Patents

by Glyn Moody


Filed Under:
evergreening, india, oxycontin

Companies:
purdue pharma



OxyContin And The Art Of 'Evergreening'

from the that's-the-way-to-do-it dept

A few weeks back, we wrote about the Indian Supreme Court's rejection of Novartis's attempt to use "evergreening" to prolong its patent on Gleevec, sold as Glivec in India. That term refers to the trick of making small changes to a drug, usually one about to come off patent, in order to gain a new monopoly that extends its manufacturer's control over a medicine. But how does that work in practice?

A recent story in The New York Times answers that question for us. It concerns the painkiller OxyContin, produced by Purdue Pharma. The main ingredient was supposed to be released gradually, for extended pain relief, but some inventive types started crushing the pills in order to get a big, single hit -- often with fatal results. So in 2010, Purdue Pharma came up with a new physical formulation that was designed to make it harder to mis-use in that way, and obtained a patent on it. Fair enough, you might think: surely it's just trying to stop the abuse of its products and save lives? Well, maybe, but as The New York Times story now tell us:

In a major policy move, the Food and Drug Administration [FDA] said Tuesday that it would not approve generic versions of the powerful narcotic OxyContin, the painkiller that symbolized a decade-long epidemic of prescription drug abuse.
That's because there was apparently a fear that the generic versions would be abused in the same way as the older formulation from Purdue. What's interesting here is the FDA's timing:
The decision by the F.D.A. came on the day when the patent for the original version of OxyContin was set to expire. That would have allowed generic producers to introduce their own version of the formulation. F.D.A. officials said that several producers had applications to sell a generic form of OxyContin pending before the agency.
Of course, now there won't be any generic versions -- at least, not immediately -- and so the price of OxyContin probably won't drop precipitously, and Purdue will keep making a nice profit from it.

That is a perfect demonstration of how evergreening works. Getting a new patent on a tweaked version of a drug that effectively extends a company's monopoly control beyond the original patent term is not enough on its own; what's then needed is some reason why the much cheaper generic versions of the original drug without the tweak are kept from the market. In this case, it's because they don't offer a formulation that combats mis-use.

Of course, it's good news that tamper-resistant versions will now be the norm, since that is likely to save lives. But as the New York Times article writes:

While companies like Purdue Pharma insist the public's health is their main concern, others note that producers introduced tamper-resistant versions of their products just as the drugs were about to lose patent protection.
I suspect we may see more of these interesting coincidences as other profitable drug patents are about to expire, and their manufacturers start to come up with yet more ways to "evergreen" them.

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  • identicon
    Anonymous Coward, 30 Apr 2013 @ 8:32pm

    and years ago

    years ago, OxyContin or it's equivalents used to have a little chunk of yellow stuff in the middle of the tablet, that meaning that you could just break the tablet open and take out the morphine component and throw away the paracetamol part that did not get you stoned.

    Then they mixed the morphine into the paracetamol making the only way to separate the two was by dissolving it in water, where the morphine would float to the surface and be easily extracted.

    They then use this morphine to make amphetamines and meth.

    Of course they should be able to patent a new formulation, it's a new formulation, in it's own right, the fact that it is about the same time as the old patent expires shows that these companies are not stupid.

    Stopping other companies (like generics) from making these medications that can easily be converted into hard, dangerous and illegal drugs (meth is a massive problem in the US) then good on them.

    But don't try to blame patents, this is a case of the FDA making an easily and often abused drug less available and harder to abuse.

    Patening a new development (a new method of achieving a result) shows that patents DO NOT stifle innovation or invention. Again, another example of how the patent system ensures continuous advancement and new technologies and better products.

    GO PATENTS !!!! YAY

    Why do you keep showing examples of the good patents do, and how effective the system is in advancing the progress of mankind ?

    But keep up the good work..

    reply to this | link to this | view in chronology ]

    • This comment has been flagged by the community. Click here to show it
      identicon
      horse with no name, 30 Apr 2013 @ 9:38pm

      Re: and years ago

      Don't confuse the author with facts.

      Oxycontin is a useful medication which also creates terrible harm to society. This move to gel the ingredients which would make it much less desirable in the illegal market is a great advancement, one that should not be denied.

