick people, I don't think that applies. Promethius should be tied to a rock for a giant eagle to eat their livers.

      They merely patented something that a "common knowledge" thing in drugs. It's how urine drug screening has worked for 20 years, it's how tons of drug effectiveness tests work (mostly drug screenings). It's a false monopoly, troll or not.

      If they invented some sort of new test for the metabolites... like a special litmus stick which would tell you the levels of metabolites, that would be completely different.

      • Re: (Score:3, Informative)

        by Grond (15515)

        The idea of testing metabolite levels is not what the patents claim, though. The patents claim testing for specific levels of a specific metabolite produced by the administration of specific drugs given for a narrow class of conditions.

        The immunosuppressant drugs in question (6-mercaptopurine, azathioprine, 6-thioguanine, and 6-methylmercaptopurine riboside) require very careful titration in order to be effective. Too little and they are not therapeutic, too much and they overwhelm the immune system. Thu

        • by Qzukk (229616)

          Mayo Clinic, which could have done the research itself, chose not to do so.

          Except that according to the article, Mayo Clinic determined its own levels of metabolites and was testing for these other levels, not the numbers that Prometheus tested for.

          Either way, the act of testing is not covered by the patent, and the claims that various university labs were being threatened for performing the test should be investigated, unless those university labs were also making decisions on the amount of drug to be admi

      • Although I appreciate the distaste of making money off sick people, I don't think that applies. Promethius should be tied to a rock for a giant eagle to eat their livers.

        You'll hear from my lawyer. I hold a patent on the method and apparatus for preemptive avian extraction of precancerous or prediseased liver.

    • by afidel (530433) on Tuesday July 21, 2009 @01:41PM (#28773027)
      Prometheus can patent their particular test for a given attribute but patenting the process of testing for that attribute is classically a no-no. Basically your unique invention can be patented but not the idea behind it. Then another clever person takes your idea and uses it to make a better/faster/cheaper test, that is how patents spur the progress of science and the useful arts. If they don't like the limitations of patent protection then they can attempt to keep the invention a trade secret.
      • Re: (Score:3, Interesting)

        by gzearfoss (829360)

        That's the way it's supposed to work, but how it's more likely to work is:
        1) Another clever person takes your idea, and uses it to make a better/faster/cheaper test
        2) You hire lawyers to take the clever person to court, and tie up their product in so much litigation it looks like the world's largest ball of twine.
        3) You either end up buying out the clever person, litigate them into bankruptcy, or delay them until you've extended the patent and your extended patent expires.
        4) You then make a minor change to

    • by Daniel Dvorkin (106857) * on Tuesday July 21, 2009 @02:04PM (#28773293) Homepage Journal

      On the other hand, the research surrounding statistical analysis of correlation between diseases and body diagnostics will surely skyrocket as people race to patent these things.

      Speaking as someone who does this kind of research for a living, I can tell you that patentability is neither necessary nor desirable to spur research in the field.

      • Re: (Score:3, Interesting)

        by eldavojohn (898314) *

        On the other hand, the research surrounding statistical analysis of correlation between diseases and body diagnostics will surely skyrocket as people race to patent these things.

        Speaking as someone who does this kind of research for a living, I can tell you that patentability is neither necessary nor desirable to spur research in the field.

        Well maybe you should talk to the venture capital funds and the people who give you researchers money to do research that might result in nothing. Or do you work for free?

        We're all quiet about drug patents when a company does something really beneficial for humanity [slashdot.org] and patents it. No one got upset with Cleveland Biomedical Labs for patenting those radiation fixing proteins--you'll notice their investors enjoyed a temporary 30% increase in stock worth that has since diminished. But when it comes to

        • by Daniel Dvorkin (106857) * on Tuesday July 21, 2009 @02:32PM (#28773615) Homepage Journal

          I work in academia, of course. My salary comes from NIH grants. And that, my friend, is how the vast bulk of basic science research gets done.

