The Nasty Patent Games Drug Companies Play To Stop You From Getting Cheaper Drugs
from the the-evilness-of-drug-companies dept
The astoundingly wonderful radio program/podcast Radiolab just recently had an episode called "Worth" -- which included a few different stories trying to establish how much something is truly "worth." The first story in the collection talked about how much extra time in life is worth, as part of a discussion on whether or not it's reasonable for certain drugs to be priced insanely high. It was an interesting discussion, mostly revolving around the question of whether it's "worth" paying tends of thousands of dollars for a drug treatment that might only extend your life a few weeks. There is just a brief discussion about whether or not it's appropriate for pharmaceutical companies to charge the rates that they do -- with the Radiolab team unfortunately accepting the tired (and incredibly misleading) claim from a drug company that because drug research includes so many failures, it needs to charge these ridiculous high rates to make up for all the failures.This is misleading in all sorts of ways, though that will need to be the subject of another post at another time. My biggest complaint, after the story was over, was that it failed in economics 101. It stuck with the premise that there was a quantifiable single amount that something was "worth" -- and that price is a reflection of that. This is something that many people tend to feel, instinctively, but it's not accurate. The value of something is different to different people and depends on many factors. The price of something may be quite different than the value -- again, something we've been highlighting for years.
Here's the key bit: the price of something is driven by supply and demand. When you -- as the program did -- look at price solely based on "value" you're only looking at the demand side of the equation, and not the supply. And that's where things get extra tricky in pharmaceutical pricing -- because the supply side is massively distorted through patents, which enable drug companies to artificially limit the supply, driving up prices to insane levels. In a normal, functioning society, we might recognize that this is a problem. Deriving pricing for healthcare solely based on demand is ludicrous, and shows a society with very short-term thinking. It prioritizes short-term narrow profits of drug companies over long-term contributions from a more healthy populace.
But this is the way of our pharmaceutical industry today. And these distortions have become something of, well, a drug to the pharma industry. They've become so fat and happy based on the monopoly rents of patents artificially limiting supply, that they can't fathom how to survive without such rents. That crutch has resulted in big pharma running into some serious problems lately -- because they haven't been discovering many really valuable new drugs lately. At the same time, many of their old drugs have seen their patents start to expire.
In response, pharmaceutical companies have been pulling out all sorts of tricks to try to extend the monopoly rents (rather than actually improving people's health or their own business model). For a while, we were discussing "pay for delay" schemes, in which big pharmaceutical companies would sue small generic drug makers... and then "settle" by paying those generic companies a bunch of cash not to compete with generic drugs for some time. That practice recently became harder after the Supreme Court said that the FTC can go after such practices as a form of antitrust enforcement.
But that's not the only game that big pharmaceutical firms have been playing. A recent lawsuit filed by New York against Forest Labs and its parent company Actavis revealed that the company was trying to force Alzheimer's patients onto a new drug, and away from one that they had been using. The only real difference in the two drugs: the length of the patent protection. Basically, the company was trying to force patients onto a drug that wasn't close to becoming available in generic forms, which would make it much, much cheaper. From the lawsuit:
This case is brought to prevent Defendants from illegally maintaining their monopoly position and inflating their profits at the expense of patients suffering from Alzheimer's disease. The manipulative tactic that the Defendants seek to employ here is what some in the industry, including Defendants' own CEO, have called a "forced Switch." In a forced switch, a pharmaceutical company that sells a drug facing imminent generic competition withdraws its drug from the market, forcing patients to switch to a different form of the drug with patents that expire later. The switch has the effect of impeding the entry of lower-cost generic drugs. A physician recently complained to Defendants, aptly describing their contemplated action as "immoral and unethical." It is also illegal.Thankfully, a few weeks ago, an initial ruling in the case found that Actavis could not move forward with these "forced switch" plans and needed to continue making the original drug, Namenda IR, available. The full court ruling [pdf] is fairly detailed in how Actavis has a monopoly on the market for memantine and is abusing it in anti-competitive ways. The court notes that merely having a patent isn't necessarily proof of a monopoly -- but in this case, Actavis absolutely does have a monopoly. Further, it notes that just because you have a monopoly, it doesn't mean you're abusing it. But... Actavis does appear to be abusing its monopoly position. It didn't help that Forest Labs CEO, Brent Saunders (recently moved up to Actavis CEO as well), was pretty open about this:
Defendants sell a blockbuster drug to treat Alzheimer's disease, called Namenda. Namenda is Forest's top selling drug, and is protected by patent and regulatory exclusivities that prevent generic versions from entering the market until July 2015. But rather than allowing patients with Alzheimer's to continue to take Namenda and switch to the less expensive generic version when it becomes available, as contemplated by federal and state drug laws, Forest instead hatched a scheme that interferes with patients' ability to make this switch.
