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Indian Supreme Court Denies Novartis Cancer Drug Patent

Unknown Lamer posted about a year and a half ago | from the better-luck-next-time dept.

Patents 288

beltsbear writes "Following a reasonable view of drug patents, the Indian courts have decided that making small changes to an existing patented drug are not worthy of a new patent. This ruling makes way for low cost Indian cancer drugs that will save lives. From the Article: 'Novartis lost a six-year legal battle after the court ruled that small changes and improvements to the drug Glivec did not amount to innovation deserving of a patent. The ruling opens the way for generic companies in India to manufacture and sell cheap copies of the drug in the developing world and has implications for HIV and other modern drugs too.'"

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Innovation (-1)

Anonymous Coward | about a year and a half ago | (#43334809)

Innovation to these people is a specially shaped shit in the streets. They don't respect intellectual property as they're a nation of rote learners at best, thieves at worst.

Re:Innovation (4, Interesting)

Zemran (3101) | about a year and a half ago | (#43334843)

Only a complete fool, April or otherwise, would base anything on imaginary property. There is nothing intellectual about that.

Re:Innovation (5, Insightful)

fustakrakich (1673220) | about a year and a half ago | (#43334863)

The only good patent is an expired patent.

Re:Innovation (2)

Zontar The Mindless (9002) | about a year and a half ago | (#43334997)

I hear you can make a really nice curry with expired patents.

Re:Innovation (3, Interesting)

sFurbo (1361249) | about a year and a half ago | (#43335025)

Until we have a better system in place for coming up with the hundreds of millions of dollars it takes to prove the efficacy and safety of a new drug, drug patents are one of few cases where patents make sense.

Re:Innovation (5, Insightful)

fustakrakich (1673220) | about a year and a half ago | (#43335067)

ibid [slashdot.org] .. That argument has been debunked a long time ago. Those millions aren't going where you think they are.

Re:Innovation (1, Insightful)

sFurbo (1361249) | about a year and a half ago | (#43335117)

People have been saying that the drug companies spend a lot of money on other things for a long time, but that isn't really relevant to my post.
Some of the money we spend on drugs today are used to test new drugs. If we are going to end the system we have today, I would prefer if we had a new system in place before that. So, what is your system for testing new drugs, and when can it be implemented? And remember, it really does cost hundreds of millions of dollars to be reasonably sure that a drug works and is safe, so your system had better be somewhat resistant towards corruption.

Re:Innovation (3, Insightful)

Anonymous Coward | about a year and a half ago | (#43335173)

And remember, it really does cost hundreds of millions of dollars to be reasonably sure that a drug works and is safe, so your system had better be somewhat resistant towards corruption.

It is the current system that has issues with corruption, because the companies financing the testing have profit motives.
There is no magic to publicly funding non-profit research/testing. It would however seem like magic because it is safer and cheaper.

Re:Innovation (5, Insightful)

fustakrakich (1673220) | about a year and a half ago | (#43335179)

...it really does cost hundreds of millions of dollars...

Yes, because it's closed market. The regulations are designed to make it too expensive to compete. It is the epitome of 'crony capitalism'. And the whole process is done behind closed doors. That must end. However none of this is going to happen until we stop reelecting company politicians who appoint company bureaucrats. And furthermore, the efficacy and safety of many of today's pharmaceuticals are highly dubious. We can do much better if we demand some transparency at the very least. Make them open the books. There should be nothing to prevent the government from hiring scientists to create drugs also. Let's give these companies some real competition. Put our tax dollars to work for us for a change, instead of subsidizing the industry.

Re:Innovation (3, Insightful)

sFurbo (1361249) | about a year and a half ago | (#43335263)

The price of testing drugs is mostly due to the number of people in the tests, and the number of people determine how certain we can be on the estimates of efficacy and efficiency. You can get cheaper testing, or you can get better testing, but getting both is tricky.

That being said, more transparency would be nice. At least force them to publish all human testing of the drugs. Or even better, remove the testing from the drug companies, though it would be problematic to ensure that they have no power over it.

As for the using government money for testing drugs, it is an intriguing idea, but corruption would still be a problem, given the amount of money at stake. I am not sure whether it would be a larger or smaller problem than today.

Re:Innovation (1, Troll)

fredprado (2569351) | about a year and a half ago | (#43335317)

Correction: the price of testing drugs is mostly due to the bribes that need to be applied for them to be approved and the patents granted.

In my opinion drug development is one of the few things that should never be delegated to private companies.

Re:Innovation (3, Interesting)

Anonymous Coward | about a year and a half ago | (#43335327)

To hell with safety.

Allow life-saving drugs to be developed more quickly and cheaply, give them an "experimental" classification complete with a legal waiver. If I'm going to die of cancer in 2-3 years without medicine, do you think I give a shit about "safety"? There's no shortage of volunteers for these kinds of drug trials.

Now that developing drugs just got cheaper, more pharma startups can enter the market, and the number of years drug patents last for can be reduced.

Since doing this would benefit everybody except lobbyists, lawyers and politicians, there is of course no chance that it would ever happen.

Re:Innovation (4, Insightful)

TFAFalcon (1839122) | about a year and a half ago | (#43335301)

Sure, but not the abuses of patents that we see now. If they want a new patent then develop a new drug. Don't just tweak the old one and demand a new monopoly on it.

Re:Innovation (2)

Jah-Wren Ryel (80510) | about a year and a half ago | (#43335305)

Until we have a better system in place for coming up with the hundreds of millions of dollars it takes to prove the efficacy and safety of a new drug

That's a recipe for stasis. If the requirement is a "better system" already implemented before we change the current system, then that day will never come. I'm not saying the current system should be totally junked tomorrow, but your requirements are impossibly high.

