4 ms·

> In medicine you don't typically do Viagra 2.0, with a boatload of new IP that makes the original obsolete (and hence any competitors shipping the old version

by Cushman 14y ago

> In medicine you don't typically do Viagra 2.0, with a boatload of new IP that makes the original obsolete (and hence any competitors shipping the old version scrambling). Actually, there is an entire class of drugs known in medicine as "patent extenders". Take your expiring patented drug, alter the formulation, or attach an unnecessary chemical group that doesn't affect the mechanism of action, et voila! Twenty more years of monopoly. As a result of this, there are drugs which were prescribed twenty years ago that are no longer available-- since the original developer has moved on to an "improved" version which may be less effective, while the generic version is not profitable enough to be widely available. What this means for intellectual property, I'm not sure. It's a tricky issue.

eridius 14y ago
How do the patent extenders work? I mean, what's to stop the generic from just continuing to make the original formula, if the alterations don't actually do anything?
- josephcooney 14y ago
  Marketing, I think.
  - Scaevolus 14y ago
    Sometimes they'll severely limit the supplies of the predecessor before it becomes generic, to "encourage" people to switch over to the new drug.
- MBCook 14y ago
  Nothing. But why prescribe the generic Lowpainex when the new Nopainatall is proven to be 0.5% more effective? Plus the Nopainatall guy gave you some pens and pads and toothbrushes, and there are ads on every night telling people to talk to their doctor about the newest breakthrough that leaves old drugs behind. Your patients don't want the old drug, do they? They don't want some pain, they want none. Of course, Nopainatall is just Lowpainex combined with Tylenol... but that's inconvenient to take separately.
  - dmckeon 14y ago
    > ads on every night telling people to talk to their doctor One wonders how many doctor-hours per year are spent by the consumers/patients initiating such conversations.
  - eridius 14y ago
    Don't most insurers these days require you to take the generic if one is available? So it shouldn't really matter whether the doctor prescribes the brand name or the generic. Or does that generic-if-possible rule not work here because the brand name one is ever so slightly different?
    - user49598 14y ago
      Thats exactly the point, if the drug is covered under patent there is no generic. So if the doctor prescribes the newer yet not better drug, there will be no generic alternative.
    - rdl 14y ago
      Yes, the new drug is different, so there is no generic for it. Another class of "patent extender" is to take two existing good drugs, package them together, and then trial and sell it as a new drug. The combined product is not the same as the two off-patent generic parent drugs.
      - SystemOut 14y ago
        I'd love to see an example of this. I'm not saying I don't believe you but I'd really like to see an example and then look to see what Kaiser (a medical insurer and provider here in CA for the non-CA and a few other state folks) does since I don't think they would go for that.
        rdl 14y ago
        Caduet (new) = Lipitor (off-patent in 2011) + Norvasc (patent protection ended 2007 after a suit). Zocor (2006) + Zetia = Vytorin. There are hundreds of examples -- this is a totally standard patent expiration strategy in medicine. This whole area is called "ever-greening". The weirdest one is getting an existing drug approved for a new use. This can be used to extend patent protection.
- burke 14y ago
  The way it generally works is that Big Pharma releases a new "2.0" version (often a cis-isomer or the same molecule with a non-functional dangly bit on it), then hands out a bunch of money to get a portion of doctors to quit prescribing the old one, and floods the market with advertising about how amazing the new one is, without letting anyone in on the fact that it's actually functionally identical (or, as Cushman points out, sometimes marginally less effective).
- nhebb 14y ago
  Nexium is a patent extension of Prilosec. In order to patent Nexium, they had to alter the chemical structure and run clinical trials to show that Nexium was an improvement over Prilosec. Some critics argued that the trials inflated the differences. IIRC, when some generic drug makers tried to sell generic versions of Nexium, AstraZeneca sued them and won. Malcolm Gladwell, covered this and other issues affecting pharmaceutical pricing in a 2004 article. It's an even-handed article, worth reading the entire piece - http://www.gladwell.com/2004/2004_10_25_a_drugs.html http://www.gladwell.com/2004/2004_10_25_a_drugs.html
- adavies42 14y ago
  partly it's payment details: a lot of patent extenders roll out right when the generic goes to over-the-counter status--insurance pays for the new prescription drug, but won't cover the old one at all anymore. the one relevant to me on a daily basis is zyrtec/xyzal -- xyzal is just zyrtec filtered for the correct chiral form, but the prescription is cheaper than the OTC for me thanks to my insurances' rules.
flyinRyan 14y ago
There should be an easy fix for this one though: only give patents if the drug either does something totally new (e.g. cure cancer) or is fundamentally different than any previous version, while being more efficient (no point in a drug that's 99% different but has the same effectiveness).
- refurb 14y ago
  You have to be careful with this! If you look at the statins, there are more than 5 distinctly different drugs that are work through the same mechanism. Me-too drugs right? Well, some patients can't take Crestor because of a rare side-effect, so they switch to Lipitor and are happy. You have to remember that patients have individual needs and sometimes what looks like two identical drugs actually provide a benefit to the patient.
  - flyinRyan 14y ago
    Sure, they only way to truly solve these things is stop making it a mechanical process and turn it into an interactive process with people involved who have common sense. Patents should be "deny by default" with the party arguing why they should get one. If they can convince the e.g. "board of experts" then they get it. Then we just have to execute the first "board of experts" member who takes a bribe. :)

by Cushman 14y ago

eridius 14y ago

How do the patent extenders work? I mean, what's to stop the generic from just continuing to make the original formula, if the alterations don't actually do anything?

