Cancer-treatment drug Nexavar will soon be available to patients at Rs. 8,880 a pack of 120 tablets, thanks to India invoking an international trade rule allowing the generic production of an unaffordable drug that is patented.
Bayer, a German multi-national, holds the patent for Nexavar (the brand name of sorafenib tosylate), which now sells at Rs.2.84 lakh.
The way for such a huge reduction in the price was cleared on Friday when the Indian Controller-General of Patents, Designs and Trade Marks granted the first-ever ‘compulsory licence' in India to the Hyderabad-based Natco, a generic drug-maker, for making sorafenib tosylate, which is used to treat kidney and liver cancer.
Natco had sought ‘compulsory licence' under Section 84 of the Indian Patent Act.
The drug is used for the treatment at the advanced stages of kidney and liver cancer. The drug stops the growth of new blood vessels and targets other important cellular growth factors. Though it is not a life-saving drug, it is a life- extending drug. In the case of kidney cancer, it can extend the life of a patient by four-five years, while in the case of liver cancer it can extend life by about six- eight months.
Natco Pharma had applied for the invoking of the provision last July after Bayer declined to accept its request for a voluntary licence to manufacture and sell the drug.
In his order issued on Friday, Controller of Patents P.H. Kurian also directed Natco Pharma to supply the drug free of cost to at least 600 needy and deserving patients every year.
Natco Pharma will also have to pay a royalty to Bayer at the rate of six per cent of the net sales on a quarterly basis, and the licence shall be valid till the entire balance period of the patent — it was granted in 2008 and will expire in 2020.
Welcoming the development, Director-General of the Central government's Council for Scientific and Industrial Research Samir Brahmachari said it was a heart-warming decision as the drug would be available at just three per cent of the current price.
Dr. Brahmachari, who has initiated an open source drug discovery programme in the CSIR to help develop drugs for tuberculosis and other diseases of public health importance, noted that in the health sector at least there was a need to strike a balance between the rights of the patent-holders and the needs of the users. “There can be profits. But, not profiteering at the cost of the patients.”
Keywords: Nexavar, sorafenib tosylate, generic medicine, cancer medicine, patent laws
India is in the hands of Rural population by Mahatma Gandhiji. But they are poors so this facility pland by the Indian Controller-General of Patents, Designs and Trade Marks granted the first-ever compulsory licence in India to the Hyderabad-based Natco a genric producing company is actually good for our Nation as well as Poors in India. As early as possibly it should come to our local market legally not illegally for our common brotherhoods benefit.
Government should also take interest to invest in research for the
prevention of such disease that causes liver and kidney cancers.
Statistical tools should be used to find root cause of the disease and a
check should be applied there.
10+ years kidney cancer . Kidney removed, matastes to spine, part of spine removed cage unit and rods put in, 2 ribs removed, iliac bone removed, tumor ate through skull May 2010. Tumors on liver, femurs, shoulders, hips , lower back. 2003 Watched info on the gene stuff for years now they say it won't work. Was rear ended and that broke his collar bone permanently. Married for 43 years met at 14 he was always the one. He worked up until May of 2010 for insurance. Sutent was about 15K a month in the beginning and it was all there was, Seemed to work great for awhile. He still wants to live and is fighting for his life. type O with rare antibodies. no one knows why he is still here but he continues to fight. Has a pain pump now and they just put a port in. The blood draws seem to be the worst part of this for him. If anyone hears of a cure email us. You'd love my guy...
A 'patient' is much more important than a 'patent'. MRPs of many of these life saving drugs are over priced to benefit intermediaries.
People from the medical fraternity must be aware of these. Whoever, has taken this bold step must be congratulated and supported. We await many more such decisions.
Welcome and bold move by the government and judiciary. Just ensure that the company NATCO PHARMA does not raise the prices in due course of time. This will nullify all the benefits provided by the judiciary order.
Its a welcome move by Indian government.I am so happy for such a nice effort taken by our government.Also there is urgent need in research work in India so that we can contribute in better way in todays world like we have done centuries ago.
When it is a matter of life and death, without any doubt, robbing Paul
to save Peter is absolutely fair. The poor may not afford to buy
medicine even at this cost but many philanthropists may find it within
their reach to donate.