Re:Innovation (2)

sFurbo (1361249) | about a year and a half ago | (#43335349)

I have been unclear, then. I merely meant to warn against junking something that works when we don't know what we should put in its place. By all means let's test new systems, I see no reason why several systems for testing drugs couln't run simultaneously, just let's not completely dismantle the current system before we have something else that works.

Re:Innovation (4, Insightful)

Opportunist (166417) | about a year and a half ago | (#43334971)

It's a smart move, and I'm surprised that there aren't more governments catching on. If I can get cheap treatment in your country, it may even be cheaper to be treated there, including the plane ticket.

Re:Innovation (2, Insightful)

sFurbo (1361249) | about a year and a half ago | (#43335019)

It's a smart move in the short term, in the long term, who knows? If this means less R&D spending on medicine, we might be worse off.

Re:Innovation (4, Insightful)

Opportunist (166417) | about a year and a half ago | (#43335249)

Is this akin to the "if we don't get unlimited copyright, the music will die"?

I highly doubt that this is going to make pharmacological research unprofitable. Maybe it will even lead to new medication when they can't milk the very same crap forever.

Re:Innovation (2)

sFurbo (1361249) | about a year and a half ago | (#43335283)

Is this akin to the "if we don't get unlimited copyright, the music will die"?

If the price of making a track was hundreds of millions dollars and took five to ten years, yes. I guess it is akin to "without copyright, we would get no more blockbuster movies", with the difference that blockbuster movies does not keep people alive. Oh, and patents are for twenty years, not forever minus epsilon.

Re:Innovation (5, Insightful)

Xeno man (1614779) | about a year and a half ago | (#43335251)

It means R&D will be spend on NEW medicine. Much less will be spent on slightly improving existing medicine. You do know the R&D stands for research and design. They would have to do some NEW research.

Financially it makes much more sense to take your existing product, make it slightly stronger or last slightly longer and file for a new patent and basically double your patent length.

Re:Innovation (3, Interesting)

jewens (993139) | about a year and a half ago | (#43335319)

How about this: Allow anyone to take an existing product (even one that is still under patent protection), make is slightly stronger or last slightly longer and allow them to file for a patent on the new product. The original patent owner would still have their patent but the owner of the improved-product patent is not encumbered in anyway by the still existing patent for the inferior=original patent. If minor changes indeed create a new patentable idea then it shouldn't matter who makes them. This would at least prevent the original patent owner from sitting on improvements until 1-day before his existing patent expires. First-to-file might be good for something after all.

Re:Innovation (1)

Fjandr (66656) | about a year and a half ago | (#43335255)

They'll still develop them, as they have a major captive market in the US.

Re:Innovation (1)

sFurbo (1361249) | about a year and a half ago | (#43335291)

And only diseases relevant to Americans would get drugs, though I suppose that is fair, given that the Americans would be the ones to pay for it all.

Re:Innovation (1)

davester666 (731373) | about a year and a half ago | (#43335111)

It already is catching on. Lots of people already do 'medical tourism', in which they have to go to another country for a procedure or medicine that they either can't get or can't afford at home.

Re:Innovation (5, Insightful)

Zontar The Mindless (9002) | about a year and a half ago | (#43334989)

They seem to understand "My right to live trumps your supposed 'right' to make money" pretty damned well, though.

Re:Innovation (1)

davidshenba (2536122) | about a year and a half ago | (#43335287)

To disgrace the people of an entire nation based on evil ideas like patent shows from what background you are from and how civilized you are.

reasonable court - April Fools (0)

rst123 (2440064) | about a year and a half ago | (#43334815)

Now this is a good april fools joke - it's almost believable - until they come to the part about a reasonable court.

Re:reasonable court - April Fools (2)

Samantha Wright (1324923) | about a year and a half ago | (#43335185)

If you want to be cynical about it, do keep in mind that this will benefit local business, as far as the court's concerned. There may still be vested interests at work.

Re:reasonable court - April Fools (0)

frootcakeuk (638517) | about a year and a half ago | (#43335289)

After the piss poor April foolery from slashdot this year, this is one of the funniest things I've read the last couple days

Huh? (1)

wisnoskij (1206448) | about a year and a half ago | (#43334827)

Well I imagine that if these small changes are not enough to get a new patent, then they are saying that this new variation of the old drug falls under the protection of the old drug.

Re:Huh? (3, Interesting)

rst123 (2440064) | about a year and a half ago | (#43334839)

except the old patent is probably expired / expiring.

Re:Huh? (1)

fustakrakich (1673220) | about a year and a half ago | (#43334851)

Yes, so the patent will expire a little sooner than the company hoped. As far these things go, it was a good ruling.

Re:Huh? (0)

Anonymous Coward | about a year and a half ago | (#43334885)

Except that the Indian Supreme Court disallowed the original patent on a technicality.

Re:Huh? (5, Informative)

sjames (1099) | about a year and a half ago | (#43334939)

The 'technicality' is that drugs were not eligible for patent under their law at the time.

Re:Huh? (1)

black6host (469985) | about a year and a half ago | (#43335271)

Except that the Indian Supreme Court disallowed the original patent on a technicality.

Which means, being the cynic that I am, that our pharma companies lobbyists are to blame, er...... thank. They didn't get what they wanted soon enough.

This news pleases me.

Re:Huh? (4, Interesting)

whoever57 (658626) | about a year and a half ago | (#43334887)

The original invention/discovery was made before the date after which drugs are eligible for patent protection in India. So the original invention was too early and the changes were not sufficient for a new patent that would have been after drigs became eligible for protection in India

It's a good thing... (5, Informative)

Anonymous Coward | about a year and a half ago | (#43334855)

A 30 day supply of 400mg tabs of Gleevec (imatinib sulfate) runs a lil over 6 thousand dollars. That's right, 6k a month to keep patients with CML, HES and certain stomach cancers alive. It's gone up over 2 thousand a month in the last 3 years alone.

