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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
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.
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!
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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!”
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!”
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!”
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.
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.
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.
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.
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...
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.
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.
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.