US Supreme Court to rule on whether practicing medicine is patentable

The Supreme Court are poised to rule in Mayo v Prometheus, a case that concerns whether medical procedures for adjusting the dosage of an out-of-patent drug can be patented. If the Supremes rule in favor of the patentability of adjusting drug doses and other common medical procedures, it will make doctors liable as patent infringers merely for practicing medicine. What's worse, judging from the hearings, the justices are ready and willing to make this loony idea into the new standard for patentability.

The American Medical Association’s brief on the matter argues that ”If claims to exclusive rights over the body’s natural responses to illness and medical treatment are permitted to stand, the result will be a vast thicket of exclusive rights over the use of critical scientific data that must remain widely available if physicians are to provide sound medical care.”

“Conscientious physicians will be unwilling and unable to avoid considering all relevant scientific information when reviewing test results. Thus, as medical knowledge accumulates, patent licenses increasingly will be required for physicians to conduct even well established diagnostic tests.”

Supreme Court Takes a Look at Medical Patents (via @bengoldacre)


  1. If the judges decide in favor of patents I can just see that human life and health will become another commodity for trade.  It’s not enough that patent trolls  make money at the cost of consumers, soon they will be allowed to make money at the cost of human lives.

      1. Yeah…you do know that (to take a random example) HIV drugs are patented and that Big Pharma has been fighting illegal generics for use in THird-World countries for a long time now, right ?

        Corporations DO NOT CARE about human life. They care about PROFIT. We need to kill them before they kill us all.

  2. 5-4 ideological vote in favor of more greedy neo-liberal economic interests profiting off of everything in sight. Ahhh the Roberts Court…

      1. When I speak of economic liberalism I do not speak of the academic definition that you have provided for me from wikipedia. I speak of the policy that is created under the guise of that definition which is, in reality, pure profit for a select group of people. Plutocracy. Oligarchical rule. I intended to speak on this (not clearly enough) when I made the comment. The academic definition that you provide is not the reality of the policy that emerges from the people that say they are acting based on the ideology of economic liberalism. The term has been co-opted by a group of greedylilfuckers (academic term) and that is all I was saying. It was impossible to tell given my comment now that I look back but I was hasty and made the common mistake of feeling like my cynicism and sarcasm would transfer well into internet text. I should have put “economic liberalism in ” “. Maybe that would have worked better. 

        1. Perhaps economic NEO-liberalism would be more fitting?

          Or in other words if someone has fenced in their property (real or imagined), then no force on earth can tell him what he can or can’t do with it or anyone that steps inside it (trespassers will be shot and all that).

          Basically the only scared concept is the concept of property…

    1. It is a fascinating thing, that the so-called proponents of the free market are so often arguing for the extension of government-granted monopolies to every conceivable circumstance.  They do this in the face of mounting economic evidence of the inefficiency it creates, and in the face of the Constitution, which permits patents and copyrights only insofar as they are useful to advance the arts and sciences.

      1. Many, if not most, of the libertarian arguments of the free market do not take this stand. The general range of opinion in the libertarian community tends from ‘Patents/Copyright/IP etc.’ is a system seriously out of whack that needs reform, to ‘Artificial government protections of IP are ridiculous and should be abolished, the only true definition of property are physical things you can touch and feel.’

        1. Quite so.  Honest people of many political stripes reach the same conclusion.  However we are not always among honest people.  I speak of, and call attention to, those who adopt free market rhetoric when it is profitable to their interest, and defend a fictive natural right to a monopoly when that is profitable.  

          Opposition to these government monopolies is a point which should have unanimity among honest people.

        2. Then how the fuck does seem that every time there is a avowed libertarian in front of a camera somewhere, the very opposite seems to be the goal?

          1. Where exactly do you find these legions of libertarians that are in favor of extending patents and copyrights to everything under the sun? Because I’ve never seen any of them. Yes, plenty of conservatives take that position, but they’re no more libertarian than Barack Obama is.  For that matter, I virtually never see an “avowed libertarian” in front of a camera anywhere – what I see are big-government conservative shills that the big-government liberal shills like to pretend are libertarians.

  3. Then the justices’ physicians can just solve the problem by using brand-new, creative medical solutions for their health problems. 

    1. I don’t think anyone’s patented bloodletting, leeches, and hot-iron cauterization. For treating the common cold, at least.

    2. Why would they have to do that?  They can just keep treating patients as usual, seeing how this case would have no effect on practicing physicians.  

  4. Sounds like a perfect opportunity for Congress to remind the Supreme Court of their Constitutional role and pre-emptively overrule the Court under Article III of the Constitution.

