Key Hepatitis C Patent Rejected In India, Clearing Way For Generic Treatment Costing A Thousand Times Less Than US Price
from the rather-exorbitant dept
As Techdirt explained back in 2009, India has a long and complicated relationship with patents, but more recently, it has established itself as the leading "pharmacy of the developing world," thanks to its generic drug manufacturers which are able to supply key medicines at affordable prices. A recent patent decision, reported here by Intellectual Property Watch, continues that tradition:Today's rejection by the Patent Office Controller of India of a patent application by Gilead company for a key drug against hepatitis C is being hailed by advocates as a path to dramatically lower costs of treatment for the disease. Hepatitis C has made news for the emergence of exorbitantly priced medicines over the past year.A press release on the news from Médecins Sans Frontières explains just how exorbitant:
The oral drug, which first received regulatory approval in the US in November 2013, and has been priced by Gilead at US$84,000 for a treatment course, or $1,000 per pill in the US, has caused a worldwide debate on the pricing of patented medicines. A study from Liverpool University showed that sofosbuvir could be produced for as little as $101 for a three-month treatment course.That gives an idea of the kind of profit margin involved -- rather excessive even allowing for generous research and development costs. But as well as being good news for those who will soon be able to afford this drug, the judgment is also significant for its underlying reasoning, as Intellectual Property Watch notes:
A look at the decision shows that a provision in India's law continues to stop patent applications if they fail to show sufficient novelty and inventive step -- and are subject to opposition.That's important because it confirms that India is still taking a very strict approach to granting pharma patents, which must meet stringent conditions of novelty and inventiveness. Millions of people in the developing world who stand to benefit from India's low-cost generics will be grateful, while some in the West may be less happy.
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Filed Under: competition, generic drugs, health, hepatitis, hepatitis c, india, patents
Companies: gilead
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Of course, if they're foolish enough to sign on with any of the recent 'trade' agreements, this 'lives over profits' stance will likely become all but impossible, so that's even more reason for countries to be extremely careful with what they sign to.
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Patents on drugs are an abomination. Get them off!
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So, once again, it's not so much about people getting paid for the research they did or the product they produced, it's about a 3rd party making as much money as possible no matter who suffers in the process.
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OK, so they actually paid less for this drug, and paid a huge amount for the additional staff and facilities that can be used to develop future drugs? I fail to see how that invalidates my point.
"They should be able to recoup their money"
Nobody's saying they shouldn't. They just shouldn't be entitled to a profit margin that excludes people from accessing a cure for their disease. They can still make back that money.
"this is a virtually symptom free cure, not just a management product."
...and why does that mean that they should be guaranteed a hugely inflated profit margin at the cost of actual human beings?
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Besides, it invalidates the argument that patents on drugs stimulate innovation. No, they stimulate profiteering.
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There is making a profit, and then there is the level of obscene we consistently see. Even after they extract several times even the most wild cost estimates, they seek even more. Then there are the games where they pay others to stay out of the market, or make a tiny change to renew the IP control... meanwhile people suffer and die.
India has the political will to actually put the needs of the many over the needs of a massive corporation to make sure the CEO gets a bigger bonus paid for in human suffering and death. Now they will pass more laws trying to make sure someone who needs the drug can not possibly import it from abroad, keeping health costs inflated & causing even more misery.
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Abolish Patents
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Capitalism says that everyone should be given freedom to create and compete with each other. Patents say that no one is allowed to create or compete with the patent holder.
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I'm not against capitalism per se, I just think we need to take our rose-tinted glasses off and be more willing to question its role in our society. Well-regulated capitalism benefits us all. Left to itself, chaos ensues as wages and safety standards plummet.
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That's what's great about free trade and globalization. If something is cheaper in another part of the world. Consumers can simply order from that part of the world where it's cheaper.
Isn't that what free trade is all about?
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They find it absolutely great when they can outsource the manufacturing to the lowest bidder, but when people try and do the same when it comes to purchasing... well, clearly that's a heinous act that just must be stopped.
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That doesn't sound like free trade. That sounds like protectionist policies. If these are the kinds of policies being negotiated for TPP and TAFTA. Using the term 'free trade' to describe these protectionist policies is extremely misleading and inaccurate.