          You want applications of scientific knowledge? Industry is great at that. And when corporate researchers come up with a novel, useful, and non-obvious way to apply knowledge in a specific way to a specific problem, patents are a great way to keep such work going. Getting the knowledge in the first place ... not so much.

          Look, I want people to make money off my work. If one of my papers ever gets mentioned in a good patent on a diagnostic or treatment that actually helps people, I'll be overjoyed. That's why I do what I do. Do I want a decent paycheck? Of course I do. But if the paycheck were all I cared about, believe me, there are easier ways to make a living. I walked away from a steady, secure, well-paid, and generally quite enjoyable DBA job to go back to grad school, and although I regret the loss of income, I don't regret the decision itself at all.

          Science is a public good. Treating the fruits of science as property pretty much guarantees that science, as we mean the word in modern usage, does not happen. If we want the benefits of our ever-increasing knowledge of the natural world, we have to make that knowledge as widely usable as possible.

    • So, while I'd argue in favor of the Mayo Clinic, I have to admit that I'd rather have the ability to test myself for a disease for $X than to not be able to test for it no matter what the cost.

      You do realize you're using a fictional book to support your false dichotomy, right?

      I don't mean that to sound as sarcastic as it does, but things were invented, written, and performed long before patents and copyright.

    • by Znork (31774) on Tuesday July 21, 2009 @02:17PM (#28773435)

      will surely skyrocket

      Most likely not beyond what it would have either way. Research is a cost with very unpredictable ROI, and total funds available to pay for medical payments don't necessarily increase much just because there are more patents (monopoly economics; you're always charging what the market can bear so there's never 'more' money available unless the consumers become wealthier). Instead they cannibalize each other, which means the pharmaceutical industry is better off not researching more than absolutely necessary (the classic 'twist a molecule one step to the left' and apply for a new patent) and fighting it out with marketing. Which is why you see more patent money funding marketing than funds research.

      I'd rather have the ability to test myself for a disease for $X than to not be able to test for it no matter what the cost.

      Ah, but you don't want to test yourself for _that_ disease. You want to get tested for _this_ disease. Your tanned doctor certainly recommends getting tested for _this_ disease, and he's been on a week long ski, er, 'conference' trip to the alps, so he certainly knows the kickbacks, er, symptoms... and no questions of why he's got lipstick smudges in the same tone that the pharmarep who just left wore.

      In the end you may still not get that test you want; the classic argument for patents has very little evidence to indicate that it actually works as intended. There is, however, a lot of evidence that monopolies become very ineffective, and you don't need to go further than a pharmacorps investor relations material to note that most money derived from those patents goes to completely different things.

      The pharmas like to claim it's expensive to do medical research. You don't need to look much to note that most everything monopolies do eventually becomes 'very expensive', so it's an open question whether patents needed because R&D is expensive or R&D is expensive because there are patents.

      I'd be interested in hearing Prometheus Labs' pricing scheme.

      Revenue, when you have a monopoly, is always maximized at what the market can bear. You jack up the prices until you lose money from the lost customers than you gain from the increased per customer profit. It's not as if someone could undercut you...

      What motive do they have ... without a monetary incentive

      What motive does anyone have in a free market economy? Either you improve your products or your competition will wipe the floor with you. Many industries live with exactly those conditions.

      If being handed free money by the state (or monopoly rights, which isn't much different in anything but name) was a prerequisite for anyone having an incentive to do anything we might as well skip the pretence of a free market.

      • by Locke2005 (849178)
        no questions of why he's got lipstick smudges in the same tone that the pharmarep who just left wore. Did the doctor accidentally leave his fly open? 'Cause otherwise, I'm just a little concerned about how you managed to see those lipstick stains...
    • So we're all going to jump on Prometheus Labs and talk about the scenario in which the Mayo Clinic informs a patient they may have disease X and that they have the ability to test for it, they just can't unless the patient pays $200 to Prometheus Labs or some such surcharge.