    For those of you Supreme Court-worshippers, this is not only legal, but it is a Congressional power acknowledged by the Supreme Court in Ex Parte McCardle in 1869.   Congress has the Constitutional authority to take appellate jurisdiction away from the Supreme Court.   This is called a “check” on the Court’s power.

    Further, medicine is a state issue.  The Federal Government has no authority to regulate or otherwise exercise jurisdiction over the practice of medicine.  And for those of you interstate commerce clause-worshippers, practicing medicine across state lines is a crime.  Medical licenses are issued at the state level.  The Federal Government has no authority in this matter and the Supreme Court has no business hearing this case.

    (Meanwhile, there IS a case that the Supreme Court should have heard by now, but hasn’t, and that is the 20 states who are suing the Federal Government over the Constitutionality of the Health Care Law. Under Article III Section 2 of the Constitution, the Supreme Court has original jurisdiction in any case where a State is a party. That means no other Court has the jurisdiction to hear the case. Any case where a State is a party goes directly to the Supreme Court. That goes for the Arizona immigration case too.)

    Following the Constitution, the Government would then bypass this case entirely and there would be no possibility of a nonsensical finding like “the Supreme Court says doctors need a patent license to regulate dosages.”

    And yes, that means Medicare and the new Health Care law are both unconstitutional too.  

    Constitution is an amazing document.  The decline of this country can be directly tracked through the passage and accumulation of unconstitutional laws. This case is simply another step in the wrong direction.

    1. Except that your argument would imply that nothing that the Federal government does not otherwise have jurisdiction over is patentable in the first place. Which, while very plausible-sounding, hasn’t got a snowball’s chance of actually happening.

      One presumes, rather, that the Constitutional authority to grant patents in the first place is the controlling law here.

      1. Except that your argument would imply that nothing that the Federal government does not otherwise have jurisdiction over is patentable in the first place.

        That’s a separate issue.  What is clear in this case is that according to the Constitution, the Federal Government has no legal authority over the practice of medicine.

        1. What is clear to *me* is that according to the Constitution, the Federal government can issue patents on pretty much any invention it wants.  And that you just made up that other stuff.

    2. The federal government certainly can regulate some aspects of medicinal practice, as they relate to the federal powers. This case, which involves patents, falls squarely on an enumerated power. Congress may also decide to invoke the first enumerated power, to promote the welfare of the nation.

      Make no mistake, there was never a restriction on creating hospitals or providing health care to people in the US.   The first such law was in 1798, and there have been many since, and the court has upheld them.

      Now you are welcome to create your own interpretation of the Constitution wherein those laws were invalid and the court decisions wrong.  And, as a legal issue, it is an interesting debate.  But there is no question as to what the law is, where it has been ruled upon.  The Constitution provides for settling questions arising under the Constitution or laws by way of the Court.  Ergo, in a dispute over interpretations, the Court’s ruling is the Constitutional ruling as a matter of law.

      1. Congress may also decide to invoke the first enumerated power, to promote the welfare of the nation.

        “To consider the latter phrase, not as describing the purpose of the first, but as giving a distinct and independent power to do any act they please, which might be for the good of the Union, would render all the preceding and subsequent enumerations of power completely useless. It would reduce the whole instrument to a single phrase, that of instituting a Congress with power to do whatever would be for the good of the United States; and, as they would be the sole judges of the good or evil, it would be also a power to do whatever evil they please.”

        “It is an established rule of construction where a phrase will bear either of two meanings, to give it that which will allow some meaning to the other parts of the instrument, and not that which would render all the others useless. Certainly no such universal power was meant to be given them. It was intended to lace them up straitly within the enumerated powers, and those without which, as means, these powers could not be carried into effect. ”

        — Thomas Jefferson

        It should be noted that Mr. Jefferson’s criticisms of the Supreme Court were well-known and apparently prescient.

        Now you are welcome to create your own interpretation of the Constitution

        See above.

        But there is no question as to what the law is

        On this much we agree.

        1. Which is precisely the Jefferson position of the Jefferson-Hamilton debate, which we all know quite well.  You may note, however, the history and precedent of the Nation since have come down on Hamilton’s side.

          1. Happily, it came down on Hamilton’s side. Otherwise we’d still be looking at forty-something tiny countries, many of which would effectively be corporate-owned, most of which would by now likely be conquered by an Asian or European power, often featuring such “state’s rights” issues as it being illegal for non-WASPs to be in town after dark, for women to vote, or to sell property to homosexuals.

