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...

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?

[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.

IP...

[oldhack]

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

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!!!

Comment removed

[account_deleted]

Comment removed based on user account deletion

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: 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.

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: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: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.

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?