What good are free trade agreements if they don't benefit the sick and dying?
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Not so.
https://en.wikipedia.org/wiki/Exhaustion_doctrine
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Re: information
kind regaerds
eddie.
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There are very few, if any, as twisted and evil as those that run pharmaceutical companies. Why should they care if they price their drugs out of reach of a large number of people, people who may very well die as a result, as far as they are concerned if you can't afford the price then you can just go ahead and die for all they care.
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Instead drug companies tend to jack up the price on new medications, relying on high price to even out lower volume, and negotiating a lower "real" cost with insurance companies to get people to actually pay their outrageous prices. $1000 dollars a pill can become $500 a pill once they finish negotiating with an insurance company to get them to cover it, only $200 of which is directly paid for by the patient. Insurance companies for their part then tend to make patients and their doctors jump through a bunch of hoops, including trying other medications, before they'll agree to pay their $300 share instead of sticking patients with the full $500 or $1000.
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That only really holds true when the product you are selling is optional or there are multiple producers of that product. With things like Hep C drugs under patent, neither of those things are true. In pure profit terms, the right thing to do for those products is to jack the price up to an absurdly high level and ignore the people who die because they can't afford it.
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This year, their patent expires - guess what, my life-saving medication probably won't be available in a generic as Novartis will pull a Dupont on us. They'll patent a "new" version with an extra sulfur atom in it, and claim that the "old" version kills people and get it banned, while reaping massive profits off the "new" safer version (which isn't any safer at all, they'll just cook the test books).
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If they care...
...about never-ending profits - they would develop treatments.
Which is it that they do again?
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Re: If they care...
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Greed will get its just deserts!
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Re: Greed will get its just deserts!
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India
India at least encourages oversight by people like the FDA HPB etc to keep the locals honest.
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Re: India
http://www.askdrmaxwell.com/2014/01/generic-drug-dangers-ranbaxy-recall-safety/
No, there's not enough oversite in India for this.
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"pharmacy of the developing world"?
Maybe headed for pharmacy for the WHOLE world. I "know a guy" who's getting 6 months supply of a medication for 90% less that here in the U.S. It's cheaper than my insurance deductible & I don't have to bother with getting it filled every month.
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Re: "pharmacy of the developing world"?
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A well costs $1600 and gives clean water to an entire village for 20-25 years. And yet, even basic clean water has not been supplied to most of the Indian people.
Believe me, this is about Indian pharmaceutical companies, NOT the Indian people, who still have active leper colonies.
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Sounds an awful lot like the water shutoffs happening to poor people in Detroit Michigan. Apparently India isn't the only country who refuses to provide clean drinking water to it's people.
http://www.theguardian.com/environment/true-north/2014/jun/25/detroits-water-war-a-tap-shut-o ff-that-could-impact-300000-people
http://www.cbsnews.com/news/detroit-water-shut-offs-brings-u-n-scr utiny/
If the US cared about their people, they would have drilled wells in their villages by now instead of waiting for United Nation groups to come in and do it for them.
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The closest either article gets to explaining the reasoning behind the rejection, is some vague suggestions that the patent application may be running afoul of an article intended to prevent minor reformulations of old medications from being patented as "new" medications, and prevent new medications from being patented unless they have "significantly different" therapeutic efficacy. However neither article really gives any information to indicate which, if either of those is actually the case, or if India's just giving the company the middle finger because they object to the company's supposed profit margins. Margins claimed by a group that has pretty much every reason to want the cost of the medicine lower.
It makes the articles rather unconvincing if you aren't the type to automatically sing praises anytime a patent or copyright gets rejected for any reason. Yes this is a good thing from the standpoint of lowering medications costs, but it's unclear if this is a good thing from the standpoint of good application of patent laws.
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Armed robber, or Big Pharma? What's the difference?
If I wave a bag of life-saving medicines under someone's nose and say "your money or your life", I can get their entire savings account with no risk of prison.
Even if I rob banks instead of individuals, the return is higher and the risk is lower being a pharmaceutical company.
This is why you only see dumb criminals getting arrested for armed robbery. The smart ones have gone into the pharmaceutical business.
