6 ms·

If big pharma charged ridiculous amounts of money for new drugs, made off-patent drugs dirt cheap, and didn't find new & ridiculous ways to re-patent old drugs,

If big pharma charged ridiculous amounts of money for new drugs, made off-patent drugs dirt cheap, and didn't find new & ridiculous ways to re-patent old drugs, I'd feel better about their business model.

iambateman 7y ago
I imagine you’re correct, but could you source ‘re-patent old drugs’? My understanding was that the drug owner had a 7 year exclusive window before the drug was released to public domain. At which point I would’ve expected the drug to be sold near cost. If it’s possible to re-patent a drug, then obviously that process would break. FWIW, 7 years of high prices in exchange for having the drug forever afterward feels like a theoretically good solution to me. Caveat: I know very little about this. ;)
- waiquoo 7y ago
  Generally it's patents on drug delivery systems, like fast dissolve gelcaps on the name brand vs pressed pills in the generic
- logosmonkey 7y ago
  The biggest thing they do is file multiple patents for different parts of a drug. So they can have a 100 or so patents on a single drug and have the patents staggered over time. (Humira is a good example of this) If that doesn't work they slightly alter stuff like dosage per pill and re-patent that.
  - rayiner 7y ago
    That doesn’t work because the original pill is itself prior art to every patent as of the date it’s released. So you either claim priority to the first batch of patents, or your later patent is defeated by your own prior art. Same thing with changing the dosage. Even if you can show a new discovery that wasn’t obvious from the original patent, that doesn’t prevent anyone from making a pill with the original dosage. The way this works in practice is that there is a stream of patents on incremental improvements. Doctors continue to prescribe the branded, patented drug (because they have no reason not to) even though the original drug was fine. Insulin is like this. If there was a substantial market for the 1923 bovine insulin produced by Eli Lilly, it would be cheap. Instead, insurance is willing to cover the high prices of newer, incrementally better versions. Leaving a relatively small market for a worse, but patent free version.
    - wiggles_md 7y ago
      You could, if you were dealing with a new chemical entity and were so inclined, file a new application with human pharmacokinetics claims, and then elect the PK patent for your FDA-assisted patent term extension. An excellent choice, since the PK claim patent will likely have the most recent priority date.
    - xyzzyz 7y ago
      Indeed, there is market for it, and it is actually very cheap ($25 for a vial in Walmart, which typically lasts around a month). The problem with it is that it’s much more inconvenient and difficult to use correctly. The modern analogues are much superior, so most people prefer to go for those instead, despite much greater price.
- benmaraschino 7y ago
  Exhibit A: Vimovo. One pill, consisting of two drugs that have been around for decades, and are available over the counter at any pharmacy. If bought separately, a month’s supply of these drugs would run you maybe $40, at most. Vimovo, on the other hand, is routinely charged to insurers by pharmacies at prices ranging to over $3,000 for a month’s supply. And somehow insurers are willing to pay for it, to the tune of nearly $500 million a year. More details here from ProPublica: https://www.propublica.org/article/horizon-pharma-vimovo-common-medication-455-million-specialty-pill https://www.propublica.org/article/horizon-pharma-vimovo-com...
  - ChrisLomont 7y ago
    Doesn't the same argument apply to the elements making any drug? Carbon, oxygen, etc.. are all pretty cheap. But there is significant value in mixing things properly and getting that mixture tested and through the FDA. If it's trivial to take these cheap drugs and mix them, then why don't people simply do that?
    - pxeboot 7y ago
      Because people just accept what is prescribed, and neither the customer or doctor is aware of the actual cost?