If you have insurance, good insurance, you might pay around 50 bucks of that a month. Without insurance, you get to use prednisone til it or the cancer kills you.

Way to go pharmaceutical companies... and do you really think they are working on a cure when they can rake in thousands of dollars a month from each and every cancer patient??? Yeah right... think again... If they understand the cancer well enough to halt it in it's tracks for 90 to 95% of the patients that are treatable by this drug, and another 90 to 95 of those that take it are alive and in full remission 5+ years later, they certainly know enough to track down a cure if they were so inclined to do so.

Greedy bastards...

Re:It's a good thing... (5, Interesting)

Anonymous Coward | about a year and a half ago | (#43334875)

Oh and the numbers I gave are based on the U.S. Dollar, inside the United States.

I've been in remission for over 3 years thanks to Gleevec, but it still sucks that they (Novartis) push for profiteering over saving lives.

Re:It's a good thing... (5, Insightful)

black6host (469985) | about a year and a half ago | (#43335297)

Oh and the numbers I gave are based on the U.S. Dollar, inside the United States.

I've been in remission for over 3 years thanks to Gleevec, but it still sucks that they (Novartis) push for profiteering over saving lives.

I'm happy to hear you're in remission, even though I don't know you personally.

You know, we have no problems taking peoples property under eminent domain for the "good of the people". There was a business owner where I used to live who was forced to sell his property to the local gov't because they needed to turn it into a parking lot to support the major retail center across the street. The reason put forth: the additional tax revenue would benefit the public. Of course the builder of this retail/hotel/restaurant center stood to profit the most and I am confident was the one who persuaded the city to take the property with the thought of increased revenue. Bastard.

I'd like to see eminent domain apply to drugs that would help save, or greatly prolong the lives of many people. That makes sense to me. But it's not the big companies who get screwed.....

Re:It's a good thing... (1)

Anonymous Coward | about a year and a half ago | (#43335005)

Except, if there's no patent and no real money to be made from it as a result, why would any manufacturer bother making and distributing it?

Re:It's a good thing... (0)

Anonymous Coward | about a year and a half ago | (#43335057)

Bacause making and distributing things is the traditional way to make money? Yeah, competition might mean you won't drown in money, but on the other hand it might mean more people can afford the drugs.

Re:It's a good thing... (3, Insightful)

Zemran (3101) | about a year and a half ago | (#43335063)

Errr, for profit is the normal reason. Why do you believe that it must be impossible to make a profit if other people can make a profit? You just have to do a good job if you want to do well. The idea of intellectual property is that you no longer have to bother doing a good job, you just have to own the right to something imaginary and you can make people pay for it. It is the most stupid and destructive idea ever. It will ruin people's lives for a long time and people will have to fight to get free of this idea. What is left of the US economy seems to be being based on this dream but it will get rejected just like it did in the middle ages. For hundreds of years, our economy and the economies of most of the world flourished without this BS, yet fools still think that it would be impossible to live without it.

Re:It's a good thing... (1)

slackware 3.6 (2524328) | about a year and a half ago | (#43335189)

What about the millions poured into cancer research by the gov through tax dollars and the millions in donations from cancer charities?

Re:It's a good thing... (3, Insightful)

fredprado (2569351) | about a year and a half ago | (#43335323)

Drug research should be a public endeavor. Drug production can be a private endeavor, without silly protections, as patents.

Re:It's a good thing... (3, Insightful)

bfandreas (603438) | about a year and a half ago | (#43335377)

Basic research is a public endeavor. A lot of the basics get done by universities. Sometimes in cooperation with the pharma industry sometimes on government grants sometimes on venture capital sometimes all of those .
The pharma industry does also research on its own but that is about turning the basic concepts discovered in proper research into products. The industry has been calling foul over patent limitations for ages. But they do not have a leg to stand on.

A lot of the so called innovation is turning something from subcutaneous shots into pills. I'm sorry, but that is nothing that takes BEEEELLLIONS to research. It's worthwhile. But it's not the tedious research bit where you painstakingly find out how an illness works and how to counter it. The basic groundwork that sometimes takes decades has already been done.

Pharma innovation is mostly about rounded corners. Whenever you hear the word "innovation" issues by an industry spokes critter ALWAYS think "rounded corners". Those are the guys who put receptionists into lab coats in their commercials.

Re:It's a good thing... (0)

DNS-and-BIND (461968) | about a year and a half ago | (#43335035)

If there wasn't money to be made, nobody would have bothered to develop these drugs in the first place.

What, altruism? We all know humans are selfish pricks who would sooner laugh at cancer patients than help. Heck, there is a big push going on right now for euthanasia for cancer patients instead of going to all the trouble of trying to cure them. The people who allocate society's resources consider it a waste as some people get a lot of help and others get little.

Re:It's a good thing... (5, Insightful)

sFurbo (1361249) | about a year and a half ago | (#43335049)

do you really think they are working on a cure when they can rake in thousands of dollars a month from each and every cancer patient??? Yeah right... think again...

I would expect all of the other drug companies to also want a piece of that pie. That means they have to come up with something that works better.

If they understand the cancer well enough to halt it in it's tracks for 90 to 95% of the patients that are treatable by this drug, and another 90 to 95 of those that take it are alive and in full remission 5+ years later, they certainly know enough to track down a cure if they were so inclined to do so.

Greedy bastards...

You are vastly, massively underestimating the complexity of cancer and of the human biology.

Shorter patents needed (1)

Anonymous Coward | about a year and a half ago | (#43335217)

"I would expect all of the other drug companies to also want a piece of that pie. That means they have to come up with something that works better."

If the motive is profit then a cure isn't a 'better' outcome. The better solution here is to reduce their patent protection till they *need* to push forward with research to survive. For patents to work, they need to be at the MINIMUM required for any market. Longer than the minimum and they slow development down.

"You are vastly, massively underestimating the complexity of cancer and of the human biology."