Defendants' strategy is to discontinue or severely restrict patient access to its original, immediate-release version of Namenda, known as Namenda IR, prior to generic entry in order to force patients to switch to Forest's newer, virtually identical, extended-release version of Namenda, called Namenda XR. Because Namenda XR is protected by patents for many years longer than the original Namenda IR, Defendants' goal is to use the "forced switch" to reap several more years of monopoly profits than they would have earned otherwise. Under generic substitution laws, a pharmacist will not be able to substitute lower-priced generic Namenda IR (known as memantine) for Namenda XR. As a result, once patients have switched to Namenda XR, it will destroy the market for the generic form of Namenda IR because of the dramatically increased burden, cost, and time needed to arrange for patients who have been switched to Namenda XR to switch back to the original version.
Saunders stated, contemporaneously with the adoption of the hard switch by Forest, that the purpose of the switch was anticompetitive: to put barriers obstacles in the path of producers of generic memantine and thereby protect Namenda’s revenues from a precipitous decline following generic entry.... He further stated: “if we do the hard switch and we’ve converted patients and caregivers to once-a-day therapy versus twice a day, it’s very difficult for the generics then to reverse-commute back, at least with the existing [prescriptions]. They don’t have the sales force, they don’t have the capabilities to go do that. It doesn’t mean that it can’t happen, it just becomes very difficult. It is an obstacle that will allow us to, I think, again go into to a slow decline versus a complete cliff.”).Of course, this particular practice, of trying to force people to avoid generic competition is increasingly widespread. As I was finishing up this post, I came across a similar, if equally disturbing, story about Pfizer directly threatening doctors should they decide to prescribe generic versions of pregabalin, an anti-epilepsy drug, that will also go off patent in 2015. But here's the tricky part: Pfizer holds a different patent on the same drug if it's used to treat pain (rather than epilepsy). Pfizer is claiming that prescribing the generic version for pain use would lead to serious problems -- even though it's the same damn drug.
You will see that, whilst the basic patent for pregabalin has expired and regulatory data protection for Lyrica expired in July 2014, Pfizer has a second medical use patent protecting pregabalin's use in pain which extends to July 2017. Pfizer conducted further research and development on pregabalin leading to the invention of its use in pain and hence was granted a second medical use patent for this indication. This patent does not extend to pregabalin's other indications for generalized anxiety disorder (GAD) or epilepsy.As Cory Doctorow notes in the article above, Pfizer here seems to be trying to take its own "stupid problem" and make it everyone else's stupid problem:
As a result of the pain patent, we expect that generic manufacturers will only seek authorisation of their pregabalin products for use in epilepsy and generalised anxiety disorder and not for pain, whilst Pfizer's pain patent is in place. Generic pregabalin products therefore are expected not to have the relevant information regarding the use of the product in pain in the PIL (Patient Information Leaflet) and SmPC (Summary of Product Characteristics). In other words, the generic pregabalin products are expected to carry so-called "skinny labels" and will not be licensed for use in pain. In the circumstances described above, Pfizer believes the supply of generic pregabalin for use in the treatment of pain whilst the pain patent remains in force in the UK would infringe Pfizer's patent rights. This would not be the case with supply or dispensing of generic pregabalin for the non-pain indications, but we believe it is incumbent on those involved to ensure that skinny labeled generic products are not dispensed and used for pain.
