India recognizes patents just like anywhere else. What they don't recognize is when drug makers trivially re-formulate their drug upon patent expiration in such a way that the old medicine cannot be made generically without also infringing on the new patent. India called BS on that, and rightfully so. Now millions of people in India don't have to die because even though a drug company made several multiples on their investment already, billions in exclusive profits per year still isn't enough.
Edited to add: This is informally called "Evergreening". I'm not an expert in that field but you can read more at http://en.wikipedia.org/wiki/Evergreening and linked sources.
In this case, they wanted to charge Indians $2600/month, and the generic is $175/month. If you have this condition and do not take this drug, you die.
As an aside, the evergreening process has taken on frightening new faces in recent years. Drugs have been repatented with the same formula for 'new' purposes. Case in point is BiDil, an active ingredient repatented for race-specific use in African-Americans without alteration to a previously patented drug formula (the case of repatenting is in and of itself an interesting study, many in the field contest the trials that validated the repatenting as well as the concept of a race-specific drug, as there is no drug-relavent biological basis for race.)
Different races, ethnicities and people differ in subtle ways. People metabolize different molecules differently. However that still is no excuse to repatent a drug.
I agree, but the correct approach is more akin to feature detection in web browsers than user agent detection. i.e. Check for the presence of a disorder like sickle cell anemia than checking the ethnicity and inferring the probability that such a condition exists.
If they paid for the clinical trial then there should be some sort of protection for the person who paid. Otherwise it will be impossible to expand what a drug is used for after the patent expires.
Doctors may just use the drug off-label. If the patient responds then they use the drug, otherwise they try something else. A formal trial really helps very little in these cases.
If a bunch of clinicians find that the drug is effective against the condition, they can (as has happened so many times) make their own study to popularize the usage.
Remember: The safety of the drug is not in question, just the efficiacy.
But how do physicians know it works if trials aren't run? You can't go by anecdotal evidence.
Hell, look at the huge niacin trial that Merck ran. Doctors have been prescribing it for 30 years and you know what? It doesn't help. Unless a massive clinical trial was run, you'd never know whether it was worth prescribing.
This is a valid point. While I won't dive into the qualms that stem from pharma companies funding and subsequently selectively choosing their trials, the case with BiDil is particularly curious [1].
When BiDil was patented, studies were carried out using _only_ African-American subjects, such that the race-specific efficacy was never actually tested. As such, the basis for the entire patent, which hinged on race specificity, has been challenged by some in the field. In my post above there's a link to a paper that came out one of the trials.
[1] - If you're interested, Ben Goldacre has a really interesting talk on the subject.
FDA already gives a special monopole privilege after clinical trials. FDA want to encourage companies in doing clinical trails, including on drugs which has an expired patent.
Evergreening is companies seeking monopole privilege after that original patent protection and the FDA protection has expired. Nothing to do with clinical trials.
Drug relevant basis here is defined by whether or not the color of one's skin alters the efficacy of a particular drug.
Sickle-cell anemia is perpetuated by a trait that appears with strong correlation to the traits that create dark skin pigmentation. IE) Black people are more likely to carry the sickle-cell anemia trait. However, the color of a person's skin does not contribute to the sickle-cell anemia pathology in any way, it is merely correlated to the presence of sickle-cell trait. A light skinned person with sickle-cell anemia responds to treatment in the same manner as a dark skinned person, the dark skinned person is merely more likely to develop the pathology due to genetic correlation.
The same logic applies to this case-study, if it were not compounded by various other idiosyncrasies. The color of a person's skin (what we use to empirically determine race) does not change the effectiveness of most drug agents, and therefore is not biologically relavent in a pharmacological context.
Sickle-cell anemia has very little to do with race and everything to do with protection against malaria - http://www.sciencedaily.com/releases/2011/04/110428123931.ht.... That people with darker skin live in areas where malaria is present is just a coincidence.
Perfect. The article kinda hinted on this but didn't make it clear. So all those generic versions could have disappeared from the market if they had gotten the patent.
This move by Novartis makes them seem very evil (not for wanting to make money, but for actually attempting to kill people who couldn't afford their drug)
Key people at Novartis (from wikipedia):
- Daniel Vasella (Chairman)
- Joseph Jimenez (CEO)
I wouldn't hire these people. And it's a pity they will never experience not being able to afford a 10 year old drug that could save their lives.
