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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.
...overturned on Appeal?
I'm sorry, that's just an insane ruling. REQUIRING a company to manufacture a specific product???
"I do not agree with what you say, but I will defend to the death your right to say it"
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.)
The company who makes it decided they wanted a new patent so they discontinued. They already had two versions of the medication but the second version was not prescribed as commonly. What's worse is that nobody knew this was going to happen, doctors or pharmacists. It took a few months to get an alternative in stock because of the sudden fake demand the manufacturer created throughout the industry.
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?
How do they insulate themselves from generic competition by stopping sales of their own brand name? If it's off-patent and there's demand then generic companies will offer it. If there's a sufficient advantage to the new one then doctors will order it in spite of the cost.
How does the new drug prevent generic clones of the old drug? If patients are used to the old drug and it works, wouldn't not offering it actually drive patients right into the open arms of generic manufacturers?
As we all know, Debian recently integrated systemd into its core system.
As we also know, systemd is rife with serious problems that just cannot be fixed. These are problems with its Windows-like, monolithic do-all-things-and-do-them-poorly philosophy that inherently conflicts with the UNIX philosophy of small applications doing one thing extremely well.
I see a parallel between this case and systemd. There's no beneficial reason for Debian to be including systemd; it's just change for the sake of change itself.
So I think that Debian should abide by the spirit of this decision, and come to the realization that unnecessary change is just that: unnecessary!
Clearly, this would mean that systemd should be stripped out of Debian. This would be change with a purpose: to restore stability, reliability, and trust in the Debian product and brand.
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.
We have a way to save you with a cheap drug but we are not gonna do it because we want you to pay a high price for your sanity.
And yes we sleep well at night because, as corporate lackeys, we have no conscience.
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.
When the copyright term is "forever minus a day", live every day like it's the last.
Stopping to make the original drug should cause immediate expiration of its patent. A patent is a government-created monopoly to encourage people to make the stuff. Clearly, if the company won't make it, there's no need for the patent. Requiring a company to make something they don't want to make is absurd; instead, just let others make it. And if they raise the prices substantially, perhaps require patent licensing in those cases (just as we did for music).
- David A. Wheeler (see my Secure Programming HOWTO)
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.
- David A. Wheeler (see my Secure Programming HOWTO)
...overturned on Appeal?
I'm sorry, that's just an insane ruling. REQUIRING a company to manufacture a specific product???
Yeah, I think so too. FTFA:
It obtained Namenda when it bought Forest Laboratories.
The drug, known generically as memantine, is one of Actavis’s most important products.
There's already a generic. So, what's the problem?
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 exclusive right to THEIR respective writings and discoveries".
I somehow don't believe the judge that he suddenly sides with "the patient". He's more likely in the age bracket that will be affected by his judgement in the foreseeable future.
We used to have a Bill of Rights. Now, with the rights gone, all we have left is the bill.
The main arguments in favor of governments regulating against evergreening are that rapid entry of multiple generic competitors after patent expiry is likely to lower prices and facilitate competition, and that eventual loss of monopoly was part of the trade-off for the initial award of patent (or intellectual monopoly privilege) protection in the first place.
You can also bet these companies got shed loads of tax breaks which helped cover costs of research.
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.
So people will switch to the new drug, which will cost a lot, just like Actavis does now. Then in July they switch to the generic, which will cost a lot less. What is the big deal?
either lead to legal proceedings against the executives responsible for these choices, or a Congressional Inquiry.
This isn't just a matter of scraping out some profit, this is intentionally compromising the safety and security of a significant portion of society. That sure sounds like either illegal behavior or behavior that needs to be codified as illegal.
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 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.
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.
Why is Snark Required?
So instead of making general law changes asking for broad restrictions to patented drugs, the government can make the case for specific patents, show the public interest, take it over turn to the generic manufacturers.
sed -e 's/Chuck Norris/Rajnikant/g' joke > fact
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 slow and painful.
The second time a drug company does something like this, the government takes their ENTIRE patent portfolio, makes it public domain and closes the company down, selling any physical assets they have to the highest bidder and any other intellectual property also becomes public domain. Yes this will have collateral damage for the first few that do it, and then this shit would stop. Share holders lose everything, maybe next time they'll think a little more about being greedy fucks and demand the company do the right thing rather than the profitable thing.
Persistent Volume manager for Kubernetes - https://github.com/dwimsey/openshift-pvmanager
" 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 Incorporation of a Company, otherwise they may either be faced with a vote by their shareholders to resign, or they may face jail time. ... and the Articles of Incorporation typically state that profit MUST be maximised to the absolute, total, complete, without fail absolute 100% top absolute top priority above all else WITHOUT fail.
so under the Articles of Incorporation of this Drug Company, saving lives is not a priority: making MONEY - the absolute maximum amount possible - is the absolute top priority.
so this judge's decision, therefore, was quite literally the only way by which those lives could be prioritised over and above the profits of the Corporation. you really should watch "The Documentary". its premise is that if a Corporation was a real person instead of a fictitous one, they give 10 reasons why that "person" would be locked up forever as pathologically and criminally insane. i no longer call Corporations "Corporations, i call them "Cancerations" because they pathologically consume all resources to further themselves with blatant disregard.
simple, really.
Having worked in pharmaceutical development for over 20 years, I can tell you this is VERY scary for your healthcare. The reason these "minor tweak" drugs are developed, is because they are, in some way, better than the original. In this case, the new formulation is a longer acting pill. This is a big deal for Alzheimer patients. One of the major hurdles for neurodegenerative diseases is dosing compliance. If you forget to take the pill, it doesn't work. If there are fewer pills to take, the chances of forgetting diminish, or a once-a-day aide can assist in medication. This ruling tells drug companies that investing in innovation to improve a drug is not worth the money. As to the continued production of the old drug, you can be assured that the originating company would not pass up the money from licensing the production and sale to another company. The plan probably involved dropping the older version of the drug for a time to build a market for the new drug, then introduce the old drug under a new manufacturer.
