Topic
Viagra judgment serves stunning reminder of the patent 'bargain.'
Pfizer, maker of Viagra, told by court its patent 'obscured the true invention.'
Should Amazon be able to patent 'one-click' shopping?
The House of Commons Committee on Industry, Science and Technology has spent the past few months hearing from a myriad of companies on the Canadian intellectual property system. With few public interest groups invited to appear, one of the primary themes has been the call for more extensive patent protections, as witnesses link the patent system to innovation and economic growth.
While policies that purport to help the economy unsurprisingly generate considerable support, the Supreme Court of Canada recently provided a powerful reminder about the true purpose of patent law in a decision involving Pfizer's patent for Viagra, the well-known erectile dysfunction medication. Teva Pharmaceuticals, one of the world’s leading generic pharmaceutical manufacturers, had lost successive challenges against the Viagra patent, but managed to pull out a win when it mattered most.
Proponents of extending patent law often focus on the benefits of encouraging innovation that may come from offering patentees exclusive rights to their invention, yet the foundation of the law is about striking a balance between public disclosure and exclusive rights to the invention.
The law includes disclosure requirements that mandate that the patentee "correctly and fully describe the invention." In this particular case, Pfizer failed to actually describe which chemical compound was effective. This led the trial judge to remark that the disclosure "plays games with the reader."
Basics of the bargain
The Supreme Court was seemingly in no mood for such games as it reminded the parties that the patent system was based on a bargain that Pfizer had failed to meet. In a paragraph that is likely to be quoted for many years, the court stated:
"The patent system is based on a 'bargain,' or quid pro quo: the inventor is granted exclusive rights in a new and useful invention for a limited period in exchange for disclosure of the invention so that society can benefit from this knowledge. This is the basic policy rationale underlying the Act. The patent bargain encourages innovation and advances science and technology."
Disclosure is therefore a crucial part of the patent bargain. The court clarified that this involves not only a description of the invention and how it works, but rather a much more practical level of disclosure "to enable a person skilled in the art or the field of the invention to produce it using only the instructions contained in the disclosure."
In this case, the court found that Pfizer failed to provide sufficient disclosure, since the pharmaceutical giant "obscured the true invention." Pfizer argued that this should not result in invalidating the patent, but a unanimous court found no other alternative. The immediate effect is that the Viagra patent is therefore voided in Canada, which will allow for generic substitutes.
Innovation only one goal
While some have tried to downplay the significance of the decision -- the Viagra patent was scheduled to expire in 2014 and Pfizer filed a motion last week for a rehearing -- the real importance lies in the court’s unequivocal assertion of the need for balance in the patent system and the broader societal benefits that must accrue in return for patent protection.
Innovation is a laudable goal, yet the court has reminded Canadians that it is only part of the patent equation. Pharmaceutical companies will undoubtedly continue to lobby for more extensive rights before Parliamentary committees and in trade agreements, but the policy focus from governments and courts should be on ensuring that the "patent bargain" remains intact. ![[Tyee]](http://thetyee.cachefly.net/ui/img/ico_fishie.png){kind=small}
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Bob Watts
25 weeks ago
?
It's HARD to know just what to say!
$25.00 per pill, for a drug that cost 2 cents per pill, to make.
Funny the rich get Viagra and the rest of the population gets antidepressants that kill sex drive!
Yep all is normal!
Maybe we'll now find out that Viagra is the cure to depression, LOL....
DavidG
25 weeks ago
Bob Watts
@Bob Watts,
Maybe 2 cents to make, but $200 million to develop.
And in order for a drug company to stay soluble, a successful drug has to pay for the development costs of all the drugs that failed.
Sometimes a drug fails at the research stage (bad), sometimes during testing (worse), and sometimes after it's been released to the public (catastrophic, for everyone).
If drug companies can't make money, they won't develop the drugs that fight cancer, lower high-blood pressure, and so forth. In order for a market to properly function, there has to be the opportunity to make profit.
According to the Supreme Court (and relayed by Michael Geist), Pfizer didn't play fair when submitting their patent claim. They wanted all the benefits of the patent system, with none of the costs.
And as an aside, I suspect that anti-depressants aren't cheap either, and there is evidence that they don't work that well (unlike Viagra).
FatherTheo
25 weeks ago
Innovation
They did a virtual reality examination of the issue of what kinds of rules promote the greatest level of innovation. Hands down it was the sharing of knowledge that worked the most effectively. Paying people to innovate (as through copyright schemes, etc.)didn't work anywhere near as well.
The wider information was shared, the more innovation there was that was taking place. Market ideas like copyright in fact slow innovation by keeping ideas out of circulation.
metacomet
25 weeks ago
Under Which Shell?
Not sure how much development cost can be attributed to a pharmaceutical that was developed for one use but coincidentally "discovered" to affect another, unintended use like Viagra was: the surprise affect on erectile disfunction was a bonus.
Being permitted to gouge the pants off of impotent men was a bonus too, a very, very big bonus. Big Pharma scientists probably got a big bonus too, just thinking about it...I mean, of it.
