India Supreme Court rejects Novartis' right to patent new version of cancer drug | Hacker News Reader

India Supreme Court rejects Novartis' right to patent new version of cancer drug

foxnews.com

254 pointsbonchibuji128 comments

Important context, and if you didn't RTFA:

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.)

[1] - http://en.wikipedia.org/wiki/Isosorbide_dinitrate/hydralazin... (BiDil)

[2] - http://www.nejm.org/doi/full/10.1056/NEJMoa042934

It's such an outrageous claim that drugs may have different impacts for different races that the FDA had no problem approving it.

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.

Some drugs do have different impacts on different races.

Science is rarely politically correct (probably a good thing).

Or maybe it's just the politics isn't scientifically correct.

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.

http://www.ted.com/talks/ben_goldacre_what_doctors_don_t_kno...

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.

>there is no drug-relavent biological basis for race.

Try telling that to people with sickle-cell anemia.

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.

That's a pretty roundabout way of saying "It's a pity they won't die a painful death".

There is no patent on morphin :P

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.”

[1] http://www.ft.com/intl/cms/s/0/c377e20a-99eb-11e2-83ca-00144...

>>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.
India win, Novartis lose

Why is this being downvoted? This is not reddit, if you disagree with his post, please give us an idea why.
As far as it goes, the only contentious part of his comment is the last line - India win, Novartis lose.
Otherwise his description of how Indians tend to deal with drug costs is a succinct portrayal of the current reality.

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.

Read about evergreening first if you dont understand it. http://en.wikipedia.org/wiki/Evergreening

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.

Not only this, drug companies also inflate the pricing on the older medication so that people will switch to the newer variety.
Why don't they just stop producing the old?

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!
[1]: https://en.wikipedia.org/wiki/Price_discrimination
[2]: http://www.joelonsoftware.com/articles/CamelsandRubberDuckie...

Because some will still buy the old at the inflated price.

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.

What kind of capitalism are you talking about?
Patents are government-granted monopolies. Nothing further from free markets.

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.

> Private land works. Mostly. With a few caveats.
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

The U.S. is the most technologically productive society in the history of the world, and we have had patents since our founding.
"Post hoc, meet Propter hoc. I'm sure you two will have a lot to talk about."

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.

Kinsella tries to explain why: https://mises.org/journals/jls/15_2/15_2_1.pdf

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.

Doesn't that happen in US, too?

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.

And yet somehow I can buy generic Claritin for pennies a pill, so somehow it must have worked out.

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:
http://www.nj.com/news/stories/0827_claritin.html
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.

Thank you, India.
Let me tell your my story. I am on a pill called Colchicine that I have to take 3 times a day for life. The pill's formula is hundreds of years old and would cost me pennies. That was until a company convinced FDA to ban the generics and only allow its own brand. The same pill that used to cost 10 cents now costs $5/pill to me here in the US. Meanwhile in India, it still costs pennies.
I wish US would take a page from India.

Interesting about Colchinine[1]. Apparently the FDA does 3-year exclusive agreements with companies in exchange for conducting new clinical trials.
The idiotic thing here is that by raising the prices, it cost Medicare $49M more a year for apparently a ~$100M investment into research.
I don't know why the government wouldn't fund it directly in this case. Or in general, why they don't add a tax onto the drug in question and do the research themselves. It seems like an odd, public-damaging way to go about things.
http://en.wikipedia.org/wiki/Colchicine#Marketing_exclusivit...

If a private company has the duty to maximise profits, shouldn't a sovereign state have the duty to maximise the benefits to its citizens while fulfilling its minimum international treaty obligations.
The cost of gleevec/year is $36,000. The average per capita income is $1219[1]. If patented about 99% of people who need this drug can not afford it. Why should any state keep 99% of its people away from a life saving drug, if it doesn't have a legal obligation to do so.
Property rights are a means to an end. Even if all of Asia and Africa refused to recognize Novartis patents, they would still have enough incentive to continue developing cancer drugs.
1. http://en.wikipedia.org/wiki/Income_in_India

Private companies don't need to have a duty to maximize profits. It's just incredibly common. See https://watsi.org/about#values