      Yup. They knew what they were getting into. If you want to make something and then charge highway robbery for it and use patent law as a bat against your competition, you should know that medical research is not the easiest place to do that. I AM NOT saying it's right or wrong, just that it is how it is, health is a different research game in many ways, ethics and PR are just two.

      I have to admit that I'd rather have the ability to test myself for a disease for $X than to not be able to test for it no matter what the cost.

      That's not the question. From TFA

      The Mayo Clinic developed its own thiopurine-related test that measured the same metabolites but relies on different âoewarningâ levels to determine when a change in drug dosage in needed. In June 2004, Mayo announced it would begin using its own test and would also offer that test for sale to others. Prometheus responded by suing Mayo for patent infringement on June 15, 2004.

      Prometheus hasn't actually come up with anything but a way to test something natural (at lea

  • by Drakkenmensch (1255800) on Tuesday July 21, 2009 @01:26PM (#28772857)
    I wanted to patent the process through which a person digests food into fecal matter, but clearly Prometheus already owns the patent on that one.
    • Re: (Score:3, Funny)

      by batquux (323697)

      Actually, their patent only covers when bulls do it.

    • by mea37 (1201159)

      There's a natural process, akin to digestion, by which you become aware of the level of drug metabolites in your blood?

      Or you read one litigants soundbyte and didn't do any fact-checking to see what the patent actually covers?

      Don't get me wrong, the patent is garbage IMO - but not for the reasons put forth in TFS.

    • by Red Flayer (890720) on Tuesday July 21, 2009 @01:58PM (#28773219) Journal
      No, no, that's someone else.

      Prometheus is the Titan who was chained to a rock by Zeus so an eagle could eat his liver every day (it grew back every night).

      Since the liver filters crap from the blood, clearly Prometheus has the patent on regenerative shit filtering, not on shit production.

      As a side note, what's ironic to me is Prometheus has become a symbol of defiance to authority, largely due to Shelley's Prometheus Unbound [wikipedia.org]. (In the original mythology, Prometheus reconciles with Zeus and submits to Zeus's will -- Shelley rewrites the myth so that Prometheus's defiance leads to Zeus's downfall). So now we have a company using the name "Prometheus", but using the full powers of authority to prevent others from using potentially life-saving technology.

      Way, way off-topic -- I know. But for this company to use the name "Prometheus" because of its association with knowledge/wisdom (Prometheus brought fire to humans, which is why Zeus punished him), but then contradict the modern association with defiance of authority... well, I find it humorous, anyway.
    • Apparently Prometheus has not yet patented the behavior they're willfully engaging in that is commonly referred to as Ass-Hat.

  • IP... (Score:5, Insightful)

    by oldhack (1037484) on Tuesday July 21, 2009 @01:26PM (#28772861)
    Such IPs seem indicative of the decay of our civilization. This wasn't the knowledge economy I was expecting.
    • Re: (Score:3, Insightful)

      by Anonymous Coward

      This wasn't the knowledge economy I was expecting.

      That's because the so-called "knowledge economy" was complete bullshit from the get-go.

      When the manufacturing base was destroyed in the late '60s and early '70s, a phony concept had to be invented by the government's court economists to keep the people from rebelling.

  • by Anonymous Coward on Tuesday July 21, 2009 @01:27PM (#28772865)

    I just read that while health care costs for everyone have been increasing, the jumps (and occurrences of illnesses) have been highest for obese people.

    Clearly, using obesity as an indicator of potential health risk is a highly valuable technique deserving of patent protection. Anyone who notices that they are overweight and think of trying to become healthier through diet and exercise should be sued for infringement! We need legislation to combat weight loss piracy!!!

  • Chicken Little (Score:5, Informative)

    by Absolut187 (816431) on Tuesday July 21, 2009 @01:27PM (#28772871) Homepage

    Everyone loves to freak out about this, but the reality is that there is a safe harbor provision for doctors in the patent statute.

    http://www.uspto.gov/web/offices/pac/mpep/documents/appxl_35_U_S_C_287.htm [uspto.gov]

    (1) With respect to a medical practitioner's performance of a medical activity that constitutes an infringement under section 271(a) or (b) of this title, the provisions of sections 281, 283, 284, and 285 of this title shall not apply against the medical practitioner or against a related health care entity with respect to such medical activity.