      - deleted 7y ago
        [deleted]
    - sooheon 7y ago
      Check out the propublica piece. Their analogy is more akin to putting pb&j in one jar. As to why it happens? People are likely to do what their doctors say and what their insurance will cover. Pharma has ways to influence both.
  - refurb 7y ago
    That’s a great example of how stupid insurers are. That drug have had zero sales, but they sneaked in the back when no one was looking.
- foota 7y ago
  I believe the idea is that they make minor changes to it and apply for a new patent. Possibly also covering the original patent?
- tacon 7y ago
  Your understanding would be correct, except when there are billions of revenue on the line. Then "the best minds" of the law profession get to work. For example, you cannot make a generic without (legally) having some sample of the drug going off patent. The drug company simply destroys all the expiring patent version of the drug, patents a minor change, and starts the clock all over again. Many other strategies are detailed in this podcast episode. [0] https://www.econtalk.org/robin-feldman-on-drug-patents-generics-and-drug-wars/ https://www.econtalk.org/robin-feldman-on-drug-patents-gener...
- NCWV 7y ago
  See albuterol inhalers. Its absurd. They changed the propellant for the delivery system and somehow that is novel enough to be awarded a new patent. People will die without these and the drug is 50 years old at this point. https://www.motherjones.com/kevin-drum/2013/10/heres-why-your-asthma-inhaler-costs-so-damn-much/ https://www.motherjones.com/kevin-drum/2013/10/heres-why-you...
entee 7y ago
One small wrinkle: what if there's an old existing compound that seems to work well for an different indication than it was originally approved for? It would be good to run the phase 3 trial (possibly phase 2 as well) but that's gonna cost a ton of money. Maybe the government does it, or maybe we let people extend a patent for a new indication, freeing up government research money for the much trickier problem of understanding fundamental disease mechanisms. There are of course good arguments against, but there's at least some good arguments to allow limited patent extensions.
- mattkrause 7y ago
  Both of your options already happen. Basically anyone can apply to the NIH for a grant to run clinical trials. It's not easy: the funding rate for NIH grants in general is in the teens and you'll need to convince the reviews that a) the trial itself generally makes sense and b) you, specifically, can pull it off, but it can be done. If you find a new use for an existing drug—and run a trial to prove it—the FDA will give you a period of "marketing exclusivity", wherein you will be the only one allowed to market that drug for that condition. It's not quite a patent, but it's meant to be a similar recompense/reward for doing the research.
  - entee 7y ago
    Yes :) I've heard of some of these mechanisms, I think they're a decent balance. All of these issues are fairly complex, it's helpful to have context.
- lojack 7y ago
  Whats preventing doctors from prescribing off label?
  - dekhn 7y ago
    if you're in the US, doctors can do this. https://en.wikipedia.org/wiki/Off-label_use https://en.wikipedia.org/wiki/Off-label_use What's preventing them? Safety, efficacy, and fear of litigation.
refurb 7y ago
big pharma charged ridiculous amounts of money for new drugs, made off-patent drugs dirt cheap That’s what happens now, for the most part. Drugs that were cutting edge 7-10 years ago are now public domain and damn cheap, like 95-97% discount to the brand name. Of course there are exceptions, but it’s generally how it pans out.
- wallace_f 7y ago
  And insulin should be dirt cheap, but is held hostage by Regulatory Capture. I don't like the ideological warfare which takes place while many times the problem is of cronyism, cheating.
  - refurb 7y ago
    The insulin of today is not the same insulin from 10 years ago. The insulin from 30 years ago is available and cheap, but no one wants to use it because the newer insulins make it easier to control your blood sugar.

