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Supreme Court Legitimizing Medical Patents?
RobinEggs writes "A case before the U.S. Supreme Court Wednesday addressed the legality of medical patents. From the article: 'The case focuses on a patent that covers the concept of adjusting the dosage of a drug, thiopurine, based on the concentration of a particular chemical (called a metabolite) in the patient's blood. The patent does not cover the drug itself—that patent expired years ago—nor does it cover any specific machine or procedure for measuring the metabolite level. Rather, it covers the idea that particular levels of the chemical "indicate a need" to raise or lower the drug dosage. The patent holder, Prometheus Labs, offers a thiopurine testing product. It sued the Mayo Clinic when the latter announced it would offer its own, competing thiopurine test. But Prometheus claims much more than its specific testing process. It claims a physician administering thiopurine to a patient can infringe its patent merely by being aware of the scientific correlation disclosed in the patent—even if the doctor doesn't act on the patent's recommendations.'"
Looks like it's time for that revolution.
Damn, and here I was hoping to never have to befriend an extremist militia.
Moving to Canada or Australia sounds good, but, like they say, "the grass is always greener".
"Helping to keep you two steps ahead of the Thought Police!"
Sorry Mr. Patient. While I know exactly what's wrong with you, the Medi-Jackass Inc. will sue me into oblivion if I prescribe the proper treatment to you!
No, I can't tell you either. They'd sue me into oblivion TWICE, then go after you too.
Un-fucking believable.
All I can hope is that medical establishments EVERYWHERE (including insurance companies) tell these people to fuck the hell off and stonewall them into bankruptcy while blacklisting every product and service they use to hasten the process.
Chas - The one, the only.
THANK GOD!!!
Just because they heard the case doesn't mean "Supreme Court Legitimizing Medical Patents".
That's a troll headline.
This is as basic as it gets. Can companies patent the use of facts? Let's see if they can get this right. If they do, at least we know there's an upper limit to their ignorance. If they can't , then it's the end of innovation in the US and the beginning of a stampede of smart, motivated people who want to do Good Things out of the US and into the EU or elsewhere. It's just that simple. Either we're free to innovate in this country, or we leave our country in favor of a land that offers more freedom and opportunity. Just like our forefathers did.
So the doctor needs a license from the patent holder to effectively administer the drug. Well I can see that generating a lot of sales of the drug. Not.
Undetectable Steganography? Yep, there's an app fo
All I can hope is that medical establishments EVERYWHERE (including insurance companies) tell these people to fuck the hell off and stonewall them into bankruptcy while blacklisting every product and service they use to hasten the process.
My hope is with you, buddy. Except I fear that whenever money is involved, ethics, humanitarianism and other socially awesome things go out the window.
I know nothing about the US patent system - but my first thought on reading this was as follows.
Proper administration of the drug is supposed to violate the patent.
The drug in question is out of patent... (for years)
Does this mean that there was an extended prior where the drug was not able to be administered correctly to start with, or does their argument cause the 'method' patent to be invalid on grounds of prior art which must have existed in order for the drug to be administrated properly in the first place.
Brazil had this idea:
http://news.bbc.co.uk/1/hi/health/4059147.stm
blindly antisocialist = antisocial
Sorry Mr. Patient. While I know exactly what's wrong with you, the Medi-Jackass Inc. will sue me into oblivion if I prescribe the proper treatment to you! No, I can't tell you either. They'd sue me into oblivion TWICE, then go after you too.
Un-fucking believable.
35 USC 287(c)(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.
There are no damages for infringement by a medical practitioner of a medical activity. No one's going to sue doctors. Stop the FUD.
There are no damages for infringement by a medical practitioner of a medical activity.
That doesn't mean the doctor won't have a pay a lawyer to convince a judge that 35 USC 287(c)(1) applies.
By the way, do not forget your rights if you become a jury - NULLIFICATION.
Which is one reason why a lot of litigants are so quick to get matters of law disposed of in summary judgment, so that the question of fact has no chance to even go before a jury.
No, this is about if a generic version of the drug can be sold as long as the label doesn't instruct the physician about the patented use. The holder of the patent wants to ban generics even though the patent on the drug itself has expired.