      Extending the patent on this basis isn't harmful to society, it's a benefit. Governments should go further and highly limit and regulate production, so as to further inhibit the illegal market.

      The author is too much in a rush to slam patents to bother thinking about the overall effects.

      reply to this | link to this | view in chronology ]

      • identicon
        Anonymous Coward, 30 Apr 2013 @ 10:11pm

        Re: Re: and years ago

        Not harmful?

        So stratospheric medical costs, less competition in the market place to put in check the abuse of those monopolies is not a problem?

        Further, hard drugs may be a problem better solved by nature itself, let Darwinism act upon society for a change in the end society will develop its own remedies and solutions, people are not stupid you know, also apparently drug abuse is going down the trend is downwards not up and it is not because of any difficulties to find drugs, you can get them even if you are in jail inside a penitentiary, so your grandstanding about the evil of drugs and the benefit to society to extend a monopoly so a company can keep prices high and exploit it clients seems shallow and self serving.

        reply to this | link to this | view in chronology ]

      • identicon
        Anonymous Coward, 30 Apr 2013 @ 10:52pm

        Re: Re: and years ago

        Hate to tell you this but it's not gonna happen. Just go take a look at bluelight.ru "a forum for junkies". Every time they try to stop abuse a new way to abuse it is figured out.

        I'm not defending the behavior because I'm a junkie myself though it's controlled these days by a massive daily dose of methadone.

        The war on narcotics in general is a pointless battle that can never be won. The only way to win it would be legalize everything and tax the fuck out of it. You'd see drug related gang/cartel violence disappear overnight. If people fuck up while they're high send them to jail.

        reply to this | link to this | view in chronology ]

        • identicon
          varagix, 1 May 2013 @ 9:29am

          Re: Re: Re: and years ago

          There'd also be a heck of a lot less people in jail for ultimately victimless crimes that have mandatory sentences, which in turn means more room for the actually violent criminals. There'd be no excuse for the habitually violent to get a suspended or reduced sentence, while people who's crime is "used/possessed pot/crack/etc a little too openly" rot for years in prison and become second class citizens when they get out due to now being a felon.

          reply to this | link to this | view in chronology ]

      • identicon
        Beech, 1 May 2013 @ 1:23am

        Re: Re: and years ago

        Yes, but if the original patent was SHORTER, than we would have gotten this "oh-so-necessary" change FASTER, and Purdue still would have gotten control of its drug for "longer." So society still would have benefited, but at a faster pace.

        reply to this | link to this | view in chronology ]

      • identicon
        Anonymous Coward, 1 May 2013 @ 3:07am

        Re: Re: and years ago

        The drug (ab)users will find other sources for their fix. The people who need the drug have to pay higher prices. The manufacturers profits are protected. Society loses out to a manufacturers greed yet again.

        reply to this | link to this | view in chronology ]

      • icon
        Vidiot (profile), 1 May 2013 @ 5:09am

        Re: Re: and years ago

        Oh, that's right... I forgot. The purpose of patents is to prevent drug abuse.

        That's a good thing, because they're sure not protecting innovation like they were intended to do. At least they occasionally serve some useful purpose.

        reply to this | link to this | view in chronology ]

        • identicon
          PRMan, 1 May 2013 @ 9:49am

          Re: Re: Re: and years ago

          Oh, that's right... I forgot. The purpose of patents is to prevent drug abuse.


          No, but that's the purpose of the FDA and it's nice to see a little bit of what they do benefit the public, instead of meeting their masters' wishes while harming the public.

          reply to this | link to this | view in chronology ]

          • icon
            John Fenderson (profile), 1 May 2013 @ 11:09am

            Re: Re: Re: Re: and years ago

            instead of meeting their masters' wishes while harming the public


            I am ambivalent about this particular case, but this could easily be seen as yet another case of the FDA meeting their master's wishes while harming the public.

            reply to this | link to this | view in chronology ]

      • icon
        btrussell (profile), 3 May 2013 @ 5:18pm

        Re: Re: and years ago

        "This move to gel the ingredients which would make it much less desirable in the illegal market is a great advancement, one that should not be denied."

