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Bayer loses patent in India test case

The Local · 13 Mar 2012, 10:44

Published: 13 Mar 2012 10:44 GMT+01:00

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The drug, used to treat liver and kidney cancers, is currently sold at more than €4,000 (284,428 Rupees) for a month’s supply of 120 tablets – well beyond the financial reach of most Indian patients.

Generic drugs company Natco took Bayer through the Indian courts to win a license to produce cut-price copies of the drug. It said in a statement it would sell the drug at less than €134 (8880 Rupees) a month.

The Indian Patents Act rules that drugs unavailable at affordable prices must be compulsorily licensed after three years of patent approval, the Times of India newspaper reported on Tuesday.

Under the agreement, Natco will pay Bayer six percent royalties on sales, but Bayer is determined to continue fighting the decision if possible.

This was decided on Monday, a spokeswoman for Bayer confirmed to The Local. “We are very disappointed and will be checking out legal options,” she said.

Indian Patent Controller PH Kurian said Bayer had priced the drug “exorbitantly,” making it “out of reach” of most Indian patents.

The case will be watched carefully by other pharmaceutical firms keen to protect their patented drugs and the high prices they can demand for them.

Under the World Trade Organization's TRIPS Agreement, which governs trade and intellectual property rules, compulsory licences are a legally recognised means to overcome barriers in accessing affordable medicines.

Story continues below…

The decision was welcomed by Medecins Sans Frontieres (Doctors Without Borders), whose policy director Michelle Childs said it, “serves as a warning that when drug companies are price gouging and limiting availability, there is a consequence.”

The Local/AFP/hc

The Local (news@thelocal.de)

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Your comments about this article

12:19 March 13, 2012 by klaus stoiber
The drug is very expensive, but why lose the patent after all the research was conducted and monies spent? This is not justice. If India has a problem then they should do their own research and heal their own people with their own funding. What this comes down to is blatant theft of a German product. We discovered xrays, aspirin, invented the petrol and diesel engines, designed the rocket that put man on the moon etc. Surely these third worlders can have a little respect for other countries patents?
13:15 March 13, 2012 by michael4096
It is a brave person that says people should die in order to maximise a big company's profits.

The article doesn't mention that Bayer's own estimate of its development costs are $300M and that its sales so far have well exceeded $1B at over 90% margin. Yes, I understand that doesn't take R&D of failed drugs into account.

I think the Indian courts have been very fair in this case and the 6% it has ordered paid to Bayer more than it needed to under international law. Of course, it would have been nicer if Bayer could have offered this voluntarily to developing countries.
13:29 March 13, 2012 by manu1111
@klaus stoiber: I have a simple question, "What has more value, human life or money?" Do think about it.

What I see from my experience is that in "your" developed world money weighs more. There is a health insurance system which kicks people out when they have to pay for such drugs. The health insurance company has to make money and this money comes with the cost of lives. See the article a few days ago where record profit from health insurances was reported. Another example from todays news is the news of the footballer who decided to go for euthanasia instead of fighting a cancer battle.

Surely these first worlders can have a little respect for the lives of others!
13:41 March 13, 2012 by anurag_bagaria
@ Mr. Stoiber, the point here is not about India v/s Germany. It's better to go into the depth of this issue. I think, even as per European (German) standards, EURO 4000 per month is not a price that most people can pay (every month!). With all other facts mentioned in later comments, I would even go to the extent of saying that even writing in support of such corporate policies should be deemed a crime. Please do re-think.
14:07 March 13, 2012 by klaus stoiber

