Tuesday, May 08, 2007

THE SOCIALIST FREE-FOR-ALL INDIAN REMEDY

Why do so many people have a conception of Indians as having a misguided socialist mentality? Part of the reason is because it's true. But partly, it is because of articles like this op-ed in the New York Times written by Suketu Mehta, author of Maximum City. (Incidentally, is it just me, or is the NYT giving vent recently to too many socialist-minded writers?)

Mehta talks about the quite ludicrous sounding patenting of yoga positions that is being done in the US. Ludicrous sounding only if you think that the patenting of breathing patterns is also not cool. Mehta wants to criticise the fact that Indians living in the US want to patent yoga positions, because yoga is the "great gift that India has given to the world".

One might argue about the benefits (patenting and other ones) of yoga positions, but the strangeness in the proportion becomes obvious when we get to Mehta's musings about patenting of drugs. Why, asks Mehta, should drugs discovered in foreign countries be patented, if yoga positions cannot be? If you agree that yoga, something that has been offered for free by India to the world cannot be patented, then so shouldn't drugs, especially based on Indian ancient remedies. After all, turmeric, neem, and bitter gourd have all been "offered" by India to humanity for free. So why should the western countries have the authority to file patents on their active principles?:
"Drugs and hatha yoga have the same aim: to help us lead healthier lives. India has given the world yoga for free. No wonder so many in the country feel that the world should return the favor by making lifesaving drugs available at reduced prices, or at least letting Indian companies make cheap generics. If padmasana — a k a the lotus position — belongs to all mankind, so should the formula for Gleevec, the leukemia drug over whose patent a Swiss pharmaceuticals company is suing the Indian government."

And more:
"For decades, Indian law allowed its pharmaceutical companies to replicate Western-patented drugs and sell them at a lower price to countries too poor to afford them otherwise. In this way, India supplied half of the drugs used by H.I.V.-positive people in the developing world. But in March 2005, the Indian Parliament, under pressure to bring the country into compliance with the World Trade Organization’s regulations on intellectual property, passed a bill declaring it illegal to make generic copies of patented drugs.

This has put life-saving antiretroviral medications out of reach of many of the nearly 6 million Indians who have AIDS. And yet, the very international drug companies that so fiercely protect their patents oppose India’s attempts to amend World Trade Organization rules to protect its traditional remedies."
Lots of barbed words come to mind against this argument, but I just want to point to one central point that many people still don't realise: Discovering and marketing a new drug is not easy. Equating the free "gift" of yoga with traditional remedies and saying that ergo drugs also should be made available cheap or free shows a quite serious disconnect from the economics and reality of the drug discovery process.

In fact, the drug discovery process is hideously tortuous and uncertain. On an average, it takes 800 million dollars and 10-15 years to come up with a new drug, and if anything this situation is going to get worse. Out of all the thousands of new molecules that show promise, only a handful make it to the market. In general, 5 out of 5000 compounds make it into human clinical trials, and 1 out of these 5 has a good chance of making it to the market. Thus, the attrition rate is enormous, and so is the wastage of funds.

The second point is that of course there's a difference between grinding a weed and eating it, and isolating, testing, modifying, and selling the active component in the weed in deliverable form. Let me ask how many of our traditional Indian remedies satisfy all these requirements for a good drug; high potency, selectivity and bioavailability (how much of the compound is actually available to exert its action without being rapidly metabolized), low or no toxicity, cheap, consumable and deliverable form, and long shelf life. Even if the neem leaf satisfies these requirements, we only have ourselves to blame then for not realising its potential and not patenting it in the past. Now this may indicate a gregarious personality- even that point is taken- but nobody can then blame other countries and researchers from taking advantage of this traditional remedy and modifying it to make a viable drug.