>If a private company has the duty to maximise profits, shouldn't a sovereign state have the duty to maximise the benefits to its citizens while fulfilling its minimum international treaty obligations.
They absolutely do. But that just shifts the argument to "what policy is the right one to maximize benefits to our citizens?"
>The cost of gleevec/year is $36,000. The average per capita income is $1219[1]. If patented about 99% of people who need this drug can not afford it. Why should any state keep 99% of its people away from a life saving drug, if it doesn't have a legal obligation to do so.
You could make the same argument in any country, including the US. And yet the system is the way it is for a reason.
>Property rights are a means to an end. Even if all of Asia and Africa refused to recognize Novartis patents, they would still have enough incentive to continue developing cancer drugs.
Would they? I wonder. It's possible eventually the grey market importation of unlicensed generics would make profits too small to justify the risk, and Novartis might decide yet another pecker perker would be a better investment than a cancer drug.

Do you have a citation for that drug price (for Indians)? Another post cited a price more than an order of magnitude lower.

The article says it costs about $2,600/month. Cheaper than $36,000/yr but not by an order of magnitude.

This drug is expensive at $2600/month. A fresher software engineer salary in IT company is about $500/month. Average Indian income is way low than that possibly less then $100/month.

To put this in perspective, Novartis Glivec is the beta crystalline form of 'imatinib mesylate' - an already known compound which went out of patent. Novartis failed to establish that the new form has demonstrable efficacy over non-crystalline form. As per section 3 (d) of Indian Patent Law designed to prevent Evergreening - inventions that are mere "discovery" of a "new form" of a "known substance" and do not result in increased efficacy of that substance are not patentable. Indian patent law follows guidelines set forth by WTO under TRIPS agreement. So Novartis has exhausted all their legal defences. Novartis did not get even one favourable verdict in the entire legal battle which played out in 3 different courts of law.

Would the crystalline form even be a viable drug? Don't drugs have to be soluble in order to circulate in the blood stream?
Is the beta cystalline form the same chemical formula as the soluble form?

Beta crystalline form has the same chemical formula as the non-crystalline form and is soluble.

Why drugs cost so much isn't really that hard to figure out.
Drugs cost a lot of money to develop. On average it costs somewhere between $250M (for an orphan disease) to $1B (for a primary care drug). The problem is that most drugs fail during development and when you take that into consideration, it's typically over $1B to develop a drug.
Where does that money come from? Just like money for anything else, it comes from the marketplace. People (not unlike readers of HN) take their money and put it into investments that get them an optimal return. If you eliminate patents, you eliminate the mechanism to get a return on R&D dollars invested. No patent (or at least a mechanism to get a return on an R&D investment) and you have no drug.

The issue here isn't getting a patent to cover the R&D costs, it's a case of the patent expiring, the drug company reformulating the drug slightly and then applying for a "new" patent on what amounts to a slightly modified version of the previous drug.

No, that's not the issue here.
In India, the only patent you can get is the initial "composition of matter" patent. These patents are typically obtained very early in the R&D process (right after the drug is discovered).
For most drugs you can't just give the drug to a patient, it has to converted to a salt (this is why most drugs have "hydrochloride" or "sulfate" after their name). The right salt to use is usually determined a few years after the drug is discovered. The company typically gets a patent on this as well.
Since India doesn't recognize patents other than novel "composition of matter" patents, Bayer can't rely on their formulation patent to extend their market exclusivity. The patent in question is NOT a new formulation, it's the original formulation. The patent in question would only extend their market exclusivity for a few years.

I looked up the drug in question and apparently it was patented in 1993. That's 20 years. Even if the second patent was filed in 2007 it's still quite more than "a few years".

Seriously? You want to start a company under the pretext of making humans' lives better, but only worsen it for them?
I will justify my sentiments:
By worsening, I mean, nothing is terrible in life than knowing there is a solution/cure to your problem, but you have to die just because you can't afford it.
India is a developing country, even something as moderate as $100 is actually a luxury for many people - Remember, we are talking about a country where millions slog their lives to death for $0.01 to $0.5 per hour (even in call centers, etc) and anything between $100-200 is NO JOKE for them.
Just don't put barriers to such things - Everybody has the same blood inside them and has a right to live on this planet irrespective of having enough money or not. You want money? Don't charge the peasants - Charge the R&D departments of the billion dollar companies that want to sponsor you and compete for fame. These peasants are already selling their blood (literally) to make their both ends meet, and this should be the last thing they should die to pay for - Their very own life.