In this regard, we believe the patent may be infringed, even potentially unwittingly, by pharmacists and others in the supply chain, if they supply generic pregabalin for the pain indication. Without information, guidance and practical solutions from the authorities, Pfizer believes that multiple stakeholders, possibly without realizing, may contribute to patent infringement which would be an unlawful act. This runs contrary to the government's established policy of rewarding additional research by the granting of a second medical use patent.
Weirder still is that Pfizer wants to make their stupid problem into everyone else's stupid problem. The fact that it's hard to enforce this kind of secondary patent is Pfizer's business, not doctors'. Doctors' duty is to science and health, not Pfizer's profit-margins. Scientifically, there's no difference between the two compounds. Doctors who prescribe generics leave their patients (or possibly the NHS) with more money to pursue their other health goals.And this brings us back to the problem discussed at the very top of this article. The entire pharmaceutical industry has built its business around the idea of artificially reducing supply -- rather than about providing more benefit (health). That's really screwed up. A good business focuses on expanding the benefit to users, not limiting it to charge more. Our patent policy has created incentives for exactly the opposite -- and that is having a massive impact on the health and well-being of people around the globe.
If your dumb government monopoly is hard to enforce, maybe you shouldn't be banking on it. But in the world of corporatist sociopathy, where externalising your costs on others isn't just a good idea, it's your fiduciary duty to your shareholders, Pfizer's actions are practically inevitable.
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Filed Under: alzheimers, brent saunders, demand, drugs, economics, epilepsy, forced switch, generic drugs, generics, health, health care, lyrica, monopoly rents, namenda, namenda ir, namenda xr, pain, patents, pharmaceuticals, pregablin, supply, worth
Companies: actavis, forest labs, pfizer
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None more vile than those that run pharmaceutical companies
Yeah, after reading what they were trying to do, I think they need to be pushed off the gorram cliff, and replaced by some other company that cares more about easing the suffering of their customers, rather than getting as much money out of them as possible, regardless of how much harm that will cause.
If the only way they can maintain their profits is by screwing over those purchasing their products, and adding to the suffering they are already dealing with, then they deserve to fail. Go broke for all I care, at this point they more than deserve it.
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Intellectual property needs to be reviewed in all fronts it seems.
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and google and youtube keep allowing everyone to post their independent videos and view them without paying me for it. how dare it. google should be taken down. i can't have competition. no one should be allowed to do anything without paying me what i ask for. you want to shoot a home video of a cat and post it on youtube you owe me royalties. that google and youtube doesn't pay me for the works of others is why they should stop existing. too bad they are a big giant Goliath that can defend themselves legally, politically, and in the face of public opinion.
and techdirt is a big problem here. free speech? no way. we own television and radio and we don't allow anyone who disagrees with us on these issues to discuss them. only pro-ip propaganda should be allowed to be communicated and techdirt is a huge problem for allowing anyone to disagree with me. it makes it that much harder for me to buy politicians through backdoor dealings when the public has figured out what kinda scam i am running. and every time i come here and complain and tell the same lies over and over everyone has the nerve to call me out on it and point out how foolish and dishonest my posts are. they make me look like a fool. how dare they. now almost no one pays as much attention broadcasting and television media that we have spent good money on wrongfully buying politicians to own. we owned the media, stole these communication channels from the public, so that no one can disagree with us and here is everyone disagreeing with us and their collective voices have political influence. we can't let democracy make laws. i need to decide the laws so that i can sit around and make money off the work of others.
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Intellectual property need to be abolished.
