How India's Patent Office Destroyed Gilead's Global Game Plan(businessweek.com)
businessweek.com
How India's Patent Office Destroyed Gilead's Global Game Plan
http://www.businessweek.com/articles/2015-01-15/how-indias-patent-office-destroyed-gileads-global-game-plan
14 comments
Gilead argued that 1) its compound is not a mere "new form" of a substance known in the prior art, and 2) even if it were, it differs significantly since it is less toxic and more active than other similar compounds.
But the Patent Office says that "efficacy" here means therapeutic efficacy, and it would need to be proven by a clinical trial.
But the Patent Office says that "efficacy" here means therapeutic efficacy, and it would need to be proven by a clinical trial.
Not very sure what they mean exactly, but the FDA mandates clinical trials, right? Can that data not be used to show increased efficacy, if any?
FDA trials are only required to compete against a placebo. A drug is accepted if it is safe and more effective than a placebo in a double-blind clinical trial. That's it.
So they have no data to show with, unless they went above and beyond to get it. (Which should teach them a lesson about testing their drugs.)
So they have no data to show with, unless they went above and beyond to get it. (Which should teach them a lesson about testing their drugs.)
You don't have to have head-to-head data to claim your drug is superior to existing therapies. Yes, head-to-head data is the best way to show it, but if you have two separate trials, each comparing to a placebo, you can draw conclusions about relative efficacy. It's not perfect, but in the case of Gilead, their drug blows away anything else currently on the market.
Can people in now go to India on medical tourism and get the treatment much cheaper?
This has always been the case [1] :-). Medicines and medical care in India is cheaper, by many folds, compared to US. Anecdotaly, whenever my Indian friends working in US visit India (parents, family) one thing they never forget is to visit dentists. I initially found it very surprising but understood their reasoning when I came to know that in US you can easily go bankrupt due to medical condition, something that's unheard of in India.
[1]: http://en.wikipedia.org/wiki/Medical_tourism_in_India
[1]: http://en.wikipedia.org/wiki/Medical_tourism_in_India
>>something that's unheard of in India.
Maybe not if you're in the 'upper middle class'. If you're from the lower income classes (maids, drivers, helpers), it's very likely that health issues can bankrupt you.
I personally know an entire family that has sunk into debt that they couldn't possibly pay-off, due to health related expenses for someone in the family.
Maybe not if you're in the 'upper middle class'. If you're from the lower income classes (maids, drivers, helpers), it's very likely that health issues can bankrupt you.
I personally know an entire family that has sunk into debt that they couldn't possibly pay-off, due to health related expenses for someone in the family.
It's hard for me to believe that people don't run out of money getting treatment in India. While prices for medical goods and services are lower than the United States, many Indians can't afford all the care they need.
Not only that, I think Indian pharmas can market the drug as generic in USA too. I am not really an expert in legal stuff though.
Before you all rush out to book your flights to India to stock up on inexpensive generic drugs, read this article:
http://www.bloomberg.com/news/2014-03-06/flies-found-by-fda-...
It's a link I posted in this[1] HN discussion. Any amount of Google-fu can turn up a plethora of similar articles. I hope you're feeling lucky, because IMO the potency and efficacy of Indian generics is very hit or miss.
I don't mean to single India out. The "race to the bottom" is one of the overarching global themes of the previous few decades of late stage capitalism.
[1] https://news.ycombinator.com/item?id=8773481
http://www.bloomberg.com/news/2014-03-06/flies-found-by-fda-...
It's a link I posted in this[1] HN discussion. Any amount of Google-fu can turn up a plethora of similar articles. I hope you're feeling lucky, because IMO the potency and efficacy of Indian generics is very hit or miss.
I don't mean to single India out. The "race to the bottom" is one of the overarching global themes of the previous few decades of late stage capitalism.
[1] https://news.ycombinator.com/item?id=8773481
Or this article: http://fortune.com/2013/05/15/dirty-medicine/http://fortune....
Basically the largest Indian Pharma company is corrupt to the core. Falsifying records, blatantly disregarding scientific method, omitting even basic engineering practises, lying on regulatory submissions, etc.
The FDA only does bans on a per-facility basis, so Sun (which acquired Ranbaxy) can continue to sell many things so long the FDA has not shut down that specific location. Even in non-Indian locations, the plants were terribly run. One Ranbaxy location in NJ shipped pills with glass in them. (And was penalized by a temporary restriction on selling the pills.)
Basically the largest Indian Pharma company is corrupt to the core. Falsifying records, blatantly disregarding scientific method, omitting even basic engineering practises, lying on regulatory submissions, etc.
The FDA only does bans on a per-facility basis, so Sun (which acquired Ranbaxy) can continue to sell many things so long the FDA has not shut down that specific location. Even in non-Indian locations, the plants were terribly run. One Ranbaxy location in NJ shipped pills with glass in them. (And was penalized by a temporary restriction on selling the pills.)
There are certainly issues of concern and needs to be improved. There have been recalls and bans elsewhere also. Ultimately though given the state of the medical industry in the US, if the only choices are get in insurmountable debts or die due to lack of medical care, a third option of affordable medicine and some small risk might be worthwhile.
I feel if companies want to operate globally then consumers so be able operate globally.
Yes of course.
Is it 84,000 USD(~50 lakh) per person in India too? That's very very expensive,even for India's software professional with 10 to 12 years of experience where average yearly salary will be around 14,000 USD to 20,000 USD. This 84,000 not affordable even for so-called 'upper middle class'.
If India wants to break patents in order to make drugs available to low income citizens that's one thing (in this case Gilead was already offering a cheap generic), to say the patent on Sovaldi is not innovative is a bit ridiulous.
