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Medicine Patents United States

Judge Rules Drug Maker Cannot Halt Sales of Alzheimer's Medicine 266

HughPickens.com writes Andrew Pollack reports at the NYT that a federal judge has blocked an attempt by the drug company Actavis to halt sales of an older form of its Alzheimer's disease drug Namenda in favor of a newer version with a longer patent life after New York's attorney general filed an antitrust lawsuit accusing the drug company of forcing patients to switch to the newer version of the widely used medicine to hinder competition from generic manufacturers. "Today's decision prevents Actavis from pursuing its scheme to block competition and maintain its high drug prices," says Eric Schneiderman, the New York attorney general. "Our lawsuit against Actavis sends a clear message: Drug companies cannot illegally prioritize profits over patients."

The case involves a practice called product hopping where brand name manufacturers make a slight alteration to their prescription drug (PDF) and engage in marketing efforts to shift consumers from the old version to the new to insulate the drug company from generic competition for several years. For its part Actavis argued that an injunction would be "unprecedented and extraordinary" and would cause the company "great financial harm, including unnecessary manufacturing and marketing costs." Namenda has been a big seller. In the last fiscal year, the drug generated $1.5 billion in sales. The drug costs about $300 a month.
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Judge Rules Drug Maker Cannot Halt Sales of Alzheimer's Medicine

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  • by Mathinker ( 909784 ) on Sunday December 14, 2014 @09:42AM (#48593161) Journal

    The practice of tweaking drugs like that is called evergreening [wikipedia.org].

    (I'd only heard about that term being used for the pharmaceutical industry practice, but the linked Wikipedia article implies it is a general term for all patents.)

    • The saddest part is that the system is designed to permit this. It takes less effort to bring a variant of an old drug to market than it does a new one. You don't have to prove that it's as efficacious as the old one, let alone moreso; you only need to prove that it doesn't kill statistically significantly more people than the old one.

  • It is a terrible thing for the drug company to force this switch.

    But doesn't this imply that the first drug can be created generically now? Can't we take Actavis out of the equation entirely by having Alzheimer's patients switch away from the company? Why must they take Actavis' new drug?

    • My understanding is that currently a patent is still valid EVEN IF the drug is taken off the market. But I think that's the right solution: Change the rules so that if you take a drug off the market, the patent is immediately declared abandoned, and anyone else can make it.
    • Read the article. The first drug can't be created generically until July when the patent expires. By then Actavis will have switched everybody to the new drug.
    • Re:Scummy (Score:5, Informative)

      by Bengie ( 1121981 ) on Sunday December 14, 2014 @10:27AM (#48593341)
      According to the article, the issue is that doctors in many areas are not allowed to prescribe generics directly. They must prescribe the name brand, and a generic may be substituted if it is identical to the name brand. In this case, the name brand would no longer be offered, meaning the generics may no longer be offered.

      Sounds like big drug makers lobbied to have these stupid rules made, and because of the rules, we have technical issues that could harm patients if a name-brand suddenly pulled a drug from the market. It's much easier to force a company to keep producing drugs than it is to change decades of medical rules.
      • Re:Scummy (Score:4, Informative)

        by TubeSteak ( 669689 ) on Sunday December 14, 2014 @01:38PM (#48594469) Journal

        According to the article, the issue is that doctors in many areas are not allowed to prescribe generics directly. They must prescribe the name brand, and a generic may be substituted if it is identical to the name brand. In this case, the name brand would no longer be offered, meaning the generics may no longer be offered.

        You might want to re-read TFA.

        Most generic drugs are dispensed because state laws allow or require pharmacists to substitute a cheaper generic when a doctor prescribes the brand-name drug. But if the brand-name version is different from the generic, then the substitution cannot be made.

        Nothing about not-prescribing generics directly.
        That would be ridiculous and insane.

  • Can somebody please explain why BigPharma creates a medication X (consisting of components A B and C) and patents it, then halfway through its life creates X+ (consisting of A B and D) and patents it again, this affects the patent for medication X? I should be able to create a generic for X using the old formula (A B and C) when the patent for X expires, regardless of any patents for X+, or Y.

    • Then all that would happen is more lobbying to outlaw the old drug for some threadbare reason ("side effects" is usually cited. That the new drug has the same or worse side effects doesn't matter, oddly).

      If you need proof, just look up and down some of the latter drug laws and watch closely what has been outlawed and when, and whether you find some correlation with the date some drugs are approved. You might be in for a surprise.

      • Then all that would happen is more lobbying to outlaw the old drug for some threadbare reason ("side effects" is usually cited.

        Sound dangerous, like a pre-admission of guilt in a lawsuit.