He's pretty much judged the drug company motivation right though, hasn't he? They have a monopoly, courtesy of patents, on their respective fields. In that case they have no incentive to push forward. If Novartis had to make a new better cancer drug every few years then the rate of development would increase enormously. Over zealous patent regimes are what's holding back drugs, Novartis can coast for quite a while now.

For Novartis, they'll make the next drug, and move it very slowly to market if their competitors come up with one. That way they can make full use of the patent length.

Re:Shorter patents needed (2)

LurkerXXX (667952) | about a year and a half ago | (#43335365)

They have a monopoly, courtesy of patents, on their respective fields.

Nope. The NIH funds a huge amount on research at it's main campus, and at research universities around the country. To the tune of about $30 Billion/year. People motivated to find cures (become famous, tenure at a major university in their field, pretty much guaranteed funding, tour the world giving lectures at universites as a guest speaker, plus a piece of the patent along with the university).

The drug companies do spend a lot on research, but most of their spending is on clinical trials, the last part of the research process, testing a drug to see if it actually works in humans. The NIH finds a huge part of the basic research looking for new cures.

Re:It's a good thing... (3, Interesting)

Okian Warrior (537106) | about a year and a half ago | (#43335295)

You appear to know about biology and related public policy, so let me ask a few questions:

1) Suppose I don't have insurance and get cancer. Why can't I simply opt out of the FAA regulation system? Why can't I get a less tested and less expensive medicine (with informed consent) the same way I would get a less expensive car? Is "death of the patient" really the best outcome?

2) The Hippocratic oath has a statement, words to the effect "first do no harm" [wikipedia.org] . Sometimes this is interpreted as "do more good than harm" (example: medicines which cause side effects) and sometimes as "do no harm whatsoever" (patient dies because treatment is not yet vetted, safe treatment but off-label application, &c). Shouldn't these two points of view be reconciled?

3) A car mechanic will give me a diagnosis of what's wrong with my car, and an accurate estimate of what it will take to fix it. He's then bound to that estimate by strong state laws which protect the consumer. If a doctor doesn't get the diagnosis right the first time, I have to pay for a 2nd diagnosis and cure and then possibly a third one until he gets it right. For surgery, you never know ahead of time how much it will cost, or even how many separate bills you will get. Should states have consumer protections laws for medicine, in the manner of automobile repair protections?

4) If not, why?

5) Doctors make educated guesses based on statistical inference. (Example: A Recent Maryland death from rabies [cbsnews.com] . The correct diagnosis was only determined after the patiend had died) An inexpensive broad-spectrum testing grid that identified [for example] 2,000 infectious agents would seem to be the answer, yet FDA testing requirements would make such a product prohibitively expensive. Why shouldn't we have a less-well-tested version which is cheap, and can be used for initial screening?

6) Magnifying glasses are available at the convenience mart. Why can't they sell inexpensive (but with limited functionality) hearing aids? Why are medical devices which do not directly affect the health of the patient (such as hearing aids) so expensive, and why do they require expensive fitting by professionals? Why can't artists build and sell prosthetic hand attachments?

Re:It's a good thing... (0)

Anonymous Coward | about a year and a half ago | (#43335321)

I would expect all of the other drug companies to also want a piece of that pie. That means they have to come up with something that works better.

What do you care? If you're a patent cheerleader, then you don't care about the free market; you just care about government-enforced monopolies over ideas. Anyone with a brain or a single care for freedom opposes patents already even if it were true that it would mean a fewer amount of drugs would get developed.

Re:It's a good thing... (0)

Anonymous Coward | about a year and a half ago | (#43335073)

Now, if only we could open source the production! Would be a great project to combine multiple disciplines for the greater good...

Re:It's a good thing... (1)

ProgramErgoSum (1342017) | about a year and a half ago | (#43335275)

Open source the chemical and initiate "3D printing of the molecule" !

Re:It's a good thing... (1)

Fjandr (66656) | about a year and a half ago | (#43335261)

A single injection of Neulasta is $6,000, and you get two a month for many standard chemotherapy treatments.

The morality of the pharmaceutical companies (1, Insightful)

fufufang (2603203) | about a year and a half ago | (#43334891)

Without the big investment by the pharmaceutical companies, new drugs would not have existed in the first place. It is a high-risk and high-reward business. However extorting dying patients is a bit morally questionable. But hey, we live in a society where everything can be measured by money.

Having said that, I think if the modification is small, and the investment into this new modification is small, then patent shouldn't be granted. I hope India doesn't end up with U.S's patenting culture, where the rounded corner on a phone can be patented.

Re:The morality of the pharmaceutical companies (5, Insightful)

Anonymous Coward | about a year and a half ago | (#43334931)

This bullshit has gone on for long enough. Most of the actual research whose fruits end up as drugs are often made by researchers with federal funding. The actual amount of money put into research is much lower than what Pharma wants us to believe, and often R&D involves a significant amount of activities unconnected with Research. Hence, you will be unable to find actual cost of research for any pharma company - inspite of all the financial documents available for the public firms.

High risk and high reward is a again a bit of an overkill considering that most of the research dollars are spent on coming up with new compounds/drugs which are barely more effective than the medicines they replace. These new drugs are significantly more expensive than the drugs they replace and accompanied by huge marketing campaigns that increase pressure on the doctors by the patients clamoring for the new drug.

  In addition they keep coming up with small changes to existing compounds and re-patent it .. thus circumventing the very process which they seem to talk so much about. Even when 'evergreening' does not work, they try to involve the generic manufacturer into drawn out legal process. Again - all this inspite of the 1984 Hatch-Waxman act which pushes the patent during out to make up for time spent in research before the actual drug is released.

