India recognizes patents just like anywhere else. What they don't recognize is when drug makers trivially re-formulate their drug upon patent expiration in such a way that the old medicine cannot be made generically without also infringing on the new patent. India called BS on that, and rightfully so. Now millions of people in India don't have to die because even though a drug company made several multiples on their investment already, billions in exclusive profits per year still isn't enough.
Edited to add: This is informally called "Evergreening". I'm not an expert in that field but you can read more at http://en.wikipedia.org/wiki/Evergreening and linked sources.
In this case, they wanted to charge Indians $2600/month, and the generic is $175/month. If you have this condition and do not take this drug, you die.
As an aside, the evergreening process has taken on frightening new faces in recent years. Drugs have been repatented with the same formula for 'new' purposes. Case in point is BiDil, an active ingredient repatented for race-specific use in African-Americans without alteration to a previously patented drug formula (the case of repatenting is in and of itself an interesting study, many in the field contest the trials that validated the repatenting as well as the concept of a race-specific drug, as there is no drug-relavent biological basis for race.)
Perfect. The article kinda hinted on this but didn't make it clear. So all those generic versions could have disappeared from the market if they had gotten the patent.
This move by Novartis makes them seem very evil (not for wanting to make money, but for actually attempting to kill people who couldn't afford their drug)
Key people at Novartis (from wikipedia):
- Daniel Vasella (Chairman)
- Joseph Jimenez (CEO)
I wouldn't hire these people. And it's a pity they will never experience not being able to afford a 10 year old drug that could save their lives.
A point of contention was the triviality of the change and thus the logic of starting the clock on the original formulation.
“Successive Indian courts have ruled that Glivec, also known as imatinib, was ineligible for a patent because it was a so-called salt – a subtly modified version of a related compound that had been previously patented. Novartis has challenged the interpretation.
Mr Herrling – formerly Novartis’s head of research and development – said that the original form of the drug was too unstable and unsafe ever to be tested in humans, and it was the 'salt' version that was ultimately approved for human use worldwide" [1]
Note that Novartis threatened, yesterday, “to stop supplies of new medicines to India if the country’s top court refuses on Monday to grant a patent for Glivec, its cancer drug.”
From what I understand, this case wasn't just about evergreening. When Prilosec was evergreened, the old formulation became available as Prilosec OTC. I don't know all the details beyond this article, but apparently in this case, Novartis wasn't just seeking a new patent on Glivec - they were also taking steps to make it harder for the generic version to be produced. The evergreening of Prilosec in the US was more of a marketing ploy, whereas the Novartis case seems much more insidious.
There are also reported cases (not direct statements by the firms, but independent analyses) of pharmaceutical brands purchasing or paying generic producers to prevent a generic from coming or remaining online and competing. (Apparently, in some cases the number of and potential for generic producers is limited enough to make this cost effective for the pharmaceutical brand.)
These firms have been granted limited monopolies in return for their contribution to the public good. Apparently, this is not enough for them. As a member of the public, I'm disinclined to offer them anything further, and rather in favor of re-evaluation this cost/benefit relationship with the suspicion that thorough independent analysis may well indicate the public should "claw back" more of this monopoly benefit we've been granting.
Patents are a social convention. Not an inherent law. Society is, with sufficient will, free to re-evaluation them. Just as "public domain" may and does override private ownership for cases demonstrating sufficient benefit to the public good. (Not that imposition of "public domain" property seizure isn't its own nest of contention and problems. But as an example of another domain where this is already accepted law.)
> drug makers trivially re-formulate their drug upon patent expiration in such a way that the old medicine cannot be made generically without also infringing on the new patent
This seems to happen in the pharmaceutical industry too often. Not only this, drug companies also inflate the pricing on the older medication so that people will switch to the newer variety.
Insane the capitalism world we living in. Now you can sit down for hours and rightfully argue with someone whether big pharma company is saving more live than killing.
right, India recognizes patents just like anywhere else. which is why all big pharma-cos get their patents denied, pure coincidence. especially as Indian generics are a big business spreading into Europe and US.
just compare to China(!) of all places. not even the Chinese government, not exactly opposed to copy and paste, is pulling these stunts.