Actually us first worlders are in our first world positions because of our own initiatives and inventions. If third worlders were to have less kids they would have more money. They cannot make their problems the problems of our firms. What would be the point of research in germany? To benefit third worlders? To continue getting things for free? India has over a billion people and each one can simply not be uplifted at the expense of german firms. Now what about this don't u understand? Should I use sign language?
14:17 March 13, 2012 by derExDeutsche
India has been producing its own version of Foreign Drugs for a long long time already. The Government is behind it. This just makes it official. Anybody that's spent some time in India knows that they don't hide the fact that they won't pay high prices for foreign drugs. Piracy, in the case of prescription drugs does not deter the Government, or the people. They feel they are completely moral and justified. and deep down, the prevailing sense is that 'Germany is pretty far away, what are they gonna do about it'? of course They say all this while wearing knock-off Ray-ban's and knock-off Nike and listening to a Mega-upload'd MP3 player.
15:31 March 13, 2012 by zene
Nobody is forcing Bayer to sell drugs in India. If they dont like it, they are free to go home. Period.

@Klaus: When i hear someone self-appoint himself as a representative of entire nation, i just see him feeling quite insecure on his own. I often see this "typische" reaction when discussions are around non-western economies that are now calling shots. And somehow it is hard to ignore wagging tails and salivating tongues when Uncle Tom is giving orders (albeit diplomatically).

So, if that helps, why does German government keep sending delegations to China & India if they dont like doing business with them.
15:36 March 13, 2012 by Jimberlin
klaus stoiber the idiot..

how can you compare Money to people's life?? Are you one of those Red Necks staright out of Hu ha Village from remote lands??

cant you see Michael and Man U have written? they are paying the liscene fee..That too after Billions they made in profit??

Or shall i use sign language?
15:44 March 13, 2012 by Ganesha
klaus stoiber... An example of arrogance at its best.

shame on you !!
17:21 March 13, 2012 by klaus stoiber
@ everyone,

India needs to do its own research,that is all I have to say.

Countries should boycott countries that have no respect for patent laws.

India is paying too little money to Bayer for this drug.
17:29 March 13, 2012 by lonesome
@ klaus stoiber --- u r such an ill-informed person (am not too sure if u are a person!!!), the next time you talk about those millions and billions of euros you so-called first worlders are so proud of, think where you got that '0' from, you arrogant dumb! Here's a list of Indian inventions & discoveries - http://en.wikipedia.org/wiki/List_of_Indian_inventions_and_discoveries

To help your lost-case a little, remember before any of these physical divisions in the world, we are all humans first!

And if you are really such a superior species, why is Mrs Merkel so desperately trying to woo all foreign workers and recognising their education and inviting immigration !!!

Its just shameful, how a few Germans shame all of us others!
17:39 March 13, 2012 by klaus stoiber

Seems like I have you right in the corner where I want you, thats why you labelled me as a "superior species", without any reason.

Now listen to me, I dont call a button an invention, its more like a coincidence. But the question still begs an answer, namely, why can they not translate their "inventions" into something that uplifts all their people to first world standards? And now this spineless german government is actually recruiting these people to work here instead of retraining unemployed germans and hiring THEM.

First make sure ones own house is in order before looking across the road.
17:57 March 13, 2012 by lonesome
@ klaus stoiber

U r dumb enuf not to even understand sarcasm when its meant - superior species, fcol !!!

Have the self-respect to at least read the article before you jump on to comment to save your butt.

As I mentioned there are innumerable inventions done by people from outside of the so-called first world, like the Indians gave the world the number "0" !!!

And since you have a problem with the Germans (first-worlders) in addition to Indians (third-worlders) and maybe the human race as well, please go inhabit another planet!
18:10 March 13, 2012 by klaus stoiber

LOL@ the number "0".. its not an invention,its a coincidence. People several thousand years ago, KNEW they had ZERo money or ZERO animals, just they never had a symbol for it.