        It has been a dangerous drug on the streets for fourteen years, yet just as that patent is set to expire, they all of a sudden have a new formula that makes it still safe to use? Yea, right.

        reply to this | link to this | view in chronology ]

    • identicon
      Anonymous Coward, 30 Apr 2013 @ 10:16pm

      Re: and years ago

      Patents are so useful these days look some guy patented a pancake, wow! that is progress.

      http://www.patentstorm.us/patents/6797310/description.html

      reply to this | link to this | view in chronology ]

    • identicon
      Justin Olbrantz (Quantam), 30 Apr 2013 @ 10:22pm

      Re: and years ago

      You missed the blindingly obvious: it wasn't the patents that brought progress, but the END of the patents.

      Correcting for that fact, your point is: the shorter the patent, the faster the progress.

      reply to this | link to this | view in chronology ]

    • identicon
      Beech, 1 May 2013 @ 1:16am

      Re: and years ago

      There are some problems with your view of the story.

      1) If the "original" Oxy is SOOOOO dangerous that the FDA just can't approve it...why was it initially approved? Did the FDA not know about how it could be abused? Once they found out about it, why didn't they yank approval immediately?
      2) Having a monopoly on Oxy didn't inspire Purdue to create a new form of it, the patent being about to expire apparently did though. So by the way it looks, if the patent on Oxy was half as long, we would have gotten the "New" version twice as quick.

      reply to this | link to this | view in chronology ]

  • identicon
    Anonymous Coward, 30 Apr 2013 @ 9:29pm

    Please feel free to correct me if I am mistaken, but I do not recall reading in the linked article that the original manufacturer of OxyCotin has a pending patent application for an improvement to the drug in the form of a tamper-resistant pill.

    According to the article the concern is associated with the prior ability of users to grind the pill, and then ingest it, thereby bypassing its time-release feature.

    Based upon my above understanding, I do not believe it is accurate to suggest that a new form of a previously patented drug somehow extends the protection previously enjoyed by the original manufacturer.

    reply to this | link to this | view in chronology ]

    • identicon
      Beech, 1 May 2013 @ 1:20am

      Re:

      Although the article doesn't mention a patent specifically, I think its pretty safe to assume that there's going to be one. You think Purdue put in the time and effort to research a new "tamper-resistant" formula for their drug just out of the goodness of their heart? And now they're just going to let any ol' anyone copy that? Please.

      reply to this | link to this | view in chronology ]

    • icon
      John Fenderson (profile), 1 May 2013 @ 11:14am

      Re:

      It doesn't. The new formulation gets a new patent. The FDA is saying they won't approve the old formulation for market anymore, so the new one must be used. This has the same result as extending the patent on the original.

      reply to this | link to this | view in chronology ]

  • identicon
    Anonymous Coward, 30 Apr 2013 @ 10:37pm

    The first few commenters completely missed the point, which is that patents were not needed for the innovation here (the anti-abuse formulation) to happen, and that the circumstances mentioned effectively grant a whole new patent term over OxyContin.

    The FDA refusing to allow generic versions of it without the less abusable physical formulation is one thing. That the patent on said formulation lets the original patent holder hang onto its monopoly for another term is another altogether.

    The FDA would probably be more than happy to permit generic versions in anti-abuse formulations. There will always be a strong market for this drug, and now that the original patent has run its course, there's no reason other companies wouldn't want to produce generics of it (with anti-abuse features to the FDA's satisfaction), resulting in a drop in price - good for just about everyone except the original patent holder. But a crucial part of the patent bargain is that the patent monopoly is only temporary - it (ostensibly) provides an incentive to invent through the monopoly, but there is no point in that if the invention will not eventually become free for all to implement, use, and enjoy. And evergreening defeats the "temporary" part, leaving only the "monopoly" part.

    reply to this | link to this | view in chronology ]

    • identicon
      Anonymous Coward, 1 May 2013 @ 7:33am

      Re:

      Evergreening is not a patent issue. After all, the original has expired and generics are free to be manufactured with FDA approval. Here FDA approval is temporarily being withheld until generics incorporate tamper-resistance, at which time they are once more free to manufacture the medication.

      reply to this | link to this | view in chronology ]

      • identicon
        Anonymous Coward, 1 May 2013 @ 9:15am

        Re: Re:

        Funny how the tamper resistance method is patented though isn't, all manufacturers of generics will have to wait 20 years or come up with a new delivery method system.

        reply to this | link to this | view in chronology ]

      • identicon
        Anonymous Coward, 1 May 2013 @ 12:41pm

        Re: Re:

        How isn't evergreening a patent issue? The very definition of evergreening is underhanded trickery of this kind to defeat the expiration of a patent.

