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Report Says Patents Prevent New Drugs

samzenpus posted more than 7 years ago | from the but-the-old-ones-were-good dept.

Patents 381

An anonymous reader writes "Current orthodoxy claims patents encourage innovation, by allowing developers to enjoy profitable monopolies on their inventions which in turn inspire them to create new inventions. A new report by the non-partisan General Accounting Office suggests that this orthodoxy is wrong — at least when drug companies are involved. According to the report, existing patent law allows drug companies to patent, and make substantial profits off of, "new" drugs which differ little from existing medicines. Given high profit margins on very minor innovations, the report argues that drug companies have little incentive to produce innovative new drugs. In other words, current patent law actually discourages drug companies from producing new medicines. Responding to the report, Senator Dick Durbin (D-IL) released a strongly worded statement suggesting that a legislative response will be forthcoming. "The findings in this new GAO report," said Senator Durbin, "raise serious questions about the pharmaceutical industry claims that there is a connection between new drug development and the soaring price of drugs already on the market. Most troubling is the notion that pharmaceutical industry profits are coming at the expense of consumers in the form of higher prices and fewer new drugs.""

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Exaggeration (5, Insightful)

Petronius.Scribe (1020097) | more than 7 years ago | (#17323826)

The headline draws rather a long bow. I think that what's clear from this report is that the current patent system is broken and stifling innovation. However, this does not invalidate the very concept of a patent, which the article summary suggests is the case. "Current orthodoxy claims patents encourage innovation, by allowing developers to enjoy profitable monopolies on their inventions which in turn inspire them to create new inventions" - this is still true. It's the current implementation of the "profitable monopoly" that is causing issues.

Re:Exaggeration (5, Insightful)

Anonymous Coward | more than 7 years ago | (#17323926)

MMM symantics,

Thats not the point at all,
the deepepast implication is that drug companies are incentivised to treat and not cure ...
the patent structure does not create market conditions that would prompt real inovations for instance cures.

*Cure's* are not good for busness.

And this i find truly disturbing.

Re:Exaggeration (2, Insightful)

Nappa48 (1041188) | more than 7 years ago | (#17324600)

This Anon has it nailed already. The whole medical world screws us over because curing is bad for their business. Someone creates a cure and they are probably frowned upon. Or in another twisted up scenario, they already have cures for most diseases...and just release them at certain times when they can predict what will happen when its released. T'is a horrible fucked up world we live in... driven by greed, regardless of what it is.

Re:Exaggeration (5, Insightful)

blakestah (91866) | more than 7 years ago | (#17324668)

That's just not true. Polio, smallpox, almost wiped off the earth. HIV infection has been made manageable, and people are working very hard on vaccines.

The medical system is HUGELY biased to work on treatments for things not working properly, rather than work on prophylaxis. This will never change unless we go to socialized medicine, because people fundamentally go to see a doctor when they are sick, and not to manage their future potential illness burdens.

I also take issue with Durbin saying this indicates a problem with the patent system. If a new drug comes out that offers no additional benefit, but has patent protection, WHY DOESN'T THE CONSUMER BUY THE GENERIC? That is the real problem. Capitalism fundamentally depends on informed consumers. If anything, I would urge Durbin to consider legislation to inform the consumer about non-patent-protected drugs in a reasonable way so they would not waste their money on a slickly marketed new drug that is only just as good as a generic.

Re:Exaggeration (4, Insightful)

kripkenstein (913150) | more than 7 years ago | (#17324734)

*Cures* are not good for business [...] And this i find truly disturbing.

True, but who said the drug companies' purpose in life is to cure Humanity's ills? They are in it for the money, and free to work on whatever they want. But the point is, other entities have the explicit purpose to cure illnesses: nonprofits and universities. Funding for them is mostly donations or government grants (and there is plenty of money in both, but should always be more).

We shouldn't expect too much from the drug companies; they are money-seeking corporations, nothing more, and often corrupt to boot. What we should do is make sure that donation and grant money for nonprofit research is plentiful, and rely on them to solve our health problems.

None of this detracts from TFA's point, however, that the patent system may need modification: even if we don't expect the drug companies to cure illnesses, we still can change things so that they do what they do do (pills that alleviate symptoms) better.

Re:Exaggeration (4, Insightful)

Qzukk (229616) | more than 7 years ago | (#17323968)

The problem is that the patent system allows one to "upgrade" a patent without revisiting the question of "now that you've told everyone how to do X, is X+1 really all that novel and non-obvious?"

Re:Exaggeration (4, Insightful)

rahlquist (558509) | more than 7 years ago | (#17324140)

Agreed, and another problem with that is the change has only to be minimal even as little as changing the purpose and/or dosage of a drug. While I can understand the reluctance of the industry to invest say what $100 million in developing a new drug, at the same time this lack of drive is caused by the patent system.

If you have an exclusive right to do something with no chance of competing with anyone else then there is no incentive to do anything to make the situation better, good example, mall food service. Many get 'exclusive' agreements for their type of food. So if a bakery opens then another competing store producing a bread product will be denied and there is no competition so the store in the mall can get away with whatever they want because what choice do you have?

I think its time to abolish patents in their current form. Or severely limit the time period they are effective for. 1 year for medial items, to allow a manufacturer to recoup their R&D costs and after that its the best fastest most efficient that would survive instead of the the company with the most Patent attorneys. Make them compete! There is no competition in a monopoly.

Re:Exaggeration (5, Informative)

sinclair44 (728189) | more than 7 years ago | (#17324486)

Agreed, and another problem with that is the change has only to be minimal even as little as changing the purpose and/or dosage of a drug.

Exactly. I'm a clerk in a pharmacy and on a particularly non-busy night we were all talking with the pharmacist about this sort of thing. He gave an example of some company which came out with Drug X (can't remember which one). As the patent on Drug X was about to expire, they created "Drug X Gel Capsule... better than before!!!" Of course, doctors, not really knowing, started prescribing the new X Gel Capsule, which had a new patent and thus no generic (and by this point, the original X's patent had expired and had cheaper generics).

Well, the pharmacist pulled out one of the new X Gel Capsules. Guess what it was? Just the original Drug X encased in a gel cap. That's it. A regular pill in a gel cap.

Re:Exaggeration (2, Insightful)

XxtraLarGe (551297) | more than 7 years ago | (#17324796)

What's next? "Strawberry Drug X Gel Capsule with GLITTER ... better than before!!!" The problem there is the retards at the patent office enable this type of thing to happen. Naturally, the drug companies are going to exploit the situation. I can't believe that they're that incompetent. If they aren't idiots, then I'm sure there are some pockets being lined at the USPTO.

So how would YOU say it? (0)

Anonymous Coward | more than 7 years ago | (#17324064)

"...the current patent system..."

"...patents as they are currently defined..."

or just simply "patents"? There is no virtual patent system available, there is only the implementation of law that we have that we call "patent".

I think you are trying to defend patents when this report is saying they don't work. What's the difference between "the patent system doesn't work" and "patents don't work" in effect? Both require that the patent system be removed. Another "patent" system could be introduced but then you'd have to show why this problem wouldn't occurr with that implementation.

Patents are broken because there are too many patents. ANY system that doesn't control the number will break this way eventually.

Re:So how would YOU say it? (2, Interesting)

Petronius.Scribe (1020097) | more than 7 years ago | (#17324260)

That's a fair question. I'd define a patent as a limited term of exclusive rights to a novel invention in return for publishing the details. The point where I think the current system breaks down is the "novel" part, and to a lesser extent the "details" part. As for controlling the number, I disagree - there's no number of patents which is too many, provided that they expire. If there's not enough freedom for competitors to operate because minor modifications are making it through the patent system, that's a separate issue and not a result of "too many patents".

Re:Exaggeration (5, Interesting)

AdamKG (1004604) | more than 7 years ago | (#17324262)

"Current orthodoxy claims patents encourage innovation, by allowing developers to enjoy profitable monopolies on their inventions which in turn inspire them to create new inventions" - this is still true.
Whether it is true or not misses the point. The question is not whether patents make Pharma stocks comfortable investments- that is never what a patent should be based on. Rather, the Government should only grant patents when they - as the constitution explicitly says- promote progress. The question we need to be asking, then, is "would a lack of patents lead to pharmaceutical companies investing less in research, or would it spur them to invest even more, so they could stay a step ahead of the competition without the 15-20 year lead of patents?" I don't see nearly enough people asking that question.