I dont have a problem with germans (myself), nor do i have with anyone else. I just have a problem with third worlders inhabiting my country and living off my taxes
19:56 March 13, 2012 by jamesbondking
@klaus stoiber ...

hi ... whats happening in greece , italy , portugal, spain????????

is it 1st world .. if so will the EURO ZONE remain intact ....

dont be a racist .... the indians also have invented so many things , the world is using today ....

ayurveda , yoga , decimal number system , 0 and many more.

may be the number system seems irrevelant to u , but if the world had used ur 1st world number system i.e. ROMAN NUMERALS V , VI , C, M .... no invention including measuring the speed of rocket would have been possible. stop being a racist .

if u have a case to show ur concern do it in a proper manner rather than shunning the so called 3rd world countries ....

the actual game has shifted now to our court , so just be a spectator and try to respect non whites as well , especially when ur white economy is shaking violently and about to collapse !!
23:05 March 13, 2012 by alex533
I have to agree with klaus stoiber. Patents are there for a reason. You can't just say "oh your products are too expensive now your patent belongs to me". It is very simple, if they want a certain product - they have to pay for it.
23:45 March 13, 2012 by germanfreund
I have to disagree with Klaus and Alex. German research with german tax payers money should simply stay in germany if they have problem with laws of other country.Since Bayer is selling in india, it already shows that the market is important for them to make profits. In an open economy dont come up with such ridiculous superiority complex.Why dosent bayer stop selling in india if it has a problem and treat all cancer patients in germany for free if social service is in mind of the multinational company
00:10 March 14, 2012 by ladydr
The article ends with the comment:(Read it and dont make comments like uneducated stupid person)

The decision was welcomed by Medecins Sans Frontieres (Doctors Without Borders), whose policy director Michelle Childs said it, ¦quot;serves as a warning that when drug companies are price gouging and limiting availability, there is a consequence.


¦quot;Access to Medicines: India Offers First Compulsory License

Delhi/Geneva ­ March 12, 2012 ­ In a landmark case, the Indian Patent Office has issued the first-ever compulsory license in India to a generic drug manufacturer. This effectively ends German pharmaceutical company Bayer¦#39;s monopoly in India on the drug sorafenib tosylate, used to treat kidney and liver cancer.

The Patent Office acted on the basis that Bayer had not only failed to price the drug at an accessible and affordable level, but that it had also failed to ensure that the medicine was available in sufficient and sustainable quantities within India.

¦quot;This decision serves as a warning,¦quot; said Michelle Childs, director of policy/advocacy at the MSF Access Campaign. ¦quot;When drug companies are price gouging and limiting availability, there is a consequence: the Patent Office can and will end monopoly powers to ensure access to important medicines. If this precedent is applied to other drugs and expanded to include exports, it would have a direct impact on affordability of medicines used by MSF and give a real boost to accessing the drugs that are critically needed in countries where we work,¦quot; she said.

Under the World Trade Organization¦#39;s TRIPS Agreement, which governs trade and intellectual property rules, compulsory licenses are a legally recognized means to overcome barriers in accessing affordable medicines.

The Indian decision actually mirrors similar moves made in other countries, including the US. In February 2011, the US Patent Office decided not to prevent a ¦quot;generic¦quot; medical device used for skin grafts from being sold, but rather insisted that its manufacturer pay royalties to the patent holder.

¦quot;Behind this action is the idea that the public has a right to access innovative health products and they should not be blocked from benefiting from new products by excessive prices,¦quot; said Michelle Childs. ¦quot;If more compulsory licenses are granted in this vein, the answer to the question of how to ensure affordable access to new medicines could radically shift.¦quot;

With today¦#39;s system, new medicines are patented and drug companies aggressively defend their monopolies, at the expense of patients who can¦#39;t afford the high prices charged. Instead, moving to a more equitable system would allow the production of new medicines produced by multiple manufacturers, each paying royalties to a patent holder. This would help recoup development costs and ensure that people in developing countries have access to lifesaving drugs.
00:53 March 14, 2012 by joysonabraham

1) Never forget how 1st world countries became 1st(Not by using what you had in your own backyard), always by looting this so called third world countries in the past. The education the technology and all stuffs are made available here as a by product of all the stuffs the 1st world grand parents did in these so called present day third world countries. I don't see any other word other than loot, sorry about that. I don't think especially Indians will be liking it when they know until 60 years back whites where taking away all their mineral, wood and all they can and when they left they divided the land in a messy way.