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At the time, Gilead made a massive investment on an unapproved treatment, and they struck oil (so to speak). This product is not a fancy new blender - this will save hundreds of thousands of lives, and in a relative sense will cost the system far less. In my opinion, they deserve the reward for taking on the risk.
Feel free to disagree with me, but if you don't have a basic understanding of how the industry works please read about it first. Things are not always what they seem.
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Many of us understand how the industry works just fine. We just find it despicable.
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Companies would then compete on quality and service as well as on price, and the competition would keep prices down. End of problem.
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Actually, we discussed this very issue just a few weeks ago. And I still disagree with you. You have your economics wrong.
https://www.techdirt.com/articles/20141225/06374929525/nasty-patent-games-drug-companies-play- to-stop-you-getting-cheaper-drugs.shtml
At the time, Gilead made a massive investment on an unapproved treatment, and they struck oil (so to speak). This product is not a fancy new blender - this will save hundreds of thousands of lives, and in a relative sense will cost the system far less. In my opinion, they deserve the reward for taking on the risk.
"The reward"? A reward maybe, but *not* an excessive reward that will kill others when they could be saved for very little.
Feel free to disagree with me, but if you don't have a basic understanding of how the industry works please read about it first. Things are not always what they seem.
We do understand. We find it despicable.
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My economics, in this specific case, were guided by the Institute for Clinical and Economic Review. If you're not aware, these are independent academics who do the pharmacoeconomic reviews for public/private payers to determine whether or not a drug is worth paying for. You're welcome to read the report at the link below, but I'll summarize with a quick line: The findings of our model suggest that the increased costs of simeprevir and sofosbuvir are offset by downstream savings from reductions in liver‐related complications and greater numbers of patients achieving SVR.
http://www.ctaf.org/sites/default/files/u119/CTAF_Hep_C_Apr14_final.pdf
Furthermore, I (having studied pharmacoeconomics) can tell you that their estimates of cost savings are not only conservative in the dollars sense, but don't take into account the quality-of-life benefits of the new treatment. The old interferon-based injection treatment is particularly nasty on the body, compared to the new oral medication. So, there's that.
"The reward"? A reward maybe, but *not* an excessive reward that will kill others when they could be saved for very little.
So who decides the reward, then? Admittedly, Gilead does have stellar profit margins to lean on. That said, their stock did take a bit of a dive late last year when they announced they would be dropping the price of a course of sofosbuvir treatment in India to $300. That point of note seems to have been omitted in Moody's article. As far as "killing others when they could be saved", it's worth knowing that the Bill & Melinda Gates Foundation's Access to Medicines Index ranked Gilead is for making medicines accessible to people who need it.
What I'm getting at here, Mike, is that the sensationalist perspective of big pharma companies denying people the right to life is overblown by people (in this case like you) who don't bother to take the time to really dive into the facts. I really like your work, and generally agree with you positions (I'm here, aren't I!), but in this case you're just not well-informed.
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Let's compare this price point to other things you might consider necessary for modern living.
As of 1/26/2015, the average US cost of regular gasoline is $2.044 per gallon. Would you mind paying $1716.96 per gallon from now on?
As of November 2014, the average cost of electricity in the US is 12.46 cents ($0.1246) per kWh. Would you mind paying $104.664 per kWh from now on?
The average price of water in the United States is about $1.50 for 1,000 gallons. Would you mind paying $1.26 per gallon from now on? Oh wait, that's about as much as the current price of bottled water in the US, so maybe that's a bad example, or maybe the bottled water industry is as bad as the pharmaceutical.
Since this is a possible cure we're taking about though, maybe the example should be a one time purchase? OK, the median new house price in the US in December 2014 was $298,100 (the average price is higher). Would you mind paying $250,404,000 for the median new home now?
If not, then please explain how you can justify such price gouging by a pharmaceutical company that didn't even discover this cure, but bought it from someone who did and most likely used a significant amount of federal research grants paid for by the US taxpayer to discover it. Even if they vastly overpaid for the rights to the cure, how is that our problem? We didn't overpay, they did.
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It really puts things into perspective. It especially puts into perspective how horrible all this price gouge of sick and dying people is.
Mike is right. It's absolutely despicable! That's putting it mildly.