I read the transcript of the arguments, and it wasn't really clear to me what way they were leaning. Sotomayor seemed mostly in favor of the patentee, while Breyer especially was critical of the patentee. But these are oral arguments, and justices can take devil's advocate positions during these in order to tease out certain details of the case. Figuring out how the court will swing based on the oral arguments is like reading tea leaves, especially when it comes to patent law.
As for the correctness of the headline: This case is in the Supreme Court because an early summary judgment motion in the district court was granted, ruling that the patent is invalid. The case was appealed to the Federal Circuit, which reversed the ruling, and then Mayo appealed to the Supreme Court.
This case only focuses on the question of patentable subject matter under 35 USC 101, i.e., what kinds of claims should be patentable. In particular, the question here is whether the claims are directed to an application of a law of nature (the metabolism of a certain drug administered to a patient) or to the law of nature itself. Laws of nature are not patentable in and of themselves, but applications of a law of nature can be, as long as the entire law of nature is not "pre-empted" by the claim. In other words, matter-energy equivalence, E = mc^2, is a law of nature. Particular applications of that principle can be patentable, but if the claims are written such that every conceivable application of the principle is covered by the patent, then the principle is pre-empted by the claim (i.e., they might as well have claimed that entire law of nature, because the claims effectively cover it entirely).
Prometheus, and the federal government, both argue that the arguments that Mayo is making are better addressed when considering the claims against the prior art (i.e., under 35 USC 102 and 103). (This is in part because Mayo is doing a hamfisted job of arguing their case, probably because they don't want to sabotage some of their own medical treatment patents.) The issue is that prior art considerations require a time-consuming process called a Markman hearing, where the court decides how to construe the various terms recited in the claims, and usually thereafter, a jury decides whether the prior art covers the claims, which makes the process extremely uncertain. It's Mayo's hope that patents like this can be killed early on in the process by a judge, rather than putting all their money on double-zero and giving it a spin with a jury.
TLDR version: Nobody really knows what SCOTUS was thinking during oral arguments. This isn't the end of the road for this case, even if Mayo loses, because prior art still has to be considered.
Considering how US laws (specially patent and copyright ones) are push over other countries, the only way to get rid of it is at the source, not running away.
You are not safe of it outside. There are plenty of american laws regarding patents and copyrighted content that are push to other countries like there is no tomorrow, and the other countries (or their legislators, those "incorruptible" entities that make laws) usually put forward those laws. See what happened around the Sinde law in Spain, even after was public why they were approving it.
or 3. The lawyers, judges, and Congress will realize that the entire government will grind to a halt if that strategy is allowed, so they will reject the strategy, completely failing to realize that this is also a problem in other areas.
1. Patent a precise method used to record patent documents in a digital form on a computing device, a computing device with a touch screen, and a hand held computing device with a touch screen.
2. Write software that can be used to record patent documents in a digital form, a vi macro would suffice.
3. Sue patent trolls for patent infringement.
4. Profit.
Most ignorance is vincible ignorance. We don't know because we don't want to know. --Aldous Huxley
Today a patent on titration, tomorrow on breathing.
On Wall Street they say "buy low, sell high" On the pad we say, "buy high, sell high" Isn't that somehow better?
According to the article:
"But Prometheus claims much more than its specific testing process. It claims a physician administering thiopurine to a patient can infringe its patent merely by being aware of the scientific correlation disclosed in the patent—even if the doctor doesn't act on the patent's recommendations."
If anyone is spreading FUD it's the patent holder.
It's bad enough that my family physician has to employ a couple of people whose sole job is to deal with the insurance companies all day long. Now it seems, if this idea is approved by the Supreme Court, they'll need to have a patent attorney on retainer to make sure they don't run afoul of some pharmaceutical company who found that a drug's effectiveness can actually be measured.
I thought it was supposed to be a bad idea to have the government getting between the doctor and the patient. If this isn't government getting between me and my doctor, I sure as hell don't know what is.
CUR ALLOC 20195.....5804M
Exactly. A similar example of this is the drug Propecia - the hair loss drug. Propecia is a 1mg dosage of Finasteride that goes for over $2 a pill and is patented so there's no generic option. The thing is, Finasteride isn't new, it has been around since the 60's in a 4mg dosage to treat prostate enlargement and hormonal issues, it isn't under patent anymore and costs about $.02 a pill. Merck came along a few years ago and claimed to invent the same damn drug for a different purpose and got an 8 year patent on it allowing them to jack the price for no good reason.
