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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.'"
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.
"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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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!”
...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.
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.
My understanding is that the bulk of the money is spent on marketing and sales.
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...