    • So the doctor can't be sued... Can the test manufacturer?
      • So the doctor can't be sued... Can the test manufacturer?

        Yes. The safe harbor does not apply to test manufacturers.

        • That's interesting - almost a reverse of a situation in Canada. In Canada the government was convinced by lobbyists that it was a social ill for women to know the sex of their fetus until late in the pregnancy (can't remember - maybe before third trimester). However the lobbyists didn't want a woman to be held responsible (punished) for trying to access this illicit knowledge about their body so the only one held responsible is the doctor administering the test requested by the woman. The fine is on the ord
    • Re:Chicken Little (Score:5, Informative)

      by Red Flayer (890720) on Tuesday July 21, 2009 @01:32PM (#28772917) Journal
      Please read the rest of that section. Emphasis mine:

      (A) the term "medical activity" means the performance of a medical or surgical procedure on a body, but shall not include (i) the use of a patented machine, manufacture, or composition of matter in violation of such patent, (ii) the practice of a patented use of a composition of matter in violation of such patent, or (iii) the practice of a process in violation of a biotechnology patent.

      That's a loophole to the medical practice exception that you could drive an ambulance through.

      • Good point. The phrase "biotechnology patent" seems extremely broad, and it is not defined in the statute. I can only assume that Congress did not intend for the "biotechnology patent" to subsume the entire safe harbor!

        • Re:Chicken Little (Score:4, Insightful)

          by Red Flayer (890720) on Tuesday July 21, 2009 @02:04PM (#28773289) Journal

          I can only assume that Congress did not intend for the "biotechnology patent" to subsume the entire safe harbor!

          Why assume that? Pharma/biotech companies give millions to electoral campaigns, and employ thousands in many voting districts. As far as I'm concerned, Congress intended to do something very similar to what you've suggested -- to remove the medical safe harbor for all but a few medical purposes.

          • Then why put it in at all?

            Courts will typically interpret statutes by assuming that Congress wouldn't waste time/paper by saying:

            This rule applies to X situations.
            Exception: X situations.

            • Because revisions to law often occur by inserting clauses into existing statute.

              Especially true for potential political hot-topics.

              This is why the laws are so convoluted... most legislation doesn't replace old law, it modifies it. It helps obfuscate the law... so instead of 'voting to remove the medical practice safe harbor' the legislator can claim they 'voted to support the biotechnology industry that employs x people in their district'. That's just one reason we end up with "spaghetti law".
      • Re:Chicken Little (Score:4, Insightful)

        by Hatta (162192) * on Tuesday July 21, 2009 @02:09PM (#28773367) Journal

        So there's an exception in patent law that protects doctors from infringing patents, unless they infringe a patent. Good god.

    • by CodeShark (17400)

      Why doesn't this give Mayo an automatic win? Or is the clinic not a provider AKA only the people that work for the corporation are providers, or ?

      • Re: (Score:3, Informative)

        by Absolut187 (816431)

        The district court's order granting summary judgment of invalidity doesn't discuss the safe harbor provision. So the answer to your question may be "because the defendant didn't raise it". The defendant has (so far successfully) argued that the patents are invalid under 35 USC 101 - lack of patent-eligible subject matter.

        This case is headed to the Court of Appeals for the Federal Circuit (CAFC).

        Note that the Bilski case, recently decided by the CAFC, has been accepted by the US Supreme Court. That should

    • Re:Chicken Little (Score:5, Interesting)

      by Anonymous Coward on Tuesday July 21, 2009 @01:58PM (#28773225)

      So where does that leave me?