2) If someone don't like to sell they can always stop selling in any market. But then is it sustainable for the seller is a question. You cant anyway find 1 billion people market in Germany. Inventions are good. But it is useful and can generate profit and create sustainability only if there are people to buy. If all German companies tried to think like you, do you think they will be able to grow like this selling only in Germany.

@everyone who oppose Klaus

1) Forcing someone to sell at the buyers price is not fair either. Just because you saw something in your neighbors backyard, which is useful, you cant force him to sell it at a price you like. You can negotiate with him for a price and if he or you don't like, don't sell / don't buy
01:00 March 14, 2012 by zeddriver

While it surely is a tough moral question to tackle.

In the case of the drug companies. After doing a little research there is no clear answer about how much it REALLY costs to bring a drug to market. Can you imagine running a company and doing ten years of research on a drug and still not be able to count on the government giving the go ahead to sell it. That's ten years of md and phd scientist's and medical study pay checks to cover. And then in the end most drugs don't make the cut and never get approved to go on the market.

Bayer AG 2010 report shows that with a total sales of 35 Billion the net after tax profits of Bayer AG was 1.3 Billion. The research budget was 3 Billion. That's 2.3 times after tax profit just in research.

Natco doesn't do research to find new drugs. They just take the research done by others to make a profit for themselves. They are surely not in it for Altruistic reasons. They can make it cheaper because they didn't have to go through the ten year (on average) process to discover these drugs. and jump through endless regulatory hoops to bring said drug to market. Were it not for Bayer AG. Natco nor any one of us would have ever heard of Nexavar.


I take it from your user name you may be a doctor. Tell me. Since doctors have to go through so much education and residency at a very great expense. And a lot of continuing education, And buy very costly malpractice insurance. Do you then say to doctors. That it would be fairer to the people if you only made what the median income was in your place of residence. So given that. How long do you think it would take before a shortage of doctors to occur. The same holds true for drug companies. If it's so darn profitable to do drug research. Then why doesn't Natco do it?
10:02 March 14, 2012 by mmf_smily
especially the lifesaving drugs, i feel its just not ethical to patent. 4000 euros for 120 tablets.. which is just insane. One should really appreciate effort of research and fining the ways to save A life, at the same time, if its not reachable to common man, whats the use?
11:20 March 14, 2012 by michael4096
Like drug companies, doctors are pretty well paid for their expertise and time. Quite rightly. However, if a doctor comes across a dying man it is still considered normal to help him first and ask about his ability to pay later. So it is with drugs and the TRIPS agreement referred to above - the WTO has tried to define more precisely the 'dying man' concept and the 'passing doctor' concept and the rules for payment after the fact in order to be fair and humane. One can argue about the details, but it's difficult to complain about the general premise.

One of the rules which I assume was followed was that India must have asked Bayer to license this drug voluntarily at a price more people could afford and Bayer refused. They could have been seen as heros but they chose to appear to the world as uncaring.
12:31 March 14, 2012 by zeddriver

A big part of the problem is the massive regulatory hurdles that a drug company must jump over to bring a drug to market. And those regulations were brought on by a spoiled consumer that EXPECTS a drug to be perfect. Cure me instantly with no bad side effects or I'll sue you for everything.

Just look at a small issue as to why a doctor needs to charge a lot for care. I read ten years ago that in the US the average Anesthesiologist paid over $50,000 per year for insurance. That cost WILL be added to your bill.