Without patents, patent-heavy fields like pharmaceutical research fall into cutthroat, razor-thin-margin price wars - but that is not a bad thing. In fact, it's not too different than desktop computers, where we've seen manufacturers keep up with Moore's law for a remarkable amount of time, even while having to struggle to break even on almost every product. Again, patents do not exist to provide peace of mind to investors; they exist only to promote progress. If ending them, and forcing pharmaceuticals to (*gasp*) innovate to stay in business (and even having a few go out of business when they fail to!) is the best way to promote progress, than that is exactly what we should do.

Of course, All of that only makes sense if Congress is competent and not corrupt... so much for that then.

Re:Exaggeration (5, Insightful)

UbuntuDupe (970646) | more than 7 years ago | (#17324544)

Without patents, patent-heavy fields like pharmaceutical research fall into cutthroat, razor-thin-margin price wars - but that is not a bad thing.

Well, cutthroat razor-thin margins generally aren't bad, but it's hard to imagine how it would be profitable to sink billions of dollars and 20 years into developing a drug, when someone can compete with you when they're already billions of dollars and 20 years ahead, merely by using your published formula.

The article's point was not that "patents" are bad, but that allowing an additional patent for an incremental upgrade is bad.

In fact, it's not too different than desktop computers, where we've seen manufacturers keep up with Moore's law for a remarkable amount of time, even while having to struggle to break even on almost every product.

Well, yes and no. It's the same in that the driving force behind Moore's law, the processors, are patented (rendering your example moot). It's different in that, even if you could legally copy the processor design, you'd have to put up a huge amount of capital (though you wouldn't need to do the research, that's a much smaller fraction of costs of bringing to market).

Again, patents do not exist to provide peace of mind to investors; they exist only to promote progress. If ending them, and forcing pharmaceuticals to (*gasp*) innovate to stay in business (and even having a few go out of business when they fail to!) is the best way to promote progress, than that is exactly what we should do.

Pharmas do innovate! And they do fail sometimes, even with patents. You seem to think that just because they don't have to struggle as much once they have a patent, they're not competing. That ignores the research competition they have to go through to find patentable medicines. Whenever someone tells me that a pharma is earning monopoly profits for doing nothing because they have a patent, I almost have to ask what they think of veterans drawing a pension. "Oh, okay, great, big deal, you fought some war a while back. What are you doing for us *now*? Why should we pay you this pension *now*?"

Just to be clear, I don't want to come across as a pro-patent extremist. My point is that the issue is a lot more complicated than people on either side give it credit for.

Re:Exaggeration (1)

AdamKG (1004604) | more than 7 years ago | (#17324852)

Well, cutthroat razor-thin margins generally aren't bad, but it's hard to imagine how it would be profitable to sink billions of dollars and 20 years into developing a drug, when someone can compete with you when they're already billions of dollars and 20 years ahead, merely by using your published formula.
Profitable? Progress is not necessarily profitable - look at NASA, DARPA, the Manhattan Project, America's Mechanization during WW2- all huge losses of money, but all incredibly innovative. And patents don't exist to make businesses profitable; they exist to promote progress. The relevant piece of information in your scenario, then, is the "billions of dollars" part. And that sounds good to me. That's what we want. What we don't really care for is the tens of billions spent on viagra or hair-loss ads.

The article's point was not that "patents" are bad, but that allowing an additional patent for an incremental upgrade is bad.

I didn't RTFA :P

Well, yes and no. It's the same in that the driving force behind Moore's law, the processors, are patented (rendering your example moot). It's different in that, even if you could legally copy the processor design, you'd have to put up a huge amount of capital (though you wouldn't need to do the research, that's a much smaller fraction of costs of bringing to market).

You're right; the designs are patented, and you're wrong; that doesn't render my argument moot. My argument- that the idea that pharmaceuticals need tremendous margins in orer to stay innovative is bunk - is quite correct. Just like with processors, there is a large enough cost of entry for medicine manufacturing that patent protection is not going to be the prime motivation for innovation. Like both AMD's and Intel's excellent offerings this year, the real incentive comes from getting more revenues by having best processor/medicine/whateverProduct, and patents are (or should be) a sideshow, if present at all.

Pharmas do innovate!
Good. But would they have innovated more with no patents? With 3-year patents? With 60-year patents? That's the question to be asking here, not "they innovate, so everything's OK."

And they do fail sometimes, even with patents.
When was the last time a big Pharma ran a net loss, let alone went bankrupt? If they're in the business of spending money to save lives, that should happen a lot more often.

That ignores the research competition they have to go through to find patentable medicines.

Well, sure. But there's no reason to letup on the competitive pressure. After all, the worst they could do is leave the business. And then what? Someone else would step in to make the profits that could be made, even without 20-year patents. Remember: our baseline is not "No innovation whatsoever." If people were no longer willing to invest billions if they couldn't get a monopoly (which turns out to be an extremely ineffecient model of getting revenue, oddly enough, and they end up spending a small fortune of potential research money on marketing), someone would be willing to invest billions to be first to market with the best product, and then they would distribute it as widely as possible, as fast as possible, to exploit the small advantage they have in being first.

That sounds good to me.

Re:Exaggeration (2, Insightful)

mwvdlee (775178) | more than 7 years ago | (#17324280)

The problem isn't so much the existence of patents but rather the frivolous "inventions" that are currently being patented. There needs to be a higher bar for patent acceptance. If somebody invents something truely unique (of the kind which doesn't combine currently available material in a straightforward way), it should be patentable.

I think we should shift more to a system which doesn't reward invention so much as it rewards the amount of effort that went into inventing it.

Perhaps some sort of "limited" patent which could be licensed for a sum of money proportionate to the quality of the invention and the age of it. At the very least the duration of patent protection should be based on the use of that actual patent; if products implementing (and not varations) a specific patent is no longer actively sold (people actually paying money for the product) by the inventor, it should end.

Re:Exaggeration (3, Insightful)

hey! (33014) | more than 7 years ago | (#17324288)


It's the current implementation of the "profitable monopoly" that is causing issues.


There are bound to be these kinds of issues no matter what the implementation of patents is.

One problem with treating an idea as property is that unlike real propert such as a a farm, it's boundaries cannot be clearly drawn. It would be clearer to draw the boundaries of the patent monopoly around a market -- say erectile dysfunction treatment. However, this would really damage innovation. If it hadn't been for WW1, American aviation would have been set back years by the Wright company's use of their patent for "wing warping" to block the introduction of modern (and very dissimilar) control surfaces by Curtiss. In effect, they were using their patent to gain control of the market for machines capable of controlled flight.

Drawing the boundaries of an invention narrowly enough to permit competitive inventions means that any patent system that does not destroy competition must encourage some level of risk minimizing "me-too" inventions. The biggest uncertainty is often whether the public actually wants a better mousetrap. Now that the "Blue Pill" is such a runaway hit, erectile dysfunction is an attractive target for drug company investment, even though Viagra is effective,and probably as safe as any equivalently effective drug is likely to be.

Patents are an artifice. In real property, such as land, exclusive use is needed to enable the owner to attempt to find an efficient use. The same plot of land can't grow wheat, corn, and serve as a parking lot. Ideas aren't like that at all. "Propertizing" ideas makes their use inefficient; it's only done to incent at least some risk taking. You don't have to go so far as saying patents never work to concede that no system of patents works perfectly, or is totally free from perverse incentives.

The answer is, of course, that we can't rely exclusively upon the private sector to do everything for us. Some people seem to be unable to visualize a middle ground between relying on the private sector for everything, and restricting the private sector so that only the government can get things done. I think that we shouldn't expect the to cure cystic fibrosis when creating a Viagra competitor is so much easier, safer, and profitable. On the other hand it is doubtful that Viagra would have become available at all if it were not for the private sector, because it was not effective at all for its intended functions: treating angina and hypertension.