       

      I'm the director of an analytical chemistry facility located at a university. We perform exactly the kinds of analysis described in the patents routinely (though not directly from blood, for various reasons). At the moment we're trying to set up a partnership with another (larger) university that has a medical school and hospital. Strangely enough, they don't have an analytical lab like the one I head, so we hope to work with them performing such analyses.

       

      Will we be protected, as "outside contractors"? Will I need to search the patent literature every time someone submits a sample, or if I need to develop a new analysis protocol?

       

      I briefly read through the patents, and they are absolutely disgusting. They look like scientific or medical review texts, without even a hint of new methods or protocols that could be (maybe, barely) defensible as patentable. This is an outright claim on knowledge itself.

      • Re:Chicken Little (Score:4, Insightful)

        by Daniel Dvorkin (106857) * on Tuesday July 21, 2009 @02:18PM (#28773455) Homepage Journal

        Talk to your university legal department immediately.

        I'm serious. Okay, first, get together with your department chair and maybe your dean. Talk to your collaborators and their bosses at the other university, too. Make sure everyone understands what a major problem this is. Then sit down with the lawyers. If you can convince them that this is a serious threat to your institution, there's a good chance they'll sign on to the case. Is your work NIH-funded? Then they might get on board too.

        Academic researchers -- you know, the people who actually create the knowledge which IP vultures try to scavenge -- need to start fighting back. It doesn't mean we should try to take up every case that offends us, however tempting that may be. It does mean that when we hear about a case that might directly affect our work, we should see if there's something we can do.

      • Will we be protected, as "outside contractors"? Will I need to search the patent literature every time someone submits a sample, or if I need to develop a new analysis protocol?

        [ And now for the standard disclaimer: Legal advice is given by an attorney duly admitted to practice law after confidentially and candidly hearing your version of the facts and applying a specialized analysis of the facts and relevant law. This, however, is a silly post on the Internet, and not legal advice. No attorney-client pri

      • Both patents were held invalid by the district court.

        Keep an eye on the appeal, but I wouldn't worry too much.

    • by Yvanhoe (564877)
      But that does not protect medical lab technicians who use or engineers who design testing systems for biological samples.
  • A clear indicator that your patent system needs reform is that you allow patents on nature.

    Having said that, Prometheus Labs are really the kinds of assholes that citizens in US society have been trained to fear: "Lawyer Mongering Freedom Trolls[TM]." If we do not stand up to the current leaders of our government (and their money hounds); we will find ourselves in a future where we become a product at conception, and thus will be subject to QA at the hands of [insert-favorite-greedy-oppressive-governme
    • Re: (Score:2, Insightful)

      by bughunter (10093)

      A clear indicator that our medical system needs reform is that corporations can engage in profit-maximizing behavior like this by treating sick people as a "resource" or "market."

      Doctors, labs, chemists, and even insurers are entitled to a fair profit for their services provided. However, they are not entitled to behave like wall street tycoons and start "innovating" in ways to screw us, and each other.

      Or at least they shouldn't be. The fact that they are is the root of the problem with health care in the

  • But I don't think that patents have any place in heathcare, ever. Aside from that, these observational patents are the most odious and absurd. These sorts of things are the realm of science, not commerce. Scientists have no need to patent discoveries, doing so undermines the very nature of science. When you apply that to medicine, you are causing some real human damage. This is absolutely unacceptable behavior and needs to be stopped ASAFP in my opinion.
    • by Dahamma (304068)

      But I don't think that patents have any place in heathcare, ever. Aside from that, these observational patents are the most odious and absurd. These sorts of things are the realm of science, not commerce. Scientists have no need to patent discoveries, doing so undermines the very nature of science. When you apply that to medicine, you are causing some real human damage. This is absolutely unacceptable behavior and needs to be stopped ASAFP in my opinion.