        Under the current circumstances, the non-approval of non-tamper-resistant forms, where the original patent holder has also patented a tamper-resistant form, is akin to a whole new patent on the drug. And that's evergreening. Which is, if nothing else, a patent issue.

        reply to this | link to this | view in chronology ]

  • identicon
    Heilager, 30 Apr 2013 @ 11:39pm

    An interesting thought

    I wounder what some detective work into when the idea of creating a tamper resistant form of the drug was discussed and researched by the patent holder would turn up?

    I wonder what a class action lawsuit on behalf of all abusers who died or came to harm would do if it claimed that the release of the reformulation was held back until maximum advantage as far as patent extension was achieved?

    There is clear motivation for the patent holder to have withheld the reformulated drug until the last moment until maximum patent extension time was achieved.

    While this does not look like the case with OxContin, we have seen where this trick has been pulled in the past and the judicial system ruled correctly in the example cited in the article.

    reply to this | link to this | view in chronology ]

  • identicon
    Anonymous Coward, 30 Apr 2013 @ 11:59pm

    Awww they nerfed my Oxy! Right when it was set to drop in price and skyrocket in availability. I guess i'll stick to good ol' heroin.

    reply to this | link to this | view in chronology ]

  • identicon
    PCDEC, 1 May 2013 @ 12:10am

    This is a great example of evergreening. Purdue really thought this one out too. I don't believe in prohibition but of course the FDA is all for it and Purdue used that to their advantage. And of course any attempt by the generic manufacturers to make a pill that is harder to abuse won't be as good as Purdue's patented method.

    reply to this | link to this | view in chronology ]

  • icon
    redleaf (profile), 1 May 2013 @ 12:43am

    One of the more profitable recent examples of this was Citalopram (Celexa) becoming Escitalopram (Lexapro). Cha-ching.

    http://www.manhattan-institute.org/html/miarticle.htm?id=7099#.UYDHFLVhSIw

    reply to this | link to this | view in chronology ]

  • identicon
    FM Hilton, 1 May 2013 @ 4:14am

    Benefits of Evergreening?

    " The war on narcotics in general is a pointless battle that can never be won. The only way to win it would be legalize everything and tax the fuck out of it. You'd see drug related gang/cartel violence disappear overnight. If people fuck up while they're high send them to jail."

    Er, what about the massive numbers of people killing themselves by taking as much of the drugs as they want? Isn't that a unnecessary side effect of such a thing? Because I always thought that the FDA was supposed to protect the consumers, not enable them to kill themselves...while I agree that the 'war on drugs' is one that we can never win, we should not help drug users to get fucked up and probably do very seriously stupid things like murdering people in cold blood while high.

    and this:

    "The drug (ab)users will find other sources for their fix. The people who need the drug have to pay higher prices. The manufacturers profits are protected. Society loses out to a manufacturers greed yet again."

    There are some drugs that should not be allowed to go generic. Oxycontin is one of them, along with other CII drugs that are equally as dangerous when taken in large amounts.

    I'm not all that thrilled with the idea of manufacturers making all those tidy profits, but I'm also not thrilled by the sheer enormity of making dangerous drugs readily available for unlimited use by the general public, because some of those 'who need these drugs' are addicts, who turn around and sell them for a very tidy profit on the street.

    I'd go so far as to ban the manufacture and sale of nearly all CII drugs for the public, making them only available in hospitals. Sorry about being in pain, but one must realize that some drugs just don't belong in the public sphere.

    They are highly addictive and there is no known sure-fire way to become a non-addict once you're hooked on them. Once an addict, always an addict in one way or another.