Considering the Pharma industry has spent over $2.1B in lobbying alone (for stuff like faster approvals, no volume pricing negotiations for Medicare etc.) .. I think it is one of the most corrupt industries in USA>

Re:The morality of the pharmaceutical companies (2)

siddesu (698447) | about a year and a half ago | (#43335017)

The real question is can you run the whole system well enough with government money. While it is true that a lot of the basic research is done with government money, it seems that most of the work that turns the scientific discovery into a working medicine is done by the pharmaceutical industry, and a lot of the costs on the way are there because of the complex regulatory framework -- necessary because of the need for safe medication. It is unclear if enough effort will go into pharmaceuticals unless there is the carrot of the huge profits that is dangling somewhere at the end of this complex process.

It is tempting to say that patents are always bad for the economy and that the pharmaceutical ones are also immoral, but I recall a study on the subject of patent effects that found that pharmaceutical patents were about the only kind that is economically justified.

It isn't all black and white, unfortunately, nor easy to fix.

Re:The morality of the pharmaceutical companies (0)

Anonymous Coward | about a year and a half ago | (#43335095)

Well, you could pay for basic healthcare from tax money, that would create an incentive to develop cheap drugs. Then you could develop them with tax money. In the end people end up paying less than they do now because nobody reaps in big rewards. Basically reduce med companies to manufacturing companies.

Re:The morality of the pharmaceutical companies (1)

siddesu (698447) | about a year and a half ago | (#43335169)

Well, with so little detail your opinion is hand-waving, and not a solution. The issue at hand isn't the "incentive to develop cheap drugs", but the incentive to develop effective drugs that are cheap.

Re:The morality of the pharmaceutical companies (0)

Anonymous Coward | about a year and a half ago | (#43335357)

The issue at hand isn't the "incentive to develop cheap drugs", but the incentive to develop effective drugs that are cheap.

The issue at hand is "Finding the most cost-efficient way to fund research/development/testing of drugs"
Production costs are usually cheap enough to be a non-issue. And where they are, patents are surely not helping because they prevent everyone else from developing cheaper ways to produce the same drug.
And of course the drugs should work as intended and have as little side-effects as possible (I guess that's what you mean by effective)

In the end, the problem always comes down to paying the researchers who develop the drugs and providing them with the necessary equipment for doing so. I don't see how patents are helping there when you (the public who has to pay for all of this one way or another) could do the funding directly?

Re:The morality of the pharmaceutical companies (0)

Anonymous Coward | about a year and a half ago | (#43334941)

A counterpoint to the entire idea of charging huge amounts for developing these drugs is that the poor of india couldn't afford to pay the costs in any case, so the original company wouldn't have made much profit by charging as much in this market as they would have demanded, while thousands(?) of people would have died from a preventable disease. I think it's totally immoral to charge anyone 'poor' (where you define that line isn't something I'll debate about right now) any more than the cost of production, while the cost of R&D can be charged to those who can actually afford it.

Re:The morality of the pharmaceutical companies (5, Interesting)

bfandreas (603438) | about a year and a half ago | (#43334945)

Problem is this practice is a bit more widespread than just one drug. It's called "evergreening". You take a drug, you make a minute change to it, you tell everybody its fresh&new&patent plx!
India said no to that. They said that Novartis had its run of the full duration of patent protection and that it wouldn't be fooled.
Also Novartis does bill patients thousands of dollars per month for this particular drug. Which is extortionist. A little bit competition is more than just a little bit needed.

The big news is India said no while Europe and the US said yes.

Re:The morality of the pharmaceutical companies (1)

ProgramErgoSum (1342017) | about a year and a half ago | (#43335257)

The big news is India said no while Europe and the US said yes.

Well said, Sir/Madam !

Re:The morality of the pharmaceutical companies (0)

Anonymous Coward | about a year and a half ago | (#43334949)

What a lying SOB! Round corner were not patented. But hey, whatever belief lets you sleep at night.

Re:The morality of the pharmaceutical companies (1)

sjames (1099) | about a year and a half ago | (#43335087)

You seem to be stuck at denial. Perhaps some grief counseling?

Re:The morality of the pharmaceutical companies (3, Insightful)

fustakrakich (1673220) | about a year and a half ago | (#43335029)

Without the big investment by the pharmaceutical companies, new drugs would not have existed in the first place.

I don't believe that. More money goes into lobbying for preferential treatment and marketing than development, while many older, perfectly suitable remedies are taken off the market and prohibited altogether. And before anybody goes off about safety issues, they should read up on the deaths and other side effects caused by many of the new drugs. Modern pharma is a pretty corrupt operation. Regulatory capture is just as big here as in energy, communications, and transportation.

Re:The morality of the pharmaceutical companies (2)

jewens (993139) | about a year and a half ago | (#43335331)

More money goes into lobbying for preferential treatment and marketing than development, while many older, perfectly suitable remedies are taken off the market and prohibited altogether.

If a pharma company publicly argues that an old version of its product is unsafe then aren't they opening themselves up to huge liability claims, and even criminal negligence charges if they sat on that information until after they patent version 1.0.1a?

BS Alert (1)

tanveer1979 (530624) | about a year and a half ago | (#43335089)

This is the BS line pharma companies would like to feed you. Much of the research happens in conjunction with universities.
Pharma companies are always in for a "maintenance" cure. They do not want the permanent cure. Corporations exist for profit, and if they get less profit, it will mean a 50,000$ car instead of a 1000000$ supercar.
But just like the MAFIAA they would like you to believe that they are some kind of angels looking over starving millions.

Huh? (5, Insightful)

Locke2005 (849178) | about a year and a half ago | (#43334893)

This doesn't make sense to me. If they make a small change, the small change should be patentable -- but that should in no way effect the extent of the patent on the original formulation. In other words, patenting the small change shouldn't stop anybody from copying the original drug. And if the "small change" actually makes a real difference in effectiveness, isn't that an argument that it _should_ be patentable?