The reason all those antiretrovirals could be made easily available to those 6 million AIDS patients is because somebody else had already invested the time, money and effort neceesary to discover those drugs. We cannot keep piggybacking forever on hard-won drugs. If we have to do original R & D in our country- and given the rise of new endemic infections and developing resistance to old ones, we will have to- we simply would not be able to afford discovering drugs and selling them so cheaply. In this light, it is also to be noted that there was a gut reaction against the Mashelkar report because it was "favourable to the drug companies". We can definitely argue the details such as profit margins, but such a general gut reaction is not warranted, because if laws are too strict towards the companies, they will never be able to recover the cost of R & D which they spend in discovering new drugs, including the cost incurred by failed ones. In the end, it may be the people who ironically pay the price.

So, to make a blanket statement that one is against any law that is favourable to the companies is to demonstrate a misinformed and socialist attitude, that if anything may make life-saving drugs inaccessible to the people themselves in the future. And columnists like Mehta need to abort the warm, socialist feelings that they may get by saying such things as the statement that drugs based on traditional remedies should be sold cheaply or for free by foreign companies, and look at the real state of affairs. Even I feel a little sad when I hear that some American company has suddenly made millions from something that we have been using for millenia. But I don't feel any resentment towards them, I feel resentment towards ourselves, we who are unnecessarily missing the potential investment returns on so much of our heritage because of some weird notions of the "common good".

Hat tip: Derek Lowe

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13 Comments:

Blogger Vivek Gupta said...

I am no patent expert, but it seems
`a big stretch' to me that a patent could be awarder to a yoga position. If this is true then what stops anybody from patenting a new recipe for Chicken Tandoori by adding a different spice. Commonsense would suggest that there must be a patent clause prohibiting 'frivolous modifications' to well-known techniques.

Coming to the point where Mehta accuses MNCs of actively 'copying' traditional indian medicines. As you point out there is a difference between chewing a Neem leaf and making a full-fledged drug out of it satisfying all the stringent regulatory requirements. If somebody used Neem or bittergourd to make a drug, crediting the achievement to `traditional knowledge' is a bit like crediting every modern scientific advance to Newton for inventing calculus, somewhat true but not quite enough to warrant writing a cheque payable to her highness queen Victoria.

7:15 PM  
Blogger Ashutosh said...

Vivek, well said! The Newton analogy is great. And building on your other analogy, restaurants should also not charge us a hefty amount to eat some sumptuous Tandoor...after all, it's India's "great gift to the world".

As far as my knowledge of patents goes, a slight modification is not at all enough now to patent your product. In case of food of course, since the taste is in the mouth of the beholder, one wonders how a modification can be patented...

Mehta has really lost it, to be honest.

7:24 PM  
Blogger small talk said...

hmm... maybe you should check your knowledge of patent law. a modification is enough to patent your product. it is not such a 'big stretch' as vivek has mentioned. and you should honestly try and get past the socialist bogeyman you have in your head.

11:47 PM  
Blogger anya said...

Patents can be either product based or process based. A significant change in any process may be patented . Whether Yoga postures and techniques can be patented or not is another thing.
And regarding patenting herb based drugs - the contention is that India says the medicines and techniques used in Ayurveda actually make use of the active ingredients in the plant and does not constitute overall use of the plant itself. So any product based on the active ingredient may not be patented as its not the first established one to do so.

4:55 AM  
Anonymous Anirudh said...

While you might be correct about Mehta's suggestions being economically unsound, labeling them socialist is wrong.

6:39 AM  
Blogger Ashutosh said...

Anirudh and Small talk: Why does this not sound socialist? Quite apart from the argument that other companies should not patent traditional Indian remedies (which is unfortunately an ineffectual argument in my opinion), Mehta's column to me has the distinct flavour of an anti-profit opinion. But if one has to get effective and potent drugs to the populace, one cannot do it without making at least some profit. Also, I am aware that one can have a patent on a modification; that is precisely why I used the word "slight". Unfortunately, I do have to agree that people can sometimes wriggle past patent laws by making slight modifications. Also, even the word "slight" can have different shades. For example, if you make a "slight" modification in a chemical structure, you may actually make a world of difference; then you will have the right to claim a new patent. So it depends.