The article explains it better instead of simply saying it's not innovative. It's worth reading these 2 paragraphs:
"India believes that the patent standards are so low that companies can get patents for inventions very easily," Amin said in an interview. The patent office's examiner ruled Gilead's patent claim "lacks novelty and inventive step," as Bloomberg News noted, and also doesn't demonstrate it's significantly more effective than already known compounds. Amin explains that the controller general's decision holds that "there are a number of earlier compound structures that are very close to what Gilead is trying to get a patent for."
But Sovaldi is a breakthrough drug. Shouldn't that be worth something? "It's important to recognize that what the patent office deals with is whether something is new in science," Amin said. "The decision says there are a number of earlier compound structures that are very close to what Gilead is trying to get a patent for. It's a scientific decision and has nothing to do with the utility of the drug." Gilead didn't offer comment on Wednesday.
"India believes that the patent standards are so low that companies can get patents for inventions very easily," Amin said in an interview. The patent office's examiner ruled Gilead's patent claim "lacks novelty and inventive step," as Bloomberg News noted, and also doesn't demonstrate it's significantly more effective than already known compounds. Amin explains that the controller general's decision holds that "there are a number of earlier compound structures that are very close to what Gilead is trying to get a patent for."
But Sovaldi is a breakthrough drug. Shouldn't that be worth something? "It's important to recognize that what the patent office deals with is whether something is new in science," Amin said. "The decision says there are a number of earlier compound structures that are very close to what Gilead is trying to get a patent for. It's a scientific decision and has nothing to do with the utility of the drug." Gilead didn't offer comment on Wednesday.
This is what I think is the vital issue. Taking a known compound and searching for every possible form in order to find one that doesn't happen to have been documented is in fact something that is "obvious to one skilled in the art," because it's a widespread activity. There are specific rules in the US patent system surrounding this issue.
So it's not like the drug maker was necessarily whacked by some rogue judge issuing a weird decision out of the blue. It may very well be that Gilead was taking a known risk at the hands of the Indian patent system.
Does Sovaldi satisfy India's standards for novelty? I don't know. I've had a patent application struck down over novelty, so I know it's not a happy day when it happens.
So it's not like the drug maker was necessarily whacked by some rogue judge issuing a weird decision out of the blue. It may very well be that Gilead was taking a known risk at the hands of the Indian patent system.
Does Sovaldi satisfy India's standards for novelty? I don't know. I've had a patent application struck down over novelty, so I know it's not a happy day when it happens.
> Taking a known compound and searching for every possible form in order to find one that doesn't happen to have been documented is in fact something that is "obvious to one skilled in the art," because it's a widespread activity.
But it is not the activity (which describes, essentially, most research) being patented, it is the result of that activity. If the search space is very large, that is actually an indication of the non-obviousness of a solution that works in practice. Drug discovery certainly meets that criteria.
But it is not the activity (which describes, essentially, most research) being patented, it is the result of that activity. If the search space is very large, that is actually an indication of the non-obviousness of a solution that works in practice. Drug discovery certainly meets that criteria.
Yes, you're quite right. As I understand it, drug discovery has special rules. The search space is large but not infinite. It involves the original drug compound in different "forms" such as crystal structures, particle sizes, counter-ion (whatever thingy attaches to the molecule and makes it soluble, etc.). The chemical effect of the drug in the body is the same, i.e., it bonds with the same receptor molecule in some cell somewhere. But changing those things can have a pharmacological effect such as the speed with which the drug is taken into the body, thus it is a different drug within the context of US and I believe European patent law, but I can't talk about India.
This could be a case of a bad decision in India, of course, but it also could be one where the patent examiners in US and Europe were more lenient than they should of been.
(Disclaimer: I helped work on equipment designed to assist in this kind of chemical searching).
This could be a case of a bad decision in India, of course, but it also could be one where the patent examiners in US and Europe were more lenient than they should of been.
(Disclaimer: I helped work on equipment designed to assist in this kind of chemical searching).
According to Wikipedia:
Sofosbuvir costs US$84,000 for 12 weeks of treatment used for genotypes 1 and 2 (about US$1,000 per pill) [...] health care costs in California could increase by US$18–29 billion per year because of this medication
Sofosbuvir costs US$84,000 for 12 weeks of treatment used for genotypes 1 and 2 (about US$1,000 per pill) [...] health care costs in California could increase by US$18–29 billion per year because of this medication
I wanted to call bullshit on those numbers, but wow. They're accurate. The math is almost exact even. It turns out 3.2 million people in the US have hep c (1%). Although most have no symptoms.
However the per year is bullshit. That's the cost to treat every person is California who has it. But it's expensive and popular because the cure rate is very high. That makes it more of a one time cost, not a per year cost.
However the per year is bullshit. That's the cost to treat every person is California who has it. But it's expensive and popular because the cure rate is very high. That makes it more of a one time cost, not a per year cost.
It's also much more effective than the competition (i.e., its cure rate is higher). It also doesn't make you feel like you have the flu during the treatment period. The higher % of people who relapse on alternative treatments could end up costing more than just paying for the better drug in the first place. The cost of the medication alone is not enough information.
Well...we would probably need to factor in the long term costs. Hepatitis C is the leading cause of liver transplantation. The pre-transplant work, surgery, and medical follow up costs on the order of $500,000 each. Not including complications. Obviously everyone with Hepatitis C does not reach cirrhosis to the point of tranplant, but it's still a sizeable number.
Calculate the annual cost (which isn't $18-$29 billion, that's the one time cost to cure everyone in CA with it) to cure a portion of the population in CA that has Hep C. Most likely we're talking $3-$5 billion per year.
Calculate the savings that curing those people produces over time (1, 5, 10, 20 years).
I'd be willing to bet the math works out in favor of spending $84,000 one time.
Calculate the savings that curing those people produces over time (1, 5, 10, 20 years).
I'd be willing to bet the math works out in favor of spending $84,000 one time.
> I'd be willing to bet the math works out in favor of spending $84,000 one time.