If you left it to the courts (which is what all Libertarian types like to do), you'd be decrying judges finding against doctors who prescribed under-tested products because that's not "free market" either.
Libertarian philosophy as I understand it is about coercion. A doctor knowingly or recklessly prescribing a health product that isn't right for a patient is coercing the patient. But if a doctor prescribes a product after weighing the risks and benefits, and a judge punishes the doctor for doing that because the FDA pulled the product from the market, the judge is doing the coercing, as was the product's maker who defrauded the FDA into pulling it in favor of the maker's new product.
They don't they just set the standards. Or should theree be no standards?
Let's just say that there are some standards willful violation of which shouldn't be a felony.
Why the fuck are profits the motivating factor!?
Because there are powerful people still alive who see socialism as the enemy because they remember World War III (also called the Cold War) against the Union of Soviet Socialist Republics.
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.
We've decided to exit the health care business because the requirements to manufacture drugs that are no longer profitable has left us an unprofitable company.
Then the market might be ripe for contraction. Sell your assets to another drug company that will benefit from economies of scale or synergy or whatever the marketroids are calling it today. Then start a video game company or something.
....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.
Il n'y a pas de Planet B.
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.
"You're right," Fisheye says. "I should have set it on 'whip' or 'chop.'"
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.
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.
The original drug company has one point that seem reasonable
It's not fair for the generic company to get a free ride for advertizing.
Aside from that, not so much.
The patent office could be a bit more skeptical as to the patent for the slight modification to a near generic drug.
It's hard to see how these patents are useful or novel.
(Except for the novel business strategy they propose.)
The key thing supporting the generic is the NDDF code.
The FDA should not let the original manufacturer kill the code if a generic manufacturer needs it.
The trademark office should take the view that the brandname goes with the NDDF code after the patent expires.
The generic manufacturer with the same formula should be able to use the brand name.
(Perhaps with their company name as well.)
If the formulas are actually the same, this would not cause market confusion, but rather clarity.
All companies selling a particular generic would have the option to advertise for that generic brand.
They would all have the same risk that the prescription could be filled with a different manufacturer's pill.
This fixes the fairness of advertising question.
A pharmacist should be give a bit more leeway to use a generic with a different NDDF code for these few, specific cases.
Perhaps after a phone call to the doc, or a talk with the patient.
The FDA would have to setup a process for the generic company for ask for the specific NDDF pair and conditions to allow swapping between.
The problem is fixable in a reasonable manner in line with the intent of generics.
Which is why it probably won't happen.
That's the lie that Dow Chemical used to shut down competition when their Freon patents were expiring. Don't battle the government. Just tell them an implausible but unverifiable story, that conveniently vastly increases their regulatory power. Then sit back and let International Treaties to save the environment fill your bank account.
Crony Capitalism FTW!!
When judges and governments can dictate what a company can and cant produce, we have lost control.
Fascism is corporatism! Learn some history.
Governments bossing around corporations is at the opposite side.
Furthermore, if you believe it is a democratic government then the government is "we" and therefore "we" collectively are exercising our control not losing it.
Democracy Now! - uncensored, anti-establishment news
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.
Before a patent holder chooses to stop selling a drug in quantity,
they should need FDA approval.
The FDA should be able to require sufficient lead time to bring a generic vendor on line
with the assurance of no patent problems for the generic vendor.
Perhaps with a minor royalty payment until the patent runs out.
The monopoly that comes from the patent is a bargain with the public.
For something lifesaving like a drug, the bargain should not include gaming the system.
It's hard to see how this rule should apply to something like Viagra.
A patent examiner shall issue a patent to an inventor so long as the inventor can prove that an invention is novel, useful, and non-obvious. On which of these three grounds shall the examiner deny the patent?
It's not novel or non-obvious because it is nearly identical to the previous drug formula. And does not seem to confer any significant useful benefit, but it does juggle some of the side-effects around.
We should deny double patents, that is the patenting of something that is already patented for the purposes of extending the patent by another 20 years.
The most disturbing point is that there is not yet any efficient drug against Alzheimer's disease. This company just want to sell snake oil for a higher fee for a longer time..
This is a federal judge, not a federal appellate panel. The company will pay to have amazing representation on appeal and is much more likely to win.
A better strategy would have been to get the old med banned for some reason which would force people on the new med and keep generics from cropping up at some point.
Seriously, if a drug company decides to stop making a drug, the patent should automatically expire.
No matter where you go, there you are.
This judge was smart, he probably knew his judgement will be reversed on appeal but he knew it would take at least a year to make it through the appeals process. Since the patents expire next year the company's plan is screwed. The judge's message to the company was a big fuck you.
This problem is simple to fix, no lawsuit needed.
If you refuse to manufacture a thing that you control with patents (or copyright or any intellectual property), then your IP claims become invalid. No exceptions.
Oh, what? You want to keep manufacturing that drug after all? Okay, great.
Like yours, a rhetorical question since you don't give a shit what the answer ACTUALLY is, you merely wish to infer that "None, ergo the idea is why India has no patents!".
WRONG.
Continue with manufacture of quantity x or license the patented drugs for manufacture by others. Court oversight, years of legal maneuvering, etc. Fear of civil litigation ought to keep the manufacturer in line.