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Indian Supreme Court Denies Novartis Cancer Drug Patent
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.'"
except the old patent is probably expired / expiring.
Only a complete fool, April or otherwise, would base anything on imaginary property. There is nothing intellectual about that.
I love stacking my barbecues in the shed at the end of summer - you can't beat a bit of grill on grill action.
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...
The only good patent is an expired patent.
“He’s not deformed, he’s just drunk!”
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
The real "Libtards" are the Libertarians!
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?
I've abandoned my search for truth; now I'm just looking for some useful delusions.
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>
The 'technicality' is that drugs were not eligible for patent under their law at the time.
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.
20 minutes into the future
That's the correct spelling for grey to you, colonist.
Actually, Wikipedia doesn't have a USA version, it has an English version.
The real "Libtards" are the Libertarians!
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.
We used to have a Bill of Rights. Now, with the rights gone, all we have left is the bill.
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 (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'.
Today's TIME has an OPED by their Delhi correspondent 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.
Tat Tvam Asi
They seem to understand "My right to live trumps your supposed 'right' to make money" pretty damned well, though.
Il n'y a pas de Planet B.
I hear you can make a really nice curry with expired patents.
Il n'y a pas de Planet B.
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.
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.
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.
"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!
My Aurora : http://www.youtube.com/watch?v=o91ZsGwJYyg
FB : https://www.facebook.com/TanveersPhotography
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.
“He’s not deformed, he’s just drunk!”
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)
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".
Il n'y a pas de Planet B.
ibid.. That argument has been debunked a long time ago. Those millions aren't going where you think they are.
“He’s not deformed, he’s just drunk!”
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.
Prediction for end of Universe #42: Fencepost error in Quantum_bogosort.cpp
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.
Enjoy life! This is not a dress rehearsal.
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.
...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.
“He’s not deformed, he’s just drunk!”
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.
Bio questions? Ask me to start a Q&A journal. Computer analogies available for most topics!
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.
We used to have a Bill of Rights. Now, with the rights gone, all we have left is the bill.
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.
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.
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.
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.
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.
When information is power, privacy is freedom.
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.
That group of bovine standing over there appears quite portentous. That's right it's an ominous cow herd.
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.
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?
That group of bovine standing over there appears quite portentous. That's right it's an ominous cow herd.
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.
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.
My understanding is that the bulk of the money is spent on marketing and sales.
Only a complete fool, April or otherwise, would base anything on imaginary property. There is nothing intellectual about that.
All property is imaginary. Anything external to you can only be described as belonging to you because of the cultural and legal framework that defines property. Property is a matter of convention, not fact.
So intellectual property is no more or less foolish than any other kind of property.
To have a right to do a thing is not at all the same as to be right in doing it
Capitalism is only good for iPhones or other unnecessary luxuries, since I don't give a toss if Apple can persuade people to spend five hundred quid on a piece of electronic jewellery
To have a right to do a thing is not at all the same as to be right in doing it
If you don't mind a lot of people getting hurt because science is hard to understand, and it is hard to understand that it is hard to understand, that system could work. I do care that people get hurt, even if it is by their own lack of insight into science, partly because I know there are areas I do not know enough about to make judgments in, or even to recognize experts. And probably some that I don't know I don't know enough about.
Lilly estimated it cost them a billion to bring a new drug to market, and that was years ago. I think they were talking about drugs for major diseases. First, they have to find a promising compound, that isn't easy. Most compounds they try are worthless. They get some help from biologicals, but it only the first step. They must figure out how to synthesize it because there are not enough green plants to do the job. There are trials, and your drug can get dinged from any of these. The FDA in the U.S. requires at least a semi-trailer full of documentation on your drug (it is probably more now). And your drug must compete against all the other drugs for the same ailment. And once your drug goes generic, there goes your revenue stream because generic drug companies do not support research.
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.
About the closest thing to a bribe you'll see in first-world drug development is the payments to the doctors who participate in the clinical trials. That is actually a considerable part of the trial costs. The payment can't induce them to manipulate the trial results, since the doctors don't have the ability to do this (the trials are double-blind - if they lied and said the patient was doing better than they actually were it would just affect the placebo group as much). However, if you don't throw money at doctors they won't bother to tell their patients about the option of participating in the trial.
Unfortunately, sometimes the money does cause doctors to enroll patients for whom the trials are inappropriate. Companies actually try to stop this, because it is likely to result in a drug NOT being approved (if you give a pill to somebody who is not expected to benefit from it, you add noise to the data which is already quite noisy).
So, while lots of money in the pharma industry gets spent on lots of stuff, the fact remains that it does cost hundreds of millions of dollars to test drug candidates, and most of the time the testing demonstrates that the drug is not safe/effective.
