6 ms·

> Even though insulin treatment itself can’t be patented, improvements in delivery mechanisms can be. These incremental improvements, no matter how small, can b

by deogeo 7y ago

> Even though insulin treatment itself can’t be patented, improvements in delivery mechanisms can be. These incremental improvements, no matter how small, can be used to extend the 20-year patent on a drug, a process called “patent evergreening.” I'm confused - wouldn't the new patent only cover the improved method, and the patent on the original, un-improved version would still expire?

DarkStar851 7y ago
Yes, the old drug patent will expire, and when this happens the company typically pulls an "oh our old version is now magically unsafe!" to wrestle away competition. Plus developing a product from the old patent still requires extensive FDA approval. Very expensive stuff.
- hjk05 7y ago
  Do you have references for that claim? If a company goes out with a claim their old product is unsafe it’s not like it’s rocket science to test the claim. And if their lying and you could literally corner a billion dollar industry by testing the claim I’d expect every producer of generics to do so. On the other hand if the product is actually unsafe that opens up liability claims from costumers.
  - Scoundreller 7y ago
    I've seen companies create "extended release" formulations of their old formulation 1 year before the patent expires to get everyone to switch over to the patented version before the generic comes out. I've even seen it done when the previous version and the new version were still both once daily (tamsulosin, I'm looking at you!) Yes, some insurers will hesitate to cover the new formulation when it comes out, but not all. Sometimes the insurer will make a deal with the manufacturer so that the manufacturer is only getting paid the generic-equivalent price. But who knows what happens behind closed doors.
    - hjk05 7y ago
      Changing the release profile of a drug from once daily to once weekly isn’t a minor thing, and no one is forcing customers to pick the once weekly over the once daily. Now with respect to the original claim, are you saying that once there was a new version of tamsulosin the company issued a statement claiming the old version was unsafe? Do you have a reference for that?
      - XMPPwocky 7y ago
        Re: "no one is forcing customers to pick the once weekly over the once daily"- Who's the customer here, the prescriber or the patient? Is a prescription for the weekly formulation valid for the daily one too?
      - Scoundreller 7y ago
        1. The consumers aren’t really choosing, their prescribers are, with a lot of friction required to change against their initial decision. 2. While they still had the patent on the regular tamsulosin formulation, they stopped making it. Effectively forcing everyone onto the XR formulation unless they wanted to change molecules entirely. The data showed little difference as I recall in terms of effectiveness because the half life was long enough to take once daily, regardless of formulation.
postpawl 7y ago
It is possible to get a generic of the un-improved version from Walmart for $25: https://www.vox.com/science-and-health/2019/4/10/18302238/insulin-walmart-relion https://www.vox.com/science-and-health/2019/4/10/18302238/in... The article says some people need up to 6 of those vials per month. So, it can still end up being $1,800 per year. Other non-US countries are able to provide a yearly supply of the newer biosimilar insulin for just $72-133 per year: https://gh.bmj.com/content/3/5/e000850 https://gh.bmj.com/content/3/5/e000850
- Scoundreller 7y ago
  Your 2nd reference talks about the theoretical lowest price that a hypothetical manufacturer could manufacture longer-acting insulins at. It doesn't identify any manufacturer actually producing at those prices.
  - rglover 7y ago
    https://www.walmart.com/ip/Novolin-ReliOn-Insulin-N/167672445 https://www.walmart.com/ip/Novolin-ReliOn-Insulin-N/16767244...
    - Thorrez 7y ago
      Scoundreller wanted a manufacturer producing "the newer biosimilar insulin for just $72-133 per year". That link doesn't appear to provide that information.
adamzk 7y ago
As mentioned in the article they are very effective at preventing smaller companies from producing generic versions based on expired patents. Then they just stop manufacturing the old drugs so there is no supply.
- mirimir 7y ago
  That's not the issue. As long as a brand drug is listed by the FDA -- whether or not it's actually being manufactured -- physicians can write prescriptions for generic equivalents. However, if a brand manufacturer has an old product delisted, then physicians can no longer prescribe generic equivalents. That's become more and more common. However, there is a workaround: compounding pharmacies. To my knowledge, accredited compounding pharmacies can make, on a customer-by-customer basis, any product that the FDA has ever approved. And many of them are mail-order pharmacies. In my experience, prices are comparable to mass-market generics, or lower.
  - gruez 7y ago
    >As long as a brand drug is listed by the FDA -- whether or not it's actually being manufactured -- physicians can write prescriptions for generic equivalents. >However, if a brand manufacturer has an old product delisted, then physicians can no longer prescribe generic equivalents. That's become more and more common. Why is the ability to prescribe a drug tied to whether the branded version in still "listed"?
    - mirimir 7y ago
      Approved drugs are listed here: https://www.accessdata.fda.gov/scripts/cder/daf/ https://www.accessdata.fda.gov/scripts/cder/daf/ Also: https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm And: https://www.drugs.com/history/ https://www.drugs.com/history/ Physicians can only prescribe FDA-approved drugs. Only brand drugs are approved on their own. Generic drugs are approved, with much less documentation required. There's no need to demonstrate effectiveness, safety, etc. Applicants must only demonstrate that products are therapeutically equivalent to approved brand drugs. That's mainly about chemical identity, purity, and rate and degree of absorption. At Drugs@FDA, search for a brand name. If there are generics, you'll see "Therapeutic Equivalents for NDA ...". Clicking that will display links to them. If there's no listed brand drug, there's nothing for a generic to be equivalent to.
rayiner 7y ago
“Evergreening” is a term made up by journalists that has no basis in patent law, and is also actively misleading. The real issue is that nobody has an incentive to prescribe the older, less good but still acceptable drug. (In the case of insulin, note, it’s not only the delivery mechanisms that have improved, but the insulin itself.) the insurance company, in particular, under the ACA, have no incentive to cut costs to improve profits.
- deleted 7y ago
  [deleted]
- pessimizer 7y ago
  Or, in the case of albuterol inhalers, the companies can actively lobby to prevent the older version from being distributed anymore. Evergreening is absolutely a thing, and absolutely planned and executed by the companies that profit from it.
  - deleted 7y ago
    [deleted]
  - pg_bot 7y ago
    The older albuterol inhalers are no longer sold because they used CFCs as a propellant. CFC usage was banned internationally by the Montreal protocol in 1987. The propellant could not be immediately replaced due to strict FDA safety guarantees so they carved out a temporary exemption for medical usage. Research and development was done to find a replacement (HFAs) and that work is now being paid for by the patents granted from that process (more expensive inhalers). Whether this was a valid trade-off is a separate discussion but company lobbying is not the reason why they are no longer distributed. https://www.fda.gov/drugs/questions-answers/transition-cfc-propelled-albuterol-inhalers-hfa-propelled-albuterol-inhalers-questions-and-answers https://www.fda.gov/drugs/questions-answers/transition-cfc-p...
  - tptacek 7y ago
    I think his point is that evergreening isn't a feature of the patent system; there's no mechanism to extend a patent, and "extension" patents of minor modifications don't extend the legal monopoly on a drug, but rather function as a marketing mechanism that preys on the industry's willingness to prescribe whatever the newest iteration of a drug is, regardless of evidence.
rhino369 7y ago
Yes, the new patent can only cover the new improvement. The issue is that doctors keep proscribing the newer, slightly improved methods. Trying to evergreen on purpose is also dangerous since your competitor can patent an improvement on your invention. I somewhat doubt it is a purposeful strategy. But rather it just reflects the iterative nature of invention.

