Doctors Fight Patent On Medical Knowledge

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.

Comments

What's next?

[Tubal-Cain]

Patenting chicken soup and lots of liquids for treating colds?

Re:What's next?

[psicop]

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.

Re:What's next?

[MightyMartian]

This seems to be like claiming that you can't use a generic circuit tester on a patented circuit board because somehow the fact that the circuit board's electrical footprint is unique means picking up the electron flow is patent protected.

It's moronic and ludicrous. What's next, companies patenting molecular spectroscopic signatures? "Oh, I'm sorry, you can't use your mass spectrometer to detect our patented chemical. You have to send the sample to us."

Re:What's next?

[fuzzyfuzzyfungus]

I'm imagining a "DMCA II" where using any analytical equipment on a patented compound is treated as attempted illicit duplication...

Re:What's next?

[Mordok-DestroyerOfWo]

Dammit psicop, I'm a doctor not a patent lawyer!

Re:What's next?

[compro01]

Since when is the name of a law required to have anything to do with the content of the law?

O to CO2 conversion

[ArcherB]

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.

Re:O to CO2 conversion

[mea37]

"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.

Re:O to CO2 conversion

[adonoman]

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.

Re:O to CO2 conversion

[AigariusDebian]

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.

Re:O to CO2 conversion

[Red Flayer]

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.

Test for Money or No Test at All?

[eldavojohn]

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?

Re:Test for Money or No Test at All?

[bugnuts]

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:Test for Money or No Test at All?

[afidel]

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:Test for Money or No Test at All?

[gzearfoss]

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 the process, repatent the idea, and repeat the process from step one.

Re:Test for Money or No Test at All?

[Daniel Dvorkin]

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:Test for Money or No Test at All?

[eldavojohn]

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 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 harvesting the money off said patents, they'll be monsters. Do we see this amount of research in other countries that don't honor patents? How are their researchers compensated? They feel good inside?

I'm all for patent reform and believe many medical patents are out of control, I'm just interested in how you see this model working if you are one of the researchers that needs compensation.

Re:Test for Money or No Test at All?

[Naturalis Philosopho]

If you take away that revenue from Prometheus, what motive do they or other labs have to continue this kind of research?

I know that you're trolling since you're purposefully misunderstanding arguments to keep this thread going, but you make a very good argument for the socialization of this type of research. If a company cannot make a profit without patenting an idea rather than a unique technology, but society finds these ideas useful, then it's time for the NIH to be funded publicly to do this research. Of course, both arguments are predicated on the misconception you're promulgating that this wasn't already a known methodology for testing all sorts of crap in our bodies.

Re:Test for Money or No Test at All?

[Znork]

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.

Re:Test for Money or No Test at All?

[Daniel Dvorkin]

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.

Re:Test for Money or No Test at All?

[Grond]

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. Thus, too little and the patient could have a potentially fatal disease flare up, too much and they could contract a fatal infection. Because of the way they work, a changed serum metabolite level takes week or months to have an effect on the disease or the immune system. Thus, it is vital that the doctor and patient be able to zero in on the correct dosage very quickly rather than through trial and error.

Figuring out which metabolite levels corresponded to the optimal dosage took a fair bit of expensive research (for starters, the drugs are not cheap, even as generics). The patent on the test is a valuable incentive for getting that research done. Mayo Clinic, which could have done the research itself, chose not to do so. Instead, it wants to free ride on the work done by Prometheus because it decided a patent infringement lawsuit is cheaper than paying for the test.

Beaten to the punch

[Drakkenmensch]

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:Beaten to the punch

[batquux]

Actually, their patent only covers when bulls do it.

Re:Beaten to the punch

[Red Flayer]

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. (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.

IP...

[oldhack]

Such IPs seem indicative of the decay of our civilization. This wasn't the knowledge economy I was expecting.

Re:IP...

[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.

obesity as an indicator

[Anonymous Coward]

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!!!

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Re:Chicken Little

[Red Flayer]

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.

Patent vs. Natural Phenomena

[ground.zero.612]

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-government-shill].

Feh.

I know I may be a bit of a leftist on this but

[thisnamestoolong]

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.

patent: new, useful, non-obvious, inventive step

[AliasMarlowe]

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.

Knowledge, or "Facts" should not be patentable.

[Puls4r]

>>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.

Re:Knowledge, or "Facts" should not be patentable.

[greyhueofdoubt]

>>such as TEST for a certain condition

That's exactly what Prometheus is patenting.

-b

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Re:Chicken Little

[Anonymous Coward]

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

[Red Flayer]

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.

Re:Chicken Little

[Hatta]

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

Re:Chicken Little

[Daniel Dvorkin]

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.

Very good argument for socializing this research

[spun]

I couldn't have put it better than you just did. We, as a society find it useful to pursue this research, but no company can monetize it without patenting patently un-patentable procedures, so we should socialize the costs of the research. Thankfully, when the free market fails us, we do have other options besides letting some unscrupulous and selfish idiots bend us over a barrel.

Re:patent: new, useful, non-obvious, inventive ste

[drunkle j]

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).

Both patents suck, but for other reasons.

On this part, I completely agree, but hopefully things are different now that KSR caselaw is in place.

Re:This is the nature of medical science

[h4rr4r]

The whole idea of patents is to force people to not use your method. If you invent a hammer for staples and I invent yet another hammer for staples that is fine.

If you invent a test for a certain metabolite and I make another test for the same thing that works in another way, how have I infringed?

To allow patenting the observation that this metabolite can indicate something about your health is absurd. Will scales be banned when I patent observing that obesity is an indicter for a heart disease risk?

Re:This is the nature of medical science

[AKAImBatman]

The problem here is in trying to patent a trade secret rather than an invention. Patents are intended to cover inventions. Real, working gizmos that operate is a specific fashion. Trade secrets cover processes and information that is of a competitive advantage.

In this case, the two are getting mixed up. The company may have a device to detect certain attributes (which IS patentable) but the fact that the attributes can be measured in order to draw conclusions is inherently unpatentable. If someone else develops a machine for measuring the attributes that works different from your machine... well... tough noodles.

All that can be done is to keep the information a secret. By keeping it secret, it is legally viewed as a "trade secret" which can be contractually protected when sharing with interested parties.

Disclaimer: I am not a lawyer, but I did stay at a Holiday Inn Express once. ;-)

Anyone else read this as

[nukenerd]

"Doctors fight patient ..." ?

Re:This is the nature of medical science

[Shamenaught]

The whole idea of patents is to force people to not use your method.

I'd have said the whole point was to get them to pay you royalties for using your R&D. Sure, some may choose not to release patents. At that point, I'd have said the point switches to "Allowing you to sue someone's ass off".

In either case, patents are all about getting money back 'cos you spent money on something. It should be proportionate, but that last factor is something many lawyers (RIAA, etc) like to exaggerate.