Psh. (-1, Troll)

Anonymous Coward | more than 7 years ago | (#17323828)

House told me this months ago, kthx.

patents = no 24 wake period? (1)

Fireflymantis (670938) | more than 7 years ago | (#17323832)

So is this why there is not yet a pill that will let me do without sleep?

Re:patents = no 24 wake period? (1)

James McGuigan (852772) | more than 7 years ago | (#17324144)

Yes there are pills/drugs that will let you go without sleep:

There is the patentend variety: Modafinil [wikipedia.org] , Adrafinil [wikipedia.org] and the soon to be released Armodafinil [wikipedia.org]

There is the popular in the morning variety: Caffine [wikipedia.org]

There is the herbal variety: Ephedra (Ma Hung) [erowid.org]

There is the unpatented and "might get you in trouble with the law" variety: Cocaine [erowid.org] , Amphetamines [erowid.org]

And then there is the non-chemical "rythym method": Polyphasic Sleep [wikipedia.org]

Re:patents = no 24 wake period? (1)

joshetc (955226) | more than 7 years ago | (#17324708)

All of these drugs make you "not tired" they do not let you safely go without sleep. Ie. your body in a sleep-like state of regeneration and other effects only fully functional and awake, sort of like a clock speed throttle on a laptop to reduce power consumption.

Re:patents = no 24 wake period? (1)

Zeek40 (1017978) | more than 7 years ago | (#17324150)

There are already plenty of those types of pills available, just contact your local "Street Pharmacist." He'll have a much greater knowledge of those types of drugs than your physician.

Already available (0)

Anonymous Coward | more than 7 years ago | (#17324578)

Just visit your local street pharmacist and ask for speed [wikipedia.org] . You can stay awake for weeks with that.

new drugs? (1)

harvey the nerd (582806) | more than 7 years ago | (#17323834)

New drugs? Bah, as long they quit trying to outlaw potent supplements like in Europe, Canada, Australia, NZ.

Re:new drugs? (1)

Cro Magnon (467622) | more than 7 years ago | (#17324272)

As long as there is big $$$ involved, the drug companies will continue to try to ban suppliments in the name of "safety". Meanwhile, pharmaseuticals (sic) with known dangerous side effects remain on the market. :(

Re:new drugs? (2, Informative)

Ninjaesque One (902204) | more than 7 years ago | (#17324738)

You're not quoting anyone. I have to burn karma, but [sic] means that was the spelling as it. As in, Meanwhile, pharmaseuticals[sic] with known dangerous side effects. . .. I get to use it, because I'm quoting you. Original texts should not have [sic] in it.

More like: (1, Interesting)

giorgiofr (887762) | more than 7 years ago | (#17323862)

Ridiculously overeaching regulation of this specific market kill innovation. With the kind of laws regulating this industry, you wouldn't even be able to research *aspirin* today, let alone have it approved or sold.

Re:More like: (1)

giorgiofr (887762) | more than 7 years ago | (#17323890)

Uhm that'd be "overreaching" and "kills". So much for posting after lunch while I'm half asleep.

You're right. The FDA is useless. (2, Insightful)

shaneh0 (624603) | more than 7 years ago | (#17324180)

I say that we should just scrap the whole thing and go back to the days of the traveling snake-oil salesmen. God knows that was much better for consumers.

And while I understand that the urge to deteriorate into meaningless hyperbole is nearly irresistible when writing a two sentence post, let's not lose touch with reality. Every year drugs with amazing complexity are trialled and approved. Say what you want about drug companies, but advances in the pharmaceutical industry are just as--if not more--impressive than in any other industry. Maybe they could be better under different circumstances, but I'm absolutely sure that they could be worse.

The grim truth is that we still only have rudimentary understanding of our own biology. The only reliable way that we've found to test drugs (and drug interactions) is by lots and lots of human trials in graduating size and complexity. How else are you going to know what drug X does when it's mixed with drugs Y & Z on a patient that used to take drugs C, D, and F and once suffered from diseases J and K?

Even now--with this rigorous testing--we find that some drugs should never have been sold. Vioxx comes to mind. These episodes are famous because they're so rare and they shake consumer confidence in the pharma industry. Imagine what it would be like if that were a weekly or monthly occurrence.

Re:You're right. The FDA is useless. (1)

Cro Magnon (467622) | more than 7 years ago | (#17324322)

Even now--with this rigorous testing--we find that some drugs should never have been sold. Vioxx comes to mind. These episodes are famous because they're so rare and they shake consumer confidence in the pharma industry. Imagine what it would be like if that were a weekly or monthly occurrence


Is it really that rare? Celebrex, which is similar to Vioxx, is still on the market. And though few drugs kill you quickly, many drugs poison you slowly, and your death, though blamed on the disese, may have been aggrivated by the drug. At least snake oil, though useless, didn't kill people.

Re:You're right. The FDA is useless. (2, Insightful)

shaneh0 (624603) | more than 7 years ago | (#17324442)

If it wasn't rare you wouldn't remember it when it happens.

And as for Celebrex, it's only similar to Vioxx in that they're both Cox-2 inhibitors. Their pharmacology is very different. Which actually illustrates my point: these things are tough and we need solid regulation on the industry.

"At least snake oil, though useless, didn't kill people."

You do realize that 'snake oil' isn't actually a real thing? To say that whatever concoction being peddled on any given day wasn't lethal is a pure guess on your part. Simple logic tells me that it probably was, at least some of the time.

Not unique to pharmaceuticals. (2, Interesting)

gravos (912628) | more than 7 years ago | (#17323864)

Seems to me that the problems with drug patents are similar to the problems we see with software patents. The guys who are approving/disapproving the patents don't know anything about the field to which the patent applies, and so make poor judges of whether or not a new patent is sufficiently innovative to deserve approval.

If you substantially increased the fee for patent applications then you could hire real experts to review new patents, and that might help solve some of these problems. Of course, many would claim that gave large companies with big coffers an unfair advantage compared to the little guy, and they would be right.

What are some real solutions to this problem?

Re:Not unique to pharmaceuticals. (4, Informative)

simm1701 (835424) | more than 7 years ago | (#17324004)

Try the japanese system - you get two years to exploit an idea with protection from so that no one else can use your idea in that time.

At the end of those two years, if you are actively exploiting the idea in a business you can get another 1 year of protection and thats it

The principal is that if a 3 year head start on your own idea isnt enough to get you established in the market then you should probably let someone else do it anyway rather than stifle future innovation

(companies also have to keep their R&D far more secure under this system and they only usually patent just prior to launching to market - this in turns requires a much faster and streamlined patent application system)

Re:Not unique to pharmaceuticals. (1)

s20451 (410424) | more than 7 years ago | (#17324398)

companies also have to keep their R&D far more secure under this system

So, no free exchange of information under this system? Is that better?

Re:Not unique to pharmaceuticals. (1)

simm1701 (835424) | more than 7 years ago | (#17324462)

until the point of patenting most companies keep their info secure - this system means that they patent at the point of release. Just the elvel of security changes.

The alternative is to patent, sit on it for a while, scalp any other company that wants to do similar for license fees, maybe eventually sell or use the patent yourself... maybe

Solution to the problem (4, Insightful)

Gr8Apes (679165) | more than 7 years ago | (#17324020)

To reject any application that can't explain in plain english and 2 sentences (120 words) or less why it is unique and deserving of a patent.

Why this criteria? Because if you have to draw comparisons with other items and state that this application improves incrementally over items 1-n, then it's not innovative and not deserving. Take the pet rock for instance (however trivial and droll):

        It's a polished rock with googly eyes, marketed as a "pet". There is nothing like it in existance today.

I'm still not sure it should have a patent, but at least you can explain it in 2 sentences or less, including the all important "unlike anything else" clause. (whether that was true or not is a different issue)

As for funding the patent process:

Make patents holders pay a percentage take to the PTO, paid at least yearly, with a minimum fee of the application itself, increasing by some scale over the years. The older they get, the more expensive they get. Failure to pay on time means it becomes public domain.