Let me tell your my story. I am on a pill called Colchicine that I have to take 3 times a day for life. The pill's formula is hundreds of years old and would cost me pennies. That was until a company convinced FDA to ban the generics and only allow its own brand. The same pill that used to cost 10 cents now costs $5/pill to me here in the US. Meanwhile in India, it still costs pennies.
Interesting about Colchinine[1]. Apparently the FDA does 3-year exclusive agreements with companies in exchange for conducting new clinical trials.
The idiotic thing here is that by raising the prices, it cost Medicare $49M more a year for apparently a ~$100M investment into research.
I don't know why the government wouldn't fund it directly in this case. Or in general, why they don't add a tax onto the drug in question and do the research themselves. It seems like an odd, public-damaging way to go about things.
If a private company has the duty to maximise profits, shouldn't a sovereign state have the duty to maximise the benefits to its citizens while fulfilling its minimum international treaty obligations.
The cost of gleevec/year is $36,000. The average per capita income is $1219[1]. If patented about 99% of people who need this drug can not afford it. Why should any state keep 99% of its people away from a life saving drug, if it doesn't have a legal obligation to do so.
Property rights are a means to an end. Even if all of Asia and Africa refused to recognize Novartis patents, they would still have enough incentive to continue developing cancer drugs.
>If a private company has the duty to maximise profits, shouldn't a sovereign state have the duty to maximise the benefits to its citizens while fulfilling its minimum international treaty obligations.
They absolutely do. But that just shifts the argument to "what policy is the right one to maximize benefits to our citizens?"
>The cost of gleevec/year is $36,000. The average per capita income is $1219[1]. If patented about 99% of people who need this drug can not afford it. Why should any state keep 99% of its people away from a life saving drug, if it doesn't have a legal obligation to do so.
You could make the same argument in any country, including the US. And yet the system is the way it is for a reason.
>Property rights are a means to an end. Even if all of Asia and Africa refused to recognize Novartis patents, they would still have enough incentive to continue developing cancer drugs.
Would they? I wonder. It's possible eventually the grey market importation of unlicensed generics would make profits too small to justify the risk, and Novartis might decide yet another pecker perker would be a better investment than a cancer drug.
To put this in perspective, Novartis Glivec is the beta crystalline form of 'imatinib mesylate' - an already known compound which went out of patent. Novartis failed to establish that the new form has demonstrable efficacy over non-crystalline form. As per section 3 (d) of Indian Patent Law designed to prevent Evergreening - inventions that are mere "discovery" of a "new form" of a "known substance" and do not result in increased efficacy of that substance are not patentable. Indian patent law follows guidelines set forth by WTO under TRIPS agreement. So Novartis has exhausted all their legal defences. Novartis did not get even one favourable verdict in the entire legal battle which played out in 3 different courts of law.
Why drugs cost so much isn't really that hard to figure out.
Drugs cost a lot of money to develop. On average it costs somewhere between $250M (for an orphan disease) to $1B (for a primary care drug). The problem is that most drugs fail during development and when you take that into consideration, it's typically over $1B to develop a drug.
Where does that money come from? Just like money for anything else, it comes from the marketplace. People (not unlike readers of HN) take their money and put it into investments that get them an optimal return. If you eliminate patents, you eliminate the mechanism to get a return on R&D dollars invested. No patent (or at least a mechanism to get a return on an R&D investment) and you have no drug.
The issue here isn't getting a patent to cover the R&D costs, it's a case of the patent expiring, the drug company reformulating the drug slightly and then applying for a "new" patent on what amounts to a slightly modified version of the previous drug.
Seriously? You want to start a company under the pretext of making humans' lives better, but only worsen it for them?
I will justify my sentiments:
By worsening, I mean, nothing is terrible in life than knowing there is a solution/cure to your problem, but you have to die just because you can't afford it.
India is a developing country, even something as moderate as $100 is actually a luxury for many people - Remember, we are talking about a country where millions slog their lives to death for $0.01 to $0.5 per hour (even in call centers, etc) and anything between $100-200 is NO JOKE for them.
Just don't put barriers to such things - Everybody has the same blood inside them and has a right to live on this planet irrespective of having enough money or not. You want money? Don't charge the peasants - Charge the R&D departments of the billion dollar companies that want to sponsor you and compete for fame. These peasants are already selling their blood (literally) to make their both ends meet, and this should be the last thing they should die to pay for - Their very own life.