Oh, I'm all for having the NIH competitively do drug development/testing/etc (and making the resulting drugs freely licensable within the US, for use in 3rd world countries, and in 1st world countries that make similar investments and reciprocate). However, I don't think that it will magically make the testing less expensive, unless the whole healthcare system changes so that doctors can be compelled to participate in trials without much additional compensation (that is something that would be more likely to work in a country with nationalized healthcare, though it is worth pointing out that clinical trials tend to happen on a global scale anyway).
In the drug industry the patent system is in part used to let the high-risk/high-cost of development pay for itself. A tweaked molecule might not be very innovative, but it is just as expensive to test. If rulings like this prevail then you simply won't see tweaked molecules developed using private money, even if the resulting drug is a substantial improvement for patients. Again, there are other ways to fund drug development, but I'd like to see those methods employed and demonstrated as successful before we just pull the plug on the drug industry. There is no reason that publicly funded efforts can't just compete with the private ones - the public drugs would be much cheaper for consumers so they'll have no trouble if the R&D labs manage to come up with the goods. The pharma industry has been laying off so many scientists of late that the NIH shouldn't have trouble hiring some...
The FDA has a budget of around $4B with $2B from fees paid by drug manufacturers.
I love Jesus, except for his foreign policy.
It depends on how you count failures.
If you ask me "how much does it cost to find out if this molecule is a good drug?" the answer would probably be around $1M - $100M. Most of the time relatively-inexpensive screening would figure out that it won't work. Other times it would require trials that would be aborted at various points in time, costing up to $100M.
If you ask me "how much was spent just on testing that one drug that was approved last week?" the answer would probably be around $100M. Successful drugs consume the upper limit of the testing costs since they need to go through the full gamut of testing to be approved.
If you ask me "what is the total R&D budget of a typical pharma company over 5 years divided by the number of approved drugs they've had in that period of time?" the answer would be in the billions. The reason for this is that most drugs turn out not to work, so before you can spend the $100M on the drug that works you first have to spend $100M on lots of molecules that don't work.
It really isn't hard to see for yourself. Most drug companies publicize their annual R&D investments (which don't go to stuff like marketing). They certainly publicize drug approvals. Just pick a company and do the math, but makes sure you count actual new drugs, and not just new indications (which are somewhat cheaper to come up with, and certainly lower risk).
Companies do spend more on marketing than research, but the research costs are still astronomical. There are other models, and I'm all for trying some out, but it would make sense to get a new drug discovery model working before simply dismantling the one we already have.
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.
Yes and no. The patent on the original drug STILL runs out. So, anybody can make the drug that they could have made even if the new drug weren't developed. The only thing that gets patent protection is the tweaked molecule - there is no extension for the original one.
I think the only thing that should matter to patients is whether the new drug is worth it. If it isn't, then don't buy it - just buy the old drug, which would be unpatented and cheap. If it is worth it, then do buy it. If you allow tweaked molecules to be patented then patients get that choice. If you don't allow those patents, then the tweaked molecule will never be developed in the first place, and patients will have no choice but to take the old drug.
That's why I don't have a problem with the whole "me too" drug thing even though it seems like everybody hates it. If the "me too" drug wasn't useful nobody would be taking it - the original drug still has its patent expire when it would otherwise expire. I've known people with drug sensitivity issues and having more options available lets them and their doctors find the option that works best for them. Drugs are approved based on the results of the "average patient" but the fact is that no patient is actually an "average patient."
They seem to understand "My right to live trumps your supposed 'right' to make money" pretty damned well, though.
That's kill the goose that laid the golden gate logic. The new drug wouldn't have been tested if the company had known it couldn't be patented in advance. They would only have had the option of using the old drug - an option they would still have had if they had ruled differently (the patent for new drug A2 does not extend the patent on related drug A1).
I do agree that the way we fund drug development is highly regressive. I'm all for public R&D going to license-free drugs. However, don't think that it will somehow magically make the drugs cheaper - it will only change who pays for them.
you do realise drug companies can write of the research and testing period expenditure in many western countries, in many cases the write off exceeds 100% of the investment.
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.
And you actually hit the nail on the head. You're entirely correct. Think about it this way, if the Original patten were still valid and another company came up with the same "Changes" could the first company sue under that patent and win? Of course they could. So how can that very same company claim that those changes are innovation? If they are innovation then the generic company should be able to make small changes and reproduce it.
India is a screwed up country but this is one area they are getting right. If only the rest of the world would follow their lead. This issue is literally killing people by the hundreds of thousands. It's sick.