Re:Huh? (0)

Anonymous Coward | about a year and a half ago | (#43334947)

the small change should be patentable

Why should such a small change be patentable? Patents (if you're the type of idiot who believes in them) are not supposed to be granted for obvious or simple things, so no, this was the right decision.

Re: Huh? (0)

Anonymous Coward | about a year and a half ago | (#43335023)

How is that fair when the US can blanket-illegalize "analogs" of research chemicals? My point isn't about how they're used, what I'm saying is if one government can essentially claim all these chemicals are the same when they don't want people to use them, why not block patents of chemicals that are possibly even more similar when there is a medically accepted use for them? Because of a "legitimate" use drugs which would be considered analogs of other (patented) drugs should be different, while chemicals that are "different" in the same way from illegal chemicals are treated as if they were the same and not only unpatentable but also illegal, potentially before they're even created? This was the right decision, and I hope the US follows suit

Depends on the "small change" (2)

bradley13 (1118935) | about a year and a half ago | (#43335165)

Patents on new drugs make sense. When these patents expire, the companies try to find some way to re-patent the drug. Too often, the change is from "take 2 25mg tablets twice a day" to "take 1 50mg tablet twice a day". In other words, the changes often really have nothing whatsoever to do with the actual active ingredient being delivered. Instead of capsules, the drug become a tablet; instead of a syrup it's now a capsule.

This case seems to be even more egregious, because Novartis did not even develop the original drug. Novartis patented their particular formulation, and hoped to use this to prevent anyone else from manufacturing competing formulations. They presumably purchased marketing rights from the drug developer, but I haven't been able to find the details. In any case, India's court has simply said that other companies can also produce the drug, and sell it in their own formulations.

Re:Huh? (0)

Anonymous Coward | about a year and a half ago | (#43335293)

... the small change should be patentable ...

That's lovely. It means, one can patent express shopping ... on the internet, patent push advertising ... on the internet, patent automatic replies ... on the internet. Guess what has already happened to the internet?

... real difference in effectiveness ...

No. A patent is granted for an advance in the use of technology. That is, an un-obvious idea. If one invents a three-wheeled device for individual transportation, a two-wheeled device for individual transportation is obvious and its efficacy is irrelevant.

Legal Gray Market sale of cheaper generics in USA? (1)

girlinatrainingbra (2738457) | about a year and a half ago | (#43334921)

Can this combine with the "Doctrine of First Sale" case [slashdot.org] by the Supreme Court a few weeks ago about the textbooks bought in Thailand and sold in the USA? Then, instead of having USA-citizens buying cheap pharma-drugs from Canadian pharmacies, they could buy the cheap generic versions from Indian pharmacies.
:>)
Someone could start a business importing the generics from India and selling them here in the USA legally, rather than those generics being a "gray market" product: http://en.wikipedia.org/wiki/Grey_market [wikipedia.org] (interestingly, the USA wikipedia uses the British spelling for grey, eh? How hoity-toity!)

Re:Legal Gray Market sale of cheaper generics in U (2)

whoever57 (658626) | about a year and a half ago | (#43334963)

(interestingly, the USA wikipedia uses the British spelling for grey, eh? How hoity-toity!)

That's the correct spelling for grey to you, colonist.

Actually, Wikipedia doesn't have a USA version, it has an English version.

Re:Legal Gray Market sale of cheaper generics in U (2)

girlinatrainingbra (2738457) | about a year and a half ago | (#43335037)

Sorry, mate, we're the Revolutionaries in the former colony. Your King George lost the war. :>)
.
Damn you for being right about the "English" language, though. And you forgot to rub it in by using the word color with the Brit-spelling "colour". (jk. IAAA = i am an anglophile)

Re:Legal Gray Market sale of cheaper generics in U (-1)

Anonymous Coward | about a year and a half ago | (#43335039)

Mhmm. Ever hear the story of why Aluminum is spelled differently (and wrongly) in the UK despite it being named there? The reasoning was that the scientific spelling didn't sound British enough- and they say the Americans are the arrogant ones.

Re:Legal Gray Market sale of cheaper generics in U (1)

AxeTheMax (1163705) | about a year and a half ago | (#43335265)

And of course see the British spelling for other metals - sodum, potassum, et.c., and also the British spelling for a certain part of the head is cranum. Sheer arrogance.

Re:Legal Gray Market sale of cheaper generics in U (1)

frootcakeuk (638517) | about a year and a half ago | (#43335329)

I actually spit my coffee out at this! Please tell me this was late for April fool, quite possibly the funniest thing I've read this year!!

Re:Legal Gray Market sale of cheaper generics in U (3, Insightful)

Zontar The Mindless (9002) | about a year and a half ago | (#43335043)

You're trying to talk sense to someone who thinks "American" is a language.

The word I'd normally use to describe such an exercise is, "futile".

Re:Legal Gray Market sale of cheaper generics in U (1)

DNS-and-BIND (461968) | about a year and a half ago | (#43335201)

Who said that, exactly? Or did you just make that up? I think you did...

Re:Legal Gray Market sale of cheaper generics in U (1)

frootcakeuk (638517) | about a year and a half ago | (#43335353)

interestingly, the USA wikipedia uses the British spelling for grey, eh? How hoity-toity!

Implication that there is a whole different wikipedia site catering for American spelling and grammar. Hilarious in itself.

Who said that, exactly? Or did you just make that up? I think you did...

Indirectly, I think they did

Re:Legal Gray Market sale of cheaper generics in U (1)

Zemran (3101) | about a year and a half ago | (#43335107)

From the article that you linked to "A grey market or gray market, also known as parallel market,..." - It seems that the English version of the page that you cite is quite clear that there are 2 ways of spelling the word. I am British and when I write on that site I write in English and point out alternative spelling just as this writer has. There is nothing wrong with the page that you link to.