A point of contention was the triviality of the change and thus the logic of starting the clock on the original formulation.
“Successive Indian courts have ruled that Glivec, also known as imatinib, was ineligible for a patent because it was a so-called salt – a subtly modified version of a related compound that had been previously patented. Novartis has challenged the interpretation.
Mr Herrling – formerly Novartis’s head of research and development – said that the original form of the drug was too unstable and unsafe ever to be tested in humans, and it was the 'salt' version that was ultimately approved for human use worldwide" [1]
Note that Novartis threatened, yesterday, “to stop supplies of new medicines to India if the country’s top court refuses on Monday to grant a patent for Glivec, its cancer drug.”
>>Note that Novartis threatened, yesterday, “to stop supplies of new medicines to India if the country’s top court refuses on Monday to grant a patent for Glivec, its cancer drug.”
Trust me as an Indian I can tell you these supreme court rulings are pretty much a engraving on the stone which nobody apart from the parliament of India can erase.
What this basically means is the supreme court ruling stands final without any change.
Will be interesting to see how Novartis responds. Last time our country faced these situations(sanctions etc) we made attempts to not depend on others and be self sufficient.
The net result is it has been beneficial to us and disastrous to companies in the west[Read: Growth of IT industry, space research, defense self sufficiency].
If Novartis decides to take these extortion tactics. The Government of India might as well invest heavily on pharmaceutical research, and come out with some real alternatives and then compete with their western counterparts globally.
A lot of people will suffer, but this is the likely outcome I see, Given the history.
The rich Indians will go abroad for treatment. The poor Indians can't afford the drug anyway. The middle class will be squeezed, but they will manage through relatives, friends etc.
It's not at all clear why Mr Herrling's point is relevant at all.
It comes out to "we patented something and prevented others from doing anything related due to the patent, but it turned out we couldn't sell that version". This seems like "tough shit", wait to patent a version that works, you got the benefit of the patent.
From what I understand, this case wasn't just about evergreening. When Prilosec was evergreened, the old formulation became available as Prilosec OTC. I don't know all the details beyond this article, but apparently in this case, Novartis wasn't just seeking a new patent on Glivec - they were also taking steps to make it harder for the generic version to be produced. The evergreening of Prilosec in the US was more of a marketing ploy, whereas the Novartis case seems much more insidious.
There are also reported cases (not direct statements by the firms, but independent analyses) of pharmaceutical brands purchasing or paying generic producers to prevent a generic from coming or remaining online and competing. (Apparently, in some cases the number of and potential for generic producers is limited enough to make this cost effective for the pharmaceutical brand.)
These firms have been granted limited monopolies in return for their contribution to the public good. Apparently, this is not enough for them. As a member of the public, I'm disinclined to offer them anything further, and rather in favor of re-evaluation this cost/benefit relationship with the suspicion that thorough independent analysis may well indicate the public should "claw back" more of this monopoly benefit we've been granting.
Patents are a social convention. Not an inherent law. Society is, with sufficient will, free to re-evaluation them. Just as "public domain" may and does override private ownership for cases demonstrating sufficient benefit to the public good. (Not that imposition of "public domain" property seizure isn't its own nest of contention and problems. But as an example of another domain where this is already accepted law.)
> drug makers trivially re-formulate their drug upon patent expiration in such a way that the old medicine cannot be made generically without also infringing on the new patent
This seems to happen in the pharmaceutical industry too often. Not only this, drug companies also inflate the pricing on the older medication so that people will switch to the newer variety.
I think this is called price discrimination[1]. Joel wrote a good article on this topic called Camels and Rubber Duckies[2]. Here is a quote:
>You see, by setting the price at $220, we managed to sell, let's say, 233 copies of the software, at a total profit of $43,105, which is all good and fine, but something is distracting me: all those people who were all ready to pay more, like those 12 fine souls who would have paid a full $399, and yet, we're only charging them $220 just like everyone else!
>The difference between $399 and $220, i.e., $179, is called consumer surplus. It's the extra value that those rich consumers got from their purchase that they would have been perfectly happy to do without.