It will never get past (1), as congress will exempt itself from the law, like it does with nearly every other regulation, and go about in their blissfully unfettered world.
Is it just my observation, or are there way too many stupid people in the world?
... that Republicans were all worried about creating Death Panels, when in fact, they were defending them.
Check your premises.
I represent generic drug companies. I can tell you that brand operations do not go after, and would not go after, individual doctors. It would be impractical. Interestingly, the Caraco v. Novo Nordisk case heard on Monday by the Supreme Court was exactly about a situation where Novo Nordisk was going after Caraco not because of anything Caraco did, but because of what doctors and patients would do. So much for that straw man. The Supreme Court is dealing with a line-drawing problem in Mayo v Prometheus. You can't patent gravity but you could have (long in the past) patent a pile driver. The Prometheus patent is about titrating medication levels for a certain class of prior art drugs using prior art tests. Too low, and the medicine is ineffective, too high and it is toxic. Nobody denies that Prometheus was the first to make the investment to come up with the decisional protocol it claimed. There is no doubt that if the claim had added the step "and administering an appropriate dose to a patient" or something like that it would be patent eligible subject matter. This is an important question. Drug companies do expensive research to find new indications to treat with a drug all of the time. Anti-psychotics often will treat other conditions, but who knows which ones? At what doses? If you cannot patent the process of treating the new disease, you cannot get a patent: the molecule is already patented. We are talking high-8 to low-9 figures here to find that out. Let me assure you, nobody will ever know if you cannot patent the result. None of the attorneys offered help to the Supreme Court in how to word the drawing of the line so that it can be applied. The Supreme Court does not take a case to take a case. It takes it to solve a problem in the law. Here, the decision will apply to non-medical as well as medical patents. As another poster pointed out, the problem that Chas complains about has been solved by Congress. It would have been impractical to sue doctors in any event. Companies go after competitors, in this case a competing testing lab. This is just about the Benjamins to both of them.
cobblers - the grass is fuckin' brown in Australia mate
Yeah, except that this is in the Supreme Court now because they are suing doctors. Well, they're suing the clinic where those doctors offer treatment, but the law you quoted covers "related health care entities" which you would hope meant the clinic they work at!
Not quite:
Mayo Collaborative Services and Mayo Clinic Rochester (collectively, “Mayo”) formerly purchased 7 PROMETHEUS LAB v. MAYO COLLABORATIVE and used Prometheus’s test, but in 2004, Mayo announced that it intended to begin using internally at its clinics and selling to other hospitals its own test.
Prometheus sued a competing manufacturer, not a doctor or just a clinic.
So they aren't usually chasing tonnes of potentially new users, they are chasing the few people that will really benefit from the drug. Perhaps a way around this would be to amend the patent laws so that people/companies are free to experiment with other uses for a patented drug. So if a drug is patented as a "blood thinner" than if someone else pays for the research and finds another use they can market their own version for that particular use. Could be the best of both worlds: corps get their money back from the primary use, public research could find the smaller volume uses and be free to license them to generics makers to keep the prices low for the people that often have much more severe medical issues that the drug works for.
or 3. The lawyers, judges, and Congress will realize that the entire government will grind to a halt if that strategy is allowed, so they will reject the strategy, completely failing to realize that this is also a problem in other areas.
This is exactly what happened in banking... they had a patent troll attack, and the bansters' government pets just made that entire sector immune [1] from the problem.
So what you get is further distancing of sectors like banking and law from the rest of us... and increases likelyhood of a (more violent) revolution.
[1] http://www.washingtonpost.com/wp-dyn/content/article/2008/02/13/AR2008021303731.html?nav=emailpage
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The major cost of testing a new compound is to prove the drug is safe, i.e doesn't kill the patient, or has any other nasty side effects. Whether it actually does any good is almost left as an afterthought. Since (almost) all of that should be well established by the time someone comes up with an idea for a second use, then no, they should't be able to get a God damned patent for using the same drug for something new. They can got a patent for the drug, that's it.
Stefan Axelsson