Birds do it, spelling bees do it, let's fall in... (1)

girlinatrainingbra (2738457) | about a year and a half ago | (#43335131)

Greetings, across-the-ponder. I only said that it was "interesting", not that it was wrong. I assume that the Great Edit Wars of the '00s (the Twenty-O-O's) and the Great Revert Battles of Wikipedia of 2010 saw much churning both within the article and in the title itself. The skies must have been filled with the e's and the a's being catapulted back and forth as the Revolutionary Forces and the east-of-the-pond residuals of the once Mighty Empire hurled vowels and invective and inflections (and once, there was a stray umlaut as a German took part in a strange time-traveling-unterseeboot up-periscoping) at each other. It's been a lone holdout, that one wikipedia article entitled "Grey Market", that outpost holding onto that grey, grey spelling.
;>)
Birds do it, spelling bees do it, let's fall in . . . loove !

Can smeone explain ? (1)

Anonymous Coward | about a year and a half ago | (#43334943)

Ok, the court did not think it was innovative enough, but I don't understand why this should affect the expiry of the patent of the previous version f the drug.
That should expire regardless, shouldn't it ?
If so, they could make generics from the previously expiring one.
There's something I don't understand about the evergreening of the patent. If someone can explain, thanks.

Re:Can smeone explain ? (0)

Anonymous Coward | about a year and a half ago | (#43334981)

If so, they could make generics from the previously expiring one.

They could, but the big pharma companies pay the little pharma companies big bucks to not make generic versions of their drugs. Why go through all those pesky FDA regulations and hard work of getting your drug approved just to sell it for $5 a pop, when you can get paid to do nothing?

Cue people telling us it's all the government's fault and if it weren't for the FDA, all the welfare recipients^W^Wgeneric manufacturers getting paid to do nothing would get off their ass and work for their money.

Re:Can smeone explain ? (1)

Opportunist (166417) | about a year and a half ago | (#43334999)

Probably some kind of legal spiel where they can claim the generic drug some other company can make is similar enough to the new patented one that it could be considered a knock off and hence it's illegal to do it?

Re:Can smeone explain ? (2)

robbak (775424) | about a year and a half ago | (#43335121)

In this case, the original patent could not be granted because India's laws did not recognize patents on drugs at the time. Now India has passed laws recognizing patentable drugs, the company wanted a patent, and claimed one for the existing drug, unpatented because of previous laws, slightly changed.

In this case, a patent would have been reasonable. But if allowed, it would be a precedent that would have been used for evergreening other drug patents in the future. So it was quite rightly disallowed.

There are more egregious examples of evergreening, for instance, where a party gains a patent on a drug, and, just before the drug's patent expires, a second patent is applied for covering an essential process or precursor for making the drug. This second patent works if they have been careful to make sure that information about the process or precursor has been kept as a trade secret, which means simply that everyone that has been informed about it has signed an NDA.

Re:Can smeone explain ? (1)

siddesu (698447) | about a year and a half ago | (#43335161)

It is a marketing issue. Where I live, generic medicine has been available for several years now and is of high quality, comparable to the branded one. However, the rules are that the pharmacy will not sell you a generic item unless the doctor indicates that a substitution is acceptable on the prescription. This is, of course all fine and cool until you consider how doctors learn about new drugs and treatments.

A lot of the doctors I've talked to seem to learn about those mostly from seminars run by the drug companies themselves. There, the newest drug will invariably be touted as much better than the old one. Of course, the training has value for the patient when it helps the doctors to better understand the implications of using the various options and provide a better (both more effective, and more cost-effective) treatment because of it. The problem is that some of these seminars are more of a marketing campaign than rigorous training, and the end result is they promote the more expensive treatment, not the most effective one.

As a result of this training system, the likelihood increases that your doctor will prescribe you a branded item, often without the option to substitute for a generic item, even if one may be available and just as effective. While there are no absolutes in this matter and, in the end, it all depends on the particular doctor, there are many who go the easy way and just give you the option they've learned from the maker's marketing literature.

I've had experiences all over the range, from doctors who prescribe the branded item because "this is the drug that is used most often", "this is the best" or "the price difference is not all that large" (in my case, the government insurance covers a large percent of the cost, so, indeed, the cost I pay directly is low, but, of course, the taxes are high and getting higher), to doctors who give a long lecture about the reasons to pick a specific drug and relate those to details of the diagnosis. On the positive side, I've seen the least amount of unnecessary expensive treatments when dealing with complex problems that required a high level of qualification from the doctor.

Re:Can smeone explain ? (1)

AxeTheMax (1163705) | about a year and a half ago | (#43335279)

I think one point is that the previous version was not patented in India (as mentioned before). So essentially Novartis tried to get a patent on a minor alteration of a patent free compound.

Good news - now Novartis will make generics :-) (5, Interesting)

bayankaran (446245) | about a year and a half ago | (#43334985)

Now, NOVARTIS will start making generics.

Generic drugs made by third parties are sorely needed by non G8 nations across the world. Indian companies are the leaders in making generics....like Chinese companies in making electronics / hardware. The argument of multinationals pharma companies like NOVARTIS claims the high cost of R & D for inventing new drugs for keeping up the high price. This has been debunked by the report on TIME [time.com] (and many other sources) which proved the same drug or treatments costs vary highly depending on who pays. And such costs are amortized from G8 nations itself. Also none of these companies are making any losses in their balance sheet whatsoever...what they demand is permanent 'rent seeking'. [wikipedia.org]

Today's TIME has an OPED by their Delhi correspondent [time.com] with grave warnings on future of Indian pharma - the type of warnings issued by World Bank / IMF / West on Developing countries - basically on the lines on "do as I say, not as I do". I guess NOVARTIS marketing droids called TIME headquarters and asked them to run a sympathetic piece. We are talking about a company with $54 billion sales and $9 billion plus profit in 2012! Imagine their power. And now imagine the 'purported losses' on a few drugs going out of patent in developing countries - it will be negligible at best.