            Sadly, the economic situation we are in is as a direct result of congress not exercising the Welfare power — the repeal of glass-steagall and enactment of the Gramm-Leach-Bliley act de-regulated the financial industry (which was made possible in the first place by the acceptance of Hamilton’s views over Madison’s).

            As a rule, anyone I’ve ever seen argue that the country ought to / ought to have use(d) Madison’s interpretation of the Welfare clause, is arguing from ignorance — we don’t know exactly what would have happened, but the informed approximations all note that the East Coast would have been reconquered by Britain, if not in the early 1800s then definitely the mid-1800’s; such an argument also ignores the long history states have had of being regressive, oppressive, oligarchic and avoidant of the rule of law.

            In short, they’re the kind of jackass that wishes fervently for a terrible flu epidemic on the basis that it would be unthinkable — and therefore impossible — for them and their loved ones to be harmed by that incident.

          2. the East Coast would have been reconquered by Britain, if not in the early 1800s then definitely the mid-1800’s; such an argument also ignores the long history states have had of being regressive, oppressive, oligarchic and avoidant of the rule of law.

            Army of whooping and hollering straw men sweep across the countryside.   Thousands flee.  Film at 11.

    3. I hate to say it, but the federal system of separation of powers that the constitution created (where almost all government power is vested at the state level and where the federal government has jurisdiction over the few things assigned to it in the constitution) is dead, dead, dead, and it ain’t coming back. The national government in Washington now has the power to regulate and legislate on everything imaginable, and the state governments have been reduced to appendages of the behemoth in Washington.  And there’s no way this can ever be undone. Indeed I expect most Americans would not want it to be undone.

  5. Because the problem with US medicine is that there’s just not enough litigation. 
    A part of me wants to say “let them, and finally the last straw will fall and a proper reform will be made”. The other part just reminds me that this point was passed a while back, and the outcry just falls on deaf ears.

    1. I’m always astounded by this sort of thing – nearly everyone acknowledges that America’s lawsuit culture is crazy, but Congress, the state legislatures, and most of the courts continue to tirelessly work to expand it.

  6. the Supreme Court has original jurisdiction in any case where a State is a party. That means no other Court has the jurisdiction to hear the case.

    I don’t think that’s what it means. But I’m not a lawyer. Do you have a citation?

      1. Thanks, but I didn’t see anything in your link to suggest that no other court has jurisdiction. It sounds to me like original jurisdiction just means they have the option of hearing it first if they choose.

        1. “ORIGINAL JURISDICTION, practice. That which is given to courts to take cognizance of cases which may be instituted in those courts in the first instance.”  

          Why explicitly grant the Supreme Court original jurisdiction if the words are to be construed such that any court has original jurisdiction?  That’s absurd.

          This is no different than the “Necessary and Proper” clause debate.  Why enumerate Congress’ powers if the “welfare of the nation” and “necessary and proper” grants Congress the authority to do as they please?  

          More specifically, why are you opposed to limiting the powers of courts inferior to the Supreme Court?   Are you generally opposed to limited power or is it something specific about Federal District and Appeals Courts?

          1. “That which is given to courts to take cognizance of cases which may be instituted in those courts in the first instance.”

            You’re focusing on “in the first instance”, but it’s “may be” that catches my eye.

            …to be construed such that any court has original jurisdiction?

            If the Supreme Court has the option, but not the requirement, to hear certain cases first, this would not imply that any court has jurisdiction in those cases.

            More specifically, why are you opposed to limiting the powers of courts inferior to the Supreme Court?

            Neither my curiosity about the meaning of “original jurisdiction”, nor my non-lawyer’s perception of what a few lay websites say about it, suggests anything about my opposition to anything.

  7. I believe this would actually constitute the practice of clinical  pharmacy to be honest with you. 

  8. this is what you get when you allow and accept the immorality of profiting off of others misfortune and illness, which is our healthcare system.

      1. I’ve already patented getting patents for suing people for violating patents.  Sorry, but you can license this technology from me for a fee.

      1. Patent laws are all about capitalism. Stupid patent laws like this are all about capitalism taking priority over sanity.


          I’m sorry! I know TYCLO and all that… but seriously. This bullshit has to get fucking addressed, so I’m going to address it right now:

          If you have a single law- there’s no such thing as a free market. Any law. Of any kind. Laws are a restriction of the free market no matter what they are. Can’t enslave people? That’s a restriction on the market. Can’t kill people (implied: you can’t do it for money)? That’s a restriction on the market. Reasonable restrictions- yes. Necessary restrictions- absolutely. 