I believe such an approach solves several issues, while still allowing invidividuals to profit from their work without undue hardships.

Re:Not unique to pharmaceuticals. (2, Interesting)

Clowning (465722) | more than 7 years ago | (#17324038)

Here is one proposal that is quickly gaining much support.

http://dotank.nyls.edu/communitypatent/ [nyls.edu]

Non OBVIOUS (0)

Anonymous Coward | more than 7 years ago | (#17324164)

If the patent office applied the 'not obvious to a person skilled in the art' test instead of ignoring it, they wouldn't get patents on minor tweaks. Again the problem is the twisting of patents by the patent office, not the original intent of them.

How dumb is it that the patent office equates number of patents issued with growth in innovation and starts thinking that if it only issues more patents then there is automatically more innovation....

No (0)

Anonymous Coward | more than 7 years ago | (#17324166)

No to increasing patent fees! As much money as we in the USA spend on bridges to nowhere and wars based on lies we can afford to hire and pay for patent officers who know and understand their respective fields. There is simply no excuse, given the amount of money we pay in taxes, for crap like this. It's time US citizens hold the goverment accountable. You mean to tell me with the billions that we're spending spilling blood in Iraq we couldn't shelter the homeless, provide basic health for all, vastly improve education and hire decent patent officers. If you're answer is no learn to think for yourself.

Re:Not unique to pharmaceuticals. (1)

engineer_girl (1030668) | more than 7 years ago | (#17324464)

I don't think hiring experts would solve the problem. Because there's such a backlog of patent applications, the PTO evaluates employee performance based solely on how many cases a patent examiner can churn out every biweek. Quality of work is not a factor. When I worked at the PTO, the "best" patent examiners were the ones that were producing the lowest quality work.

Also, the PTO would have a hard time getting experts to do that work. They have a hard enough time holding on to the employees they have now (mostly entry-level engineers like I was). If an entry-level engineer gets fed up with such tedious and unchallenging work, someone who's been in the field for years is not going to put up with it either. When I worked there it was always the guys with PhDs that were out of there the fastest.

I think this means more or less (1)

OeLeWaPpErKe (412765) | more than 7 years ago | (#17323868)

That the patent department is stupid and cannot judge wether a patent is "a substantial technical improvement" as required by law. Not a problem with the patent system itself.

Perhaps peer review would prevent these issues. Give everybody who requested a patent last year the chance to review current patents and accept them or not. If not, they need to explain why and an agreement needs to be found by e.g. removing some claims. Something like this might just work.

Something different? (5, Interesting)

itlurksbeneath (952654) | more than 7 years ago | (#17323872)

I realize that making drugs (or any other product, for that matter) requires research and testing, etc., and manufacturers need to recoup that money spent. Plus, profits from a block-buster drug go into funding expensive research on drugs that can only target a very small portion of the population. However, making tiny changes to an existing drug and calling it "new" sucks, unless the change actually has an effect on how the drug works or reduces a side-effect.

Having said all that, maybe there should be a patent peer review board (or, in government speak, the PPRB) that reviews the validity of a patent request. Maybe patents should be harder to get and you should really have to prove your stuff is unique. After some of the vague, hand-waving tech patents, I've read, it's obvious that the guys in the government reviewing these things don't have a clue.

Re: Something different? (4, Informative)

Black Parrot (19622) | more than 7 years ago | (#17324374)

> I realize that making drugs (or any other product, for that matter) requires research and testing, etc., and manufacturers need to recoup that money spent. Plus, profits from a block-buster drug go into funding expensive research on drugs that can only target a very small portion of the population.

Actually (according to various news outlets over the past several years), these companies spend ten dollars on marketing for every dollar they spend on research.

Claritin vs. Clarinex (5, Informative)

Cutie Pi (588366) | more than 7 years ago | (#17323874)

One example is Claritin vs. Clarinex. (Both are anti-histamines that don't cause drowsiness in most people). Claritin was a cash cow for Schering-Plough whose patent expired a few years ago. It used to be prescription-only and the cost used was around $1 a pill. Now you can buy 300-ct bottles over-the-counter at CostCo for ~ $10.00.

Enter Clarinex, which Schering claims is certified for both indoor and outdoor allergies. Once again, it's a prescription-only medication with high prices. The punch line: Clarinex is exactly the same drug as Claritin after Claritin passes through your liver once. There are tons of examples like this, where drug companies change the chemical formulation only slightly, usually in inactive places of the molecule (i.e. the "business end" that interacts with the target enzymes is unchanged). Why new formulations like this are granted patents is beyond me.

Re:Claritin vs. Clarinex (1, Funny)

ForestGrump (644805) | more than 7 years ago | (#17323918)

intwesting. if i had mod points still (i think expired 2 or 3 days ago) I'd mod you up. That, and cause you're such a cutie pi.

Re:Claritin vs. Clarinex (1, Informative)

Anonymous Coward | more than 7 years ago | (#17324000)

Based on your description of the change to Claritin, it sounds like Schering modified the molecule to increase its half-life in the body. Although this change does not affect the ACTIVITY of the drug, it is a significant enough change to warrant the label "new."

Re:Claritin vs. Clarinex (1)

ScentCone (795499) | more than 7 years ago | (#17324194)

Clarinex is exactly the same drug as Claritin after Claritin passes through your liver once.

So, other than not being the same, it's the same? Regardless... how does your example back up the notion that the people who invest the up-front millions in new drugs should have less protection (in the form of a patent)? How will reducing their ability to recoup their investment cause them to produce more innovative drugs? Big innovation (as opposed to incremental changes in products) costs more money. Chipping away at the money they're making isn't going to be much of an incentive to stay in that line of work, let alone take much larger risks with their stockholders' cash.

Re:Claritin vs. Clarinex (1)

AdamKG (1004604) | more than 7 years ago | (#17324576)

Chipping away at the money they're making isn't going to be much of an incentive to stay in that line of work
Then let them leave. It's their decision to get into the market; it they can't possibly survive with all that nasty "competition," then maybe the competitive marketplace isn't for them, and they should get into something where talent, intelligence and hard work has less of an influence on your paycheck.

Like the Patent Office.

Re:Claritin vs. Clarinex (1)

CaffeineAddict2001 (518485) | more than 7 years ago | (#17324748)

I think you're missing the point. All the talent, intelligence and hard work that goes into these products has already been done by the time comes around to manufacture it.

Patents protect the innovators from having every vulture on the block swoop in, reverse engineer their product and manufacture and sell it as their own.

Pharmaceutical patents are a bad idea (4, Interesting)

Christian Engstrom (633834) | more than 7 years ago | (#17324238)

The organization Doctors Without Borders [msf.org] experience first hand the effects of the patent system in third world countries.

For example, in a recent press release [accessmed-msf.org] they write:

The case of AIDS illustrates the trend. While fierce generic competition has helped prices for first-line AIDS drug regimen to fall by 99% from $10,000 to roughly $130 per patient per year since 2000, prices for second-line drugs - which patients need as resistance develops naturally - remain high due to increased patent barriers in key generics producing countries like India.
By allowing the pharmaceutical companies to keep their prices artificially high, the patent system kills people every day, particularly in third world countries. And it's completely unnecessary.

The standard argument for allowing the pharma companies to charge whatever they want for patented drugs, is that they spend the excess revenues on research for new drugs. But that is not true.

We can look at the numbers for Novartis [novartis.com] , Pfizer [pfizer.com] or AstraZeneca [astrazeneca.com] .

They all spend around 15% of their revenues on research. The number is typical for the industry. The other 85% go to other things, according to their own figures. More than half their revenues are spent on marketing an profits.

So there are clearly better ways to finance drug research than to hand out patent monopolies to the big pharma companies, and hope that they will spend the money they make on research. Because clearly, they don't.

The Swedish Pirate Party has one proposal for an alternative system [piratpartiet.se] . Many others have suggested other alternatives.

But at least it is time for us to start discussing the problem in earnest. Today's situation is expensive, wasteful and completely immoral. There must be a better way.