Diet is a huge factor in quality and longevity in life. "Good" food is a lot more expensive than processed horse muck. So even there a financial divide exists. Unless we want to lean over to a more socialist way, that sort of divide will always exist. Poor people will usually die before richer people, mostly its down to food and water and sanitation, even fitness. I'd rather get those things right first, then worry about funky cancer drugs. Might need less cancer drugs if these things were addressed. Might need less drugs in general.
I believe this is where India has got it's patent system right. I am not a lawyer, but as I understand it, the Patent Office (Controller General of Patents Designs and Trademarks) rejects patents that are obvious and not a genuine invention.
Furthermore, you can only patent a process not an idea or a product. This was the key reason that you have so many generic alternatives for otherwise patented medicines. The process encourages competition and its the consumer who wins.
And this is why medical research should be directly funded by goverments, exactly like they fund military research, the cost shared among the developed nations, and directly throw away the patent system.
Throw the baby out with the bathwater? I speak from an Indian perspective. Almost everything the government touches leads to crippling corruption. Including the police force. I have colleagues from government-run research centers, and I've heard enough stories from them to never wish to deal with one.
I am a Biotechnology Student in India...
Even if the older version exists, pharmaceutical companies have the power to enforce the new drug with their buying power...Pharma Companies gift a lot of doctors with various goodies to enforce the newer version - thus allowing company to make profits....
The Point to be noted here for Developers, Designers and Other Technologists - " Where Do you Draw the line ?"
Novartis might have made a slight modification to the structure of the drug - and thereby requesting patent for the new drug.. The new drug might be more effective or not, they would want to sell it at a premium...So where does one draw a line towards how much of a change is ok for the drug to be accepted as a new drug.. should the change be in effectiveness or structure or something else...
The same question applies to developers and designers - when someone uses their designs or code.. Where do you draw the line ?
Novartis said in their submission "Generic companies should be able to compete with the original version of the product after expiry of the earlier filed patents. Thus, the scope of those improvement patents must always be narrower than the earlier filed patents so that third parties are normally in a situation to use the older technology after expiry of the earlier filed patents without infringing the follow-on patents" http://pharmapatentsreview.govspace.gov.au/files/2013/01/201...
“We certainly do not wish the law of patent… to develop on the lines where there may be a vast gap between the coverage and the disclosure under the patent; where the scope of the patent is determined not on the intrinsic worth of the invention but by the artful drafting of its claims by skilful lawyers; and where patents are traded as a commodity not for production and marketing of the patented products but to search for someone who may be sued for infringement of the patent.” said by Bench of Justices Aftab Alam and Ranjana Desai.
As I understand, all hue and cry from Novartis is - they have invested big in R&D and yet not reaped reasonable returns. Also, they claim that this dents their effort to come with better drugs in future as profitability is at stack and such judgements are demotivating for any actual R&D to take place. Just wondering with crowdfunding gaining acceptance would this be a relevant argument ? What are real chances of getting a life saving drug as good as Imatinib seeing light of the day. What are practical challenges ?
It might be worth mentioning that India has a large generic pharmaceutical manufacturing industry. Many generics sold in the US and around the world are manufactured in India.
I would love such a provision in US law for patents if it does not yet exist. I'd hate to see someone patent linked lists where the "previous" node pointers are at the top of the data structure and the "next" node pointers are at the end. Or some other silly re-structuring.
Why haven't you, personally, dedicated your life to making cancer drugs?
The people that do so would rather like to be compensated for it. You may think it's an imperfect system but until you personally start making cancer drugs for the world for free maybe you should think a little deeper on the subject.
Medical patents involve a lot of money invested into making the drug, ex. producing new chemicals, laboratory equipment costs, huge salaries for scientists in R&D, etc. Patents are one of the best ways to "earn back".
Why a cancer drug? Why not? There are lots of companies fighting for this huge market, and if you're the first to have invented a medicine, you would like to be rewarded, isn't it?
They talk about tricks like mirror versions of a drug can then be patented after the first drug expires. Then the company can push them over the original, which is not necessarily bad, mirror versions can be better or sometimes worse.
I do not understand the hoopla. When the patent on the old version expires, anybody can make it for pennies a day. An expensive new formulation hurts no one, since they are free to huy the cheap one.