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good one...
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Then you, sadly, are part of the problem.
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Crooked men, like crooked rivers, always follow the path of least resistance.
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There is far more money
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Scaring pharmacies too
A Pharmacists wouldn't usually know if a doctor has prescribed a medication for pain instead of epilepsy. So the risk-averse pharmacy may eliminate this generic from their racks altogether (regardless of the use).
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Re: Scaring pharmacies too
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Recommended Viewing ...
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Plant Patents
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Re: Plant Patents
Also, cannibis itself cannot be patented. According to the USPTO, here is the summary of when you can patent a plant:
(http://www.uspto.gov/patents/resources/types/plant_patents.jsp)
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Reverse the "worth" matrix a bit...
"Cost" of a life - priceless.
"Cost" of medication - outrageous.
This hits home as just one of my medications that I "have" to take to stay alive costs approximately $7k USD a month.
Penalty to a drug company that prices a life-saving medication so high that people cannot afford it and therefor die... every last dime they've ever made or ever will make.
Sounds about right to me.
Let's start suing pharmaceutical companies who's drugs are so expensive that people have to choose between Food and other essentials and medications and end up dying because the person starved if they chose medication, or died because they chose food instead of the medication.
Let's sue the pharmaceutical companies for pain, suffering and mental anguish due to the high prices causing our standard of living to drop below the poverty level.
I might end up liking this game where we can blame the pharmaceutical companies for middle-class submersion to lower-class citizens without any of the government handouts that go with that status.
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reminding kampers of Big Pharmas bullshit...
DO NOT let them blind you with their smoke and mirrors: they spend a LOT MORE on MARKETING than they do R&D...
a LOT...
AND a LOT of so-called R&D is really marketing bullshit in disguise: will we sell more pills if they are this shape or that shape? will we sell more pills if they are that color or this color ? etc, etc, etc... that is ALL marketing bs, has NOTHING to do with the delivery or efficacy of the drugs...
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Re: reminding kampers of Big Pharmas bullshit...
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The way that drugs are approved for use is similarly suspect, based on the method of production rather than the composition of the product. Then again, it's only in the last few decades that more complex antibodies could be analyzed so accurately. And nobody has ever accused the government of adapting.
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it's about "values" alright...
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Oh, right. Mike Masnick hates patent law.
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Oh, right. Mike Masnick hates patent law abuse.
FIFY
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In my opinion, the abuse should result in:
1) Punishment for those responsible. (About a week in jail)
2) Ending the monopoly for those two drugs. (Making Namenda IR/XR generic)
3) Reducing the duration of exclusivity for that corporation. (Shaving off 1 year (5%) for any patent the company holds, now and in the future. The reduction should be inherited through any fusion, split, trade with "IP", bankruptcy and so on)
This might be meek compared to the abuse, but will at least give some motivation to not abuse the citizens rights.
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If it were a free market, we wouldn't have this problem to begin with. The issue is the pharmaceutical companies accepting the government distortion of the free market (patents) and then abusing it to the detriment of the public. If we're going to set up a system to limit competition, there need to also be safeguards to make sure that system isn't abused. The last thing these companies want is a free market.
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What we seem to have is a business that works just like every other business. It provides goods to the public at a price it believes the market will bear. If you do not like the price then purchase something else.
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Whatever company gets the patent has a monopoly on that drug. So yes, they're being told they cannot manufacture the same product, thus competition is limited.
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As for patents being non-competitive, I can think of no instance where one who needs a product or service for a particular use is unable to do so because one embodiment of an available product or service happens to have an associated patent. It is foolish and irrational to believe otherwise, in part because products and services secured by patents are virtually never the only game in town as no suitable substitutes are available.
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If you're interested, try looking for stories about medical patents in particular. I'm sure you'll find plenty of examples of patients unable to afford treatment because of patents.