Re:Pharmaceutical patents are a bad idea (1)

deKernel (65640) | more than 7 years ago | (#17324762)

...the patent system kills people every day...
You really need to rephrase that statement. The patent system did make the person get sick. The patent system didn't put them in a third world country run by governments that rape the country. The patent system is not the cause of the problem here.

Re:Pharmaceutical patents are a bad idea (1)

collectivescott (885118) | more than 7 years ago | (#17324780)

You know, the flip side of that arguement is that the patent system is actually protecting the value of the drugs. If more people with AIDS are given the new and more effective drugs, the HIV virus will adapt more quickly, rendering the current drugs less effective.

Granted, that may seem offensive to some people because its basically saying that the value of human life isn't universal. I'm not actually taking this position, just playing devil's advocate here.

Really, AIDS drugs are a poor example because none of them actually cure the disease. (Although some may prevent the transmission to a child by a pregnant woman, that use should be promoted.)

Re:Claritin vs. Clarinex (0)

Anonymous Coward | more than 7 years ago | (#17324328)

So let's assume that there is a some minor difference (but one nevertheless) that makes Clarinex patentable, despite having the same effect.

The real question is: if the pharmaceutical effect is identical, and Claritin has passed into the public domain, why does anyone actually bother buying Clarinex? Basically, the new patent should have little to no market value, but for some reason the market prefers it over Claritin generics in some cases.

If Clarinex is a symptom of dysfunction in the process, what is the cause of the problem? If it is kickbacks to doctors from the drug companies, then perhaps that is where the real problem lies. Or perhaps it is because my health insurer only pays for prescription drugs, not over the counter ones. Sounds more like some kind of failure in the market, rather than bad patents.

Re: Claritin vs. Clarinex (3, Interesting)

Black Parrot (19622) | more than 7 years ago | (#17324334)

> One example is Claritin vs. Clarinex. (Both are anti-histamines that don't cause drowsiness in most people). Claritin was a cash cow for Schering-Plough whose patent expired a few years ago. It used to be prescription-only and the cost used was around $1 a pill. Now you can buy 300-ct bottles over-the-counter at CostCo for ~ $10.00.

> Enter Clarinex, which Schering claims is certified for both indoor and outdoor allergies. Once again, it's a prescription-only medication with high prices. The punch line: Clarinex is exactly the same drug as Claritin after Claritin passes through your liver once.

And even if Clarinex were better, they'd have no reason to release it until the Claritin patent expired. In fact, they'd have good reason not to release it.

Re:Claritin vs. Clarinex (1)

blakestah (91866) | more than 7 years ago | (#17324588)

When a generic is on the market for three cents a pill, and a trademarked patented new drug is $1 a pill, but does the same thing, why is the consumer buying the trademarked patented drug?

Any why is that viewed as a problem with the patent system?

Re:Claritin vs. Clarinex (1)

dinsdale3 (579466) | more than 7 years ago | (#17324698)

Let me turn this around. If Claritin becomes Clarinex in the liver and Clarinex is the molecule that is actually having the desired effect on your body, then why would you want to expose yourself to Claritin in the first place (ignoring cost here)? The more different chemical entities that are in a drug or its metabolites, the more possibilities for side-effects and drug interactions.

Its at least partially the consumers fault (4, Insightful)

PingSpike (947548) | more than 7 years ago | (#17323886)

If the drug companies can get away with sticking a capital letter on the end of an existing drug while changing its dosage to get a new patent, thats certainly an issue with the patent system. But its only one element in a perfect storm in this case. If consumers weren't so brand horny, and were more cost oriented when buying their drugs then these drugs wouldn't even sell. Few of them offer any signifigant benefit, and I'd argue none have any benefits worth the extra cost. But consumers see that 'D' or some other moniker advertised and assume thats the new one with less side effects that they need to demand from their doctor while asking for antibiotics to treat their viral infections. For health care providers part though, its their job to recommend drugs to their patients...and since a lot of them seem to be getting a kickback from the drug companies, they don't always make the the correct decisions.

My company offers a generous healthcare plan for this day and age. But they ask all of us to do our best to keep costs down. I can't tell you the number of times I requested a generic from my awful dermatologist when I didn't even know one existed, only to find out that it did...and wasn't the automatic first choice! Most people aren't concerned with those costs since the insurance pays for it...but we've seen what that attitude has caused, insurance is more expensive and less people have it.

I personally don't think HSA and the like are the solution. But I can understand why they are being tried. Consumers need to be more proactive about doing their part to keep insurance costs down.

Re:Its at least partially the consumers fault (0)

Anonymous Coward | more than 7 years ago | (#17324520)

In Australia, most scripts are now automatically printed GENERIC, - and there is a stink on 'free GP's software' that subliminally advertises brand names, that may be ending soon. Thanks to US FTA tampering, our PBS efficiency has moved from #2 to #7. Since Vioxx, those old fashioned tablets look good.

But you know what, very few blockbuster drugs have come onto the market since the 80's. So the smart thing is to put things pack to the 60's/70's where innovation was at a peak.

Re:Its at least partially the consumers fault (1)

James McGuigan (852772) | more than 7 years ago | (#17324666)

I have a friend in the UK pharmaceutical industry (Glaxo), and there is a three stage process in making new drugs.

The first is trying to synthesizing the drug on a test tube scale.

When it comes to clinical trials for govenment appoval, they have to synthesize at least 3 batches in 500 gallon tanks. This shows they can produce the drug consistantly, and overcome some of the issues involved in scaling up the reaction process.

When it comes to full-scale production, they use 6000 gallon tanks.

One thing that may be non-obvious to people unfamiliar with chemistry, that there is alot of hidden knowledge in scaling up a chemical reaction to the 500 and 6000 gallon scale, the relative quantities of input chemicals and catalysts as well as the order and timing of their mix.

Chemical reactions don't all happen in a linear fashion, or on a linear timescale, so making sure that certian chemicals don't react too slow/fast or are adding at the wrong speed and thus get into the wrong ratio locally within the mix (thus generating the wrong set of reactions) and to ensure that all the chemicals have been reacted and not left in the final pill.

Its not unknown for a new chemical to be patented but then fail because they could not ramp the production process to 500 gallons, or to even get regulatory approval after successfully producing it at 500 gallons, but then fail to get mix correct at 6000 gallons.

One possible issue with generics from small pharmaceutical factories vs the big brands, is the issue of quality control in the mix process. Its the same argument when buying a cheap south-east asian knock-off for consumer electronics (though you do also stand a decent chance of getting something just as good without the brand name for half the price).

Cure for AIDS, cancer discovered in 1990? (-1, Offtopic)

phantonym (998149) | more than 7 years ago | (#17323930)

From http://educate-yourself.org/be/ [educate-yourself.org] : In the Fall of 1990, two medical researchers, Drs.William Lyman and Steven Kaali, working at Albert Einstein College of Medicine in New York City made an important discovery. They found that they could inactivate the HIV virus by applying a low voltage direct current electrical potential with an extremely small current flow to AIDS infected blood in a test tube. Initially, they discovered this in the lab by inserting two platinum electrodes into a glass tube filled with HIV-1 (type 1) infected blood. They applied a direct current to the electrodes and found that a current flow in the range of 50-100 microamperes (uA) produced the most effective results. Practically all of the HIV viral particles were adversely affected while normal blood cells remained unharmed. The viral particles were not directly destroyed by the electric current, but rather the outer protein coating of the virus was affected in such a way as to prevent the virus from producing reverse transcriptase, a necessary enzyme needed by the virus to invade human cells. Reverse transcriptase allows the virus to enter a human T cell line (called CEM-SS) and commandeer the DNA reproduction machinery. After using the host cell to reproduce itself into thousands of new virii, the swollen host cell (now called syncytia or giant cell) will burst and spew the contents into the bloodstream or lymph system. This is how the virus spreads, but lacking reverse transcriptase, the HIV virus can't invade the host cell and it becomes vulnerable to destruction by the body's immune system. (The details of this experiment can be read from Kaali's patent application.) I advice everyone to watch the following video: http://video.google.com/videoplay?docid=-338394831 5844437935 [google.com]

Re:Cure for AIDS, cancer discovered in 1990? (0)

Anonymous Coward | more than 7 years ago | (#17324010)

The process of electrolysis/electrocoagulation and its effects on virus proteins are nothing new. The fact that they found a current level that could denature HIV's protein shell without denaturing every other protein in the blood is, but as a treatment, it's unclear how one would use this, except if one were to insert it into the heart or the aorta where all of the blood would pass through the electrodes. Then there is the question of if the blood cells are unaffected, would the HIV proteins currently being assembled in an infected T cell be affected, or would you need to continuously do this for the length of time of several generations of HIV (even assuming HIV takes longer than one blood circuit to reinfect another T cell). Also, since HIV is found in other bodily fluids, would the HIV in, say, the host's semen reinfect him?