    I'm speaking only for myself, but as a pharmacy tech working in a retail setting, these drugs are nothing but a danger to the public just by being allowed to be sold by prescription. You'd be amazed at how high the crime rates for holdups in pharmacies over CII drugs is.

    I've been through one, and it's not a very pleasant experience, to say the least.

    reply to this | link to this | view in chronology ]

    • identicon
      Anonymous Coward, 1 May 2013 @ 5:10am

      Re: Benefits of Evergreening?

      Some people would say that it's a basic right of any human to decide what to put in and do with their own body. Worse the hidden nature of the drug market allows low quality/knockoff products to be sold (ie it could be cut with anything) it also causes wildly varying strengths of drug which imo is part of the reason we have so many ODs.

      Your point about someone selling on drugs is only valid under the current climate of prohibition. If these things were legal there would be no buyers for such second hand drugs since people would want to buy from a reputable source.

      I'm not sure why you assume that a drug being produced as a generic would somehow increase addictions or violent behavior. Firstly they'd still probably be prescription only regardless of their manufacturer. Secondly if the drugs are cheaper surely there is pressure to an addict to steal to get his fix since his money will go further due to greatly reduced prices?

      reply to this | link to this | view in chronology ]

    • icon
      ChrisB (profile), 1 May 2013 @ 6:27am

      Re: Benefits of Evergreening?

      What are you talking about? "Sorry about being in pain." Are you kidding me?! Have you ever lived with chronic pain?

      All those problems--B&E's, pharmacy holdups, etc.--are caused BECAUSE these drugs are so hard to get ahold of. Do you think people are committing suicide using oxy? No, they die because the drug is so hard to get ahold of and expensive, they need to try crazy ways to increase the efficacy of the pills they have. If oxy was cheaper, they wouldn't be dying. Were you asleep during the crack and heroin epidemics?

      The reality is these drugs are excellent at managing pain, but also are very addictive PRECISELY because they are so good at masking pain. If doctors stopped fearing addiction, but actually discussed it rationally, we could lessen the problems. Did you see Trainspotting? There is a way to deal with withdrawal. Pretending it doesn't exist isn't it.

      I've had major surgery a few times, and each time I left the hospital an unwilling morphine addict. Did a doctor ever once tell me how to deal with the horrific withdrawal symptoms? NEVER! I had surgery as recent as 5 years ago and not a peep. If doctors and pharmacists would pull their heads out of their collective asses and talk openly about addition, we could mitigate the risk of it, and keep these effective drugs.

      reply to this | link to this | view in chronology ]

    • identicon
      DCX2, 1 May 2013 @ 10:15am

      Re: Benefits of Evergreening?

      Regarding "the massive numbers of people killing themselves"...here are some statistics

      The CDC says there were 14,800 prescription pain killer overdoses in 2008. http://www.cdc.gov/homeandrecreationalsafety/rxbrief/

      The CDC estimates there are 80,000 alcohol related deaths each year. http://www.cdc.gov/alcohol/fact-sheets/alcohol-use.htm

      The CDC says there were 33,687 deaths related to motor vehicles in 2010. http://www.cdc.gov/nchs/fastats/acc-inj.htm

      So what you're saying is that we have 2*massive numbers of people killing themselves with cars and 5*massive numbers of people killing themselves with alcohol. Do cars and alcohol belong in the public sphere?

      reply to this | link to this | view in chronology ]

      • identicon
        DCX2, 1 May 2013 @ 10:21am

        Re: Re: Benefits of Evergreening?

        BTW, I'm not trying to defend drug abuse. But I have a loved one who deals with chronic pain, and your attitude towards people in such a condition is abhorrent, so I felt a specific need to add some statistics to your unsubstantiated claims.

        reply to this | link to this | view in chronology ]

    • icon
      John Fenderson (profile), 1 May 2013 @ 11:19am

      Re: Benefits of Evergreening?