by deogeo 7y ago

DarkStar851 7y ago

Yes, the old drug patent will expire, and when this happens the company typically pulls an "oh our old version is now magically unsafe!" to wrestle away competition. Plus developing a product from the old patent still requires extensive FDA approval. Very expensive stuff.

hjk05 7y ago
Do you have references for that claim? If a company goes out with a claim their old product is unsafe it’s not like it’s rocket science to test the claim. And if their lying and you could literally corner a billion dollar industry by testing the claim I’d expect every producer of generics to do so. On the other hand if the product is actually unsafe that opens up liability claims from costumers.
- Scoundreller 7y ago
  I've seen companies create "extended release" formulations of their old formulation 1 year before the patent expires to get everyone to switch over to the patented version before the generic comes out. I've even seen it done when the previous version and the new version were still both once daily (tamsulosin, I'm looking at you!) Yes, some insurers will hesitate to cover the new formulation when it comes out, but not all. Sometimes the insurer will make a deal with the manufacturer so that the manufacturer is only getting paid the generic-equivalent price. But who knows what happens behind closed doors.
  - hjk05 7y ago
    Changing the release profile of a drug from once daily to once weekly isn’t a minor thing, and no one is forcing customers to pick the once weekly over the once daily. Now with respect to the original claim, are you saying that once there was a new version of tamsulosin the company issued a statement claiming the old version was unsafe? Do you have a reference for that?
    - XMPPwocky 7y ago
      Re: "no one is forcing customers to pick the once weekly over the once daily"- Who's the customer here, the prescriber or the patient? Is a prescription for the weekly formulation valid for the daily one too?
    - Scoundreller 7y ago
      1. The consumers aren’t really choosing, their prescribers are, with a lot of friction required to change against their initial decision. 2. While they still had the patent on the regular tamsulosin formulation, they stopped making it. Effectively forcing everyone onto the XR formulation unless they wanted to change molecules entirely. The data showed little difference as I recall in terms of effectiveness because the half life was long enough to take once daily, regardless of formulation.