josephcooney 14y ago
Marketing, I think.
- Scaevolus 14y ago
  Sometimes they'll severely limit the supplies of the predecessor before it becomes generic, to "encourage" people to switch over to the new drug.
MBCook 14y ago
Nothing. But why prescribe the generic Lowpainex when the new Nopainatall is proven to be 0.5% more effective? Plus the Nopainatall guy gave you some pens and pads and toothbrushes, and there are ads on every night telling people to talk to their doctor about the newest breakthrough that leaves old drugs behind. Your patients don't want the old drug, do they? They don't want some pain, they want none. Of course, Nopainatall is just Lowpainex combined with Tylenol... but that's inconvenient to take separately.
- dmckeon 14y ago
  > ads on every night telling people to talk to their doctor One wonders how many doctor-hours per year are spent by the consumers/patients initiating such conversations.
- eridius 14y ago
  Don't most insurers these days require you to take the generic if one is available? So it shouldn't really matter whether the doctor prescribes the brand name or the generic. Or does that generic-if-possible rule not work here because the brand name one is ever so slightly different?
  - user49598 14y ago
    Thats exactly the point, if the drug is covered under patent there is no generic. So if the doctor prescribes the newer yet not better drug, there will be no generic alternative.
  - rdl 14y ago
    Yes, the new drug is different, so there is no generic for it. Another class of "patent extender" is to take two existing good drugs, package them together, and then trial and sell it as a new drug. The combined product is not the same as the two off-patent generic parent drugs.
    - SystemOut 14y ago
      I'd love to see an example of this. I'm not saying I don't believe you but I'd really like to see an example and then look to see what Kaiser (a medical insurer and provider here in CA for the non-CA and a few other state folks) does since I don't think they would go for that.
      - rdl 14y ago
        Caduet (new) = Lipitor (off-patent in 2011) + Norvasc (patent protection ended 2007 after a suit). Zocor (2006) + Zetia = Vytorin. There are hundreds of examples -- this is a totally standard patent expiration strategy in medicine. This whole area is called "ever-greening". The weirdest one is getting an existing drug approved for a new use. This can be used to extend patent protection.
burke 14y ago
The way it generally works is that Big Pharma releases a new "2.0" version (often a cis-isomer or the same molecule with a non-functional dangly bit on it), then hands out a bunch of money to get a portion of doctors to quit prescribing the old one, and floods the market with advertising about how amazing the new one is, without letting anyone in on the fact that it's actually functionally identical (or, as Cushman points out, sometimes marginally less effective).
nhebb 14y ago
Nexium is a patent extension of Prilosec. In order to patent Nexium, they had to alter the chemical structure and run clinical trials to show that Nexium was an improvement over Prilosec. Some critics argued that the trials inflated the differences. IIRC, when some generic drug makers tried to sell generic versions of Nexium, AstraZeneca sued them and won. Malcolm Gladwell, covered this and other issues affecting pharmaceutical pricing in a 2004 article. It's an even-handed article, worth reading the entire piece - http://www.gladwell.com/2004/2004_10_25_a_drugs.html http://www.gladwell.com/2004/2004_10_25_a_drugs.html
adavies42 14y ago
partly it's payment details: a lot of patent extenders roll out right when the generic goes to over-the-counter status--insurance pays for the new prescription drug, but won't cover the old one at all anymore. the one relevant to me on a daily basis is zyrtec/xyzal -- xyzal is just zyrtec filtered for the correct chiral form, but the prescription is cheaper than the OTC for me thanks to my insurances' rules.

flyinRyan 14y ago

There should be an easy fix for this one though: only give patents if the drug either does something totally new (e.g. cure cancer) or is fundamentally different than any previous version, while being more efficient (no point in a drug that's 99% different but has the same effectiveness).

refurb 14y ago
You have to be careful with this! If you look at the statins, there are more than 5 distinctly different drugs that are work through the same mechanism. Me-too drugs right? Well, some patients can't take Crestor because of a rare side-effect, so they switch to Lipitor and are happy. You have to remember that patients have individual needs and sometimes what looks like two identical drugs actually provide a benefit to the patient.
- flyinRyan 14y ago
  Sure, they only way to truly solve these things is stop making it a mechanical process and turn it into an interactive process with people involved who have common sense. Patents should be "deny by default" with the party arguing why they should get one. If they can convince the e.g. "board of experts" then they get it. Then we just have to execute the first "board of experts" member who takes a bribe. :)