Re:Cure for AIDS, cancer discovered in 1990? (0)

Anonymous Coward | more than 7 years ago | (#17324204)

I believe the process they are suggesting would involve pumping all your blood out of your body and passing it through a machine which would electrify it and then return it to your body. This notwithstanding, the evidence of this process working is dubious at best.

All information on the process seem to be verbatim repetition of the patent application, which was taken out by doctors true, but if you look them up you'd realize that the doctors concerned are a gynecologist and psychologist from a very small school [yu.edu] in NY. There appears to have been no peer review of the idea, and looking up the lead doctor involved indicates that his only other major achievement [nytimes.com] beside this patent is ignoring the anti-abortion protesters [nytimes.com] outside his clinic.

Re:Cure for AIDS, cancer discovered in 1990? (0)

Anonymous Coward | more than 7 years ago | (#17324846)

it's unclear how one would use this, except if one were to insert it into the heart or the aorta where all of the blood would pass through the electrodes

what about using something like a kidney dialysis machine ? after all doesn't that filter all the blood and pump it back in again treated ? surely zapping it along its path would be trivial

We don't need many new drugs (3, Insightful)

erroneus (253617) | more than 7 years ago | (#17323940)

Many of these "newer drugs" are simply older drugs with some manipulation...patented manipulation.

Frankly, I avoid the use of drugs whenever and wherever possible. I find that addressing the cause rather than the symptoms is a better approach -- at least for simple stuff. I'm not a medical professional, but I (and many other slashdotters I have noticed) find that better health can be had by eliminating stuff from the body rather than by adding foreign substances.

People often have some weird ideas when it comes to medicines. TV commercials don't help much when they draw diagrams of something taken in the mouth somehow routing around the digestive tract and directly to the troubled area. The only drugs I can think of off he top of my head that behave that way are topical cremes and ointments and suppositories. Beyond that, people seem to expect often magical properties from "modern medicine." It ain't happening.

Re:We don't need many new drugs (2, Informative)

swelke (252267) | more than 7 years ago | (#17324214)

You forget sulfa drugs. They're concentrated in the urine. If you have a bladder infection, those work wonders (and stink like the devil).

Patents == bad, or Crappy Patents == bad? (3, Insightful)

bsmoor01 (150458) | more than 7 years ago | (#17323960)

From TFA: "the ability of drug manufacturers to easily obtain patents for minor changes to products, or to receive patent exclusivity for new uses of existing products, have reduced incentives to develop new drugs."

Sounds to me like its the ability to get a patent on something that's essentially already out there in the market that is stifling innovation. This sounds a lot, to me at least, like the general distaste for 'junk patents' in the software/computer industry. Perhaps if we start requiring inventions to be unique before we allow patents on them, we'll actually start encouraging bolder, newer ideas again?

A FAR more serious problem... (5, Insightful)

dpbsmith (263124) | more than 7 years ago | (#17323978)

...is that profits are much lower for drug products, such as vaccines and antibiotics that are extremely effective and "cure" in a small number of doses, than for drugs products that merely help, or palliate.

The invisible hand of the marketplace skews development toward drugs that must be taken forever, such as blood pressure medication, or cholesterol lowering medication, or anti-depressives and so forth. These drugs are godsends if you need them, but the fact remains that drugs that actually save lives, with a small number of doses, are less profitable than drugs that merely improve or prolong them, and need to be taken continuously and repeatedly forever.

It is this warped incentive that needs to be fixed.

The antibiotics we have are losing effectiveness. Hospital infections are becoming more and more dangerous. My generation is probably going to be the only generation in human history to live its life mostly free of the mortal fear of dying from bacterial infection. There are virtually no new antibiotics in development.

Re:A FAR more serious problem... (1, Interesting)

Anonymous Coward | more than 7 years ago | (#17324058)

[url:http://www.cubist.com/about/]I beg to differ.[/url].



As for the lack of vaccine development, consider the clinical trials. With a disease treatment, particularly for drugs treating life-threatening illnesses, you are testing your drug on people who are sick and will die without treatment. The risk and cost of harming a patient is much lower, and the results are much more easy to measure than with a vaccine, where you are administering it to HEALTHY people to prevent them from getting sick. As a doctor in a country (the US) that is so malpractice lawsuit happy, would you want to participate in a vaccine clinical trial or an anti-cancer treatment clinical trial?



In other words, it's not the patents, but rather the litigation that discourages vaccine development.

Re:A FAR more serious problem... (1)

the eric conspiracy (20178) | more than 7 years ago | (#17324626)

It is this warped incentive that needs to be fixed.

It is easy to point a finger at some issue like you describe, anybody can do that. But the question is HOW. A drug company is first and foremost a commercial enterprise. It would be silly for such an organization to pursue development of drugs like antibiotics and vaccines that bring all of the long and expensive developmnet and testing process with them, along with the legal liabilities, and then return no money.

Unltimately a lot of this situation is due to government regulatory impact on the drug industry. The only way to solve it is by changes in the way government regulates the drug industry.

analogous to Open Source .. (5, Insightful)

rs232 (849320) | more than 7 years ago | (#17323980)

The pharmaceutical industry is where the software industry would be if it wasn't for the existence of Open Source. That the closed source companies are pushing for a US style patent regime in Europe and elsewhere is a given. What with patented GM crops we see farmers being sued in the US for reusing GM seeds grown from their own crops. Something practiced for centuries.

It's also difficult to avoid infringing some patent as the GM crops cross-fertilise with plants in the next field. The resultant seed being also covered by the same patent. The GM companies would of course have the farmers buying their seed annually from the companies. What next, produce sterile crops and totally outlaw unlicensed seeds.

As the report says in relation to pharmaceuticals, you can see the same thing in the closed Windows monopoly, little real innovation, "new" software that is differs little from the old and a small number of companies making vast fortunes and lastly it's the consumer that suffers from no real choice.

Re:analogous to Open Source .. (1)

NoCoolName_Tom (987517) | more than 7 years ago | (#17324390)

What next, produce sterile crops and totally outlaw unlicensed seeds.
The rest of the world appears to be way ahead of the US in resisting this. http://www.unesco.org/courier/1999_06/uk/ethique/t xt1.htm [unesco.org] (1996) http://commonground.ca/iss/0602175/cg175_marya.sht ml [commonground.ca] (2006)

Seed growers already have protection (1)

nietsch (112711) | more than 7 years ago | (#17324436)

And it is exactly like you described, only without the GM. It takes a lot of time to grow a new cultivar, and without that protection/monopoly there would be no incentive to develop new ones. There is no way one could keep their cultivar secret, as it is the very product the farmer is selling.
On the other hand, the farmers themselves still have the demand for better/different cultivars, so abolishing these breeders rights will not undermine the driving force of the breeders market, and the traditional breeders would still be the ones with the most marketable knowledge. The game would just shift from paying for products (seedstock) to services (if you cross this batch with this batch you will get a bigger harvest).

its a pickle alright (1)

Rooked_One (591287) | more than 7 years ago | (#17323996)

when an industry is the 3rd most profitable, aren't you justified in charging your consumers out the ass for your product, and then say "oh, our R&D is really expensive"

wait... that doesn't sound very moral to me

Your a Pickle all Right! (2, Interesting)

Anonymous Coward | more than 7 years ago | (#17324326)

I work for one of those major (top 3) drug companies. It always irritates me when people like you make comments about subjects you know nothing about. I tell you what is not fair... 1) Our company spends a BILLION dollars developing a new drug and jumping through all the regulatory hoops required of us. 2) Years are spent doing extensive testing of the product to get FDA approval. 3) The drug significantly reduces the chance of DEATH for those taking it. 4) We get sued for a $300 Million dollars when a small group of people have an adverse reaction and die (as they probably would have anyway). That my friend is why DRUGS ARE EXPENSIVE! At any minute we could get tagged for a lawsuit for BILLIONS in damages when we have done everything required of us by the FDA and a dozen other regulatory agencies. You want to reduce the cost of drugs? Protect drug companies from lawsuits on FDA APPROVED drugs.