Anya: You are right about the process and product based patents, and that's a distinction which we in India have massively taken advantage of in the past. So our companies are certainly not loathe to profit making. As for the remedies, I might claim that pasta has kept me well and alive for 90 years, so every active ingredient in pasta can be patented by me (or Italy for that matter)...I mean, there has to be a distinction between something that may even show some correlation with anti-cancer or anti-Alzheimer's effects, and actually isolating an active ingredient that shows a reasonable causal relationship with killing cancer cells or slowing down Alzheimer's. Also, most of the times, the active ingredients are highly modified.

8:11 AM  
Anonymous siddharth Rege said...

Folks, in the above comments I see a lot of innocent thinking about patents that, well I indugled in too, but is frankly not true. Being employed as a research engineer in a huge US MNC, albeit bankrupct, I am listed in 5 patents. Apart from 1, on the other 4, if I were the patenting officer I would reject them outright.
There is a HUGE problem with patent giving in the US. Anything and everything can be patented as long as you have enough lawyers pushing the issue. The tiniest of modifications can be patented. The problem is that the patent examiner and the lawyer usually do not have the required background in the subject at hand which makes them very poor judges of whether to grant a patent or not. I can make a simple change to an optical design, akin to adding one more spice to tandoori chicken, but with some confusing jargon and liberal use of phrases like 'improvements obvious to those skilled in the art' I can pretty much patent anything, as long as I have the compary paid lawyer, who earns far far more for the patent that I do, pushing it long enough. I am really very disallusioned with the patenting process, which I looked up to as some sort of great engineering achievement as a grad student.

So while the US needs to reform its patent process, and I frankly don't know how (maybe something akin to a peer reviewed scientific journal), Indian companies should go ahead and patent any damn thing they can. That is the american way.

Sid

8:12 AM  
Anonymous Anonymous said...

I think what Mehta is trying to say is that if piracy of drugs is wrong, so is piracy/patenting of traditional knowledge like Yoga.

He isnt making an argument about efficacy of Indian drugs vs. western drugs etc. You have completely misread what he has written.

Heres the relevant part of his op-ed.

>> There’s more at stake than just the money involved in the commercial exploitation of traditional knowledge. There is also the perception that the world trading system is unfair, that the deck is stacked against developing countries. Unless the World Trade Organization and developed countries correct this, the entire project of globalization is at risk.

>> If the copying of Western drugs is illegal, so should be the patenting of yoga. It is also intellectual piracy, stood on its head.

12:02 PM  
Blogger Ashutosh said...

Anon: I don't think I have misread him. You are right that he is saying that if copying of Western drugs is illegal, then so should patenting of Yoga positions. But what he is really implying is that BOTH Yoga positions AND medicines derived from traditional Indian therapies should be free or cheaply available.
And I am not sure that the deck is stacked unfairly against developing countries; with Indian companies cranking out tons of generic drugs and selling them all over the world, it does not seem like it has been. Whatever the other aspects of the problem are, isn't one aspect clear, namely that our companies are making and selling drugs when they never spent the millions of dollars and efforts necessary in researching and testing those drugs?

Sid; You are absolutely right...my real resentment too is that our companies are not exploiting and patenting this knowledge...as you implied, that will be the only way in which we can beat the American IP regime at its own game. You are quite right that given the right kind of lawyers, one can patent anything in the US. Now maybe our companies are not doing this because they have some benign notion of the common good. Agreed. The problem with this attitude is that they as well the people they want to cure are going to lose in the future if they don't generate the revenue necessary for future critical R & D.

1:02 PM  
Blogger Vivek Gupta said...

The discussion on this blog could not have been more timely. US supreme court has addressed our concern on granting of frivolous patents and in a recent landmark verdict has ruled against this frustrating practice.

http://www.businessweek.com/magazine/content/07_20/b4034049.htm?chan=innovation_innovation+%2B+design_innovation+strategy

While on the subject, I was surprised
to know that a patent allows a monopoly of 20 years. In this day and age where innvoations become obsolete even before they come to the market, a 20 year monopoly is a sure recipe for retarding progress.
I think the greater good of society
will be better achieved if there were some kind of graded patent system. This patent system should take into account the man hours, money spent and the brilliance of the idea in rewarding the appropriate protection. For example, a life saving drug costing
hundreds of millions could be awarded a 20 year protection but a slight modification to the existing medicines for erectile dysfuntion should deserve only 5 years at most. Just a thought.