I'd love for the state to announce ahead of time how much they would pay for, say, a cure for diabetes. Have them calculate what the NPV is for a lifetime of diabetes treatment. Publish that figure.
Then some drug company can show up with a cure, charge 90% of that figure, and we can see people whine that the drug company is costing the state money.
I'd love for the state to announce ahead of time how much they would pay for, say, a cure for diabetes. Have them calculate what the NPV is for a lifetime of diabetes treatment. Publish that figure.
Then some drug company can show up with a cure, charge 90% of that figure, and we can see people whine that the drug company is costing the state money.
The funny part is that a common criticism of the pharmaceutical industry is that they don't want to create cures because they make more money with drugs that have to be taken chronically.
So a drug company releases a cure for a disease and everyone complains about the price. Ironic.
So a drug company releases a cure for a disease and everyone complains about the price. Ironic.
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I'm all against "obvious" patents, but suing to be free to produce a product because it "also doesn't demonstrate it's significantly more effective than already known compounds" is a contradiction in terms. If the other compounds were just as good, then you wouldn't be suing to be able to produce this new one.
That logic doesn't always hold up. You could make tiny tiny alterations to some plastic container, put some random bump here or there, or make the flap stick out a little more, and the plastic container might suddenly not be usable due with a third party automatic coffee maker. That's a huge effect, despite the tiny change.
But I doubt that would make that case that because of that huge effect, those random bumps and extended flap deserve patents. We are after all talking about basic shapes here, nobody should be able to patent "a round shape with a tiny bump sticking out" so that others cannot use that shape.
But I doubt that would make that case that because of that huge effect, those random bumps and extended flap deserve patents. We are after all talking about basic shapes here, nobody should be able to patent "a round shape with a tiny bump sticking out" so that others cannot use that shape.
I don't see how this addresses grandparent's comment: if it does not have increased efficacy, why are so many people desperate to use it? The amount of alteration is a separate issue.
The original article has an interview with an Indian patent examiner that clarifies that the efficacy was not a factor in deciding whether the drug was patentable. It's difference(in chemical structure) from previously well known molecules -- or lack thereof -- was the decisive factor in rejecting that patent.
Thanks for the info.
But then my doubt is the same: If the old ones are the same as this one, then why sue to be able to use the new one free? Just produce the old one... it's the same.
But then my doubt is the same: If the old ones are the same as this one, then why sue to be able to use the new one free? Just produce the old one... it's the same.
One way of looking at this is the legal system keeping a clear distinction between patents and copyright.
I'm disappointed this article doesn't mention the effect this will have on future pharmaceutical investment. Companies spend billions researching and testing drugs for safety and effectiveness. Companies capable of developing successful drugs need an adequate period in which to recoup their investment and earn enough to fund new drug research. If companies know they won't have meaningful ownership over medicines they develop, they won't spend the huge amounts of capital necessary to develop them. When countries like India let competitors produce generics of American drugs, they are stealing the fruits of other people's labor. That isn't to say this theft isn't justified; generics will save the lives of those who can't afford the original. But those lives would have been lost all the same if no such drug had been developed in the first place. Stealing drugs will certainly help India in the short run, but it will slow the advance of medicine in the long run, for Indians and everyone else.
> spend billions... adequate period to recoup... earn enough... huge amounts of capital
All these words don't carry meaning without proper data. Unless we know how much they've spent, how much they need to recoup & grow, these claims are vague.
> stealing the fruits of other people's labor
Without studying the merits/demerits of the patent, this is a hyperbole. I'm saying, maybe your statements are true, maybe not. But without backing up with facts, they are merely sentimental.
Here's an interesting case of drug pricing. Albendazole is a fairly common/old drug. It's a broad spectrum anthelmintic that retails for a few cents in most parts of the world. Recenty, U.S. price of albendazole has increased by >4000% to over US$100 per 200-mg tablet[1].
Another example: Novartis, the company that makes the leukemia drug Gleevec, keeps raising the drug’s price, even though the drug has already delivered billions in profit to the company. [...] Novartis is just keeping up with other companies as they charge more and more for their drugs. They know we can’t say no.[2]
[1] http://en.wikipedia.org/wiki/Albendazole#Controversy
[2] http://www.nytimes.com/2015/01/15/opinion/why-drugs-cost-so-...
All these words don't carry meaning without proper data. Unless we know how much they've spent, how much they need to recoup & grow, these claims are vague.
> stealing the fruits of other people's labor
Without studying the merits/demerits of the patent, this is a hyperbole. I'm saying, maybe your statements are true, maybe not. But without backing up with facts, they are merely sentimental.
Here's an interesting case of drug pricing. Albendazole is a fairly common/old drug. It's a broad spectrum anthelmintic that retails for a few cents in most parts of the world. Recenty, U.S. price of albendazole has increased by >4000% to over US$100 per 200-mg tablet[1].
Another example: Novartis, the company that makes the leukemia drug Gleevec, keeps raising the drug’s price, even though the drug has already delivered billions in profit to the company. [...] Novartis is just keeping up with other companies as they charge more and more for their drugs. They know we can’t say no.[2]
[1] http://en.wikipedia.org/wiki/Albendazole#Controversy
[2] http://www.nytimes.com/2015/01/15/opinion/why-drugs-cost-so-...
Many generic drug manufacturers did not have the proper acilities to meet drug standards. The recent prow increases are a direct result of those direct manufacturers having to spend to bring their processes up to code.
I don't think companies spend as much as we believe in researching drugs. Companies spend most on advertising and incentivizing the doctors to prescribe their medicines. The book: Bad Pharma [1] is an eye opener.
The drug "Sovaldi" is making them $2.8ish billion dollars per quarter, that is almost $12 billion a year. I don't believe they spent tens of billions in developing the drug. [2]
1: http://www.amazon.com/Bad-Pharma-Companies-Mislead-Patients-...