          They are still restrictions on the market. As you move your way down the list of these restrictions (which are not universal since slavery was a fact of life for a long time) you eventually hit other restrictions that are arguable. Like about whether or not you can spew toxic waste into the air.

          The “free market” is a complete cop out- a way ignoring the fact that the entire concept of “free” is so subjective as to be useless. The vast majority of people interested in maintaining any system that preserves private property are arguing in favor of a free market, they merely differ as to what constitutes freedom.

    1. Yes, because “unfettered capitalism” is all about government-granted monopolies…

      The whole purpose of patents and copyright is to fetter pure capitalism through government regulation, supposedly for the good of the collective.

  9. This primate is obtaining a patent on employing the reductionist/mechanistic-scientific method as regards to all life sciences… BAM. Pay up, microbiology!

  10. This will happen.  They need to reach that point where they can charge us for breathing air.  This is the necessary first step, making decisions patentable. Once that happens, nobody will be able to teach a skill to another person, because that skill was taught to them by a company and is owned by them.  The obvious place they will use this is in education.  Xerox has the patent on written communication, so parents have to pay Xerox a licensing fee so their children will legally be allowed to learn how to write.  Just getting that much closer to usage fees for breathing.

  11. My God, do the terrible ideas never stop? These people are a type of negative genius…

    Sometimes I think that our congress is run by 4Chan.

    So, if this passes, can I file a patent on acupuncture???

    1. Only if you perform it with an Ice Pick or Crochet Hook. 

      It is amazing, isn’t it. I’ve used a knife to open a letter, piece of carpet as a furniture mover and a wooden clog as a hammer…..Have I broken any laws?

      What about the definition of Deadly Weapons for that matter? I manufacture Candle Sticks; I think I’ll file suite against the makers of CLUE.
      I think I’ll go big and patent an entire religion, or a new way of life. Maybe a new sexual position to boot. The position will be sex without touching. I’m a genius. How about a new way to travel.

      I’m going to patent skipping. Everyone pay me if you want to skip. Skip To My Lou is already patented, mines the next best though, it’s called Skipping A Beat. If your heart skips a beat, I own it.

  12. Hi Cory

    Do you know if the statement “…it will make doctors liable as patent infringers merely for practicing medicine…” is accurate?

    Specifically, I thought that medical techniques can be patented (i.e. disclosed), however there is an exception in law that prevents the courts from enforcing liabilities against doctors who use the patented techniques to provide treatment. 

    e.g. Suppose someone patents X, the protocol for adjusting a drug dosage. Following this, if the man in the street uses method X for a non-medical purpose and without a license (e.g. suppose the method is also useful for mixing paints) – in that case they are liable to be sued by the patent owner.

    Medical doctors can go ahead and do X with impunity, however, whenever doing so provides a treatment. The courts are not allowed to enforce damages against a doctor who infringes a patent while practicing medicine, nor can they enforce damages against anyone who is directed by a doctor and engaged in providing a treatment.

  13. I think I raced my motorcycle faster than it’s stated and patented RPM’s….can I patent the difference?

    1. So the article title is wrong and misleading?  Physicians and patent/health attorneys are well aware that you can’t enforce patents against physicians.  While the Forbes (not valid source for legal analysis) article doesn’t mention this, all the legal articles and blogs do.

      I’m shocked BB got this so wrong. Maybe  they could use a fact checker / research assistant. It’s like media articles that twist a non-conlusive medical study into “green jelly beans cause cancer!” type of thing.

  14. Funny – I was reading about this case in the Minneapolis Star this weekend.  They quoted Roberts saying something like, “I had an idea – you put wood on a grate, heat it, and get fire.  I can patent this?”  From what I’ve seen, the justices are not close to agreeing but find this kind of patent ludicrous.

  15. When I was studying for a doctor of pharmacy degree, one of the assignments in the pharmacokinetics course was to develop an equation for dosing adjustments in patients with kidney failure, using data from medical literature on the assigned drugs. Would this exercise be possible if dosing algorithms were patentable?

    1.  Would your algorithm be adequate enough to transform a law of nature into an application of a law of nature? Does it preempt the use of a law of nature? Is it novel? Is it obvious? Is it transformative?  This case has no application to the  simple dosing scenerio you mention.  It’s more complex and interesting than that.  

      1. I disagree, I think my example is exactly analogous. After all I would be developing a unique equation for adjusting the dosage of a drug, based on serum creatinine and population data on the blood levels of that drug for patients with varying degrees of renal function. In this case, it’s dosing adjustments based on serum levels of the drug’s metabolite. Same idea.

        1. You’re talking about science and I’m talking about law.  Concepts like “transformative” or “law of nature” are very different in each field.  