Re:Your a Pickle all Right! (1)

shutdown -p now (807394) | more than 7 years ago | (#17324792)

Well, you aren't exactly starving, are you?

Sounds familiar (1, Funny)

gamer4Life (803857) | more than 7 years ago | (#17324034)

According to the report, existing patent law allows drug companies to patent, and make substantial profits off of, "new" drugs which differ little from existing medicines. Given high profit margins on very minor innovations, the report argues that drug companies have little incentive to produce innovative new drugs.


I can think of one example in the software industry where this easily applies.

Good (-1)

Anonymous Coward | more than 7 years ago | (#17324068)

Good, we don't need more freakin drugs.

Innovative drugs will still be created, and they will still make a ton of money off them. We're already an over-medicated society as is.

I sure hope so (1)

Joebert (946227) | more than 7 years ago | (#17324120)

Report Says Patents Prevent New Drugs

Isn't that kinda the whole point of getting a Patent ?

Re:I sure hope so (1)

lixee (863589) | more than 7 years ago | (#17324614)

Isn't that kinda the whole point of getting a Patent ?
That's at least what "they" want you to believe.

There are more reasons than just patents. (0)

Anonymous Coward | more than 7 years ago | (#17324152)

There are other reasons, like it is a lot safer to make a trivial change to an already approved drug with known side-effects than to release something new and risk being sued or not having it pan out. We are too unwilling to let a couple people die even if it would save several hundred.

Also the incentives to cure and treat minor diseases tend not to be there. The incentives to find new uses for non-patentable drugs is also not present.

Technically the incentives to discover a cure should still be there. You just take all that income you would have gotten over the life of a patent and figure out the NPV. That is what you charge for it.

Antibiotics are losing their effectiveness because of over-prescribing, lack of compliance by patients and the agricultural industry. But the main reason is because insurance shields the customer from seeing the price. If people had to pay more for antibiotics and other drugs, they would probably take less of them and doctors would be more careful in prescribing.

Thank You For Me-Too Drugs (5, Interesting)

mcwop (31034) | more than 7 years ago | (#17324182)

I for one am super thankful for me-too drugs. I have been through 4 iterations of basically the "same" drug for my condition. The first one caused a lot of awful side effects, and stopped working for me after awhile. The next few variations of the same thing (5-aminosalicyclic acid (5-ASA) were more effective and had no side effects. I was diagnosed with my condition about 14 years ago, and these little innovations have made all the difference.

Re:Thank You For Me-Too Drugs (0)

Anonymous Coward | more than 7 years ago | (#17324636)

So how would you feel knowing that some pharma companies intentionally withhold the most effective drugs and put the inferior ones on the market first, so that they can patent the improvement years later? The problem is that with the current system, pharma companies do not have the incentive to give you the consumer the best drug, or the one with the least side effects, that they can make. Their incentivized only to use the patent system to maximize their profits, and that can mean giving you an inferior drug for 14 years then reintroducing the improved version so they can continue charging you much more than it costs them to manufacture the drug, even though they have already recouped their initial investment costs.

Link to the report, plus, get them for free (3, Informative)

jeblucas (560748) | more than 7 years ago | (#17324200)

GAO Reports can be shipped to you for free if you request them (and you are a US resident). The report referred to in this article is GAO-07-49. Request a paper copy here [gao.gov] . If you want to read the PDF, you can click here [gao.gov] The GAO's a pretty amazing resource. I have a feed of their recent reports on my aggregator, they have a monthly top 10 [gao.gov] , etc.

GAO Junkie

It is not that simple (1)

ebbe11 (121118) | more than 7 years ago | (#17324218)

Many moons ago I worked for a drug company [lundbeck.com] for ten months. So let me explain how the process works:
  • A drug company gets an idea for a new drug. They do some initial tests and take out the patent. They have to patent early because it is impossible to keep things secret once the drug goes into trials.
  • At first the drug is tested on animals. However, as was discovered in Great Britain [www.hon.ch] , that is no insurance that it will work properly in humans.
  • So the tests on humans are absolutely necessary. They also have to be performed for long enough to see if there are any side effects.
  • Another problem is how to produce the drug in large quantities. Scaling up production of complex chemicals is not a trivial problem.
  • All this testing etc. etc. takes somewhere between 10 and 15 years and may take longer if the tests do not give a conclusive result. Since a patent only lasts 25 years, that leaves not that much time to recap the expense let alone make a profit.
  • All together this means that developing a new drug, from idea to market costs roughly $200 million. And if a drug fails late in the test cycle, the drug company can just wave goodbye to the money spent on it.
So to me it is perfectly understandable that a drug company wants to recap its expenses.

Try applying the same standard eksewhere (1)

Lurker2288 (995635) | more than 7 years ago | (#17324220)

Okay, so from now on, software companies aren't allowed to patent new products unless they do something in a totally new way. And no more "me too" games like, say, Half Life, or Counterstrike--don't they know that we've already got an FPS game? Or maybe Coke--no more of this cherry coke, coke vanilla nonsense. Come back when you've got Coke Filet Mignon!

I'm not going to say that the current system of IP as it applies to pharma is ideal; certainly, if companies can get away with marketing a slightly improved version of a drug for a premium price, they're going to. I just don't trust Congress to implement intelligent regulations of such a complex issue.

Most firms are now getting into pharmacoeconomics, which uses market data to figure out (in essence) what drugs are worth producing. I'd feel much better about a market-derived, self-regulation than anything imposed by almighty goverment.

Good! (1)

risk one (1013529) | more than 7 years ago | (#17324250)

Cause drugs are bad, right? Yeah for patents!

Socialise it then (1, Interesting)

Anonymous Coward | more than 7 years ago | (#17324300)

Having to become somewhat familliar with the ins and outs of many kinds of medications- their are many many problems with medical standards and practices. What's bothersome is more basic: Currently America is one of only a handfull of counteries that has "private" medical-ie medical that isn't socialised such that costs from the doctors and patients comes from taxes. Few companies have any sort of insentive to release patents any sooner than absolutely legally required, and even then fight it tooth and nail. I pine very heavly for the days when medicaition costs are in part part of ourtaxes, yeah having higher taxes will suck , on the other hand it will probably suck about as much as spending around 400 yearly for medication-but at least mabie then I also won't be also spending 100 per a session to see my cute chinese medical doctor

This is why we should ban advertising (4, Insightful)

antifoidulus (807088) | more than 7 years ago | (#17324344)

You know what the nicest thing about Japanese and German television is compared to American TV? It isn't what you see(TV is pretty dumb the world over), but more of what you don't see. No ads for prescription drugs for starters(no ads for ambulance chasers either, but that is a different story). The reason drug companies patent drugs that vary little from existing drugs is because they can still make money off of them by advertising them both to patients and to doctors. Patients go in and demand the name brand of the drug they saw on TV(which further feeds into the trend of self-diagnosis, but that is another rant) and doctors who are required to get a certain amount of education every few years enroll in drug company sponsored classes. They turn a well meaning law into profit for drug companies.

If we really want to see new drugs AND get cheaper health care, banning advertisements is a good start.

Re: This is why we should ban advertising (2, Informative)

Black Parrot (19622) | more than 7 years ago | (#17324422)

> If we really want to see new drugs AND get cheaper health care, banning advertisements is a good start.

And it used to be banned in the USA, until "someone" bought enough congressmen to get that reversed.

(Same with the ambulance chasers that you mentioned in passing.)