Anyway, even if it did cost $200 million to develop, for whatever intent and for whatever regulatory hoops required for the unintended use, Viagra has sold billions and billions of these pills, surely enough to have put the costs to bed a long time ago.
igbymac
25 weeks ago
DavidG
It's pretty apparent to me that you don't understand the pharmaceutical business model at all. Drug companies do not make, and have no intention of ever making, any drugs that prevent disease. They consistently make drugs that address the symptoms of specific diseases, while these same drugs also provide a huge list of detrimental side effects in the process.
Over 100,000 people in the USA alone die every year from properly taking their prescribed medicines. This is not an inconsequential number. Illegal wars have been launched for far, far less. And let's not forget the amount of money pharmaceuticals spend each year in advertising, and in lobbying the same folks who, in their wisdom, launch these illegal wars. My point is the problem is systemic.
The reality is that the vast majority of modern chronic degenerative diseases are traceable to poor, and far less than optimal, nutrition. But if that word got out, despite being scientifically understood quite comprehensively for half a century, the pharmaceutical trade would dry up.
And your doctor doesn't know much, if anything, about it. This is not the modern medicine taught in our universities, or the information provided by the same drug companies through advertisements with the population and the medical community.
The clear proof of what I say is in your words, where you understandably suggest that these pharmaceutical companies are looking for a cure to cancer. Well, man tends to only hit that which he aims at. And curing cancer is not the target. The target is addressing the symptoms of cancer to allow its victims to carry on alive despite the diseased state persisting.
For there is no money in health, and there is no money in death. All the money is in the middle ground, where people remain diseased yet are able to carry on functioning. That is, functioning enough to pay their taxes and to continue buying cures in one pill form or another from the Pharmaceutical Industry.
We boastfully claim we are living longer now than ever. And in the purely mathematical sense that is correct. Less children are dying at child birth, and less people are being maimed and dying from injuries. Those two factors alone contribute much to the analysis. Yet more of us than ever are also inflicted with disease for much of our lives.
One notable signal is the obesity epidemic, which is actually a nutritional based disease. Counter-intuitively, many of the same signs of a nutritional deficiency is found in the blood work of the morbidly obese as the anorexic. In reality we can summarize our state of health as a malnourished population which is dying for too long.
Bernardo
25 weeks ago
@DavidG -- that's the propaganda
Big Pharma is the acknowledged most profitable sector of the American economy.
Yes it is very expensive to develop and test new drugs. Especially the testing (lab tests, animal test, human tests), but then most of the really basic research is done at universities on the public dime, and the big pharmaceutical corps take up what looks most promising.
"Most promising" means "most profitable" -- there are known examples of very promising treatment that were dropped because it was decided it wouldn't pay enough -- such as simple chemicals that were already cheaply available (hence not patentable) or patentable new compounds that were an excellent treatment for significant diseases, but dropped because the diseases were characteristic of third world countries that couldn't afford the high price (but produced anyway when proving attractive for high-end facial/beauty-creams),
We don't live in Lloyd C Douglas's world any more (if we ever did).
DavidG
25 weeks ago
@igbymac....
First, "I apparently don't understand the pharmaceutical industry" is an "ad hominem" attack (Latin, for "to the man") and is a logical fallacy - trying to make my argument wrong by attacking me personally.
Second, "Drug companies do not make, and have no intention of ever making, any drugs that prevent disease."
They have, and do, make drugs that prevent disease. The flu shot is an obvious and simple answer. As are many vaccines we all get as children. Vaccines for AIDS, and drugs to prevent Alzheimer's are also in the works.
If you are correct, why would a company market a polio vaccine when they could make more money selling wheelchairs?
Other diseases are life-style/environment/genetics, and getting them or not getting them is a bit of a crap-shoot. This is no possibility of a drug that will "prevent" cancer. They're all very different. There are even multiple types of breast cancer. And you might not get it.
But drug companies are coming out with tests to get an idea of your odds of getting a specific type of cancer. While not prevention, it allows women to make the choice to have a mastectomy if the chances look grim. Why would they do this if they could make more money manufacturing chemotherapy drugs? Well, if they don't market the test, someone else will. Maybe they don't make chemotherapy drugs, and to get one approved is daunting to say the least.
I am in no way defending the medical system, that responds to diseases rather to prevent them. Yes, when doctors aren't available to fulfill prescriptions, patient deaths go down - doctors are over-prescribing. But while related, the medical system and the pharmaceutical companies are not the same thing. You're muddying the waters.
DavidG
25 weeks ago
@Bernardo
Yup - you're correct. There isn't much work done on advanced ant-malarial drugs. Not because you make more money treating the symptoms, but because the people that would need them are too poor to pay.
AIDS vaccines are also too expensive for Africa. So what happens? The African states pass a law that allows local companies to produce knock-offs. That might be why Pfizer did not go into (enough) detail on which compounds worked, and how/why.
It's not market system is not perfect, but it's better than all the others that have been tried (to paraphrase Winston Churchill). It's up to governments to step in and do something when the market does not provide incentive.
igbymac
24 weeks ago
DavidG
I am not attacking you, I am attacking your source of information and the views you are espousing because of that information.