8:00 PM  
Blogger anya said...

Vivek: Actually what you are saying .. "In this day and age where innovations become obsolete even before they come to the market" - applies directly to the use of the patent. In fact because technology is advancing so fast .. there are innumerable patents which are quite useless to the patent-owner much before the 20 years are over. I used to work for a company which dereives a majority of its revenue from patents .. and frankly .. they have to keep inventing and improving upon their technology to keep earning royalties.

4:03 AM  
Blogger Ashutosh said...

Vivek, I agree that every frivolous change in an existing patent should not be awarded a 20 year shelf life. But what Anya says is a major part of the problem. Here's what happens; a company markets their blockbuster 5 billion dollar drug, then for the next 10 years, they struggle but don't manage to come up with any new equally good product. They become somewhat desperate because they need to keep the cash flowing in, so the only way out for them is to try to extend the existing patent by any means possible. I am not saying that this is good practice, but unfortunately it has become accepted practice in a business model that is increasingly seen wedded to the idea of billion dollar blockbusters, that is not satisfied with marginal profits of "only" a few hundred million. So I agree with you that the courts should judge patent shelf life based on individual product merit, but what is a more serious issue is the business model of current US pharma, which does not settle for anything less than a billion.

9:00 AM  
Anonymous Chetan said...

I think you are right in terming Mehta's argument socialist. The argument has a clear, rich are getting richer while poor are being exploited owing to WTO regime being unfair, ring to it.

I have no objetion in him being a socialist so I am a bit amused as to why calling Mehta such should offend somebody else. But that is another issue.

If I had read that article without reading your criticisms, I would have been nodding my head to everything Mehta has written. This despite being aware of all the things you have mentioned in your critique about how much effort goes into drug discovery and also the marketing of the drug itself. The whole issue is somewhat infuriating. Why, I do not know. Probably the same way capitalism always intuitively seems 'unfair' to me.

Which brings me to the first question you raised in your post. "Why do so many people have a conception of Indians as having a misguided socialist mentality?"

In my opinion that conception is a reflection of reality. I am in India for the past one and a half week (that is why I haven't been a regular here) and have been amazed at how differently my friends view capitalism from their American counterparts. Despite the bouyant optimism about business and India taking on the world, there is a constant lingering guilt associated with the wealth. Even the well-read intelligent friends bring up repeatedly the argument about how the trade regime favours the West and conjure up some conspiracy theory after another about the Indo-US nuclear deal. Let alone that, there is speculation in the Marathi newspapers (Loksatta) about why mangoes have been allowed in the US.

I think because of inhabiting the Indian blogosphere where most writers are from the US and are either Libertarians or a variation of free market fundamentalists, I had come to believe that Indians have all changed and become pro-market rather than reluctant reformers with guilt associated with leaving our socialist past. But after my interactions (and this may not be a general trend or a proper sample space to extrapolate) I think the cultural conditioning about greater common good and how to achieve it, and also regarding ideas of fair/unfair is still stacked against capitalism. This, coupled with pride in our heritage, makes us easily susceptible to falling prey to arguments such as Mehta's.

So I think if people do have that conception about Indians being misguided socialist, it is rooted in reality. I think we feel guilty/infuriated about things that my American friends would not even care to give a thought to making the arguments that you present counterintuitive rather than obvious as they ought to be.

Also, given that this cultural conditioning plays such a major role in shaping our worldview, how do we overcome it and find a solution to the problem you have raised in responding to Siddharth...

"Now maybe our companies are not doing this because they have some benign notion of the common good. Agreed. The problem with this attitude is that they as well the people they want to cure are going to lose in the future if they don't generate the revenue necessary for future critical R & D."

12:01 AM  

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