  • Memantine (AKA Axura, Akatinol, Namenda, Ebixa, Abixa and Memox) has been around since 1968, why in the world is it still under patent? I fully understand why individuals/companies should be GRANTED LIMITED patents, and even why those patents should be longer for medical applications, but 46 years? From what I can understand the patent on this drug has been sold so many times its nowhere near the original developers, the constitution seems pretty clear that patents apply "to AUTHORS AND INVENTORS the exclu

  • by nystul555 ( 579614 ) on Sunday December 14, 2014 @10:25AM (#48593329) Homepage

    The summary doesn't make clear whats going on. I've been dealing with this personally for several months and what Actavis has been doing is terrible, the judge made the right decision.

    They have been making the drug in question, Namenda, for many years and it has become a critical component of treating Alzheimers and several other related conditions. It is an instant release form.

    There are no generics, it is still under patent until later next year. What Actavis did was create a new version of the drug which is extended release, and patent that. Its the exact same thing but with some coating that makes part of it release more slowly.Earlier this year they announced that they were discontinuing the instant release version, and they stopped manufacturing it.

    Again, there are no generics yet, and no alternatives. The point was to force everyone to switch over to the extended release (which they have the patent on until 2025) BEFORE any other company could start making a generic version of the drug. This would make it extremely unlikely that any generic company would start making it at all since sales would be low and margins on generic medications aren't high. Most generic manufacturers don't have much in the way of a marketing budget, so once Actavis has gotten everyone prescribing the extended release version it would be too difficult for the generics to get doctors to switch back to the instant release version just because there was a cheaper option. Additionally, you don't want to change an Alzheimers patients medication any more than you have to, and since Actavis is forcing them to switch from the instant release to extended now you wouldn't want to switch them back to the instant just a year later, unless you had to.

    To be clear Actavis stated all of this in their shareholder report. They were confident this plan would prevent generic manufacturers from taking any significant amount of the sales.

    To make this much worse, Actavis stopped making the instant release without making nearly enough of the extended release. Google Namenda shortage to see the affects this has caused. Nursing homes have been forced to give patients their medication every other day, or instant some days and extended other days, because there isn't nearly enough to go around. I had to fill a 30 day Rx for it in September and had to contact 44 pharmacies to find one that had any (I was lucky and it had just arrived). People have been flying to other cities, even other states to fill the medication for their loved ones. Its been terrible for anyone suffering from Alzheimer's or any of the other conditions that it treats, as well as their families and the people providing care for them.

    • Re: (Score:3, Interesting)

      by roman_mir ( 125474 )

      AFAIC the market has to remain free, the company in question must be able to do this of-course. The actual problem is government issuing patents in tge first place. Patents and copyrights protected by governments are the actual problem. Beyond that the government rules that doctors must prescribe the brand name and can only prescribe generics if they are exactly the same is a problem. FDA is the problem, it should not even exist. Blaming a company for HACKING the government laws to extend its own profi

  • Murder for profit (Score:5, Insightful)

    by Required Snark ( 1702878 ) on Sunday December 14, 2014 @11:02AM (#48593481)
    At best, this is gaming the system for guaranteed profit. At worst, it's murder for profit.

    This is not an environment were the consumer can just automatically go to another vendor. The myth of a free market does not apply because there is no parity between the user and the producer. Although generics exist, they cannot always be substituted, and sometimes they don't even exist.

    Medical companies are profit driven to the extent that they cannot be trusted. They routinely lie about both the safety and the efficacy of their products. This puts the health and even the lives of patients at risk all the time.

    For example, De Puy/Johnson and Johnson [wikipedia.org] produced metal on metal hip implants, and their own internal data showed that they were failing at a high rate and requiring additional surgery. Additionally, metal fragments were released into the bodies of recipients and causing metal poisoning. They decided to phase out the product because of "declining sales" and did not do a recall or inform doctors or the FDA.

    At the beginning of 2010, DePuy Orthopaedics said they were phasing out the ASR Hip Implant because of declining sales, but never mentioned the high failure rate data from an Australian implant registry. In March 2010, the New York Times reported that DePuy issued its first warning to doctors and patients about the high early failure rate. However, at this point, they still had not issued a recall of the product. In fact, they claimed any statements referencing a recall were false.

    Regulation is a necessity because the history of drug and medical equipment is filled with business practices leading to horrible outcomes, including needless death.

    In addition, drug companies get huge direct and indirect subsidies from the government. A lot of the basic research is government funded and handed over the the drug companies at no cost. When a drug is going off patent, it is legal for the patent holder to pay other drug companies to not produce generic versions. This is the polar opposite of free enterprise. It's legalize collusion to maintain state sanctioned monopolies.