While true. The issue is that most doctors don't find dying men in the streets all that often. As opposed to the que's forming at the doors of drug companies. But as I said. It is a heck of a dilemma morally. If Bayer AG or any drug company for that matter can have a patent taken away. It will not bode well for future research into new medicines. Would Bayer have even done the research for this drug if they had knowledge that the formula would be given to a company that had no monetary liability in it's discovery. and undercut Bayers ability to recoup the monies spent researching this drug. And therefore many more than right now would have no hope for treatment because it may have not been worth the effort to spend such monies to research it.
12:33 March 14, 2012 by joysonabraham

"And now this spineless german government is actually recruiting these people to work here instead of retraining unemployed germans and hiring THEM."

how can you blame German government like that. How can you even think that every unemployed German is suitable for any job. The ability to do a job depends on ones brain, intellect, health and a lot more parameters. When you own a firm you will know how hard it is to find, train and make people work the way you want and in a productive way. its not dependent on color.

means sometimes you have to pool from other countries and other races to run a successful business while some of your own folks may be in difficulty. Just to generate money you need to support your own people who don't have enough money or can't find good paying jobs or to make money for hartz v or pension etc. But allowing expatriates to stay until they die may be a problem for you. This as also required sometimes because if one cant bring their own family, how ever intelligent he or she is, he may not be willing to work for long as an expatriate. Its a competitive world. If Germany say no to an intelligent person some other country or company will say yes to him. Means your business rival gets a good shot at you in the long run.

unfortunately for you, the so called first world countries are not socialist or communists to accommodate every one (idiot or intelligent) for a particular job or position an for same pay, and you know what happens when you do such a thing like socialism or communism from human history. If you do like them 1st world becomes 3rd world in a few years
12:48 March 14, 2012 by venkyfra
Bayer is very much aware of Indian patent act. So does other pharma companies. TRIPS is something used by every country. Bayer doesnt have much sympathy with Indian public. Morale is something non-existent for companies like Bayer. After all they were selling banned carcenogenic endosulfan in India(till 2011). FYI.. Endosulfan is a patented product of Bayer corpscience. They still sell it in other countries. It will be interesting to find if this form of cancer came into existence due to endosulfan. This disputed cancer drug treats only 8800 people in India. Indian govt normally doesnt show that it has balls. So I guess this legal drama is going to get spicy.
12:50 March 14, 2012 by Cambooya
Patent holders should only have that patent monopoly right while that particular patent is still recovering research and development monies, this is to insure that the underlying bussiness can continue to research and develop. Once that monetary recovery is complete, all governments should be able to set fixed prices on all such drugs, with the understanding that monetary recovery of the manufacturing process is covered along with a defined profit margin based on that particular production process for that particular industry. Further more when you have life saving drugs, so called production limits that do nothing but drive prices up further should also be illegal. Every company knows what their R&D costs are for a particular product, and once that money is recovered, the patent rights should just vanish in their own right.
13:03 March 14, 2012 by venkyfra
@klaus, zeddriver,

India doesnt need this drug. There are only 8800 people who are in need of this drug. 8800 in 1.2 billion is nothing.

Its obvious that India is putting foundation for a much bigger legal trouble.

Bayer knows that very well. So dont sweat it. India is not stealing anything from Germany.

As a matter of fact german drug are full of Indian ayurvedic medicine and we never cry foul about it. As long as it helps someone we are fine with it.

An example drug which is used in this flu season : Mucosolvan. The drug Ambroxyl (used in lot of brand) is the latin name of adathoda (ayurvedic herb).
13:46 March 14, 2012 by zeddriver

To me the people of India are not what this is about. It was about an Indian drug company (natco) wanting to get in on the profits of an important drug that they had no legal right to make (because of that pesky patent). Oh yes! they very skillfully argued about all of the people they could help. But I'll tell you this. If the money department of natco would not have seen a profit potential in this the case never would have seen the light of day. Natco absolutely did not do this for altruistic reasons. It was and is about money. As I said. Natco could only make money from this drug at a lower price because they do not have ANY research monies on the line.