But if you nationalize so many industries they might not be as profitable and then they couldn't pay as many people high salaries and those people would not have enough disposable income to buy iPhones and data contracts. Please before you make any drastic changes, think of the poor iPhones - they need owners to care for them. Think of the baby iPhones who will never taste the sweet sweet data from the cloud.
A fool throws a stone into a well and a thousand sages can not remove it.
Well, taxpayers are paying the money, just in the form of drug prices.
Both models have their advantages. I'd like to see some Government drug R&D (end-to-end, royalty-free) if for no reason other than seeing for sure if it works. If you spend a few billion dollars on R&D in a fairly open manner something good is likely to come of it at least in terms of spin-offs, and when you compare that to stuff like bombing Arabs it seems like a decent investment.
If it doesn't work out then we can stop arguing about getting rid of the Pharma industry. If it does work out, we won't have to get rid of the Pharma industry as it will be obsolete on its own (if the NIH is coming out with 10 cent pills left and right there won't be a market for $5 ones). Most likely we'll find that each model has advantages and disadvantages, and more drugs will be cheap but some will still be expensive. Along the way both the private and public R&D models are likely to improve from the competition. Consumers win.
What I don't like is the whole "let's just get rid of patents" business. That might be the de facto end result of a government takeover of R&D, but let's start by building the new R&D model before we just sledgehammer the old one. Considering we can't even afford to send a few guys to space any longer it seems like Congress is going to take a while to approve some $100B/yr expansion of federal drug research. Let's start small with some experiments and see how it goes.
You know what's even more simple and obvious -- make everything free, including unnecessary luxuries, and just rely on everyone's good nature to make the system work.
It's so simple and obvious I can't believe nobody has tried that before.
Do you have a citation for that? That patently untrue. The simple fact is drug companies spend more on advertising than on R&D. Once drug companies were allowed to advertise - yes they were prevented from doing so - their marketing budget sky rocketed.
AND FYI the GAO did a study on patents and pharmaceuticals and found that they did not encourage innovation and break through drugs. Allergy medications seem to be the only "innovative" drugs they are able to make. Patents drove up costs and did not drive innovation.
Agreed, especially the part about the government scientists. If we weren't currently in such a "limit the government" mode, NIH - or some similar entity - could get the ball rolling. Just as DOD and NASA laid the groundwork for some now-commerical enterprises (anything Internet-related, GPS, private space exploration), NIH could do the same for drugs and medical devices. Granted, the government is not always as cost-effective as it should be, but in this case, what would be lost, given how expensive the industry is anyway?
And if the "small change" actually makes a real difference in effectiveness, isn't that an argument that it _should_ be patentable?
The problem with that idea is that drug studies can't show a small difference in effectiveness.
Here's how the drug companies maintain their grip: They work on derivatives of the original drug which are slightly different but which do more or less the same thing, and have them ready before the patent on the existing drug expires. In the USA (and possibly other developed nations, but I haven't done the research) the approval of derivatives is fast-tracked. It is notably cheaper and the bar is much lower when compared to approval of a "completely" new drug. Then the old but perfectly functional drug is deprecated due to one or more means. One way is to step up the commercials announcing settlements for death or loss of function due to the old version. Another is to induce medicare (or similar) or insurance companies to not cover the old form of the drug.
The "new" drug may not actually be any safer or better; if the study can be made to make the new drug look about as safe as the old one, it receives approval. In the USA there is not even a test for efficacy for these slightly changes to old drugs. But the slightly changed drug does receive a patent, and therefore it cannot be sold in generic form. Since insurance (or even public health) won't cover the old drug, people will buy the new one. And Big Pharma spends more on advertising than on R&D — most of which is targeted not as physicians but at patients, who are encouraged to ask their doctors about them. The doctors themselves may or may not be getting any kickbacks from the pharmaceutical companies (though some clearly are) but it's easiest to simply prescribe the patient what they ask for, and collect payment.
"You're right," Fisheye says. "I should have set it on 'whip' or 'chop.'"
And the original patent term should be more than adequate for that! Making minor adjustments to an existing patented drug, like "time release" for instance in order to justify a new patent is an old shell game for the drug companies.
Oh, and patents are for twenty years, not forever minus epsilon.
And that is in fact a key factor in the ruling: the patent _does_ end in 20 years, rather than 20 + 20 because we used a levorotatory protein + 20 because we added this binding agent that releases more smoothly over time + 20 because we adjusted the gel coating to resist acid better and deliver more of the drug to the intestines + 20 because...
"Indian" Court.
You must have thought it was a US Court where "Oh, you changed the marking on it from an M to a W?" is usually enough.