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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Companies: purdue pharma

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Comments on “OxyContin And The Art Of 'Evergreening'”

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Anonymous Coward says:

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.


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..

horse with no name says:

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.

Anonymous Coward says:

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.

Anonymous Coward says:

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.

varagix says:

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.

btrussell (profile) says:

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.

Beech says:

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.

Anonymous Coward says:

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.

Beech says:

Re: 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.

Anonymous Coward says:

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.

Anonymous Coward says:

Re: 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.

Anonymous Coward says:

Re: 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.

Heilager says:

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.

PCDEC says:

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.

FM Hilton (profile) says:

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.

Anonymous Coward says:

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?

ChrisB (profile) says:

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.

DCX2 says:

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 2massive numbers of people killing themselves with cars and 5massive numbers of people killing themselves with alcohol. Do cars and alcohol belong in the public sphere?

BentFranklin (profile) says:

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.

PCDEC says:

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.

Anonymous Coward says:

>> 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.

nasch (profile) says:

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?

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