7 ms·

The point of the patent system is that we are giving inventors a time-limited monopoly on their invention in exchange for them sharing it with the world. We all

by mabbo 8y ago

The point of the patent system is that we are giving inventors a time-limited monopoly on their invention in exchange for them sharing it with the world. We all benefit because we have access to this new invention and soon can make it ourselves, and the inventor has an incentive to promote and sell as much as they can while they own the monopoly. But it's not working here. The patent holder is effectively saying society isn't allowed to have the invention. They're using a legal means meant to share the knowledge with the world to instead horde it away from the rest of us. When the system doesn't work, the system must be improved. How can we incentivize inventors to not do this?

ams6110 8y ago
If a patent holder is not producing the patented thing, and not licensing it to someone else who is, the patent should expire. Kind of like a trademark that is not defended. Seems that would fix the problem?
- d4l3k 8y ago
  It still wouldn't get the drug to the people who need it. Most of the cost involved is in getting it approved by the authorities for human use. There's nothing stopping people from manufacturing the drug for personal use, other than that it's likely extremely hard to make.
  - ineedasername 8y ago
    In this case it's already been approved for human use. So that's a non issue. But yes, I'm sure that is a hurdle for plenty of other pharmaceutical research
- tptacek 8y ago
  No, not here.
- ekianjo 8y ago
  for drugs you usually patent them about 10 years before you can have them on the market. That would be not very compatible with the current requirements of regulatory bodies.
tptacek 8y ago
If the drug is patented, then by definition the best known mode of implementation has been disclosed. That's what a patent is. The problem with alipogene tiparvovec probably isn't the IPR†. Rather, it's that the treatment is extraordinarily expensive to administer (ironically, because it's something close to a total cure with a long-term impact, the drug seller is required to provide long-term monitoring to patients), has a microscopic market (that's why it's so expensive), and is of questionable effectiveness --- it improves quality-of-life metrics but not necessarily clinical ones like blood fat levels. Many (all?) national health systems in Europe, where it is approved, refuse to pay for it. If the drug had a clear market, even if the current owner no longer wanted to provide it, it could license to some other drug company. But it's likely that no other viable concern wants to shoulder the costs and uncertainty of this particular drug. That's not the fault of the patent system. † In fact, it's possible that the patent here has expired; I'm still trying to confirm that, but it would explain why the treatment had "orphan drug" status in Europe.
- ethbro 8y ago
  > is of questionable effectiveness --- it improves quality-of-life metrics but not necessarily clinical ones like blood fat levels "Although based on a small number of patients and episodes, overall pancreatitis incidence up to 2 years post-alipogene tivarvovec injection decreased by 5-fold" "However, several signs of clinical efficacy independent of plasma TG were noticed up to 2 years after LPL gene transfection and raised the possibility that TG-rich lipoprotein characteristics, particularly the size, lipid content and kinetics of CMs, rather than plasma TG concentration per se, are the best surrogate markers of pancreatitis risk in LPLD." https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4956470/#!po=37.1951 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4956470/#!po=37... From what I read, 2-year follow-ups seem to find continued (post-26 week) activity of the inserted gene. So it's inaccurate to say there were no clinical improvements.
  - tptacek 8y ago
    I worried about the word "clinical" here, which might not be what I meant. It is not, however, inaccurate to say that concerns about efficacy were behind EU health system refusal to pay, and behind the therapy being taken off the market.
ezoe 8y ago
Patent was and is always like that. We have a massive improvement on 3D printer and VR display because... the patent expired. Patent is a system to freeze the invention from society for 20 years. But in this case, patent alone is not on the blame. Still we need to change the patent system something like the patent holder must offer patented product or license the patent for reasonable price or face losing the patent.
rayiner 8y ago
It's bad to analyze this issue through the medium of a long-form article, which wraps the story up in emotional narrative. Here is a better write-up in the MIT Technology review: https://www.technologyreview.com/s/601165/the-worlds-most-expensive-medicine-is-a-bust https://www.technologyreview.com/s/601165/the-worlds-most-ex.... The gist of the problem is this: > The Amsterdam company spent more than $100 million testing the drug and carving a path through Europe’s medical rules and regulations, which weren’t geared to consider a new technology like gene therapy. Initially, for instance, regulators said they expected a clinical trial of 342 patients. Executives wryly noted that there were only 250 people with the disease in all of Europe. > Nor has Glybera convinced the national regulators in Europe who decide what drugs get reimbursed. Last year, French authorities said they would not pay for the drug. Germany judged Glybera’s benefits “non-quantifiable.” It leaves doctors and insurers to make decisions on a case-by-case basis. Here's a drug that cost $100 million to make, and will require even more money to move through clinical trials in the U.S. And the pool of potential patients is a less than 1,000 people, and oh many of then can't pay either because they lack insurance (U.S.) or the cost/benefit panel math doesn't work out (Europe). Viewing this after-the-fact leads one astray, into thinking there is some problem with the system that leaves this potential cure out of the hands of patients. Patents, money, it's all just a proxy for effort in, benefit out. Even if you had the government make this drug, you're talking huge amounts of money per patient, which few governments would pony up. (And rightfully so, because you could save a lot more lives with that amount of tax dollars.) The answer is probably that this drug doesn't make economic sense, and the abandonment of it by the maker is just an indication that it was a misguided effort to begin with.
- skadamou 8y ago
  This is an excellent response and you clearly understand the issue well. I'm curious though, what do you think about the long term effects of continuing to practice gene therapy? Sure, the cost for treating the first few patients will be exorbitant but wouldn't we expect researchers to find ways to bring costs down over time? How will we know if this is even possible if we abandon gene therapy at such an early stage? It might not make market sense to produce these therapies right now but I think there is a strong argument for governments to fund this type of research.
windows_tips 8y ago
>We all benefit because we have access to this new invention and soon can make it ourselves Two decades is not "soon".
teekert 8y ago
... Or punish them when the do do this.
Farradfahren 8y ago
Exponentially increase patent holding costs? First year 1000 $, 2000 year $, 3 year 4000 $, and so forth
jswizzy 8y ago
It's also such an easy fix too. If a company isn't actually using a license or copyright they should loss all claim to it.