          Not trying to belittle your grad school homework, I’m just guessing that your algorithms weren’t the kind that end up at the Supreme Court. The  justices are discussing things like: “‘What has to be added to a law of nature to make it a patentable process?…If you put too little in the answer to that question, I believe I can make things like E=mc2 patentable.”

  16. ” it will make doctors liable as patent infringers merely for practicing medicine”

    What!?  Not only sensational, but completely false.  It’s common knowledge that federal law protects doctors from any kind of patent infringement in treating patients.  This kind of misguided armchair legal analysis seems so out of place here… 

    Please read 35 U.S.C. 287(c)

    1. The problem is that the blood tests in question are not ordinarily performed in the doctor’s office. Rather, the samples are generally sent to a contract laboratory for analysis. The laboratory does not enjoy the 35 USC 287 (c) protections. It’s neither [2 (B)] a natural person licensed to practice medicine in a State, nor [2 (C)] the natural person’s employer.  So, while the doctor cannot be sued for interpreting the test, the laboratory can and will be sued for providing the test results for interpretation. And the fact that the doctor is immune to suit for direct infringement may not imply that the laboratory might still be guilty of contributory infringement – one of the points at suit is that the doctor may still be an infringer; merely a privileged one.

      1. I’m not sure I understand what a doctor as privileged infringer means, but I do understand  that the labs may be liable. Because the US is one of two countries (along w/Australia) that allow the patenting of medical methods, Congress has provided physicians with considerable liability protection under 287(c).Some experts in the patent community reason that that the entire case should be dismissed because it has  statutory immunity from patent suit under 287(c), so I think some of the legal issues you bring up are pretty open.

        My point is that the BB post  and Forbes article make it seem like some doomsday scenario is upon us where doctors would be limited in their ability to practice, and would be breaking the law if they did so.   There’s no risk of this, and those simply aren’t the type of issues being considered in the case.

        1. 287(c) isn’t that clear-cut.  287(c)(1) states:

           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.

          Fair enough.  However, 287(c)(2)(A) states:

          (2) For the purposes of this subsection: (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.

          In other words, 287(c) is not a get-out clause; it only covers the performance of a medical or surgical procedure.  Prometheus’s patent (US/20606/0216726A1) could certainly be considered to fall under the definition of “biotechnology patent” in 287(c)(2)(A)(iii), as its primary US classification is 435 (chemistry: molecular biology and microbiology) and secondary is 436 (chemistry: analytical and immunological testing), or equivalently C12Q and G01N33 in the IPC classifications.

          Patent doc here:

          Classification doc here: 

          OECD classifications for biotech patents here: 

    2. But is there is the possibility of impeding medical research? Physicians may be free from the consequences of such rulings, but in order for them to practice science-based medicine effectively, they rely upon unfettered access to the best possible medical information. 

      1. I’m just stating the fact that physicians would be legally protected in the case being discussed.   

        “Unfettered access to the best possible medical information”sounds good to me!

  17. Somebody seems to be really really intent on a real-life Reductio ad Absurdum.

    Of  patents, copyright and intellectual rights as applied and enforced today.So far, Corporatocracy in America. I wonder, Is there be enough of an open society in the USA to change things and supersede all this absurdity? Or will it eventually implode and collapse like (not) merry old Marxism and the USSR did?

    By the way, it’s quite ironic that the suing party is called “Prometheus”, of all characters.

  18. Derek Lowe, who writes about drug discovery and related IP issues over at In The Pipeline, very pertinently says:

    what they’re claiming is the process of using a blood test to decide whether or not to administer a drug. Prometheus Labs did not discovery any immune-mediated gastrointestinal diseases. They most certainly did not discover thioguanine, nor did they discover that giving thioguanine is beneficial to people who are deficient in it. No, they make a test kit, and they are claiming the process of checking a patient’s blood levels (their test kit’s function) in order to make a medical decision. The Mayo Clinic planned to offer a competing test kit, and Prometheus sued, and here we are.Now, think about a world in which such processes are patentable … Prometheus seems to be claiming that the awareness of needing to test for thiopurine levels in order to decide whether to dose a patient is enough to infringe their patent. Doesn’t matter if the physician doses anyone or not – just the idea of testing their blood is enough. IP rights have been infringed. Money must change hands. Ka-ching. Imagine every new bit of medical practice broken down into the smallest patentable, monetizable steps. A physician reads about a new finding that might affect clinical practice – but not so fast! Better check to see what the patent rights are. Wouldn’t want to get sued for applying the scientific literature without the proper licensing fees.

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