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Correct me if I'm wrong but the link you posted says that the results are estimates based on only the initial trial.
If that is true why was the initial trial for
sofosbuvir + R done for 24 weeks (= ~$176,000)
but the initial trial for
sofosbuvir + simeprevir + R was done for 12 weeks (= ~$155,000)
(Assuming the second drug is the same as the first with the addition of simeprevir)
This is on Page 65 if it helps. I'm just a little confused so input would be helpful.
(I know I'm missing some information but I can't quite find it)
Also the summery on 83 is confusing as well ($88,000 to a high exceeding $175,000 drug vs >$300,000 drug). That's not what I really need to think about though, I guess it doesn't matter too much?
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Economics is not just about the demand side, but the supply side.
The problem with pharma pricing is that it artificially restricts the supply, and then whines when people point that out. Price is driven by supply and demand and when you artificially block supply don't be surprised when people call you out on it.
Let me give you a simple example: were I to cut off all of the oxygen to your lungs, you might be willing to pay me a ridiculous sum of money to let you breathe again. And it would be "worth it" to you given the downstream benefits.
But I think both you and I would agree that's ethically unconscionable. Yet that's exactly what you're supporting here.
Think about that.
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And, I'm sure, the day that Gilead begins injecting patients with the Hep C virus so they can extort money for treatment, we'll be able to return to your analogy here and reflect on how relevant it was. Until then, it's not constructive and only serves to illustrate how little you understand about healthcare policy, the pharmaceutical industry, and business financing in general.
Is it opportunistic to charge $84k for a life-saving healthcare therapy? Sure. Is it unethical to do so in Western markets where payers (governments, insurance companies, assistance programs) can afford it? No, it's not. Especially when the cost of the drug is negated by the savings to the system long-term. And especially when they're offering the drug for $300 in emerging markets that can't afford the price!
I'll encourage you to continue your research. You have a lot to learn about the dynamics between the market, pharmaceutical companies, payers, regulators.
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So much wrong...
We live in a country where costly medicines like this are denied to Americans who can't afford insurance, who are stuck in part-time jobs, or who fall between the cracks of eligibility for Medicare or Medicaid and the provisions available to them in the states they live in under the ACA. Savings to the system? Yeah, when these people die off.
We have already learned that dynamics between the market, pharmaceutical companies, payers, and regulators is warped by the existence of patents on drugs and medical equipment, etc. in favor of the pharmaceutical companies that make things and the companies that own patents on drugs, etc. and no amount of patronizing BS from yourself is going to persuade us that this can be a good thing. It is not. It's corrupt and morally unacceptable.
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I can understand pricing restricting demand because fewer people may be willing to part with their money for a product. It is the restricting supply part that could use some elaboration to explain what is meant.
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Two mistakes in your statement here. First, no one said that pricing restricts supply. It's patents that restrict supply.
Second, "supply" and "quantity supplied" are two different things. They are related, but not the same. Quantity supplied is a point on the supply curve. I'm talking about using patents to restrict the supply which artificially inflates the price.
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So much so that they decided to financially speculate by paying $11 billion on buying the company that developed this drug (Pharmasset). That company has therefore already benefited massively, it's just the stock traders who might miss out on recouping their gamble (articles at the time seem to suggest it was considered overpriced).
Strange how you miss this particular fact while you're defending the poor maligned corporation who might have to settle for a lower profit margin while peoples lives are actually saved...
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The company who actually produced the drug gavea cost estiamte of I think abt $110 a pill - RETAIL
THEY HAD DECLARED THAT.
It then got acquired and now each pill is $1000. Explain ur asseconomics in that. No matter what kind of economics you talk abt, this price will make u fall flat on ur face.
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Or are you really arguing that new potential cures for diseases should not be priced much less than current treatments that don't cure the disease over the same duration?
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Because I have Stage 4 Cirrhosis I will have to be on for 180 Days or $180,000
Fuck You Big Pharma & US GOV !
REAL ASSHOLES.........fucking over the Citizens for a buck.
We really need a French Revolution again.I am very fed up and so are millions of other people and who knows maybe even a Billion people.
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your money or your life
Healthcare outcomes and cost
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90 day medical tourism trip to India
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