      Well - it's pretty misleading to claim that a company

      • by Qzukk (229616)

        technology that THEY developed

        Read the claims, they didn't develop any technology. Their claims pretty much say they're using liquid chromatography to figure out how much of the metabolite is in the blood. The only thing the claims bring to the table is very specific ranges of metabolites to use to decide whether the patient needs more or less drug. Now, maybe someone can argue that the discovery that 230pmol of 6-thioguanine per 8E8 blood cells is "too low" should be patentable, but there is nothing at

        • by Dahamma (304068)

          Read the claims, they didn't develop any technology

          Read my post, I clearly said the patent in the article was absurd (I think my exact words were: "the example patent in this article is absurd!")

          I was responding to the OP's claim that there should be no patents on medical technology anywhere, ever. And my argument is just that it's not remotely practical... if medical research had no significant costs or could effectively be funded by the govt/public without sacrificing basic human services, sounds great!

        • by Bigjeff5 (1143585)

          He wasn't talking about this specific case, he was responding to the GP (? GGP? I lose track) who said that -NO- health care related discoveries should be patentable. Which is rediculous. That's as sure a way to inhibit new medical developements from ever coming about as ever there was one.

          Furthermore, the system worked, albeit later than it should have. It got caught on the final check. The district court ruled both patents invalid. Promethius will probably lose on appeal, and there will be no more abs

    • Re: (Score:2, Insightful)

      by clickety6 (141178)

      I originally read your comment "But I don't think that patients have any place in health care, ever." and thought it sounded like a pretty apt summation of health care in the US ;-)

  • Is this covered by the constitution? I'm not sure, "writings and scientific discoveries". It seems to be contrary to what the founding fathers had in mind to be able to patent "knowlege". But then again, they never had twoo hundred year long copyrights in mind, either.

    It's a damned good thing patents expire in twenty yeras, as opposed to copyright. It's funny, you spend millions on an invention, thousands more patenting it, and the patent expires in twenty years. Meanwhile some dufus spends twenty minutes w

    • Neither writing a song nor writing a book are trivial endeavors. Actually, some scientific research takes less time and effort than either to publish.
      • by Bigjeff5 (1143585)

        Scientific Research does not get patented.

        The results may be patented, i.e. a new type of telescope design that offers 3x the resolution of current designs, or a process for measuring the amount of some molecule in the blood can be patented. Both of those, however, must pass the test of being novel.

        Promethius patented the process for measuring a particular drug in the blood. They Mayo Clinic developed their own process for detecting the same drug, which is different from Promethius's process. Promethius

  • This has at least two potentially controversial issues.

    The first is the USPTO "we'll patent anything, including arse-wiping techniques" attitude, already familiar to Slashdot. I don't need to elaborate on that. Not here, anyway.

    The second is how much right to protection from competition does a corporation have when it comes to essential needs, such as clean water and basic healthcare? At what point does such protection interfere with patients' rights to basic needs?

    In other words, if a monopoly on a test

    • At what point do we say "STOP! This unrestrained capitalism is KILLING us!" and apply some sort of humane regulation??

      I've lived in Japan several times, totaling six years there. One thing that I became aware of was how this very different society prioritizes different things, such that changing an established practice takes a different amount of effort or carnage.

      I came up with the idea of "death quotient" from thinking about accidents and disasters, and how people react. Sometimes the reaction is to i

  • by Puls4r (724907) on Tuesday July 21, 2009 @01:52PM (#28773149)
    >>with knowledge patented From the post, there's the problem. Facts, and knowledge, shouldn't be patented. You don't patent the fact that the earth has a moon. You don't patent the fact sex gets people pregnant. You patent tools that do things - such as TEST for a certain condition, help you to look at the moon more clearly, or keep people from getting pregnant.
  • All patents either "cite a natural phenomenon" or imply it. It's the act of applying that knowledge in a new and non-obvious way that makes it patent worthy. So, are they arguing that this procedure is obvious to anyone who understands basic science (and if so then wouldn't there be a mountain of prior art to nullify that patent)?
    .
    Or am I missing something?

    • by Hatta (162192) *

      , are they arguing that this procedure is obvious to anyone who understands basic science

      Yes.

      (and if so then wouldn't there be a mountain of prior art to nullify that patent)?