There is no way any Indian - except for the 2-3% of the elite - can afford a $2600 ~ Rs 130000 / - cost for a month long treatment. This is a country with no health social safety net other than public medical colleges and affordable primary health care facilities and medicines. (Private Health Insurance is a new phenomenon, slowly catching on, the advantages and disadvantages we know...we have to look at USA.)

The only argument which can be made against Indian generics - "if you can't afford the drug, why don't you suffer the consequences". I guess even the most hard nosed penny pinching corporate drone is not THAT heartless.

Instead of fighting the generic manufacturers, NOVARTIS should create their own special generic versions and beat them on a price point. But the suits running the show looked at some powerpoint and decided, lets first fight, if we lose start making generics.

Re:Good news - now Novartis will make generics :-) (1)

ap7 (963070) | about a year and a half ago | (#43335053)

A legal framework is needed to separate R&D in pharma from manufacturing and marketing. The R&D companies license the drug to whoever applies. Competition will keep the marketing and production company costs down to an optimal level thus saving money. Pharma marketing has massive budgets. I know of doctors travelling abroad every 15-20 days for lavish Pharma sponsored 'conferences' in exotic locations. Many malpractices exist in the whole Pharma marketing ecosystem that put the IT industry to shame in their sheer scale and audacity. Curbing them will definitely cut costs.

On the other hand, pharma R&D will make its money solely from creating new drugs and licensing fees. Their primary incentive will be to keep revenues flowing from licensing, therefore creating new drugs rapidly. The only issue to be resolved is the licensing fee R&D can charge for each new drug. I am sure a proper regulatory framework can come up with something that ensures good incentives for companies doing R&D, keeping net returns well above the pharma industry average to incentivize setting up of a lot of R&D companies. More competing R&D companies will mean more innovation and lower licensing fees too.

Finally, the Time correspondent in Delhi will basically have heard the pro-pharma argument from a PR company and leant towards it. You will be surprised how many journalists can be fed material so easily.

Re:Good news - now Novartis will make generics :-) (1)

TubeSteak (669689) | about a year and a half ago | (#43335229)

Instead of fighting the generic manufacturers, NOVARTIS should create their own special generic versions and beat them on a price point.

In the developing world, premium priced branded generics are turning into big money for pharmaceutical companies.
The people are very aware of counterfeit drugs, so they'll pay a premium for Bayer Aspirin
(festooned with holograms and safety seals on the boxes and bottle)
even though aspirin has been generic for an exceedingly long time.

Re:Good news - now Novartis will make generics :-) (1)

Anonymous Coward | about a year and a half ago | (#43335303)

Novartis DOES have a generic division. It's the second largest generics manufacturer worldwide (TEVA, the Israeli Generics Manufacturer is the largest)

Re:Good news - now Novartis will make generics :-) (1)

Anonymous Coward | about a year and a half ago | (#43335363)

The only argument which can be made against Indian generics - "if you can't afford the drug, why don't you suffer the consequences". I guess even the most hard nosed penny pinching corporate drone is not THAT heartless.

Randroids are. Even though their idol was a welfare queen, who, incidentally let the government pay for her smoking induced lung cancer treatment.

Thank God (1)

Redmancometh (2676319) | about a year and a half ago | (#43335001)

The ROT13 and other April fools crap is over with. That was really annoying. Someone needs a stern talking to about what "obnoxious" means.

This is very big... (4, Interesting)

tanveer1979 (530624) | about a year and a half ago | (#43335027)

"Evergreening"
This is a process where pharma companies make teeny weeny changes to compound and get a new patent, bypassing the 20 year limit on patents. Indian law(thankfully) does not allow "Evergreening". Patents cannot be issued on "new versions" or "slight changes".
The courts are very sensitive to this, and will not allow pharma companies to get away.
What this ruling has done is that many more common drugs can now be sold as generics. Cancer is a relatively rare disorder, but there are other more common diseases where patented drugs are very expensive.
With this ruling generics will get a big boost. Not only that, there is a push by the govt to prevent doctors from recommending "brands" and recommend generic brand name drugs which are 1/10 the cost, or even cheaper.
There has been lot of pressure by the WTO to allow corporate to plunder the masses, but the govt has held out on its own. There are many things wrong with India. Thankfully. patent system as it stands today is not one of the things wrong!

Re:This is very big... (0)

Anonymous Coward | about a year and a half ago | (#43335307)

Kinda like how Big Media has successfully lobbied for eternal copyright term... disgusting!

Cancer is a relatively rare disorder

No, it certainly isn't. About a third of all people will get cancer at some point.

Good! (0)

Anonymous Coward | about a year and a half ago | (#43335163)

Delurking for the first time in a long time to say this: to the lowest hell with the people whose greed will let them watch other humans suffer, wither, and die for want of these drugs. "Evergreening" is scum and in a better world would be felonious.

We must have a change of heart as a race. We must ask, "is money for humankind, or is humankind for money?" Especially in a global economy full of floating currencies, money only has value while it has velocity, as one cannot see the wind but only feel its effects.

India has the potential to be a world leader in sustainability...or it may become a living nightmare zone with a population of billions. Only the decisions made deep in the hearts of those in power will tell, and the consequences will spiral out into eternity.

Ask the right question (1)

Anonymous Coward | about a year and a half ago | (#43335371)

There are millions who cannot afford the exorbitant prices charged by large pharma companies. It is a fact that they will die or suffer a lot if they dont get these drugs. The right question is whether we want them to die or suffer. Pharma companies need to work out their financial and business plans by taking this question into consideration. They cannot ignore this question because they do not live in a perfect worlds.

The statement that this will kill innovation is wrong. Irrespective of the supreme court ruling in India...these millions are NOT going to buy the drugs at the exorbitant prices at which these large pharma companies sell simply because they don't have that kind of money. So this ruling does not impact their finance and hence their innovation in any way.

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