>It's sort of like if you were all set to buy that new merino wool sweater, and you thought it was going to cost $70, which is well worth it, and when you got to Banana Republic it was on sale for only $50! Now you have an extra $20 in found money that you would have been perfectly happy to give to the Banana Republicans!
Insane the capitalism world we living in. Now you can sit down for hours and rightfully argue with someone whether big pharma company is saving more live than killing.
Patents are government granted monopolies in the same way any other property right is a government granted monopoly. Propertizing things so they can be traded in a market is a crucial aspect of what makes capitalism work.
Looking at it another why: why are patents on land, which grant people property rights over land that they did not create, somehow fundamental to capitalism, while patents on new drugs, which grant people property rights over formulas they did create, are anathema to capitalism?
Land is a resource. If I claim exclusive use of a piece of land, no one else can use that land as they wish. Inventions are NOT like that. Comparing patents and land, the way you have, leads to a bizarre form of capitalism. "Propertizing things" is, again, a wrong way of looking at it: a patent is not a "thing" or even a resource.
Looking at things through in your "propertizing things" manner, why can't laws and regulations be "propertized" too, bought and sold to create bizarro capitalism?
> "Propertizing things" is, again, a wrong way of looking at it: a patent is not a "thing" or even a resource.
Why do we only have to propertize "things"? That is to say, why should the motivating principles that lead us to allow propertization of land not be generalized to the propertization of drug formula or MP3s?
Looking at whether something is a "thing" or "not" is not a particularly useful basis for deciding what kinds of things should be turned into property. The rational thing to do is look at the economic properties of various kinds of things, and grant property rights based on economic phenomena.
Why do we grant patents in land? We do so to order economic activity--allow people to develop land without others free-riding on their efforts. We create incentives for people to say clear a plot of land and sell it to a farmer, a market transaction which is not possible without a patent on the land. The same principles generalize easily to many other scenarios in which it is possible to gain the benefits of someone's work without engaging in a market transaction with them.
> Looking at whether something is a "thing" or "not" is not a particularly useful basis for deciding what kinds of things should be turned into property.
But that is not the criterion now. The criterion is resource. That's why bandwidth is a property, and can be bought, sold or utilized just like a piece of land.
> The rational thing to do is look at the economic properties of various kinds of things, and grant property rights based on economic phenomena.
That is one of the many approaches. "Rational" has nothing to do with it. It depends on what principles you are deriving your rationality from. Starting with my own principles, what you proposed is not rational. Quite apart from that, you do agree that laws and regulations have economic properties too, right? Why can't we buy and sell those?
I'm fairly confident the Kinsella article that @icebraining linked to covers the basis of rights and patents. I can't confirm it because the document is not loading at the moment.
> Quite apart from that, you do agree that laws and regulations have economic properties too, right? Why can't we buy and sell those?
I'm not sure if you get my point. It's not the fact that patentable subject matter has economic properties that warrants protection, it's what those properties happen to be. Things like drug design are susceptible to the free-rider problem, an propertization is a legal tool that can address that problem. Vast swaths of the law can be seen as basically existing to address various economic problems that undermine markets, and the free-rider problem is a common one and propertization is a typical solution.
There are economic issues created by laws and regulations (regulatory capture, etc), but they are not the kind of problems amenable to being solved by propertization.
Well the obvious and well-know difference is that land is naturally scarce, but patents are just artificial scarcity.
But it doesn't really matter. What matters is: Does it work?.
Private land works. Mostly. With a few caveats. There are a few awful stories about this also. Usually "goverments and friend monopolists" are to blame, too.
Do patents work? Not sure. Sometimes maybe. In mathematics (software patents) they don't. In medicine we see this problem, and many others.
Are they the best system we could conceive? Hardly.
Tell that to all the people who could easily live on the vast swaths of property suburbanites have set aside for doing absolutely nothing with (lawns).
> Usually "governments and friend monopolists" are to blame, too.
I assume you let homeless people pitch camps in your yard, and are thus not part of the problem?
> Do patents work? Not sure. Sometimes maybe.
The U.S. is the most technologically productive society in the history of the world, and we have had patents since our founding. Much of the valuable technology around us was funded either by: 1) patent monopolies; 2) natural or government-sanctioned monopolies; 3) government research funding. Much of what wasn't was funded by other mechanisms for reducing competition (for example, Intel's trade secrets to keep its manufacturing edge).