      Yes, there's tons of prior art concerning the use of metabolites to divine what's going on in the body. There's just no prior art concerning the use of this specific metabolite.

  • No they are medicine patent troll, which puts them in the same pot together with the Nazi troll and RIAA troll in Hell.
  • The phrase "To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries;" shall be struck and repealed.

    ..... on the grounds that it has been more hassle than it's worth, and *stifled* progress rather than promote it.

    Alternative amendment if that would fails in Congress:

    Strike the phrase "limited Times" and replace it with "14 years". If an artisan can't make profit off his works during the first fourteen years time, then too bad. Make it public domain so society as a whole can profit.

    • by Locke2005 (849178)
      Actually, I don't think 14 years for every invention is appropriate. The length of the patent should be proportional to the amount of time and money required to develop the invention. A new drug that requires several years and millions of dollars in clinical trials to prove safe and effective should be patentable for 14 years. An idea like "one click ordering" that requires a few beers, a few minutes, and a cocktail napkin to come up with should be given a much shorter period of exclusive use, e.g. 6 months
  • I can imagine someone getting a patent for an apparatus or an invented method of testing something, if that method involves the need for an patentable apparatus. But to patent the testing for anything in itself is totally ridiculous. That would be like a patent of measuring temperatures if I happened to be the first one to discover a way to do that and deny everyone else the right to measure the temperature of anything unless they used *my* method.
    I hope those patents will be blown out of the water and Prom

    • Taking the devil's advocate position, what reason would there be for private entities to research which markers indicate a particular condition? Without knowing what markers mean, there's no usefulness to the tests.

      Back to the honest person's argument, the problem is that they are patenting a "fact." The rub here is that learning what the "facts" are takes effort, and in the IP world, the expectation is that anything which requires effort should be patentable.The argument most of /. is making is that this

  • For one thing, there are new restrictions on "process" patents, and this would not seem to meet the new standards. As for utility patents, these would not meet the obviousness or prior art tests.

    From the description given, it seems to me that these are just patent trolls, who should be taken out and shot.
    • by Locke2005 (849178)
      I'm sorry, but that would violate my patent #96937642, "Method of effectively dealing with patent trolls by taking them out and shooting them". I'm afraid stringing them up by most of the obvious parts of their anatomy has also been already patented. I'm afraid you'll have to come up with a much more unique way of dealing with patent trolls.
  • Naturally, Prometheus Labs sees this whole story differently, arguing that the Mayo Clinic will profit from treating patients with knowledge patented by them.

    Um, I'm pretty sure that, as a 501(c)3 - Charitable Organization, Mayo Clinic can't profit from anything. Just a nit.

  • In March 2008, the district court held the patents invalid under 35 USC 101 for lack of patentable subject matter. The case is now on appeal to the Court of Appeals for the Federal Circuit (CAFC).

    The CAFC recently decided two important cases under 101: In re Bilski (now on appeal to US Supreme Court) and In re Ferguson.
    http://www.patentlyo.com/patent/2009/03/bilski-v-doll-round-i-of-amicus-briefs.html [patentlyo.com]
    http://www.patentlyo.com/patent/2009/03/in-re-ferguson-patentable-subject-matter.html [patentlyo.com]

    I could see the CAFC

  • This is clearly an attempt to patent laws of nature and mental processes -- they claim to have patented the correlation of metabolite levels with toxicity, and the "business method" of thinking about adjusting the dosage of a class of drugs based on a particular kind of test result. Hopefully this will be thrown out. I wonder, however, what the court would say had the patent been for a specific algorithm for changing the dosage, implemented as a computer program. I suspect the "pure mental process" would
    • by Locke2005 (849178)
      So, you are saying the following is patentable?
      if (metabolitesTooHigh)
      increaseDosage();
      else if (metabolitesTooLow)
      decreaseDosage();

      Oh no! Now they will sue me for copyright infringement!

If the facts don't fit the theory, change the facts. -- Albert Einstein

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