INDIA’S BAYH-DOLE: INDIA’S SCIENTIFIC RENAISSANCE?

The Bayh-Dole Act passed in the US in 1980 provided universities and academic scientists with ownership of their patents and inventions and led to significant wealth creation in the public research sector. An Indian bill modeled on this act is due to be put up for passage in 2009. This bill could reenergize the Indian research enterprise and potentially be the turning point for India’s flagging scientific institutions. As in other such endeavors, it promises fond and cautious hope for Indian scientists, and more than a smidgeon of prudence…

…Read the rest of the entry on my Desipundit blog

DAMN THEM BRAZILLIONS!

Since we are on the contentious subject of drugs and patents, it is worth pointing to another lively debate that has been going on in the blogosphere. In a nutshell, this is what it is about; Merck has a bestselling anti-HIV drug named Efavirenz. They offered to sell it to Brazil at a reduced price. Brazil did not accept the price, and then broke Merck’s patent (due to expire in 2009) and now are going to produce the drug through a compulsory license issued by the President. And they think Ahmedinejad is defiant…

This has raised a lot of heckles. Some are pointing to Brazil’s hypocrisy; while on one hand, they tout themselves as a fast-growing economy with a modern space program (and ethanol fueled cars), on the other hand they want to play the pauper and demand outrageously low prices for drugs. Of course, price control and price setting are very complex issues, but one question that surfaces is, does Merck have the right to decide whether a price is cheap enough for a country like Brazil to afford? On the other hand, it may always be in the interest of a developing country to display its (true or contrived) empty pockets to get the best deal. And of course, Merck simply may not be able to make enough profit if it sells the drug at that price, which leads us down the always thorny path of asking “How much profit is ‘enough’ profit?”

Many questions arise in this context, and I wonder what the world is going to look like ten years down the line if such things continue to happen. Firstly, who are the losers? Brazil, because its international image is going to suffer and this may deter further pharmaceutical investment in it? Or Merck, because now, where they were going to make at least some money earlier, they will make none? One thing is for sure, such brazen flaunting of patents is surely not going to encourage pharma to sell drugs to developing countries. And I don’t think the option of regularly breaking patents and producing drugs is too favourable for a country’s political and international health.

Merck also says that,

“Research and development-based pharmaceutical companies like Merck simply cannot sustain a situation in which the developed countries alone are expected to bear the cost for essential drugs in both least-developed countries and emerging markets. As such, we believe it is essential to price our medicines according to a country’s level of development and HIV burden, thereby ensuring equitable access as well as our ability to invest in future innovative medicines. As the world’s 12th largest economy, Brazil has a greater capacity to pay for HIV medicines than countries that are poorer or harder hit by the disease.

This decision by the Government of Brazil will have a negative impact on Brazil’s reputation as an industrialized country seeking to attract inward investment, and thus its ability to build world-class research and development.”

I sort of agree with that, and even generics producing countries have to consider this; it’s not about profit making, it’s about being a perpetual free (or cheap) rider, profiting on other hard-earned inventions. And this time, the IP laws also seem quite reasonable; it’s not like Merck made a “slight” modification on some existing product and is now raking money off the patent.

One extreme result I can see of such generics piggybacking and/or sidestepping IP regimes, is that companies may refuse to disclose the formula for a new drug, simply asking the FDA and patients to be content with its therapeutic benefits. While this scenario does not sound realistic, every generic country and developing country would be in deep trouble if it is realised. There is also another serious problem that might surface. One of the grievances of the developing world is that western pharmaceutical companies are not focusing on diseases that are dominant in developing countries, such as infectious diseases. It’s only recently that western companies are devoting resources to develop new medications for infectious diseases, motivated largely by hospital infections in patients in their own countries affected with HIV and other such ailments, but also motivated in part by the prospect of suddenly having a huge new market open up in developing countries. Imagine how much motivation will remain for them if generics for their anti-infection compounds are hijacked and produced by developing countries outside the patent the moment they are approved. That would pretty convincingly deter them not to devote further resources to such remedies.

A sane way out of this may have been for Brazil to subsidise the drug to make it cheaply available to the people. If the government of Brazil thinks something is too expensive, then it only sounds fair for them to pay for that product, instead of flaunting and trampling over patents and IP regimes. Isn’t that what taxes are for?

I am not against generics companies, but at the same time, one has to keep within the boundaries of some IP regime, otherwise the world will descend into a free-for-all in which, ironically the “flaunters” will end up being the “flauntees”.

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