Name change; link to report (1, Informative)

Anonymous Coward | more than 7 years ago | (#17324354)

GAO is now the Government Accountability Office. Here's a link to the report.

http://www.gao.gov/new.items/d0749.pdf [gao.gov]

IP always IMPEDES innovation (1)

kaltkalt (620110) | more than 7 years ago | (#17324372)

Patents and copyright always act as a force to IMPEDE innovation. The problem is that this fact is very counterintuitive. Intellectual property exists for the sole reason of fostering innovation, and on paper it seems like it should do that. Monopoly as motive to create. Sounds logical. But communism looks good on paper too. Unfortunately both communism and IP are total and complete failures, as well as oppressive regimes which crush individual freedom. You can't publish that 30 year old email. You can have a website with a one-click purchase button. You can't market that life-saving pill. You can't cover that song. Unless you pay me a government-sanctioned extortion fee. Patents don't just hurt innovation with new drugs. They hurt innovation accross the board. But we'll never get rid of them.

Another questionable study (1)

Bob-taro (996889) | more than 7 years ago | (#17324392)

I'll admit, I didn't read the entire 52 page PDF report [house.gov] , but I skimmed it. I'm having trouble seeing how they can reach those conclusions just by looking at drug trends in number of NMEs vs non-NMEs since 1993. Also, considering where the pdf was posted, and taking into account the democratic party's desire to take over the health care industry, I suspect a political motive. The main reason for this report was to get some key phrases that are "backed by scientific research" such as: "drug development is stagnating", "discouraging innovation", etc.

If we really want to measure the effect of IP on drug innovation, it might be better to compare the U.S. drug companies to those in other countries where the laws are different. Even then, it would be very difficult to draw conclusions because there are so many factors. And is it bad if more research is being done on non-NME's? Presumably that's because there is a greater expected ROI, which may mean there is a greater need for those drugs.

Re: Another questionable study (1)

Black Parrot (19622) | more than 7 years ago | (#17324452)

> I'll admit, I didn't read the entire 52 page PDF report, but I skimmed it. I'm having trouble seeing how they can reach those conclusions just by looking at drug trends in number of NMEs vs non-NMEs since 1993. Also, considering where the pdf was posted, and taking into account the democratic party's desire to take over the health care industry, I suspect a political motive.

a) The problem has already been known for about a decade.

b) The Demoncrats don't pwn the GAO.

A few things about R&D and Med. (1, Insightful)

Anonymous Coward | more than 7 years ago | (#17324460)

There is really a main part of the patent system. Encouraging innovation is just a side effect. The idea is that without patents there are a few outcomes.
1) Companies would keep their "trade secret" forever, if the person who knew it died in an unfortunate plane accident with the plans in his briefcase there would go the life saving drug.
    A Patent gives the company incentive to reveal their secret and at the same time are protected for some time it's an exchange.

2) Competition (such as in the early part of the industrial revolution) would hire employees of said company to steal the trade secret, since there is no legal protection, and it would be very hard to prove this type of theft. The patent system creates a legal system were people file their inventions and are protected from this behavior.

The vast majority of research in drugs or is done at the medical school level, where they have people paying for the privilege of doing research. Pharmaceutical companies are partnered with them to get that research (funded by governments in many countries). It wasn't until the 1990s that collages were allowed to patent research paid for by public money, so in many cases they gave their work to companies that then got the patent on this research paid for by the public.

This has changed and now many universities hold a significant patent portfolio when it comes to drugs and drug research. In addition there are huge government grants to fund research for drugs that will have limited or no ability to make a profit during the life of a patent.

The other major issue is liability, drug companies don't want to be sued, so its better for a big name to create a spin off company that can do the research on very new drugs that way if any issues come up (big lawsuit) then they can fold that company, and then reap the profits with a new warning label.

The bottom line is that its not just patents, its a whole string of problems that exist with the system, and no one who has the ability to change things is really interested in doing anything. If there were no patents, we would quickly see the only drug these companies put out would be safe ones that they are sure will sell allot of.

Patent Laws discourage New uses for Old drugs (1)

BruceKusens (1042414) | more than 7 years ago | (#17324494)

Pharmaceutical companies cannot afford to fund the necessary studies to evaluate the effectiveness and safety of their drugs for new and different uses as patent protection applies to the drug not the use. For example the patent on Prozak has expired, shortly before its expiration, there were very promissing studies on its effectiveness as part of a therapy on recovering stoke patients. These vital studies however will not be continued because there is no way to recover the cost of the study through the sale of the drug. I am a recovering stroke paient and I attribute a great deal of my recovery to this drug, yet further exploration of it's life restoring capability will likely never be performed and hundreds of thousands of people will suffer needlessly. We have orphan drug laws to fund research for curable but rare diseases, we need something similar for new uses of old drugs. Bruce Kusens

I'm confused why this matters (1)

PhysicsPhil (880677) | more than 7 years ago | (#17324508)

It is certainly believable that drug companies will patent minor changes to drugs to gain more protection, but I don't quite see how that stiffles competition. Consider a drug company that makes a genuinely new drug, labelled A, and patents it. A little while later, they also patent a slight variant on the drug, call it B.

17 years(?) later, the patent on drug A expires and anyone who wants to can create copies. The patent on the "me too" drugs are still in effect, but does that matter? As long as I only want to copy the original formulation, the patent on the original drug A would seem to be the only one of relevance.

Can someone who knows about the drug industry enlighten me?

Re:I'm confused why this matters (1)

vidarh (309115) | more than 7 years ago | (#17324580)

Consider the risk for a company that focus on developing a few new drugs and then milk it for decades with minor improvements vs. one that keeps spending money developing completely new drugs regularly.

The point is that under the current system there's a greater capital return on the former approach, and so the capital is invested in small incremental improvements, and less is available for the groundbreaking (and high risk) research.

Re:I'm confused why this matters (0)

Anonymous Coward | more than 7 years ago | (#17324716)

The reason the drug company still benefits from the patent on drug B is because after the patent on drug A expires, they huge amounts of money they spend on promoting drugs to both doctors and patients will be used to promote B even though drug A is now being sold cheaply by multiple vendors.
If you don't believe this is an issue, notice how hard the drug industry lobbies against any law requiring them to disclose how much they spend on gifts to doctors. Or how many of the people they hire to promote drugs to doctors are recuited out of college cheerleading programs.
So even if drug A and B are equally effective and drug A cost .10 a pill vs 1$ a pill for drug B, guess which gets prescribed?

No surprise (2, Insightful)

the_womble (580291) | more than 7 years ago | (#17324514)

I sued to be an analyst at a fund managemetnt company. I used to look at pharmas (although I was not a sector specialist).

A few things I noticeded.

1) Lots of patents cover minor improvements of existing drugs.
2) Lots new drugs are similar to existing drugs.
3) Patents are such a wonderfully effective mechanism that regulators (the FDA etc) have to give pharmas additional incentives (such as orphan drug deisgnation) to develop certain drugs.
4) Patents do more to boost marketing expenditure than R & D expenditure.

There is also no real evidence of what effect patents have. We know from academic studies that they have little positive impact on semiconductors or software, as for eveything else, we have no idea.

Shaky Conclusions (1)

the eric conspiracy (20178) | more than 7 years ago | (#17324764)

There are a lot of scientists who have noted that finding new, safe effective drugs is becoming a lot harder - as the small molecule combinations are becoming exhausted and the large molecule drugs have not achieved success like people had hoped. Increasingly the new drugs that are introduced are relatively small improvements even when they are based on new chemistries.

Drug patents have existed for over a century, during this period of time there have been great waves of introduction of useful medicines, all driven by advances in sciences. The patent system didn't seem to inhibit the introduction of these drugs.

This report tries to draw a conclusion based on the correlation between drug patents and an apparent drying up of the new drug pipeline, and then state that it is cause and effect. Correlation of course does not prove causality, and in fact I wonder if you take a longer term view of what has happened in the drug industry if the correlation actually exists.

Patents only seem to encourage... (1)

Assmasher (456699) | more than 7 years ago | (#17324836)

...more patents.

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