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There is one possible solution to what seems to trouble the principals and so many readers of this site. Start your own companies and run them with your collective notions of how you believe others should be running theirs.
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Are doctors or hospitals abusing a government granted monopoly position to raise prices? If so, then the monopoly should be abolished or another solution should be found to prevent them from doing that. If not, then it isn't an analogous situation.
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Namenda
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It is particularly bad in this case because of the sickening ethical and morality issues, and because what they were trying to do might be illegal.
This is why you need strong government. We all need someone who can fight against this and stand up for the public's interests. Government may not do this well, nor as often as they should, but they can, and do from time to time. And governments are more likely to respond to people then large companies are (see Comcast).
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I will if I get around to it, but that's an unnecessarily high bar. Even if there are alternatives, they may not be as effective, or may not be as effective for certain people, or may also be patented or otherwise expensive or hard to get. Just because there's an alternative doesn't mean there's no problem.
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AC, look it up. You're owned. Off you go.
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There also seems to be a deep-seated belief here that a patent somehow, and quite magically, gives a patentee the ability to gouge the public at large, with the fallacy underlying this belief being that a drug covered by a patent sits all by itself in the marketplace with no competition whatsoever that serves to influence pricing decisions. Maybe such a situation has actually arisen in the past, but if it has I have certainly never heard of it. Every drug I have ever encountered, under patent or not, has other drugs of similar therapeutic efficacy that are available from other unrelated and independent suppliers. Are you seriously suggesting that the availability of suitable products from a multiplicity of sources does not have a price restraining effect on a drug that happens to be under a patent? I submit it is utter nonsense to even make such a suggestion, but such suggestions are made all the time here both by this site's principals in their own right and by their constant approval of similar suggestions from others of like mind. The term "confirmation bias" comes to mind, and when it comes to drugs and patents it is in full force here.
Do not get me wrong. People are not saints, and certainly can do things that strike most of us as cold hearted, mean, and morally/ethically suspect. Even so, in the case of a drug for treating a medical condition, unless everyone who has a product for treating the condition has engaged in collusion amounting to price fixing, pricing decisions are generally made based upon a "what the market will bear" analysis, and I see nothing wrong with this since alternatives abound (just like there are alternatives to the Bugati I would like to have but cannot afford, and those alternatives are perfectly fine in meeting all of my needs and desires other than "supercar-mania").
Now, if you can find me an example of a situation where there are absolutely zero alternatives we can begin to have a discussion that is based upon fact and not fancy. Like I said, I have never seen such a situation during my professional career, which has involved at times work on behalf of several well-know domestic and international pharmaceutical companies. I have also worked with medical research institutes, durable medical goods developers and manufacturers, etc., and even as to them my preceding observations hold equally true.
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Again, why is that the only situation you're interested in discussing.
my professional career, which has involved at times work on behalf of several well-know domestic and international pharmaceutical companies.
Somehow I don't find that at all surprising.
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Yes, a very modest amount of my time over the past 37 years has involved matters associated with a few pharmaceutical companies. Most was associated with trademark law. Patent law? Prosecution? No, since I have not engaged in a chemical practice. Other? Yes, but only to the extent that expertise in chemistry is not a necessity. To the core though of your snide remark, you want others to believe that one who has represented the legal interests of such companies is obviously biased. Try this on for size. Perhaps it reflects not a bias, but some familiarity with the industry sufficient to recognize when critics are uninformed about the industry and trying to come across as experts on subjects about which they are woefully ignorant.
As a lawyer I engage in fact-based discussions. All I have asked here is for an example that can be substantiated so that such a discussion, one of fact versus fantasy, can take place. Provide one and we can have a thoughtful discussion from which we can each learn something. Keep dodging the question and all we will have is another typical TD experience regarding the subject matter of the article.
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http://www.globalissues.org/article/52/pharmaceutical-corporations-and-medical-research#Hidingb ehindpatentstopreventlegitimateandcheapergenericuse
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