2: http://www.bloomberg.com/news/2014-10-28/gilead-reports-lowe...
The drug "Sovaldi" is making them $2.8ish billion dollars per quarter, that is almost $12 billion a year. I don't believe they spent tens of billions in developing the drug. [2]
1: http://www.amazon.com/Bad-Pharma-Companies-Mislead-Patients-...
2: http://www.bloomberg.com/news/2014-10-28/gilead-reports-lowe...
It's not what they spent developing Sovaldi -- it's the fortune the industry as a whole spends developing drugs that never make it to market.
That said, it's quite likely true that marketing is a bigger share of costs than R&D. Pharma companies are out there to maximize revenue, just like any other corporation. It's a reflection of the poor state of regulation in the US that we pay far more of than our share (compared to the rest of the world).
That said, it's quite likely true that marketing is a bigger share of costs than R&D. Pharma companies are out there to maximize revenue, just like any other corporation. It's a reflection of the poor state of regulation in the US that we pay far more of than our share (compared to the rest of the world).
Here's the piece of the picture that everyone's missing from this particular example - an $11b acquisition [1]. Gilead bought Pharmasset for $11b. It no longer matters what it cost Pharmasset to research/test/approve/produce the medicine anymore. Certainly all of that was factored into the acquisition price but since Gilead's total cost ended up being $11b, that is what they need to recoup at the least.
There are 3.2 million hep C patients in the US [2] but most don't feel ill or even know they have hep C. If every single person buys the drug, Gilead must still sell it for at least $11b / 3.2m = $3500/person! But if only 5% buy the drug, they need to sell it for $69,000 just to break event on the acquisition without even taking any other costs into account.
This is just rough calculation to highlight that a sky high acquisition price resulted in a company demanding an equally high price per dose. Gilead paid the high price to acquire Pharmasset because they thought they could sell the drug for at such a high price per dose. If Gilead is proven right (and their stock price from $18 in 2011 to $100 in 2015 seems to reflect that indeed), then this just encourages more and more drug companies to be bought at astronomical prices.
And the worst part of this is that the very government that gave this company the right to operate a monopoly via a patent is now asking them why they're charging so much [3]. None of this happened because of some singular evil cabal. It happened due to misaligned incentives.
Government grants pay researchers, who develop medicines at paid-for-by-public-funds university labs, which sell the patents back to the researchers at fire-sale prices, who then go on to create biotech startups, which productize the research, and then sell to Fortune 100 pharmas, who can then demand almost any amount of money, which CMS will have to pay because USPTO said nobody else can sell this drug, FDA agreed that the drug works, and ACA ensures that the patients cannot be denied any drugs that work at any cost.
[1] http://en.wikipedia.org/wiki/Pharmasset [2] http://www.hhs.gov/opa/reproductive-health/stis/hepatitis-c/ [3] http://www.finance.senate.gov/imo/media/doc/Wyden-Grassley%2...
There are 3.2 million hep C patients in the US [2] but most don't feel ill or even know they have hep C. If every single person buys the drug, Gilead must still sell it for at least $11b / 3.2m = $3500/person! But if only 5% buy the drug, they need to sell it for $69,000 just to break event on the acquisition without even taking any other costs into account.
This is just rough calculation to highlight that a sky high acquisition price resulted in a company demanding an equally high price per dose. Gilead paid the high price to acquire Pharmasset because they thought they could sell the drug for at such a high price per dose. If Gilead is proven right (and their stock price from $18 in 2011 to $100 in 2015 seems to reflect that indeed), then this just encourages more and more drug companies to be bought at astronomical prices.
And the worst part of this is that the very government that gave this company the right to operate a monopoly via a patent is now asking them why they're charging so much [3]. None of this happened because of some singular evil cabal. It happened due to misaligned incentives.
Government grants pay researchers, who develop medicines at paid-for-by-public-funds university labs, which sell the patents back to the researchers at fire-sale prices, who then go on to create biotech startups, which productize the research, and then sell to Fortune 100 pharmas, who can then demand almost any amount of money, which CMS will have to pay because USPTO said nobody else can sell this drug, FDA agreed that the drug works, and ACA ensures that the patients cannot be denied any drugs that work at any cost.
[1] http://en.wikipedia.org/wiki/Pharmasset [2] http://www.hhs.gov/opa/reproductive-health/stis/hepatitis-c/ [3] http://www.finance.senate.gov/imo/media/doc/Wyden-Grassley%2...
well that's nice and all, so next time CEO wants a new fleet of jet aircrafts for him, all should pay more for the medicines? Because, you know, we can?
Companies should definitely make profit, but their default modus operandi is "milk the cow as long as possible", which would directly result in many deaths... not much sympathy from the crowd there. Let's not forget simple math here - company is/was charging for medicine that doesn't cost more than few tens of bucks to produce... 69,000? Sorry, ridiculous all the way through. Don't care about research bla-bla
Just turn on that weird device that used to be called TV. During winter, 1/3 of the adds are medicines. Who pays for those adds? All those who buy medicines...
Companies should definitely make profit, but their default modus operandi is "milk the cow as long as possible", which would directly result in many deaths... not much sympathy from the crowd there. Let's not forget simple math here - company is/was charging for medicine that doesn't cost more than few tens of bucks to produce... 69,000? Sorry, ridiculous all the way through. Don't care about research bla-bla
Just turn on that weird device that used to be called TV. During winter, 1/3 of the adds are medicines. Who pays for those adds? All those who buy medicines...
> Don't care about research bla-bla
Of course you wouldn't, since that's what costs billions to discover the medication that eventually costs "tens of bucks" to produce, which completely undermines your argument.
Of course you wouldn't, since that's what costs billions to discover the medication that eventually costs "tens of bucks" to produce, which completely undermines your argument.
One reason we pay so much more is that one lawsuit can cost a company billions. In a place like China, good luck suing anyone and actually winning.