Charge the R&D departments of the billion dollar companies that want to sponsor you and compete for fame.
What companies are those, willing to pay billions for the development of new drugs just for the PR?

Diet is a huge factor in quality and longevity in life. "Good" food is a lot more expensive than processed horse muck. So even there a financial divide exists. Unless we want to lean over to a more socialist way, that sort of divide will always exist. Poor people will usually die before richer people, mostly its down to food and water and sanitation, even fitness. I'd rather get those things right first, then worry about funky cancer drugs. Might need less cancer drugs if these things were addressed. Might need less drugs in general.

Not much money to be made in healthy foods, much more money to be made in processed foods and cancer drugs. I don't think there is some grand conspiracy and huge collusion. I just think the profit factor is so huge in giving people crap foods. Then there is tons of money to be made selling them exotic drugs. Healthy foods means someone cooks fresh vegetables a few minutes before you eat it, can't store that in a warehouse.

There are many profitable businesses going after the healthy / natural food market. You just need to change your business and marketing to go after that segment.
Additionally it's not as simple as "you can't store that in a warehouse". If you do the have the time to buy fresh vegetables (y'know every day or 2)and if you don't have the time to make them, then you can't eat that form of diet.

I hope you did not mean it, but cancer drugs are not funky. A better drug can mean anything from a permanent remission or cure to a few more months of life. And the poor get treatment in government-run hospitals(some of which are the best hospitals in the country).

I believe this is where India has got it's patent system right. I am not a lawyer, but as I understand it, the Patent Office (Controller General of Patents Designs and Trademarks) rejects patents that are obvious and not a genuine invention.
Furthermore, you can only patent a process not an idea or a product. This was the key reason that you have so many generic alternatives for otherwise patented medicines. The process encourages competition and its the consumer who wins.
Perhaps this is something that US can learn from.

Didn't India introduce product patents quite some time back?

They did. But I believe it's still somewhat a gray area. They are more in the form of Geographical Patents (such as Darjeeling Tea) http://en.wikipedia.org/wiki/Indian_Patent_Office#Geographic...

And this is why medical research should be directly funded by goverments, exactly like they fund military research, the cost shared among the developed nations, and directly throw away the patent system.

Throw the baby out with the bathwater? I speak from an Indian perspective. Almost everything the government touches leads to crippling corruption. Including the police force. I have colleagues from government-run research centers, and I've heard enough stories from them to never wish to deal with one.

No. Research would still be done by private companies. But we would pay them directly with money, instead of with an artificial monopoly. It's not free market anyway.
These companies could focus on pure research, and leave manufacturing to others. Their income would be more predictable too.
Cost could be shared among countries, proportional to their wealth. Research is very expensive, but it's a fixed cost. No reason to reinvent the wheel twice.
No more "convincing" doctors with "gifts" to use their products. No more money wasted on publicity. No more fake studies to boost sales.
Effort could be aimed towards deadly, rare or specially awful diseases, instead of profitable ones.
I guess patent lawyers would lose.
This system is far from perfect, as we know there is a lot of corruption in getting government contracts. But I still think it would be an improvement on what we have today. Medical research is already very difficult. No reason to make things worse with an outdated, inefficient and sometimes just outright evil funding mechanism.

Here's a related idea, proposed by MIT Finance professor Andrew Lo:
http://www.technologyreview.com/news/506916/economist-propos...
It's basically a fund that would develop drugs in a portfolio-based fashion, to take some of the uncertainty out of drug development by aggregating risk over a set of efforts.
This scheme might preserve some of the benefits of the market-based system we have now, but promote development of a class of drugs that is hard for the market to develop.

Question remains, if they had gotten a new patent. Wouldn't the old version still be open for the public?