iambateman 7y ago

I imagine you’re correct, but could you source ‘re-patent old drugs’? My understanding was that the drug owner had a 7 year exclusive window before the drug was released to public domain. At which point I would’ve expected the drug to be sold near cost. If it’s possible to re-patent a drug, then obviously that process would break. FWIW, 7 years of high prices in exchange for having the drug forever afterward feels like a theoretically good solution to me. Caveat: I know very little about this. ;)

waiquoo 7y ago
Generally it's patents on drug delivery systems, like fast dissolve gelcaps on the name brand vs pressed pills in the generic
logosmonkey 7y ago
The biggest thing they do is file multiple patents for different parts of a drug. So they can have a 100 or so patents on a single drug and have the patents staggered over time. (Humira is a good example of this) If that doesn't work they slightly alter stuff like dosage per pill and re-patent that.
- rayiner 7y ago
  That doesn’t work because the original pill is itself prior art to every patent as of the date it’s released. So you either claim priority to the first batch of patents, or your later patent is defeated by your own prior art. Same thing with changing the dosage. Even if you can show a new discovery that wasn’t obvious from the original patent, that doesn’t prevent anyone from making a pill with the original dosage. The way this works in practice is that there is a stream of patents on incremental improvements. Doctors continue to prescribe the branded, patented drug (because they have no reason not to) even though the original drug was fine. Insulin is like this. If there was a substantial market for the 1923 bovine insulin produced by Eli Lilly, it would be cheap. Instead, insurance is willing to cover the high prices of newer, incrementally better versions. Leaving a relatively small market for a worse, but patent free version.
  - wiggles_md 7y ago
    You could, if you were dealing with a new chemical entity and were so inclined, file a new application with human pharmacokinetics claims, and then elect the PK patent for your FDA-assisted patent term extension. An excellent choice, since the PK claim patent will likely have the most recent priority date.
  - xyzzyz 7y ago
    Indeed, there is market for it, and it is actually very cheap ($25 for a vial in Walmart, which typically lasts around a month). The problem with it is that it’s much more inconvenient and difficult to use correctly. The modern analogues are much superior, so most people prefer to go for those instead, despite much greater price.
benmaraschino 7y ago
Exhibit A: Vimovo. One pill, consisting of two drugs that have been around for decades, and are available over the counter at any pharmacy. If bought separately, a month’s supply of these drugs would run you maybe $40, at most. Vimovo, on the other hand, is routinely charged to insurers by pharmacies at prices ranging to over $3,000 for a month’s supply. And somehow insurers are willing to pay for it, to the tune of nearly $500 million a year. More details here from ProPublica: https://www.propublica.org/article/horizon-pharma-vimovo-common-medication-455-million-specialty-pill https://www.propublica.org/article/horizon-pharma-vimovo-com...
- ChrisLomont 7y ago
  Doesn't the same argument apply to the elements making any drug? Carbon, oxygen, etc.. are all pretty cheap. But there is significant value in mixing things properly and getting that mixture tested and through the FDA. If it's trivial to take these cheap drugs and mix them, then why don't people simply do that?
  - pxeboot 7y ago
    Because people just accept what is prescribed, and neither the customer or doctor is aware of the actual cost?
    - deleted 7y ago
      [deleted]
  - sooheon 7y ago
    Check out the propublica piece. Their analogy is more akin to putting pb&j in one jar. As to why it happens? People are likely to do what their doctors say and what their insurance will cover. Pharma has ways to influence both.
- refurb 7y ago
  That’s a great example of how stupid insurers are. That drug have had zero sales, but they sneaked in the back when no one was looking.
foota 7y ago
I believe the idea is that they make minor changes to it and apply for a new patent. Possibly also covering the original patent?
tacon 7y ago
Your understanding would be correct, except when there are billions of revenue on the line. Then "the best minds" of the law profession get to work. For example, you cannot make a generic without (legally) having some sample of the drug going off patent. The drug company simply destroys all the expiring patent version of the drug, patents a minor change, and starts the clock all over again. Many other strategies are detailed in this podcast episode. [0] https://www.econtalk.org/robin-feldman-on-drug-patents-generics-and-drug-wars/ https://www.econtalk.org/robin-feldman-on-drug-patents-gener...
NCWV 7y ago
See albuterol inhalers. Its absurd. They changed the propellant for the delivery system and somehow that is novel enough to be awarded a new patent. People will die without these and the drug is 50 years old at this point. https://www.motherjones.com/kevin-drum/2013/10/heres-why-your-asthma-inhaler-costs-so-damn-much/ https://www.motherjones.com/kevin-drum/2013/10/heres-why-you...

entee 7y ago

One small wrinkle: what if there's an old existing compound that seems to work well for an different indication than it was originally approved for? It would be good to run the phase 3 trial (possibly phase 2 as well) but that's gonna cost a ton of money. Maybe the government does it, or maybe we let people extend a patent for a new indication, freeing up government research money for the much trickier problem of understanding fundamental disease mechanisms. There are of course good arguments against, but there's at least some good arguments to allow limited patent extensions.

mattkrause 7y ago
Both of your options already happen. Basically anyone can apply to the NIH for a grant to run clinical trials. It's not easy: the funding rate for NIH grants in general is in the teens and you'll need to convince the reviews that a) the trial itself generally makes sense and b) you, specifically, can pull it off, but it can be done. If you find a new use for an existing drug—and run a trial to prove it—the FDA will give you a period of "marketing exclusivity", wherein you will be the only one allowed to market that drug for that condition. It's not quite a patent, but it's meant to be a similar recompense/reward for doing the research.
- entee 7y ago
  Yes :) I've heard of some of these mechanisms, I think they're a decent balance. All of these issues are fairly complex, it's helpful to have context.
lojack 7y ago
Whats preventing doctors from prescribing off label?
- dekhn 7y ago
  if you're in the US, doctors can do this. https://en.wikipedia.org/wiki/Off-label_use https://en.wikipedia.org/wiki/Off-label_use What's preventing them? Safety, efficacy, and fear of litigation.

refurb 7y ago

big pharma charged ridiculous amounts of money for new drugs, made off-patent drugs dirt cheap That’s what happens now, for the most part. Drugs that were cutting edge 7-10 years ago are now public domain and damn cheap, like 95-97% discount to the brand name. Of course there are exceptions, but it’s generally how it pans out.

wallace_f 7y ago
And insulin should be dirt cheap, but is held hostage by Regulatory Capture. I don't like the ideological warfare which takes place while many times the problem is of cronyism, cheating.
- refurb 7y ago
  The insulin of today is not the same insulin from 10 years ago. The insulin from 30 years ago is available and cheap, but no one wants to use it because the newer insulins make it easier to control your blood sugar.