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Judge Rules Drug Maker Cannot Halt Sales of Alzheimer's Medicine
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.
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.
The practice of tweaking drugs like that is called evergreening.
(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.)
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.
Were the drug company sending hit squads round to take out the doctors that were prescribing generics? Did they launch a tactical air strike on the generics factories? Hijack the lorries carrying the generics?
I'm sorry but, so far as I can tell, manufacturers are free to manufacture the generic, doctors are free to prescribe it and patients are free to take it. I don't see why Actavis should be forced to produce a drug they no longer want to produce and I don't see what this can possibly achieve because once the drug leaves patent protection the generics manufactures will be able to manufacture it regardless and, before then, patients will have to buy the pricier brand-name drug anyway.
I don't think the patent had actually expired yet on the older medicine. It was just getting close to expiring. Drug companies have figured out the 'new' way to keep you off of generics is to 'improve' the formula so that your doctor wants to keep you on the new one. I'm on Tribenzor, which is literally just a mix of three regular and cheap blood pressure medicines, but it's 'not generic' so I have to pay a much more expensive rate.
So yeah, this is just scum sucker scam way of maximizing profits at the cost of the patient and his insurance.
No! It's a *SIG*. Keep the Special Interest Groups away! (Con joke!)
The term for the old drug has not run out yet, it is still patented, so there is no competition yet.
read the fucking article. they plan to continue making it but only for certain 'special needs' patients.. so the judge is just telling them they can't restrict distribution but must make it available to all. makes sense...
further, the company is by far the largest producer of the drug worldwide, generic or namebrand, and its market share likely triggers antitrust provisions for it.
the new version, btw, is only the same fucking drug, just in an 'extended release capsule' instead of a 2x daily tab. one of the easiest and most common ways a drug company pulls this shit.
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.
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.
I couldn't agree with you more. It's not illegal currently but should be. Alternatively as others have suggested, if you stop making a medication other companies should be able to make a generic version.
Others have called this "ever-greening" but that's not completely right. The Namenda XR is evergreening but what Actavis/Forest (it was Forest when this started, now they are part of Actavis), what they have been doing is known as a "forced-switch" and has only been tried a few times. Its been extremely effective. Companies normally lose 90% market share when a generic comes out, but if they've done a forced-switch a year or more in advance it is usually only around a 25% loss.
Forest (now Actavis) has been desperate since the patent expired on their other blockbuster drug, Lexapro, in 2012. This was an attempt to retain the marketshare of their other blockbuster, and would have worked if they hadn't screwed up the implementation so badly. Forest cut over $500 million from their RnD and manufacturing budget in the last 2 years which I'm guessing is part of why they couldn't ramp up manufacturing of the new extended release quickly enough. Drug makers have to report on shortages and potential shortages to the FDA, and Forest/Actavis was fully aware that they could not make enough of the extended release to cover all the people they were forcing off of the instant release. However they decided to stop the manufacturing lines making their instant release anyway, since they knew the longer they kept making the instant release the more market share they would lose to the generic manufacturers when the patent expired. They really are scum.
2) I can cease production all I want and not have the patent voided, as long as I do not switch production to a different drug designed to do the same thing.
So, you were saying?
You really can't see the loophole in that? The new drug isn't designed to do the same thing. It would do something slightly different. Sure, you could try to reword that, but that's the difficulty with creating laws...you either get too broad and have unintended consequences, or you get too specific and someone finds a way around it on a technicality you didn't anticipate.
In the U.S. there hasn't ever been an exploitation requirement per se. The only kind of IP that explicitly requires action by the holder is a trademark, which they're required to aggressively defend at the risk of losing it otherwise. However, it used to be that you could file an application and tie up the approval process for years without it actually being issued, which effectively let you secretly hold a patent as long as you wanted and have it formally issued only when it was to your advantage to do so. About 20 years ago the U.S. changed patent terms from "date of issuance" to "date of filing", so the clock now starts ticking when you first send in the application.
Please stand clear of the doors, por favor mantenganse alejado de las puertas
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.
[Fuck Beta]
o0t!