I am a Biotechnology Student in India... Even if the older version exists, pharmaceutical companies have the power to enforce the new drug with their buying power...Pharma Companies gift a lot of doctors with various goodies to enforce the newer version - thus allowing company to make profits....
The Point to be noted here for Developers, Designers and Other Technologists - " Where Do you Draw the line ?"
Novartis might have made a slight modification to the structure of the drug - and thereby requesting patent for the new drug.. The new drug might be more effective or not, they would want to sell it at a premium...So where does one draw a line towards how much of a change is ok for the drug to be accepted as a new drug.. should the change be in effectiveness or structure or something else...
The same question applies to developers and designers - when someone uses their designs or code.. Where do you draw the line ?

In Australia, they're reviewing this area of patent law to see if the parameters are right http://www.ipaustralia.gov.au/about-us/public-consultations/...
Novartis said in their submission "Generic companies should be able to compete with the original version of the product after expiry of the earlier filed patents. Thus, the scope of those improvement patents must always be narrower than the earlier filed patents so that third parties are normally in a situation to use the older technology after expiry of the earlier filed patents without infringing the follow-on patents" http://pharmapatentsreview.govspace.gov.au/files/2013/01/201...

I'm not a patent lawyer, but I fail to see why this would be the case.
If the old version was held by someone else, would it then also be open for the public ?
As far as I can tell, patents pretty much stand on their own.

They were wanting a new patent for a slightly improved version of their drug. They held the patent for the previous version which expired.
Since they were fighting so hard for a new patent, I was wondering if such a patent would affect a generic drug made from the pervious version.

Yes.
I don't think they ever had a patent for this drug in India though hence they were already producing a generic version.

“We certainly do not wish the law of patent… to develop on the lines where there may be a vast gap between the coverage and the disclosure under the patent; where the scope of the patent is determined not on the intrinsic worth of the invention but by the artful drafting of its claims by skilful lawyers; and where patents are traded as a commodity not for production and marketing of the patented products but to search for someone who may be sued for infringement of the patent.” said by Bench of Justices Aftab Alam and Ranjana Desai.
Well! This says it all

An hypothetical question is : Would Brian Drucker apply at https://www.microryza.com ?
As I understand, all hue and cry from Novartis is - they have invested big in R&D and yet not reaped reasonable returns. Also, they claim that this dents their effort to come with better drugs in future as profitability is at stack and such judgements are demotivating for any actual R&D to take place. Just wondering with crowdfunding gaining acceptance would this be a relevant argument ? What are real chances of getting a life saving drug as good as Imatinib seeing light of the day. What are practical challenges ?

It might be worth mentioning that India has a large generic pharmaceutical manufacturing industry. Many generics sold in the US and around the world are manufactured in India.

I would love such a provision in US law for patents if it does not yet exist. I'd hate to see someone patent linked lists where the "previous" node pointers are at the top of the data structure and the "next" node pointers are at the end. Or some other silly re-structuring.

Bravo india Bravo. hope USA learn something from you

Why would you patent a cancer drug?

Why haven't you, personally, dedicated your life to making cancer drugs?
The people that do so would rather like to be compensated for it. You may think it's an imperfect system but until you personally start making cancer drugs for the world for free maybe you should think a little deeper on the subject.

I only regret that I have but one vote to give for bringing this comment out of the gray (apologies to Nathan Hale).
And, I would add: talent, on average, goes where the money is. We've seen it in sports, and it's true in academic pursuits.
Plus, it takes a helluva lot of money to get these drugs to market. Nobody gives that money to a company without a fair shot of getting it back. Hence, for the time being anyway, patents are a requirement in that field.