Secondly, chronic degenerative disease is what I am talking about specifically, and admittedly that wasn't absolutely clear.
As for cancer, since you bring it up, it is another chronic degenerative disease which is linked to poor nutrition. It isn't an infection or something one can get a vaccine for. (Nor is Alzheimers which is also a chronic degenerative disease linked directly to less than optimal nutrition. FYI, there are over 70 such degenerative diseases.)
For the most part, cancer is caused by free radical damage to the nucleus (where the DNA sits) of the human cell. Once damaged it either dies or starts to reproduce bad copies of itself. Free radical damage occurs because the cell is both vulnerable due to degradation caused by deficiencies in the diet, and because it is under attack brought on by excessive oxidative stress.
I suspect you think heart disease is also something that can be cured with a pill, and that high cholesterol is the problem. I say this because that is the mainstream rhetoric. So have you asked yourself the simple question, why,after 40 years of lowering cholesterol counts across Canada and the USA, is heart disease worse now?
It, too, is a dietary problem. But have no fear, the drug companies will continue to propagandize that when your diet and exercise regime is insufficient, they have a pill for you.
The solutions are known, and have been known for centuries. Hippocrates said around 2400 years ago, "Let food be thy medicine, and medicine be thy food". Today our food supply is degraded so we must do something more. Any idea what that might be?
igbymac
24 weeks ago
DavidG
I must respond to your allegation that I am muddying the waters between the medical system and the pharmaceutical corporations.
Let me say this, but when the pharmaceutical corporations steer political policy on health, when they fund vast amounts of medical research in the universities, when they set the parameters regarding the interpretation of the research results, when they in part control the content of the medical texts read by the doctors in training, and when they are relentlessly disseminating information about their 'research' or new miracle pill to the general medical community, I take strong exception with your view.
In short, it is critical to understand the muddied waters between health and pharmacy in our modern world. Otherwise one is operating in a world of theory.
DavidG
24 weeks ago
igbymac
I don't believe heart disease can be cured by a pill. I believe lifestyle (diet, exercise) plays a huge role in chronic disease.
I am suspicious of the link between saturated fat, cholesterol, and cardiovascular issues.
I believe sugar, processed foods, and lack of exercise are more likely to be the root cause. I don't eat sugar, or processed foods, and I buy pasture raised organic beef and poultry.
But I am not willing to paint the entire pharmaceutical industry with the same paint brush. There was a collective belief in "things", like hydrogenated fat was better than saturated fat, that carbohydrates were less risky than saturated fat, and evidence has cast doubt on that.
Studies conflict, and advice is contradictory, and I suspect it will be a few decades before there will be consensus again. And when there is, it still might be incorrect.
As for cancer, it is believed that a quarter of cases are genetic in origin, a quarter environment (chemicals, asbestos, etc), and the other half are lifestyle.
So... to sum up, drug companies make drugs to cure disease based on scientific hypothesis (and they do test drugs). Some disease is not preventable by drugs. Chronic disease can often, but not always, can be prevented via lifestyle.
There is a connection between large pharmaceutical companies, medical schools, doctors, and politicians. In some areas, government relies on experts to help craft legislation, as they do not have the expertise to do so. Medicine is one such place.
I believe that drug companies advance their own agenda, as do all for-profit entities, and perhaps have more opportunity, due to the highly technical nature. So do nurses, doctors, teachers.
And like nurses, doctors, and teachers, I also recognize that drug companies they do a tremendous amount of good.
igbymac
24 weeks ago
DavigG
Well, what ever contribution attributable to genetics is minimal, but for the poor person with the weak link, in terms of chronic disease. Cholesterol is for the cause of heart disease, certainly not the way it is portrayed in the rhetoric. Forty years of lowering cholesterol and more cases than ever. It is oxidized LDL levels and homocystine levels that are far more indicative of a problem coming he's way. But there aren't drugs to lower these symptoms of lifestyle, so we don't hear about it.
I have unchallenged reason to believe that virtually all chronic degenerative diseases are attributable to vitamin and mineral deficiencies over the long run, coupled with oxidative stress no longer relieved through our degraded food supply.
Thanks for the informed exchange I always love talking nutrition and health ;)
igbymac
24 weeks ago
I'd take exception with a" tremendous amount of good"
... considering how much better things could be if political footballs like these were not driven by policy controlled by profiteers. In my opinion, there is scant little said by state that isn't shrouded in a lie.
justin_m
24 weeks ago
Justin
Generics has already suppressed many brand drugs. Because of lower cost people are able to afford generic drugs like generic version of Viagra e..g Kamagra , Caverta etc. , . However Brand drugs are gud & effective but due to high cost most of the people can't able to afford it.
So Big companies having patent should always try to produce the product in such a manner that it will be proved to be the best (both in price as well as effectiveness ). Big companies are definitely there for profits, but if they produce the affordable product which will be effective, cost you less , surely they will have increase in profits.
Justin
you can find more info. on generic drugs at http://www.medstorerx.com
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