Patents Getting In The Way Of Saving Lives; Fabry Disease Sufferers Petition US Gov't To Step In
from the patent-problems dept
Whenever I read stories like this one, it just makes me wonder how people can defend patents in certain situations. Genzyme is a pharma firm that has a patent on a drug, Fabrazyme, which is used to treat Fabry disease, an enzyme deficiency that can create very serious problems in those who have it -- including kidney failure and heart attacks. The problem? Genzyme apparently can't produce the supply needed by patients. Now, in a true free market, when supply was less than demand, a competitor would step up production, but (oh wait!) there can't be any competitor, because the patent means that Genzyme is currently the only one legally allowed to make the drug. Now a group of patients who have been forced to ration their dosage at one-third the usual amounts, leading to serious health problems and at least one death, has petitioned the government for the right to break the patent.They're not trying to completely strip Genzyme of the patent. They're merely asking the government to let others produce the drug, and pay Genzyme a mandated 5% royalty. Now, I know the typical response from patent system supporters: without the patent, perhaps this drug wouldn't even exist. The only problem with that is that it's almost certainly not true. The actual research for Fabrazyme was actually done by the Mount Sinai School of Medicine financed by the National Institute of Health. Yes, you read that right. This drug was discovered with taxpayer money... but they were still able to get a patent and then license it to Genzyme.
Chances are this petition won't be approved. These petitions are never approved. But it does highlight the ridiculousness of the current patent system potentially putting people at risk. It's a travesty that federally funded research has been locked up under a patent and limited to only one producer, leading not only to very high prices for the drug, but also excessively limited supply that is putting people lives in danger, and may have already killed one person.
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Filed Under: fabrazyme, fabry, health care, patents
Companies: genzyme
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Only Genzyme can produce the drug?
Wouldn't it be more accurate to say that because it holds the patent on this drug, only Genzyme can decide if other companies can produce the drug? I mean, patents don't prevent a patent holder from contracting out the manufacture of its patented product. It's just that in this case, Genzyme is choosing not to do this, right?
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Re: Only Genzyme can produce the drug?
You're correct. Fixing the post.
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Re: Re: Only Genzyme can produce the drug?
And is a 5% royalty customary in pharmaceutical patent licensing deals?
Regardless of good intentions, I get very nervous when the government is called on to sieze or otherwise control private rights or property. Should we also put salary caps on the doctors who will then administer the drug to the patients?
HM
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Re: Re: Re: Only Genzyme can produce the drug?
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Re: Re: Re: Only Genzyme can produce the drug?
I believe the answers to your two questions are
1. No
2. No
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Re: Re: Re: Re: Only Genzyme can produce the drug?
Are companies ready to manufacture the drug in sufficient quantities? Unknown but likely, somebody would pick it up.
Gensymze is refusing to license to them? Yes, obviously.
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Sounds like DRM for Humans...
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I have wondered about publicly funded research
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Re: I have wondered about publicly funded research
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Look up the WHO article on global deaths due to the high price and low availability of pescription drugs. The death are in the tens of millions. Whats one more to a drug company.
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Just came up with a solution
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I admit I don't know that much about patent licensing - but isn't it common practice to only give out an exclusive license in return for assurances that the licensee will be able to meet demand? If they're failing to do so, couldn't Mount Sinai withdraw their exclusivity and license out to other companies to make up the shortfall?
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The NYT article also notes that these are particularly rare genetic diseases, with the one involved here having about 1,000 people who have been receiving the drug from the patent holder.
The petition requests the USG to exercise "march in" rights, but one does have to wonder if this would make the slightest difference if the petition was granted. Are 1,000 patients a sufficiently large market for a company to decide in favor of almost immediate market entry?
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Easiest Fix:
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Aren't we Forgetting Something?
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Re: Aren't we Forgetting Something?
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Re: Re: Aren't we Forgetting Something?
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Re: Re: Re: Aren't we Forgetting Something?
Of course, the drug could be very expensive to produce. So even if the license fee were $0.0, other drug companies may still not offer to produce it.
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WTF?
Patents are neither property nor a right. They are a GOVERNMENT GRANTED monopoly. What the government gives, so can it take away.
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more details
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Re: more details
Then no one should have a problem if the govt temporarily suspends the patent being that it won't make a difference anyways.
Heck, if this were true then why doesn't the patent holder temporarily suspend the patent until he can finally produce at full capacity and restore the lost products, under the condition that anyone who produces the drug will later be subject to the patent and either be forbidden to produce it or have to pay royalties.
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Re: Re: more details
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Re: Re: Re: more details
I got that point, but you missed my point, that if the patents are not the problem then there should be no problem temporarily revoking the patents being that it won't make a difference.
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Re: more details
Do you have facts to back this up?
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Re: Re: more details
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Re: Re: Re: more details
Any company wants a monopoly, but that hardly constitutes evidence that a monopoly does anyone but the monopolist any good.
"Did all this add up to a situation where Genzyme decided that if they didn't get exclusivity, they would not make a deal?"
The relevant question is would the drug be produced without patents, whether by Genzyme or otherwise. and, beyond speculation and unsubstantiated guesswork, I see no evidence to suggest that it wouldn't or that patents do anything to promote the progress. For instance, see
http://levine.sscnet.ucla.edu/general/intellectual/against.htm
There is tons of evidence to suggest that people will find other ways to fund it. Patents make it difficult by locking non patent holders out after taking away their incentive for finding ways to find research.