by mabbo 8y ago

ams6110 8y ago

If a patent holder is not producing the patented thing, and not licensing it to someone else who is, the patent should expire. Kind of like a trademark that is not defended. Seems that would fix the problem?

d4l3k 8y ago
It still wouldn't get the drug to the people who need it. Most of the cost involved is in getting it approved by the authorities for human use. There's nothing stopping people from manufacturing the drug for personal use, other than that it's likely extremely hard to make.
- ineedasername 8y ago
  In this case it's already been approved for human use. So that's a non issue. But yes, I'm sure that is a hurdle for plenty of other pharmaceutical research
tptacek 8y ago
No, not here.
ekianjo 8y ago
for drugs you usually patent them about 10 years before you can have them on the market. That would be not very compatible with the current requirements of regulatory bodies.

tptacek 8y ago

If the drug is patented, then by definition the best known mode of implementation has been disclosed. That's what a patent is. The problem with alipogene tiparvovec probably isn't the IPR†. Rather, it's that the treatment is extraordinarily expensive to administer (ironically, because it's something close to a total cure with a long-term impact, the drug seller is required to provide long-term monitoring to patients), has a microscopic market (that's why it's so expensive), and is of questionable effectiveness --- it improves quality-of-life metrics but not necessarily clinical ones like blood fat levels. Many (all?) national health systems in Europe, where it is approved, refuse to pay for it. If the drug had a clear market, even if the current owner no longer wanted to provide it, it could license to some other drug company. But it's likely that no other viable concern wants to shoulder the costs and uncertainty of this particular drug. That's not the fault of the patent system. † In fact, it's possible that the patent here has expired; I'm still trying to confirm that, but it would explain why the treatment had "orphan drug" status in Europe.