I would like to discuss this claim that it takes a lot of money to bring a drug to market, and this is why drugs are currently so expensive.
This seems to be common wisdom in this thread, but I note an extreme lack of actually cited sources, so I decided to go dig some up.
I remember reading a book in 2004 discussing what percentage of medical industry profits went towards research and development, verses what percentage went towards marketing. While I cannot recall the title (I have read thousands of books since then), the idea did stick with me, and a bit of quick Googling produced some results:
First, and perhaps most shocking: http://www.bmj.com/content/345/bmj.e4348
Here is a copy of this research without the paywall: http://www.pharmamyths.net/files/BMJ-Innova_ARTICLE_8-11-12....
According to the pop-sci summary of this article in the HufPo, what these numbers translate to is that Pharma companies spend 19 times as much on self-promotion as they do basic research: http://www.huffingtonpost.com/2012/08/09/pharmaceutical-comp...
If you assert that drugs are so expensive because of the cost to develop them, and yet I have demonstrated that the R&D budget is a small percentage of the money which the drug companies are spending, do you withdraw your assertion? Given the aforementioned lack of sources in this thread I somehow doubt it.
Ah: I found a review/summary of the book which originally sparked this comment. It's The Truth About the Drug Companies, and is by Marcia Angell, the first female editor of the New England Journal of Medicine. The review is available at: http://www.nybooks.com/articles/archives/2004/jul/15/the-tru...
More: http://www.slate.com/articles/business/the_customer/2011/03/...

The author of the article you posted, Donald Light, has done a pretty poor job of supporting the numbers he has come up with.
If you want to see what drugs cost to develop, just ask the scientists who develop them: http://pipeline.corante.com/archives/2012/08/09/getting_drug...
His numbers don't even pass the sniff test. If you want to find out how much it costs to develop a new drug, there is nothing stopping you from calling a CRO and asking how much they charge for phase III trials (they are all in competition, so they'll freely give you a quote).
The average cost for a phase III trial is approximately $15,000/pt/yr. 1000 patients is a pretty average size trial, so now you are at $15M for one trial and the FDA requires at least two phase III trials.
And that's just the cost of phase III trials which doesn't include: phase I, phase II, manufacturing, regulatory costs, etc. Donald Light's claim that drugs cost $45M to develop is laughable and the could only come from someone with no understanding of drug development.

15000 USD/pt/yr seems to be a cost of phase 3 drug trial in a wealthy (western) nation. there has been a boom in conducting human trials across developing nations , through private contractors. A search for 'drug trials in developing nations' returns millions of links , including reputable sources like bbc and pbs. I will let you pick the best ones :) per capita income in india is 12000 usd/yr. there is no way, a drug firm will spend 15k usd in a place like that to perform human trials.Do remember that 12000 usd is the average income. the rural poor are some of the poorest in that world. you can safely assume that the cost of a drug trial in countries like india is much much lower. Indian poor have also been a test bed for human clinical trials. http://www.bbc.co.uk/news/magazine-20136654
Drug companies use poor as guinea pigs , marking up the price for wealthy nations and worst of all , prevent life saving care for billions of people. some on whom the drugs were tested on. So, there is more than one reason this victory is sweet for the developing nations.
p.s sorry about the multiple edits..

I am somewhat confused by the term "article you posted" in your comment. I had believed that I had posted a variety of different articles from several different sources, one of which was written by Marcia Angell, former editor of the New England Journal of Medicine and presumably someone who knows how much a drug costs to develop.

The article I was referring to was the BJM article.
Oh yes, I know all about Marcia Angell. She has been rallying against the pharma industry for over a decade. The link I posted also goes into some of the outrageous things she has said that are completely unsupportable.
Here is another article talking about Marcia:
http://www.forbes.com/sites/johnlamattina/2012/12/14/marcia-...
Does pharma do bad things? Yes! But claiming there is a pharma conspiracy to drive down "target" cholesterol levels so they can sell more drugs is laughable. It ignores all the scientific evidence (most of it NOT from pharma companies), much of it published in her the journal she works for.

"Marketing" is not just ads. It's important things like talking to doctors and patients about the shortcomings of current drugs and their perception of the relative benefits of potential new drugs. It's analyzing your competitors' pipelines to avoid spending hundreds of millions developing a drug that will be obsolete before it is launched. It's understanding the regulatory environment in dozens of markets and adapting a product and sales strategy for each. And yes, it's communicating to doctors and patients the benefits of your new products.
If these companies could produce more drugs that would help patients and ensure that doctors, hospitals, patients and insurers knew enough about those drugs to spend more money to acquire them by spending less money on marketing, of course they would. So would Toyota, or IBM or any other company with something to sell.