    I'm routinely baffled and angered by self-styled "defenders of capitalism" who excuse dangerous and grossly anti-competitive business behavior. If the government did things like this they would be screaming like stuck pigs, but when the same or worse is done under the flag of capitalism it somehow is transformed into a sacred act, and negative consequences are left out of the picture. It seems obvious to me that the same kind of scrutiny should be applied to any big organization. Only being critical of one side is just stupid. Stop doing it.

  • There is already a well established practice by which the Government can show public interest, take over private property (after compensating the current owners) and use it for public purpose. In fact courts have ruled govt can even turn over the properties taken under eminent domain to other private parties! Why should the eminent domain be restricted to real estate? It can easily be extended to intellectual properties.

    So instead of making general law changes asking for broad restrictions to patented drug

  • Fuck your patents. We're making it anyway, you just lost your privileges to do business under normal business rules. The drug and any derivatives of it become public domain, and any knowledge you have relating to that particular drug becomes public domain. ALL OF IT, regardless as to how it relates to other work you have.

    Then, as stage two, take all the execs and every employee who didn't openly, publicly, actively work against this move out back and shoot them, preferably in a way that makes their death

  • " Drug companies cannot illegally prioritize profits over patients"

    actually, it's not illegal, and in fact what the judge is doing is directly against the Articles of Incorporation of the Company. if this is something you're not familiar with, watch the first few minutes of the Documentary called "The Corporation" or read professor Yunus's book "Creating a World Without Poverty". basically it is a LEGAL REQUIREMENT that the Directors of Corporations enact - pathologically and absolutely - the Articles of

  • i.e. if a patent is not used in an actual product it will go invalid after a short amount of time. I think a year or two at most should be sufficient. Same should go for copyright obviously. If the owner is not interested in doing reprints then it should be allowed for others to do so.

  • ....I invite you to compare the cost of health care in the US with that in just about any other developed country in the world.

  • by fnj ( 64210 ) on Sunday December 14, 2014 @01:52PM (#48594553)

    I freely admit to being absolutely mystified how the social compact of a supposedly enlightened civilization does not include basic nutrition, shelter, schooling and health care for all without direct charge. I am serious. I don't get it. With regard to the topic, this should include medical research including development of drugs, absent repulsive features such as some getting rich off the misfortunes of others.

    If you don't think society, with today's robotics, can afford to provide basic nutrition, shelter, schooling and health care for all without crass commercialism and people falling through the cracks, IMO you are an idiot; an ass. I say this as a believer in TRUE free enterprise (not necessarily corporatism with all the sickening corruption that goes with it). I just think these three necessities trump everything else, and a society is not worth having if it spurns providing them.

    Please note, when I say basic, I mean basic. The nutrition would be in the form of cost free provision of healthy but plain foods PICKED FOR the user and SERVED TO him. Shelter would be in the form of shared communal or semi-communal barracks. The health care would be limited to necessities for health. There would be no limit for what is truly needed, including dental and vision, but no pampering. If you want contact lenses instead of glasses, cosmetic surgery, sex change BULLSHIT, go ahead and pay for that shit yourself, but fuck you if you expect the pampering. If you want TV, cell phone, car and other pure luxuries, you pay. For free you would get lending libraries and communal computers.

    If you raise specific objections, for example the living spaces would not be respected because they are free, and people would let them become decrepit, there are ways to deal with this. I won't belabor the details here; I think it is fairly obvious given any serious thought given to the matter.

    You can be goddam sure there would still be a sizable worth ethic for those who desire more than the basics. Probably as much as, or more than, there is in the USA today. As it is, with provision of raw money to the "needy", some get to enjoy luxuries without working for them, while others fall through the cracks completely.

    I don't really think this makes me a "communist". "From each according to his ability" is pretty obsolete given the state of robotics today. And if you want o cede "to each according to his needs" to the communists, tell me why. I certainly don't see why the rest of us should cede the high moral ground.

  • by l2718 ( 514756 ) on Sunday December 14, 2014 @01:54PM (#48594565)

    The summary above is highly misleading, possibly because of the bad headline the NYT editor put on the story. The judge didn't rule on the merits at all. All he did is issue a preliminary injunctiion, which forces the drug company to maintain the status quo for the duration of the trial. The judge didn't "block an attempt by the drug company" he just deferred the attempt until the case is over. If New York wins its case, the judge will actually block the attempt by entering a permanent injunction.

    In other words: this ruling only reflects a judgement that, until we know who wins, it's better to force the company to keep the drug on the market, which is obvious to everyone. It doesn't reflect a judgement on whether the drug company may legally withdraw the drug.

  • Simple Solution (Score:4, Insightful)

    by pubwvj ( 1045960 ) on Sunday December 14, 2014 @06:12PM (#48596075)

    Use it or lose it.
    As soon as they stop making it they should lose the patent.
    It's a simple solution.
    Even limiting supply should trigger this clause.
    This also works against the patent trolls who never did use it.

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