First, sometimes they try to get a new patent that will cover some aspect of the old process, too.
Secondly, a lot of effort goes into getting people on the newer formulation. Look at Concerta versus Ritalin. Both are methylphenidate, but I've met several people that think Concerta is a totally new drug and that "Ritalin didn't work for me". I've even talked to doctors that thought they were different chemicals. Not the drug company's fault, but it still "hurts someone".
this is India playing with fire. and it is not about securing access to important drugs to Indian patients - it is about boosting the native Indian generic pharma industry. while India itself does not provide any significant output in R&D spending in pharma.
so yeah, big pharma is evil and greedy, however no one else takes 1bn$ to try out a new product and have it fail in front of the FDA - which is the usual scenario, as most(!) new products get denied.
how many other industries out there need to PROVE that their products are not only safe but also have an actual benefit? as this is HN, let's see all those fancy task/email/collab/social apps prove their usefulness in scientific trials - and get denied if they fail to be better than notepad.
so yeah, awesome, let's kill pharma's business model without any alternative in sight.
how about having generic makers pay a fixed % of their revenue into a R&D fund? without it they are just leeching off.
Read about evergreening first. The issue is not that India is denying some novel invention - but a slightly modified version of an already expired patent.
[+] [-] lawnchair_larry|13 years ago|reply
India recognizes patents just like anywhere else. What they don't recognize is when drug makers trivially re-formulate their drug upon patent expiration in such a way that the old medicine cannot be made generically without also infringing on the new patent. India called BS on that, and rightfully so. Now millions of people in India don't have to die because even though a drug company made several multiples on their investment already, billions in exclusive profits per year still isn't enough.
Edited to add: This is informally called "Evergreening". I'm not an expert in that field but you can read more at http://en.wikipedia.org/wiki/Evergreening and linked sources.
In this case, they wanted to charge Indians $2600/month, and the generic is $175/month. If you have this condition and do not take this drug, you die.
[+] [-] jkimmel|13 years ago|reply
[1] - http://en.wikipedia.org/wiki/Isosorbide_dinitrate/hydralazin... (BiDil)
[2] - http://www.nejm.org/doi/full/10.1056/NEJMoa042934
[+] [-] hmottestad|13 years ago|reply
This move by Novartis makes them seem very evil (not for wanting to make money, but for actually attempting to kill people who couldn't afford their drug)
Key people at Novartis (from wikipedia):
- Daniel Vasella (Chairman)
- Joseph Jimenez (CEO)
I wouldn't hire these people. And it's a pity they will never experience not being able to afford a 10 year old drug that could save their lives.
[+] [-] JumpCrisscross|13 years ago|reply
“Successive Indian courts have ruled that Glivec, also known as imatinib, was ineligible for a patent because it was a so-called salt – a subtly modified version of a related compound that had been previously patented. Novartis has challenged the interpretation.
Mr Herrling – formerly Novartis’s head of research and development – said that the original form of the drug was too unstable and unsafe ever to be tested in humans, and it was the 'salt' version that was ultimately approved for human use worldwide" [1]
Note that Novartis threatened, yesterday, “to stop supplies of new medicines to India if the country’s top court refuses on Monday to grant a patent for Glivec, its cancer drug.”
[1] http://www.ft.com/intl/cms/s/0/c377e20a-99eb-11e2-83ca-00144...
[+] [-] nhebb|13 years ago|reply
[+] [-] pasbesoin|13 years ago|reply
These firms have been granted limited monopolies in return for their contribution to the public good. Apparently, this is not enough for them. As a member of the public, I'm disinclined to offer them anything further, and rather in favor of re-evaluation this cost/benefit relationship with the suspicion that thorough independent analysis may well indicate the public should "claw back" more of this monopoly benefit we've been granting.
Patents are a social convention. Not an inherent law. Society is, with sufficient will, free to re-evaluation them. Just as "public domain" may and does override private ownership for cases demonstrating sufficient benefit to the public good. (Not that imposition of "public domain" property seizure isn't its own nest of contention and problems. But as an example of another domain where this is already accepted law.)
[+] [-] akandiah|13 years ago|reply
This seems to happen in the pharmaceutical industry too often. Not only this, drug companies also inflate the pricing on the older medication so that people will switch to the newer variety.