Ultimately, there is no money in highly competitive markets. Competition drives prices towards the marginal costs of production, which not only saps R&D budgets in capital-intensive fields, but without IP protection reduces any incentive to engage in capital-intensive R&D when the results can be easily copied by competitors.
Look at one company we consider innovative today: Google. Google benefits from several features of its industry that tend to undermine perfect competition: network effects, a government granted monopoly (over the trademark Google--imagine if Samsung could redirect "Google Searches" to their own search engine), a privately-granted monopoly (domain names), government-monopolies over their copyrighted-software, etc. And of course, the half-trillion dollar advertising industry from which it derives nearly all its revenue would collapse if trademark monopolies didn't prevent companies from free-riding on advertising investments. As a result, Google makes a ton of money, and can use it to do cool things like research Google Glass and self-driving cars that don't immediately turn a profit. If Google was trying to eke out an existence in a perfectly-competitive market based purely on the quality of its search results, none of this would happen.
>Tell that to all the people who could easily live on the vast swaths of property suburbanites have set aside for doing absolutely nothing with (lawns).
People could not "easily live on the vast swaths of property suburbanites have set aside for doing absolutely nothing with (lawns)." For one, lawns serve a useful purpose (groundwater / aquifer recharge, flood control, etc). For two, https://www.google.com/search?q=kowloon+walled+city
Private land can be viewed from many angles. One can see it as a privilege given by the state, and others as property owned by the person living on it. The biggest difference is how one want to look at it.
If the state owns it, then they decide what to do with it. Build a road through the house? No problem! If its a property owned by the individual who lives on it, then no way a road can just be built there.
The person arguing that land is owned by the state then must accept that the state then has ll the right to do what ever they want with the land. Its theirs after all.
With your statement, you assume that the state is the owner of everything. That mean that the car in the house is not yours, its the states car that they give to you as a privilege.
I for one object heavily on the idea that the state is the owner of everything. Physical objects I got in my own house is mine. Not the state. However, state privileges, be that the right to carry weapons in public places, sell drugs, manufacture weapons, or export dangerous products to any country that I like is not rights. They are privileges give out by the state.
My car is not a privilege, but a property I own and has rights to. Privilege given by the state is not property. please stop mixing the two concepts up and try to make them look like one and the same. The state do not own my stuff.
Why is it insane that you can argue that? If it were cut-and-dried that they were killing many people and providing no benefit, something would likely have been done about it by now. As it is, they exist in a grey area with plenty of room for argument, but I don't think that makes it an insane situation on its own.
Yes, all the time. A good example is claritin. IIRC when the patents for claritin expired, the drug makers patented the metabolite, which they called clarinex. Then they declared that all generic versions of claritin were illegal, because they become clarinex in the body when swallowed.
Incorrect. It took several years to resolve, over which time the con artists at Schering-Plough (now Merck) stole several billion dollars from consumers, none of which has ever been reimbursed.
Several billion dollars isn't really that much money in consumer terms. American consumers spend something like a billion dollars on scented candles each year.
Besides, it doesn't seem to me like there was much of a delay at all in getting generic loratadine to consumers:
The patent expired in December 2002 and Geneva/Novartis had first-challenger exclusivity for 6 months. By August 2003, only a month or so later, the lawsuit was decided and the floodgates opened.
right, India recognizes patents just like anywhere else. which is why all big pharma-cos get their patents denied, pure coincidence. especially as Indian generics are a big business spreading into Europe and US.
just compare to China(!) of all places. not even the Chinese government, not exactly opposed to copy and paste, is pulling these stunts.
India recognizes patents just like anywhere else. What they don't recognize is when drug makers trivially re-formulate their drug upon patent expiration in such a way that the old medicine cannot be made generically without also infringing on the new patent. India called BS on that, and rightfully so. Now millions of people in India don't have to die because even though a drug company made several multiples on their investment already, billions in exclusive profits per year still isn't enough.
Edited to add: This is informally called "Evergreening". I'm not an expert in that field but you can read more at http://en.wikipedia.org/wiki/Evergreening and linked sources.
In this case, they wanted to charge Indians $2600/month, and the generic is $175/month. If you have this condition and do not take this drug, you die.