> I remember reading a book in 2004 discussing what percentage of medical industry profits went towards research and development, verses what percentage went towards marketing.
That doesn't even make sense. Neither R&D nor marketing come out of profits. Otherwise they wouldn't be profits...
Ironically, I can't get at that article because of a paywall, but my guess would be that HuffPo is defining "basic research" in a way that excludes most of the R&D spending (which undoubtedly goes to "applied research") and is defining "promotion" in a way that includes not just advertising, but things like the sales network.
The fact is that say Merck spends much more on R&D than on advertising: http://www.fiercebiotech.com/special-reports/7-merck-top-15-..., http://www.fiercepharma.com/special-reports/merck-top-13-adv...

You are making a very common mistake, which is to equate the concept of drug development cost with the concept of basic R&D. They are not remotely the same thing; R&D is one of many expenses in the total development cost of a given drug.

I would like to discuss this claim that it takes a lot of money to bring a drug to market, and this is why drugs are currently so expensive.
I never asserted your second clause. Pharma makes a shit-ton of profit, indeed.
I personally am grateful for your research in this comment(+1)- I regret that I don't have the time to have a proper discussion right now. Perhaps someone else could pick it up.

Sorry -- I used your comment as a jumping-off point for this research rather than making my comment a complete reply to yours! I was more talking about the thread in general, where the point is made a few times. For instance, see https://news.ycombinator.com/item?id=5472735 Once again my apologies if I seemed to put any words in your mouth. I was looking for the right entrypoint to the thread and must not have selected the perfect one.

No worries. Looks like your plan worked pretty well.

To be realistic, this is not about compensation vs free, it's more like 40 million vs 40 billion.

Medical patents involve a lot of money invested into making the drug, ex. producing new chemicals, laboratory equipment costs, huge salaries for scientists in R&D, etc. Patents are one of the best ways to "earn back".
Why a cancer drug? Why not? There are lots of companies fighting for this huge market, and if you're the first to have invented a medicine, you would like to be rewarded, isn't it?

What does controlling a market have to do with being rewarded for saving people from dying of cancer?

Nothing. Its to do with getting back the millions invested in the R&D. Do you even have the slightest idea how much it costs to develop these drugs? Often the rewards for the actual people who do the R&D are pretty poor.

> Often the rewards for the actual people who do the R&D are pretty poor.
It seems to be in line with the this [1] comment but due to completely different reasons. If you have some insight into money allocation in a drug company could give an answer to the linked comment?
https://news.ycombinator.com/item?id=5472861

If you are first to market with a drug (RealGoodDrug tm) against X. Then you can test your RealGoodDrug tm against a placebo.
If you are second to market you have to test your drug against RealGoodDrug tm and not against a placebo (because that would be immoral).
So you can't come up with a half good drug, or a just as good drug with more side-effects.

There are multiple benefits:
1) Be able to pay the best scientists in the world to find ways to extend our lives. 2) To be able to afford to produce the drug so that people can actually benefit from the work of the above mentioned scientists 3) To make enough money to fund research in other areas of medicine
Or put another way, currently no one has found a way for private companies to do cutting edge research, and manufacturing of drugs without having a guaranteed profit stream.

Hmm. Maybe because you've spent many millions of dollars developing it, proving it works to some significant degree, and getting it approved by various government authorities?

because people are disgusting... companies are obsessed with money and they really give a shit if there are hundred of thousands dying because they aren't rich enough for buying their products.
The right to use certain information (aka patents) is more important than human life in our society.

I think the whole evergreening and "patent a trivial change to our drug because the previous patent expiring" thing is wrong, but a company should profit after inventing a life-saving drug.
Look at it this way, if tomorrow a company came out with a complete cure for cancer, and we took away their right to profit from it, yes it'd put cancer victims in a good spot. But it'd screw everyone with a not-yet-cured disease over, when the company can't afford to pay employees, and the medical research industry goes down the drain.
People work for a profit, and that includes medical researches, who go through years of school. You take away that profit motive, they'll have to go do something else to put a roof over their head, and you'll save more lives in the short-term at a very high very long-term expense.