[+] [-] joering2|13 years ago|reply
[+] [-] mtgx|13 years ago|reply
[+] [-] pinaceae|13 years ago|reply
just compare to China(!) of all places. not even the Chinese government, not exactly opposed to copy and paste, is pulling these stunts.
[+] [-] zaidf|13 years ago|reply
Let me tell your my story. I am on a pill called Colchicine that I have to take 3 times a day for life. The pill's formula is hundreds of years old and would cost me pennies. That was until a company convinced FDA to ban the generics and only allow its own brand. The same pill that used to cost 10 cents now costs $5/pill to me here in the US. Meanwhile in India, it still costs pennies.
I wish US would take a page from India.
[+] [-] MichaelGG|13 years ago|reply
The idiotic thing here is that by raising the prices, it cost Medicare $49M more a year for apparently a ~$100M investment into research.
I don't know why the government wouldn't fund it directly in this case. Or in general, why they don't add a tax onto the drug in question and do the research themselves. It seems like an odd, public-damaging way to go about things.
http://en.wikipedia.org/wiki/Colchicine#Marketing_exclusivit...
[+] [-] shabda|13 years ago|reply
The cost of gleevec/year is $36,000. The average per capita income is $1219[1]. If patented about 99% of people who need this drug can not afford it. Why should any state keep 99% of its people away from a life saving drug, if it doesn't have a legal obligation to do so.
Property rights are a means to an end. Even if all of Asia and Africa refused to recognize Novartis patents, they would still have enough incentive to continue developing cancer drugs.
1. http://en.wikipedia.org/wiki/Income_in_India
[+] [-] windsurfer|13 years ago|reply
[+] [-] tsotha|13 years ago|reply
They absolutely do. But that just shifts the argument to "what policy is the right one to maximize benefits to our citizens?"
>The cost of gleevec/year is $36,000. The average per capita income is $1219[1]. If patented about 99% of people who need this drug can not afford it. Why should any state keep 99% of its people away from a life saving drug, if it doesn't have a legal obligation to do so.
You could make the same argument in any country, including the US. And yet the system is the way it is for a reason.
>Property rights are a means to an end. Even if all of Asia and Africa refused to recognize Novartis patents, they would still have enough incentive to continue developing cancer drugs.
Would they? I wonder. It's possible eventually the grey market importation of unlicensed generics would make profits too small to justify the risk, and Novartis might decide yet another pecker perker would be a better investment than a cancer drug.
[+] [-] kvb|13 years ago|reply
[+] [-] anuraj|13 years ago|reply
[+] [-] jostmey|13 years ago|reply
Is the beta cystalline form the same chemical formula as the soluble form?
[+] [-] refurb|13 years ago|reply
Drugs cost a lot of money to develop. On average it costs somewhere between $250M (for an orphan disease) to $1B (for a primary care drug). The problem is that most drugs fail during development and when you take that into consideration, it's typically over $1B to develop a drug.
Where does that money come from? Just like money for anything else, it comes from the marketplace. People (not unlike readers of HN) take their money and put it into investments that get them an optimal return. If you eliminate patents, you eliminate the mechanism to get a return on R&D dollars invested. No patent (or at least a mechanism to get a return on an R&D investment) and you have no drug.
[+] [-] ascendantlogic|13 years ago|reply
[+] [-] neya|13 years ago|reply
I will justify my sentiments:
By worsening, I mean, nothing is terrible in life than knowing there is a solution/cure to your problem, but you have to die just because you can't afford it.
India is a developing country, even something as moderate as $100 is actually a luxury for many people - Remember, we are talking about a country where millions slog their lives to death for $0.01 to $0.5 per hour (even in call centers, etc) and anything between $100-200 is NO JOKE for them.
Just don't put barriers to such things - Everybody has the same blood inside them and has a right to live on this planet irrespective of having enough money or not. You want money? Don't charge the peasants - Charge the R&D departments of the billion dollar companies that want to sponsor you and compete for fame. These peasants are already selling their blood (literally) to make their both ends meet, and this should be the last thing they should die to pay for - Their very own life.
[+] [-] icebraining|13 years ago|reply
What companies are those, willing to pay billions for the development of new drugs just for the PR?