Elimination of punitive damages or more importantly making punitive damages excluded from lawyer commissions would be a step in the right direction. Additionally, punitive damages ought not go to the complainant, but to the taxpayer and thus funneled into grants, etc for basic science research to potentially lower the costs of future development. The only person that benefits from a punitive award is the lawyer and the 'victim.' Lawsuits should not be a lottery ticket.
Elimination of punitive damages or more importantly making punitive damages excluded from lawyer commissions would be a step in the right direction. Additionally, punitive damages ought not go to the complainant, but to the taxpayer and thus funneled into grants, etc for basic science research to potentially lower the costs of future development. The only person that benefits from a punitive award is the lawyer and the 'victim.' Lawsuits should not be a lottery ticket.
Isn't that because the US disallows importing drugs? It's supposedly for safety but of course it's just protectionism as I, at least, have heard of no other country doing the same.
This would be easy to study, figure out, and possibly come to conclusive results over: examine the budgets and expenses of pharmaceutical R&D departments.
A single FDA clinical trial can cost up to 100 million. Total spend to get a new drug to market can be as much as 1 billion dollars. Most drugs don't make it. So the successes have to pay for themselves and all the losses. And the potential upside to having a success must be worth the significant financial risk required to get there.
You don't understand gravity of situation. India has third highest population of AIDS patients. Around 2.1 million people are infected[1]. That is twice the population of Cyprus. Around 170k children and adults lost their lives in 2009 [2]. India has 32.7 % of its population below poverty line [3]. That's an income below $1.25 per day. If they can't pay for the drugs doesn't make them less deserving.
And as far as drug developments go, due to GPU computing and molecular dynamics and monte carlo simulation methods, the cost of developing drugs has gone significantly down [4][5]. For starters they take a molecular structure, add or replace a functional group, and run the simulation with a particular protein structure. Drug development costs are not that high now, compared to twenty years ago. Most of the money goes in marketing.
If Government of India thinks more about it's 2.1 million than bunch of corporate companies trying to siphon money from wherever they can, then YES, they are in the right direction.
1. http://www.bmj.com/content/340/bmj.c621 2. http://www.indexmundi.com/g/g.aspx?c=in&v=37 3. http://povertydata.worldbank.org/poverty/country/IND 4. http://www.ncbi.nlm.nih.gov/pubmed/16758486 5. http://www.biomedcentral.com/1741-7007/9/71
And as far as drug developments go, due to GPU computing and molecular dynamics and monte carlo simulation methods, the cost of developing drugs has gone significantly down [4][5]. For starters they take a molecular structure, add or replace a functional group, and run the simulation with a particular protein structure. Drug development costs are not that high now, compared to twenty years ago. Most of the money goes in marketing.
If Government of India thinks more about it's 2.1 million than bunch of corporate companies trying to siphon money from wherever they can, then YES, they are in the right direction.
1. http://www.bmj.com/content/340/bmj.c621 2. http://www.indexmundi.com/g/g.aspx?c=in&v=37 3. http://povertydata.worldbank.org/poverty/country/IND 4. http://www.ncbi.nlm.nih.gov/pubmed/16758486 5. http://www.biomedcentral.com/1741-7007/9/71
> And as far as drug developments go, due to GPU computing and molecular dynamics and monte carlo simulation methods, the cost of developing drugs has gone significantly down [4][5].
I don't see where they show that the cost of clinical trials etc. for getting drugs through the FDA is affected. From what I can tell, those are the largest costs involved. Especially considering that most of the drugs discovered, even using those advanced methods, fail in the trial phase after hundreds of millions invested.
> If Government of India thinks more about it's 2.1 million than bunch of corporate companies trying to siphon money from wherever they can, then YES, they are in the right direction.
"Siphon money" or "capture the rewards of the value they provide"? Undermining global incentives to invest billions in research that could save hundreds of millions around the world does not seem like the "right direction". Not the first time the Indian government has done something selfish but shortsighted. (Pokhran comes to mind.)
I don't see where they show that the cost of clinical trials etc. for getting drugs through the FDA is affected. From what I can tell, those are the largest costs involved. Especially considering that most of the drugs discovered, even using those advanced methods, fail in the trial phase after hundreds of millions invested.
> If Government of India thinks more about it's 2.1 million than bunch of corporate companies trying to siphon money from wherever they can, then YES, they are in the right direction.
"Siphon money" or "capture the rewards of the value they provide"? Undermining global incentives to invest billions in research that could save hundreds of millions around the world does not seem like the "right direction". Not the first time the Indian government has done something selfish but shortsighted. (Pokhran comes to mind.)
> I don't see where they show that the cost of clinical trials etc. for getting drugs through the FDA is affected. From what I can tell, those are the largest costs involved. Especially considering that most of the drugs discovered, even using those advanced methods, fail in the trial phase after hundreds of millions invested.
Agreed, but I compared the costs of developing drugs 20 years ago. They had to synthesize and experiment with each and every drug. Not that's not the case. And most of the drugs which being developed now, use the principals I explained above. If clinical tests are proven successful then they file patents, but it's not an "innovative" process as per say. India has been working to get rid of such patent trolls for some time now.
> "Siphon money" or "capture the rewards of the value they provide"? Undermining global incentives to invest billions in research that could save hundreds of millions around the world does not seem like the "right direction". Not the first time the Indian government has done something selfish but shortsighted. (Pokhran comes to mind.)
Agreed, these kinds of researches has to be done, but not at cost of people's lives, I have explained statistics of people affected by AIDS above. It is a grave social injustice. These research and development processes are flawed in the sense that they cannot provide affordable alternatives to existing methods. These companies must adapt to affordable and agile development processes or someone else will replace them, remember "Mars Orbiter Mission" by ISRO.