While on the surface that may sound good. But the truth of the matter is that most of these new drugs have been discovered, developed, And researched in capitalist countries/companies. If you say to these companies. We will only let you recoup your research costs then hand over your product to other companies. It is very likely that research into new drugs will slow down significantly. The very idea of the patent was to let a company that spent a lot of money developing a product make a "profit" from said product. Not just recover the cost of development.
14:11 March 14, 2012 by venkyfra

Agreed, NATCO didnt spend any R&D money so they cant sell if for higher price. No one knows NATCO. Even the newspaper which reported had to first give a introduction who NATCO is. Its kind of clear no skilfull arguement ever happened & these guys were probably chosen for this case.

The drug in dispute Sorafenib(chemical form) is not even proven effective. Bayer could even get rights to sell it in UK. I dont know if its sold in Germany. They got sort of go-ahead to sell it in USA bcz it was co-developed with american company Onyx pharma. I dont know if any other country is using it.
14:47 March 14, 2012 by michael4096
@zeddriver - you talk as though you think patents are a fundamental human right. They aren't. They are a device invented by society in general as a mechanism to encourage inventions that will benefit society as a whole.

If the same society that invents patents also feels that in some circumstances the patent concept should be tweaked in order to benefit society even more then who are you, or I, to deny that? You cannot simply say that society has the right to invent patents but not to add a rider to the concept. We are not talking about someone riding off into the sunset with a bag of swag over his shoulder; this is a country's judicial system doing what it is supposed to do under international treaties.

BTW "...most doctors don't find dying men in the streets..." I know quite a few doctors and yet to meet one that isn't called regularly to emergencies outside the work they get paid for.
16:01 March 14, 2012 by zeddriver

"They are a device invented by society in general as a mechanism to encourage inventions that will benefit society as a whole."

I agree with that. Patents are not a basic human right.

That mechanism is not allowing others to profit from an inventors hard work before they have had a chance to make a profit from their labors.

And yes those patent laws are subject to being tweaked. But being tweaked doesn't necessarily always lead to good things. Most things, Including laws can be tweaked out of alignment quite easily. Or made better. We will find out in the future. I for one hope that in the end it works out for the benefit of all parties.

The bottom line is that if we tweak the patent laws to far so as to make the already high risk and very expensive task of doing drug research even more risky monetarily. We run the even greater risk of stifling future research. And that leads to the moral dilemma that we have before us. If it were not for the potential big profits Nexavar and a lot of other drugs would have never been invented/researched and put on the market. Take away that potential for big profit. Then why bother to spend billions on researching new drugs.
17:43 March 14, 2012 by michael4096
@zeddriver - I understand what you are saying. However, the tweaks are being invented by essentially the same guys as the patent laws themselves - they have become part of patent law. It is possible that a change in the law makes the law worse, this has happened before, but it doesn't stop it being the law.

Theoretically, Bayer cannot lose from this and therefore it cannot be put off trying to invent new drugs. It cannot lose because the only people that will get the drug under this scheme are people that could not buy it before anyway. And, they still get their license fee. Theoretically.

In practice, of course, they can lose as the generics can escape from the target audience. But, again, Bayer had the opportunity to make tighter controls as part of voluntary agreements. By forcing the courts to set the rules they have lost that opportunity.
23:30 March 15, 2012 by amithbn
Quite predictably the discussion turned nationalistic. And there's always someone who loses no opportunity to point out the contribution of India to science --> "0". Respect for all the investment in science and research that is happening in Germany. We, Indians, have loads to learn from it. But selling a drug at €4,000 (284,428 Rupees) is idiotic. It is way too exorbitant for Indians. Out of reach for everyone. Even a top-level manager in a big corporation wouldn't make that kind of money. However, the Germans needn't be that disappointed with the the new price tag I suppose. Because lowering it to €134 (8880 Rupees) makes it accessible to a huge middle class, In the order of 150-300 million. Assuming that it is not a rare disease, Bayer can make similar profits with selling the drug in much bigger volumes. They can probably make similarly huge profits while saving many more people adjusting the price tag accordingly working out the math. Essentially, this can be reduced to a problem of price as opposed to volumes.
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