[+] [-] alan_cx|13 years ago|reply
[+] [-] slaxman|13 years ago|reply
Furthermore, you can only patent a process not an idea or a product. This was the key reason that you have so many generic alternatives for otherwise patented medicines. The process encourages competition and its the consumer who wins.
Perhaps this is something that US can learn from.
[+] [-] saurabhnanda|13 years ago|reply
[+] [-] nova|13 years ago|reply
[+] [-] lake99|13 years ago|reply
[+] [-] hmottestad|13 years ago|reply
[+] [-] machbio|13 years ago|reply
The Point to be noted here for Developers, Designers and Other Technologists - " Where Do you Draw the line ?"
Novartis might have made a slight modification to the structure of the drug - and thereby requesting patent for the new drug.. The new drug might be more effective or not, they would want to sell it at a premium...So where does one draw a line towards how much of a change is ok for the drug to be accepted as a new drug.. should the change be in effectiveness or structure or something else...
The same question applies to developers and designers - when someone uses their designs or code.. Where do you draw the line ?
[+] [-] Maxious|13 years ago|reply
Novartis said in their submission "Generic companies should be able to compete with the original version of the product after expiry of the earlier filed patents. Thus, the scope of those improvement patents must always be narrower than the earlier filed patents so that third parties are normally in a situation to use the older technology after expiry of the earlier filed patents without infringing the follow-on patents" http://pharmapatentsreview.govspace.gov.au/files/2013/01/201...
[+] [-] div|13 years ago|reply
If the old version was held by someone else, would it then also be open for the public ?
As far as I can tell, patents pretty much stand on their own.
[+] [-] westi|13 years ago|reply
I don't think they ever had a patent for this drug in India though hence they were already producing a generic version.
[+] [-] rajksarkar|13 years ago|reply
Well! This says it all
[+] [-] samyak_bhuta|13 years ago|reply
As I understand, all hue and cry from Novartis is - they have invested big in R&D and yet not reaped reasonable returns. Also, they claim that this dents their effort to come with better drugs in future as profitability is at stack and such judgements are demotivating for any actual R&D to take place. Just wondering with crowdfunding gaining acceptance would this be a relevant argument ? What are real chances of getting a life saving drug as good as Imatinib seeing light of the day. What are practical challenges ?
[+] [-] joonix|13 years ago|reply
[+] [-] unknown|13 years ago|reply
[deleted]
[+] [-] ChuckMcM|13 years ago|reply
[+] [-] salilpa|13 years ago|reply
[+] [-] imran|13 years ago|reply
[+] [-] InclinedPlane|13 years ago|reply
The people that do so would rather like to be compensated for it. You may think it's an imperfect system but until you personally start making cancer drugs for the world for free maybe you should think a little deeper on the subject.
[+] [-] shared4you|13 years ago|reply
Why a cancer drug? Why not? There are lots of companies fighting for this huge market, and if you're the first to have invented a medicine, you would like to be rewarded, isn't it?
[+] [-] bonchibuji|13 years ago|reply
[+] [-] aaron695|13 years ago|reply
They talk about tricks like mirror versions of a drug can then be patented after the first drug expires. Then the company can push them over the original, which is not necessarily bad, mirror versions can be better or sometimes worse.
[+] [-] Daniel_Newby|13 years ago|reply
[+] [-] MichaelGG|13 years ago|reply
Secondly, a lot of effort goes into getting people on the newer formulation. Look at Concerta versus Ritalin. Both are methylphenidate, but I've met several people that think Concerta is a totally new drug and that "Ritalin didn't work for me". I've even talked to doctors that thought they were different chemicals. Not the drug company's fault, but it still "hurts someone".
[+] [-] pinaceae|13 years ago|reply
so yeah, big pharma is evil and greedy, however no one else takes 1bn$ to try out a new product and have it fail in front of the FDA - which is the usual scenario, as most(!) new products get denied.
how many other industries out there need to PROVE that their products are not only safe but also have an actual benefit? as this is HN, let's see all those fancy task/email/collab/social apps prove their usefulness in scientific trials - and get denied if they fail to be better than notepad.
so yeah, awesome, let's kill pharma's business model without any alternative in sight.
how about having generic makers pay a fixed % of their revenue into a R&D fund? without it they are just leeching off.
[+] [-] product50|13 years ago|reply