And speaking of Pokhran, it was not a short sighted decision. India has Pakistan, an irresponsible nuclear capable neighbor, with whom India has been in state of war since 1947. Effects of Pokhran economic sanctions were not severe, because foreign trade of India constituted to 4% of it's GDP, while USA participation was only 10%. After Pokhran, under then PM Atal Bihari Vajpayee, India achieved record breaking 6-7 % growth rate in GDP. A few problems could be pointed out, but it was not a short sighted decision at all.
I am not being a socialist, but I must add that such innovation and development should be done for the people, not American people, not British people, but keeping people of the world in mind. Please don't monopolize products which can save a lot of peoples lives.
Agreed, but I compared the costs of developing drugs 20 years ago. They had to synthesize and experiment with each and every drug. Not that's not the case. And most of the drugs which being developed now, use the principals I explained above. If clinical tests are proven successful then they file patents, but it's not an "innovative" process as per say. India has been working to get rid of such patent trolls for some time now.
> "Siphon money" or "capture the rewards of the value they provide"? Undermining global incentives to invest billions in research that could save hundreds of millions around the world does not seem like the "right direction". Not the first time the Indian government has done something selfish but shortsighted. (Pokhran comes to mind.)
Agreed, these kinds of researches has to be done, but not at cost of people's lives, I have explained statistics of people affected by AIDS above. It is a grave social injustice. These research and development processes are flawed in the sense that they cannot provide affordable alternatives to existing methods. These companies must adapt to affordable and agile development processes or someone else will replace them, remember "Mars Orbiter Mission" by ISRO.
And speaking of Pokhran, it was not a short sighted decision. India has Pakistan, an irresponsible nuclear capable neighbor, with whom India has been in state of war since 1947. Effects of Pokhran economic sanctions were not severe, because foreign trade of India constituted to 4% of it's GDP, while USA participation was only 10%. After Pokhran, under then PM Atal Bihari Vajpayee, India achieved record breaking 6-7 % growth rate in GDP. A few problems could be pointed out, but it was not a short sighted decision at all.
I am not being a socialist, but I must add that such innovation and development should be done for the people, not American people, not British people, but keeping people of the world in mind. Please don't monopolize products which can save a lot of peoples lives.
Getting way off-topic, but...
> And speaking of Pokhran, it was not a short sighted decision.
Pokhran very certainly was a short-sighted decision. It benefited absolutely nobody except the government by buying it some temporary popularity while actively retarding the country's economics for years afterwards.
> India has Pakistan, an irresponsible nuclear capable neighbor, with whom India has been in state of war since 1947.
Pointing to Pakistan is not an excuse: the whole world knew India had nuclear weapons capability. It had nothing to gain by proving the world what it already knew. Consider Israel: it's geopolitical situation is even worse, being a tiny country surrounded on all sides by many, much larger nations that would see it destroyed. Israel also is known to have nuclear weapons capability. Did they have to go perform a demonstration so the world?
And despite Pokhran, Pakistan has not wavered. Pokhran did nothing to slow Pakistan's regular shelling across the borders. Pokhran did not prevent 26/11. Pokhran did not reduce the number of subsequent terrorist attacks and infiltration attempts. It has done nothing at all to improve the Pakistan situation, and very likely made it worse.
> Effects of Pokhran economic sanctions were not severe, because foreign trade of India constituted to 4% of it's GDP, while USA participation was only 10%. After Pokhran, under then PM Atal Bihari Vajpayee, India achieved record breaking 6-7 % growth rate in GDP.
I don't think anyone knows the true extent of the economic effects, but they are much worse than you suspect. It was not just the US that imposed sanctions. Many countries and companies imposed official and unofficial sanctions that directly impacted business relations and international collaborations. It was not only foreign trade. Companies that were going to set up local manufacturing plants and partner with Indian companies pulled out. That was a direct loss to the local economy. I personally know of business deals with private companies in Germany and Japan that abruptly fell through because of this. Nobody has measured the real impact. The 6 - 7% GDP growth may well have been much higher, but we will never know.
Funny you should mention ISRO because they were also directly impacted: https://news.ycombinator.com/item?id=6552947 It's a credit to ISRO that they delivered despite the governments actions. ISRO could have dedicated resources towards newer and more interesting projects rather than re-inventing technology that became unavailable purely due to political posturing. The opportunity cost is unmeasurable.
The only thing Pokhran bought was national pride that was short-lived and had ultimately no practical value, economic or otherwise. I have seen nothing positive come out of it, only a large amount of negative impact. I cannot see how it was anything but a terrible decision.
> And speaking of Pokhran, it was not a short sighted decision.
Pokhran very certainly was a short-sighted decision. It benefited absolutely nobody except the government by buying it some temporary popularity while actively retarding the country's economics for years afterwards.
> India has Pakistan, an irresponsible nuclear capable neighbor, with whom India has been in state of war since 1947.
Pointing to Pakistan is not an excuse: the whole world knew India had nuclear weapons capability. It had nothing to gain by proving the world what it already knew. Consider Israel: it's geopolitical situation is even worse, being a tiny country surrounded on all sides by many, much larger nations that would see it destroyed. Israel also is known to have nuclear weapons capability. Did they have to go perform a demonstration so the world?
And despite Pokhran, Pakistan has not wavered. Pokhran did nothing to slow Pakistan's regular shelling across the borders. Pokhran did not prevent 26/11. Pokhran did not reduce the number of subsequent terrorist attacks and infiltration attempts. It has done nothing at all to improve the Pakistan situation, and very likely made it worse.
> Effects of Pokhran economic sanctions were not severe, because foreign trade of India constituted to 4% of it's GDP, while USA participation was only 10%. After Pokhran, under then PM Atal Bihari Vajpayee, India achieved record breaking 6-7 % growth rate in GDP.