      The FDA should be focused just on ensuring that the drugs are correct and pure, and that they do what they claim to do (including complete disclosure of risks and side-effects).

      reply to this | link to this | view in chronology ]

  • identicon
    Anonymous Coward, 1 May 2013 @ 4:40am

    If some fool wants to risk his/her life by abusing this drug we should let them. Allow natural selection to do it's thing!

    reply to this | link to this | view in chronology ]

  • icon
    BentFranklin (profile), 1 May 2013 @ 4:43am

    FDA won't approve anyone making the old version because it isn't safe and now there's a safer alternative. That isn't a patent issue. This decision was probably in the works but they rushed it to coincide with the patent expiring to stop anyone from manufacturing it the old way.

    I feel ripped off by this article. It did not deliver it's promised dosage of anti-patent content. Articles that stretch their point like this don't help the cause, they hurt it, and make it hard for me to get friends interested.

    reply to this | link to this | view in chronology ]

    • icon
      nasch (profile), 1 May 2013 @ 8:41pm

      Re:

      This decision was probably in the works but they rushed it to coincide with the patent expiring to stop anyone from manufacturing it the old way.

      You really think it was pure coincidence that Purdue happened to have this new version ready to go right as the patent on the old one was about to expire?

      reply to this | link to this | view in chronology ]

  • identicon
    Anonymous Coward, 1 May 2013 @ 6:09am

    Celexa v Lexapro

    If you read depression forums, you can see that a lot of people switching between "equivalent" doses do not have the same results between the drugs. it isnt just an issue of potency for many.

    reply to this | link to this | view in chronology ]

  • identicon
    PCDEC, 1 May 2013 @ 6:54am

    This is a great example of evergreening. Purdue really thought this one out too. I don't believe in prohibition but of course the FDA is all for it and Purdue used that to their advantage. And of course any attempt by the generic manufacturers to make a pill that is harder to abuse won't be as good as Purdue's patented method.

    reply to this | link to this | view in chronology ]

  • icon
    johnjac (profile), 1 May 2013 @ 7:50am

    Albuterol

    This happend with Albuterol when CFC had to be removed. Only one company had a patent on the new delivery method, and all the generics were removed from the market.

    reply to this | link to this | view in chronology ]

  • identicon
    Anonymous Coward, 1 May 2013 @ 10:16am

    >> 1 AC

    > could just break the tablet open and take out the morphine

    Oxycontin contains oxycodone, which has similar action in the body but is not morphine.


    > They then use this morphine to make amphetamines and meth.

    Not all drugs of abuse can be interconverted. Morphine is chemically nothing like amphetamine (apart from having lots of carbons and a nitrogen); meth tends to be made from starting materials that actually resemble amphetamine and are more readily available.

    reply to this | link to this | view in chronology ]

  • icon
    Mike Raffety (profile), 1 May 2013 @ 11:50am

    Extending drug patents?

    Why does changing the delivery method result in a patent extension? It's the same drug.

    Just because it's now in a tamper-proof form, or has extended/sustained delivery, or packaged with another drug, should not result in a new patent, nor an extension of the old one. Same drug!

    reply to this | link to this | view in chronology ]

    • icon
      BentFranklin (profile), 1 May 2013 @ 12:34pm

      Re: Extending drug patents?

      The new patent is only on the new delivery method. That's why this is a bad example of evergreening.

      reply to this | link to this | view in chronology ]

      • icon
        nasch (profile), 1 May 2013 @ 8:44pm

        Re: Re: Extending drug patents?

        The new patent is only on the new delivery method. That's why this is a bad example of evergreening.

        It's evergreening because the new patent plus the FDA not approving the old version for generics means the patent is effectively extended. Why is the old version only too dangerous now that there's a new patent on a new version?

        reply to this | link to this | view in chronology ]

        • identicon
          DCX2, 1 May 2013 @ 9:50pm

          Re: Re: Re: Extending drug patents?

          The old version is very dangerous - for Purdue's profits, since it no longer has patent protection. The greatest threat in America is to interfere with a corporation's God-given right to a profit.

          reply to this | link to this | view in chronology ]

  • icon
    Kevin (profile), 2 May 2013 @ 3:29am

    One out another in

    If Oxycontin is made so the extraction of the morphine is either impossible or expensive then what stops the extractors switching back to MS Contin?

    reply to this | link to this | view in chronology ]


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