Also, pharma usually refuses independent auditors to audit their costs and independent studies, presented on techdirt before, have shown that the costs are much lower than what pharma claims.
They want a monopoly but they don't want to justify their monopoly. I think such unregulated monopolies are unacceptable. If they want a monopoly that distorts the free market then it aught to be regulated, I want independent auditors to ensure that the patents are justified. But you will refuse because you know the costs are unjustified.
and not to mention that the most risk was taken by tax payers, only later after public research has taken the most of the risk of figuring out that the drug shows promise did the pharma perhaps decide to fund anything.
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Re: Re: Re: Re: more details
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Re: Re: Re: Re: more details
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Re: Re: Re: Re: Re: more details
Irrelevant, I'm not arguing this point that you keep mentioning for no good reason.
"but surely they have the right to decide how they run their own business"
and that's fine, but they don't have a right to a government granted monopoly. The government should only grant these monopolies to the extent that they promote the progress.
"If there were other companies that were interested and were shut out, it was Mt. Sinai's decision, not Genzyme's."
This isn't what I'm arguing. But the government is being petitioned here and, regardless of who owns the patent, the government has the authority to free the market by temporarily revoking the patent.
"but in this particular situation, what were the alternatives and how well would they have worked?"
The government funded most of the more risky R&D, the early R&D, and I see no reason to believe that alternatives would not have worked.
"Again, if there is blame to hand out for not taking advantage of alternatives, it falls on Mt. Sinai, not Genzyme."
It falls on the government, for not fostering a free market that first encourages alternatives before granting a patent after the alternatives fail.
"Deciding ahead of time who the heros and villians are doesn't lead to any progress."
I'm not deciding ahead of time, I'm looking at the evidence and deciding based on the evidence. and I'm not trying to decide who the hero and villains are, I'm trying to discuss the best government policy for encouraging progress.
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Re: Re: Re: more details
I think companies know that if they don't have a patent there is no use in funding R&D because whoever does have a patent will likely sue for infringement.
I think we need a system that first gives people, companies, and organizations the opportunity to conduct and fund R&D, and figure out ways to fund that R&D (be it by donations of those affected by a disease the drug seeks to cure or by the collaborative donations to a specific researching organization of various corporations that wish to sell the drug) without patents. Then, if no one accepts, the govt can allow exclusivity. But I know the outcome, and you know it too, that most promising looking drugs will find funding without patents and so you will disagree with granting such an opportunity because you want your monopoly rents.
Patents should only be granted after the free market, without patents, has spent some time looking for a cure to something and couldn't find it. To grant to whoever asks for it first takes away much of the free market incentive that the rest of the free market has to conduct R&D.
After all, Google invested 1 billion on Youtube without exclusivity to video websites. People find ways to invest into things without exclusivity, they always have, and you know it. Patents aren't needed, even in pharma, and you know this (the evidence shows it and you have absolutely zero evidence to support your position beyond mere speculation) which is why you would never even agree to try to give an opportunity to private researchers to conduct R&D without patents before granting patents if no one takes the offer.
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Re: Re: Re: more details
and I wouldn't be surprised if drug development accelerated without patents, especially given the fact that the evidence agrees with me on this one.
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Re: What The Patent Is On
DrZZ claimed:
And it’s not the part covered by the patent in question. The patent is for the drug, not for the manufacturing process. There seems to be no patent specifically covering the manufacturing process for this drug. Given that, as you point out yourself, the patent doesn’t actually cover the hard work anyway, why be mangy about licensing it?
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Re: Re: What The Patent Is On
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This will bite them hard
We need politicians who don't have "SOLD" on their name tag after they visit big businesses like these. Too much is owned by too few for this to end without innocent people getting hurt.
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the children, THE CHILDREN!
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Genzyme and the federal govt.
Fabrazyme was developed by NIH scientist!
Some of them hold patents, but because they are (were) Federal employees , they receive no money.
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Re: Genzyme and the federal govt.
Apparently 15 USC 3710c has never been brought to your attention.
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Genzyme
The patent system should never allow taxpayer money to help private companies get a patent.
The patent system should mandate licensing, especially in drugs (no monopolies!)
All IP, patents, trademarks, and copyrights, should have "use it or lose it" provisions (trademarks does, though it is not enforced effectively enough).
All IP should be for a "reasonable time", and copyright, as the most extreme case of such abuse, certainly is NOT for a "reasonable time"!
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In response to Gene Cavanaugh
Why has it taken so long to bring this form of Govt. subsidizing private " for profit" companies. A fact that makes it almost completely risk free! for the contracted business. Genzyme profited from a similar drug developed by NIH scientist , paid for with taxpayer monies.
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really?!
it is'n't mixing sugar and water and making a pill... this is a biological that required years of testing and if it was so easy... wouldn't genzyme be able to reproduce it in any other plant they own... and they own may.
bunch of ignorants.. do your research before you talk... genzyme cares about the patients, they care about the person who died... they care about many others as they offer the drugs they make free of charge to many. Unbelievable you are!
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The NIH's analysis of the situation can be found at:
http://freepdfhosting.com/d30ee703c3.pdf
It's analysis of the background associated with this matter addressed each of the reasons why it believed the exercise of "march-in" rights would at this time prove to be a fruitless endeavor.
To understand a situation such as this highlights why it is very important to understand both sides of an issue.
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