Sure... US $58.566 billion (2011) is not enough profits

But they only have that profit because they have patents. You can't use it to justify the claim that patents are unnecessary.

I'm assuming you think drugs come from the Easter bunny.

What's the legality (in US) for a Kickstarter model R&D and clinical trials for new drugs?

I you find this stuff interesting I found Bad Pharma an interesting read (Random Review: http://boingboing.net/2012/11/06/bad-pharma-account-o.html )
They talk about tricks like mirror versions of a drug can then be patented after the first drug expires. Then the company can push them over the original, which is not necessarily bad, mirror versions can be better or sometimes worse.

I do not understand the hoopla. When the patent on the old version expires, anybody can make it for pennies a day. An expensive new formulation hurts no one, since they are free to huy the cheap one.

First, sometimes they try to get a new patent that will cover some aspect of the old process, too.
Secondly, a lot of effort goes into getting people on the newer formulation. Look at Concerta versus Ritalin. Both are methylphenidate, but I've met several people that think Concerta is a totally new drug and that "Ritalin didn't work for me". I've even talked to doctors that thought they were different chemicals. Not the drug company's fault, but it still "hurts someone".

Hurts? Immediate release methylphenidate has a half-life of 2-4 hours, while Concerta has a duration of effect of 12 hours. Given the narrow therapeutic window of methylphenidate and the harsh wthdrawal syndrome, they are different drugs.

this is India playing with fire. and it is not about securing access to important drugs to Indian patients - it is about boosting the native Indian generic pharma industry. while India itself does not provide any significant output in R&D spending in pharma.
so yeah, big pharma is evil and greedy, however no one else takes 1bn$ to try out a new product and have it fail in front of the FDA - which is the usual scenario, as most(!) new products get denied.
how many other industries out there need to PROVE that their products are not only safe but also have an actual benefit? as this is HN, let's see all those fancy task/email/collab/social apps prove their usefulness in scientific trials - and get denied if they fail to be better than notepad.
so yeah, awesome, let's kill pharma's business model without any alternative in sight.
how about having generic makers pay a fixed % of their revenue into a R&D fund? without it they are just leeching off.

Read about evergreening first. The issue is not that India is denying some novel invention - but a slightly modified version of an already expired patent.

see, and this is why nerd-news is so frustrating. one article, plus one cool term 'evergreening'. super, let's hit wikipedia and whoa i can spout internal sounding knowledge.
problem being that here we have a larger pattern in india's behavior which is not neatly laid out in a few linked articles. so no way to quickly read up on it, you need to be in the industry or closely following it.
so yeah, evergreening, awesome. same with roche, bayer?
and in novartis case: you know that the original molecule was never patented in india? india only started recognizing patents issued after the early 90s. you know that novartis already gave away 95% of this particular product for free in india? right?
this new item is a trainwreck, just like the pycon thing. problem that far fewer people here will recognize that.

Oh, well, if your problem is that people are on India's side without the due knowledge to make an informed opinion, how's this: I have a degree with honours in Biochemistry, and I worked for Novartis for eight years in clinical safety.Glivec was one of the drugs we handled all the reports for. I have no axe to grind with Novartis, it's a good place to work and it'll be a long time before I'm as well-off as a programmer as I was when I was working for them.
I'm of the opinion that India got it absolutely right.

Almost on par with:
https://news.ycombinator.com/item?id=35079

Thanks - you enlightened me. Typical aloof nerd behavior - just assuming that other people do not understand the complexity and you do. I am from India and have been following the Indian patent industry since early 2000s including when they switched over from process-patenting to product-patenting (http://www.lorandoslaw.com/Publications/Changes-in-Indias-Pa...). And that 95% free distribution is Novartis' assertion and they heavily regulate the distribution of the drug - you never know how many people who actually needed the drug got it. And guess what, the Indian Supreme Court (and India is a democracy) disagreed with Novartis in terms of how novel their invention was (thus effectively mooting your point).
But, of course, being the ever-cool nerd you are - you know everything and have already proclaimed others are ignorant/flagrant personalities.

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