I don't think anyone knows the true extent of the economic effects, but they are much worse than you suspect. It was not just the US that imposed sanctions. Many countries and companies imposed official and unofficial sanctions that directly impacted business relations and international collaborations. It was not only foreign trade. Companies that were going to set up local manufacturing plants and partner with Indian companies pulled out. That was a direct loss to the local economy. I personally know of business deals with private companies in Germany and Japan that abruptly fell through because of this. Nobody has measured the real impact. The 6 - 7% GDP growth may well have been much higher, but we will never know.
Funny you should mention ISRO because they were also directly impacted: https://news.ycombinator.com/item?id=6552947 It's a credit to ISRO that they delivered despite the governments actions. ISRO could have dedicated resources towards newer and more interesting projects rather than re-inventing technology that became unavailable purely due to political posturing. The opportunity cost is unmeasurable.
The only thing Pokhran bought was national pride that was short-lived and had ultimately no practical value, economic or otherwise. I have seen nothing positive come out of it, only a large amount of negative impact. I cannot see how it was anything but a terrible decision.
Drug development costs are not that high now, compared to twenty years ago. Most of the money goes in marketing.
That is entirely false.
1. Why would you include marketing in the cost of developing a drug? They don't market it until it's launched.
2. The cost of drug development is not lower than it was 20 years ago, even by a long shot. FDA approval requirements have gotten more and more complex each year. 20 years ago you could run a trial on a few thousands patients and call it a day. Now the FDA would require a 10,000 person trial over two years for approval. That costs money.
That is entirely false.
1. Why would you include marketing in the cost of developing a drug? They don't market it until it's launched.
2. The cost of drug development is not lower than it was 20 years ago, even by a long shot. FDA approval requirements have gotten more and more complex each year. 20 years ago you could run a trial on a few thousands patients and call it a day. Now the FDA would require a 10,000 person trial over two years for approval. That costs money.
There is a difference between:
1. Getting justified fruits for people's labor (researchers). Say- getting a great ROI like 1000% or huge ROI of 100000%
2. Getting greedy and trying to multiply the the ROI at the cost of human lives.
I have seen pretty stupid patents (that are logically obvious or near common sense) granted to American companies in tech sector (and have been astonished since I helped create some of those). I believe pharma is no different.
1. Getting justified fruits for people's labor (researchers). Say- getting a great ROI like 1000% or huge ROI of 100000%
2. Getting greedy and trying to multiply the the ROI at the cost of human lives.
I have seen pretty stupid patents (that are logically obvious or near common sense) granted to American companies in tech sector (and have been astonished since I helped create some of those). I believe pharma is no different.
This is a textbook example of why some economic activities cannot be based on a profit motive.
There should be an international drug research agency, to which every country should contribute, and that agency should be responsible for exploring cures for diseases, by funding academics, labs, etc.
There should be an international drug research agency, to which every country should contribute, and that agency should be responsible for exploring cures for diseases, by funding academics, labs, etc.
There are national labs. Canadian one sold Ebola vaccine license for $200K to some no name US lab, that same lab turned around and resold it to Merck for $50mil. Merck bought it only because it is standing to make few billion off of it.
Here's an argument in the Jacobin that argues for nationalizing pharmaceuticals:
https://www.jacobinmag.com/2013/06/socialize-big-pharma/
I am also disappointed, but not because I have presupposed the answer. I am genuinely curious as to whether Gilead will say "All right, drugs were fun but we're gonna do mobile gaming now," or whether they are making enough revenue from other markets and perhaps other drugs that they'll continue to discover and develop drugs like Sovaldi. I don't think the answer is obvious to someone (like me) who hasn't been paying close attention to the profitability of drug development, so I would have appreciated
In particular, while I can see grassroots protestors not thinking about the long term, I vaguely assume that Médecins Sans Frontières knows what they're doing, and wouldn't have been backing this strongly if they didn't think it was also a long-term good strategy. But I definitely would have appreciated more discussion of that point, since I don't put much stock in my own vague assumptions.
In particular, while I can see grassroots protestors not thinking about the long term, I vaguely assume that Médecins Sans Frontières knows what they're doing, and wouldn't have been backing this strongly if they didn't think it was also a long-term good strategy. But I definitely would have appreciated more discussion of that point, since I don't put much stock in my own vague assumptions.
Not like your average Indian who makes $6 a day can afford the patented medicines that costs $10 a tablet anyways.
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What I don't understand is how this would ease the export of this now-generic drug to other countries.
Surely each of them has a patent office, doesn't it?
Surely each of them has a patent office, doesn't it?
1. they'd already licensed it, so the patent holders are already compromising 2.patents are really not that long..5yrs? 20 yrs? nothing like life+99 or whatever it is for copyright.. 3.because patents are relatively short lived the pharma firms have to turn up "hits" which have to pay for all the other misses.. i'm guessing they would really rather market+brand their existing products than invent new ones if the protection they get from patents start to get eroded..not sure thats a good thing..
A definite case of seen and unseen consequences.
Developing a biopharmaceutical product requires the following:
1. A professional who discovers the possibility of a new chemical entity, requires infrastructure: comprised of medical grade equipment (centrifuges, beakers, pipets, filters, microscopes, testing equipment, etc.), experts capable of understanding applications of drug, and many iterations of tests. There will be about 5,000 to 10,000 opportunities for these to address something like Hepatitis C.
2. The NCE is developed for dosage and scheduling. Again more testing.
3. The drug needs to be optimized for manufacturing: infrastructure requires additional experts and assessments
4. Preclinical testing is completed. Only 250 products out of that initial 5,000-10,000 NCE group make it here.
5. Only now is a submission made to the FDA.
6. Go through the process of FDA approval starting with human trials. Only around 10 of these from the 250 will be instigated.