postpawl 7y ago

It is possible to get a generic of the un-improved version from Walmart for $25: https://www.vox.com/science-and-health/2019/4/10/18302238/insulin-walmart-relion https://www.vox.com/science-and-health/2019/4/10/18302238/in... The article says some people need up to 6 of those vials per month. So, it can still end up being $1,800 per year. Other non-US countries are able to provide a yearly supply of the newer biosimilar insulin for just $72-133 per year: https://gh.bmj.com/content/3/5/e000850 https://gh.bmj.com/content/3/5/e000850

Scoundreller 7y ago
Your 2nd reference talks about the theoretical lowest price that a hypothetical manufacturer could manufacture longer-acting insulins at. It doesn't identify any manufacturer actually producing at those prices.
- rglover 7y ago
  https://www.walmart.com/ip/Novolin-ReliOn-Insulin-N/167672445 https://www.walmart.com/ip/Novolin-ReliOn-Insulin-N/16767244...
  - Thorrez 7y ago
    Scoundreller wanted a manufacturer producing "the newer biosimilar insulin for just $72-133 per year". That link doesn't appear to provide that information.

adamzk 7y ago

As mentioned in the article they are very effective at preventing smaller companies from producing generic versions based on expired patents. Then they just stop manufacturing the old drugs so there is no supply.

mirimir 7y ago
That's not the issue. As long as a brand drug is listed by the FDA -- whether or not it's actually being manufactured -- physicians can write prescriptions for generic equivalents. However, if a brand manufacturer has an old product delisted, then physicians can no longer prescribe generic equivalents. That's become more and more common. However, there is a workaround: compounding pharmacies. To my knowledge, accredited compounding pharmacies can make, on a customer-by-customer basis, any product that the FDA has ever approved. And many of them are mail-order pharmacies. In my experience, prices are comparable to mass-market generics, or lower.
- gruez 7y ago
  >As long as a brand drug is listed by the FDA -- whether or not it's actually being manufactured -- physicians can write prescriptions for generic equivalents. >However, if a brand manufacturer has an old product delisted, then physicians can no longer prescribe generic equivalents. That's become more and more common. Why is the ability to prescribe a drug tied to whether the branded version in still "listed"?
  - mirimir 7y ago
    Approved drugs are listed here: https://www.accessdata.fda.gov/scripts/cder/daf/ https://www.accessdata.fda.gov/scripts/cder/daf/ Also: https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm And: https://www.drugs.com/history/ https://www.drugs.com/history/ Physicians can only prescribe FDA-approved drugs. Only brand drugs are approved on their own. Generic drugs are approved, with much less documentation required. There's no need to demonstrate effectiveness, safety, etc. Applicants must only demonstrate that products are therapeutically equivalent to approved brand drugs. That's mainly about chemical identity, purity, and rate and degree of absorption. At Drugs@FDA, search for a brand name. If there are generics, you'll see "Therapeutic Equivalents for NDA ...". Clicking that will display links to them. If there's no listed brand drug, there's nothing for a generic to be equivalent to.

rayiner 7y ago

“Evergreening” is a term made up by journalists that has no basis in patent law, and is also actively misleading. The real issue is that nobody has an incentive to prescribe the older, less good but still acceptable drug. (In the case of insulin, note, it’s not only the delivery mechanisms that have improved, but the insulin itself.) the insurance company, in particular, under the ACA, have no incentive to cut costs to improve profits.

deleted 7y ago
[deleted]
pessimizer 7y ago
Or, in the case of albuterol inhalers, the companies can actively lobby to prevent the older version from being distributed anymore. Evergreening is absolutely a thing, and absolutely planned and executed by the companies that profit from it.
- deleted 7y ago
  [deleted]
- pg_bot 7y ago
  The older albuterol inhalers are no longer sold because they used CFCs as a propellant. CFC usage was banned internationally by the Montreal protocol in 1987. The propellant could not be immediately replaced due to strict FDA safety guarantees so they carved out a temporary exemption for medical usage. Research and development was done to find a replacement (HFAs) and that work is now being paid for by the patents granted from that process (more expensive inhalers). Whether this was a valid trade-off is a separate discussion but company lobbying is not the reason why they are no longer distributed. https://www.fda.gov/drugs/questions-answers/transition-cfc-propelled-albuterol-inhalers-hfa-propelled-albuterol-inhalers-questions-and-answers https://www.fda.gov/drugs/questions-answers/transition-cfc-p...
- tptacek 7y ago
  I think his point is that evergreening isn't a feature of the patent system; there's no mechanism to extend a patent, and "extension" patents of minor modifications don't extend the legal monopoly on a drug, but rather function as a marketing mechanism that preys on the industry's willingness to prescribe whatever the newest iteration of a drug is, regardless of evidence.

rhino369 7y ago

Yes, the new patent can only cover the new improvement. The issue is that doctors keep proscribing the newer, slightly improved methods. Trying to evergreen on purpose is also dangerous since your competitor can patent an improvement on your invention. I somewhat doubt it is a purposeful strategy. But rather it just reflects the iterative nature of invention.