It is good for the patient who honestly deserves it. However this should have been done is a cordial manner with the company. Personally working in the Research and development field, I can tell you that the drug development is a painful process and takes about 10-15 years! so the companies have to invest lots of money and time to fund its research and development program which runs into billions. So the step taken by the Government is not foresighted. If all the governments take such a decision then pharmaceuticals comanies cannot survive!
Molecular targets of the drugs (including Nexavar) are well known and are published in scientific journals. Therefore finding an alternative is not impossible. Our Government has taken initiative to pursue indigenous drug discovery programs which only needs to be pursued with foresight and vigour. In summary the decision is great in the short run, but populist and very detrimental in the long run.
Landmark and bold & courageous decision by Indian patent controller in order to affordable by the poor patient suffering from kidney cancer in country on humanitarian ground by invoking the existing law to allow local firms to manufacture and supply on cheaper price (even that is also costly for Indian patients when it compare to country per capita income). If the MNC drug maker doesn’t challenge this assuming not impacting much on its market share as compare to little patients number in India counterpart to other nations. But it let other generic firms to make use of this judgment to other lifesaving drugs on the same ground which have been patented. Coming days really a overcrowded by generic drugs of crucial diseases if this judgment sustains in next level courts or may take it to international level to defend their patented drug.
A flood of litigation is probable. This might bring to limelight a lot of issues related to intellectual property rights. India may not have a strong system of enforcing tough regulations. Someone who has worked hard to develop the formula might be deprived of the riches. But, people who have cancer cannot be expected to expect anything but a cure and a reduction in cost achieved by whatever means, is always more than what we gain by law and due procedure - it is about saving human life and easing the pressure off the poor patients. Intellectual rights versus the right to life. Choice should not be hard.
Need of the hour. Appreciate the steps taken by the government authority as well as the manufacturer.
It is encouraging to see Indian bureaucracy finally working in some places. As a North American resident, I have come to learn that Big Pharma such as the Bayer and their likes are nothing but ruthless exploiters who think they can rip off Indian people the same way they have shafted North Americans and Europeans for the past century. I am all for free market and respecting intellectual property, but boundaries must be set as has been done in this case in order to prevent helpless patients. If not for this clause, poor patients would be forced to sell their homes and farms to be able to buy drugs that would keep them alive for a few months longer. Indian government must not sell out to big corporations and fight for the lower class. Sounds like a dream but they have shown that it is possible, at least in this case. More battles are yet to be fought against Big Agro- i.e. Monsanto, Dow, etc. Indian people must not lose against the deep pocketed interests or India will be worse off.
That is a great news. Way to go India.......
A fair balance between the rights of patent holders and the needs of patients (especially those affected by killer diseases like cancer) is a moral issue in an interdependent world today. It is true that most cancer patients cant pay for the drugs. It is also true that most commercial companies will not invest in the extremely difficult and costly research and developments against diseases like cancer if they have no profits. I wonder what a good politician or economist has to say on this moral issue.
This whole thing is unfair. So, let me get this straight. Bayer, the German drug giant who did
bulk of research are assigned a patent on this drug. This was made possible because it took risk while conducting reserach and in due course of time was rewarded with IP rights. If people in companies in India like Dr. Reddy's lab and Ranbaxy are smart how come they did not discover and realize that cancer is deadly diseases and work on it, instead of copy cat research and survive on generic manufacturing tactics. The fact of the matter is Indian companies do not take risk and they are free loaders. Coming to the present if this drug is made in India as a public service to the patient population that is fine, but the company that makes the active pharmaceutical ingredients is actually going to profit still at lower price. And, that is no public service but day light robbery at the behest of government.
It is a relief for the middle class family with a sick relative but it is still a far cry for a financially poor cancer patient. Indian scientists need to do more research in natural medicines rather than investing all their potentials in the development of synthesized drugs. All my life is spent as a chemist and medical researcher and now I find it is cheaper and more effective to follow the medicines provided to mankind by mother nature. There should be unique fusion of the modern medicines with the age old Ayurveda.
I appreciate the government move to make the cancer drug available in cheaper
rates.Being an affected man having lost my wife due to cancer, I suggest that the government may consider that people below poverty line may be supplied with such drugs even by allowing some subsidy.
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