7. FDA human trials, a three to four step process that only 21.5% entering the process will make it through.
8. Production of drug.
9. Sale of drug for seven years to recoup costs
10. Post-Surveillance of drug
11. In people with an asymetric heart ventricle that exhibits heart murmurs but only on Wednesdays, the approved drug causes uncontrollable urination. The drug company has to deal with trial lawyers who develop a lawsuit in the general area of $300 million. And this lawsuit can be brought against the company throughout the lifecycle of the drug and in some cases, the original patent holder can be held liable for the generically produced NCE's.
12. Drug finally goes to generic and the generic manufacturers in Brazil and India sell it for pennies, wiping out all profit margins for your product.
13. A third world nation tries and successfully invalidates a patent that you hold, wiping millions off of the revenue forecasts, thus eliminating the monies needed to test up and coming NCE's. Then someone on a forum
The amazing part in all of this is that a drug gets made at all. The argument that it costs pennies to make, apply the same logic to a cars production. The modern car costs about $1,000 to manufacture, this includes materials and labor costs, the other monies include research, development, marketing, and all the other accouterments that make it possible; why are people not screaming for the costs to be lower, because they understand that there are costs and regulatory capture involved.
[1] http://www.forbes.com/sites/matthewherper/2013/08/11/the-cos... [2] http://en.wikipedia.org/wiki/Drug_development
Developing a biopharmaceutical product requires the following:
1. A professional who discovers the possibility of a new chemical entity, requires infrastructure: comprised of medical grade equipment (centrifuges, beakers, pipets, filters, microscopes, testing equipment, etc.), experts capable of understanding applications of drug, and many iterations of tests. There will be about 5,000 to 10,000 opportunities for these to address something like Hepatitis C.
2. The NCE is developed for dosage and scheduling. Again more testing.
3. The drug needs to be optimized for manufacturing: infrastructure requires additional experts and assessments
4. Preclinical testing is completed. Only 250 products out of that initial 5,000-10,000 NCE group make it here.
5. Only now is a submission made to the FDA.
6. Go through the process of FDA approval starting with human trials. Only around 10 of these from the 250 will be instigated.
7. FDA human trials, a three to four step process that only 21.5% entering the process will make it through.
8. Production of drug.
9. Sale of drug for seven years to recoup costs
10. Post-Surveillance of drug
11. In people with an asymetric heart ventricle that exhibits heart murmurs but only on Wednesdays, the approved drug causes uncontrollable urination. The drug company has to deal with trial lawyers who develop a lawsuit in the general area of $300 million. And this lawsuit can be brought against the company throughout the lifecycle of the drug and in some cases, the original patent holder can be held liable for the generically produced NCE's.
12. Drug finally goes to generic and the generic manufacturers in Brazil and India sell it for pennies, wiping out all profit margins for your product.
13. A third world nation tries and successfully invalidates a patent that you hold, wiping millions off of the revenue forecasts, thus eliminating the monies needed to test up and coming NCE's. Then someone on a forum
The amazing part in all of this is that a drug gets made at all. The argument that it costs pennies to make, apply the same logic to a cars production. The modern car costs about $1,000 to manufacture, this includes materials and labor costs, the other monies include research, development, marketing, and all the other accouterments that make it possible; why are people not screaming for the costs to be lower, because they understand that there are costs and regulatory capture involved.
[1] http://www.forbes.com/sites/matthewherper/2013/08/11/the-cos... [2] http://en.wikipedia.org/wiki/Drug_development
Can you cite a source for the $1000 to manufacture a car?
Unfortunately, this is anecdotal information as my professor, he had worked at Ford, in our finance engineering class made a lecture that raw materials and labor for a vehicle would be $1,000. The additional costs are from tooling, r&d, and other items that ensure a profit margin for the company.
I have very unreliable page here: http://www.answers.com/Q/How_much_does_it_cost_to_manufactur...
I tried to find additional information to back up this claim through the web, sadly, sources will either be: 1. Sales representatives within car sales pointing to an invoice sheet from the manufacturer showing a percent difference or dollar difference, but this would include the tooling, r&d, and operation costs. http://www.reddit.com/r/cars/comments/2bvxn5/how_much_does_i...) 2. Manufacturers who make statements about profitability. http://singletrackworld.com/forum/topic/how-much-does-a-new-... 3.
You can find further information about how the $40,000 Volt obfuscates its costs: http://www.treehugger.com/cars/how-much-does-chevy-volt-cost...
I tried to find additional information to back up this claim through the web, sadly, sources will either be: 1. Sales representatives within car sales pointing to an invoice sheet from the manufacturer showing a percent difference or dollar difference, but this would include the tooling, r&d, and operation costs. http://www.reddit.com/r/cars/comments/2bvxn5/how_much_does_i...) 2. Manufacturers who make statements about profitability. http://singletrackworld.com/forum/topic/how-much-does-a-new-... 3.
You can find further information about how the $40,000 Volt obfuscates its costs: http://www.treehugger.com/cars/how-much-does-chevy-volt-cost...
Thanks!
And the US continues to subsidize health care across the world. You're welcome world, you're welcome.
Ok, so that's unnecessarily strong sarcasm, but it has more than a few ounces of truth to it. Even Canada has significantly cheaper drugs because US citizens get the privilege of paying more.
Ok, so that's unnecessarily strong sarcasm, but it has more than a few ounces of truth to it. Even Canada has significantly cheaper drugs because US citizens get the privilege of paying more.
Thats so great, But remember the all old technologies/ Maths/Science/Writing system/ Languages are not developed in US, US is using rest of world patents with paying anything, May this how they should pay back.
It relies on section 3(d) of the The Patents Act, 1970 (as amended up to Patents (Amendment) Act, 2005) [1]:
> What are not inventions. —The following are not inventions within the meaning of this Act,— (d) the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.
Explanation. — For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy;
This is the same section that was opposed to Novartis in 2013 [2]
1: http://www.wipo.int/wipolex/en/text.jsp?file_id=295102
2: http://articles.economictimes.indiatimes.com/2013-04-01/news...