ethbro 8y ago
> is of questionable effectiveness --- it improves quality-of-life metrics but not necessarily clinical ones like blood fat levels "Although based on a small number of patients and episodes, overall pancreatitis incidence up to 2 years post-alipogene tivarvovec injection decreased by 5-fold" "However, several signs of clinical efficacy independent of plasma TG were noticed up to 2 years after LPL gene transfection and raised the possibility that TG-rich lipoprotein characteristics, particularly the size, lipid content and kinetics of CMs, rather than plasma TG concentration per se, are the best surrogate markers of pancreatitis risk in LPLD." https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4956470/#!po=37.1951 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4956470/#!po=37... From what I read, 2-year follow-ups seem to find continued (post-26 week) activity of the inserted gene. So it's inaccurate to say there were no clinical improvements.
- tptacek 8y ago
  I worried about the word "clinical" here, which might not be what I meant. It is not, however, inaccurate to say that concerns about efficacy were behind EU health system refusal to pay, and behind the therapy being taken off the market.

ezoe 8y ago

Patent was and is always like that. We have a massive improvement on 3D printer and VR display because... the patent expired. Patent is a system to freeze the invention from society for 20 years. But in this case, patent alone is not on the blame. Still we need to change the patent system something like the patent holder must offer patented product or license the patent for reasonable price or face losing the patent.

rayiner 8y ago

It's bad to analyze this issue through the medium of a long-form article, which wraps the story up in emotional narrative. Here is a better write-up in the MIT Technology review: https://www.technologyreview.com/s/601165/the-worlds-most-expensive-medicine-is-a-bust https://www.technologyreview.com/s/601165/the-worlds-most-ex.... The gist of the problem is this: > The Amsterdam company spent more than $100 million testing the drug and carving a path through Europe’s medical rules and regulations, which weren’t geared to consider a new technology like gene therapy. Initially, for instance, regulators said they expected a clinical trial of 342 patients. Executives wryly noted that there were only 250 people with the disease in all of Europe. > Nor has Glybera convinced the national regulators in Europe who decide what drugs get reimbursed. Last year, French authorities said they would not pay for the drug. Germany judged Glybera’s benefits “non-quantifiable.” It leaves doctors and insurers to make decisions on a case-by-case basis. Here's a drug that cost $100 million to make, and will require even more money to move through clinical trials in the U.S. And the pool of potential patients is a less than 1,000 people, and oh many of then can't pay either because they lack insurance (U.S.) or the cost/benefit panel math doesn't work out (Europe). Viewing this after-the-fact leads one astray, into thinking there is some problem with the system that leaves this potential cure out of the hands of patients. Patents, money, it's all just a proxy for effort in, benefit out. Even if you had the government make this drug, you're talking huge amounts of money per patient, which few governments would pony up. (And rightfully so, because you could save a lot more lives with that amount of tax dollars.) The answer is probably that this drug doesn't make economic sense, and the abandonment of it by the maker is just an indication that it was a misguided effort to begin with.

skadamou 8y ago
This is an excellent response and you clearly understand the issue well. I'm curious though, what do you think about the long term effects of continuing to practice gene therapy? Sure, the cost for treating the first few patients will be exorbitant but wouldn't we expect researchers to find ways to bring costs down over time? How will we know if this is even possible if we abandon gene therapy at such an early stage? It might not make market sense to produce these therapies right now but I think there is a strong argument for governments to fund this type of research.

windows_tips 8y ago

>We all benefit because we have access to this new invention and soon can make it ourselves Two decades is not "soon".

teekert 8y ago

... Or punish them when the do do this.

Farradfahren 8y ago

Exponentially increase patent holding costs? First year 1000 $, 2000 year $, 3 year 4000 $, and so forth

jswizzy 8y ago

It's also such an easy fix too. If a company isn't actually using a license or copyright they should loss all claim to it.