Deprecated (16384): The ArrayAccess methods will be removed in 4.0.0.Use getParam(), getData() and getQuery() instead. - /home/brlfuser/public_html/src/Controller/ArtileDetailController.php, line: 150
 You can disable deprecation warnings by setting `Error.errorLevel` to `E_ALL & ~E_USER_DEPRECATED` in your config/app.php. [CORE/src/Core/functions.php, line 311]
Code Context


        trigger_error($message, E_USER_DEPRECATED);

    }
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 You can disable deprecation warnings by setting `Error.errorLevel` to `E_ALL & ~E_USER_DEPRECATED` in your config/app.php.'
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deprecationWarning - CORE/src/Core/functions.php, line 311
Cake\Http\ServerRequest::offsetGet() - CORE/src/Http/ServerRequest.php, line 2421
App\Controller\ArtileDetailController::index() - APP/Controller/ArtileDetailController.php, line 150
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Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
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Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Error\Middleware\ErrorHandlerMiddleware::__invoke() - CORE/src/Error/Middleware/ErrorHandlerMiddleware.php, line 96
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Http\Runner::run() - CORE/src/Http/Runner.php, line 51
Cake\Http\Server::run() - CORE/src/Http/Server.php, line 98

Deprecated (16384): The ArrayAccess methods will be removed in 4.0.0.Use getParam(), getData() and getQuery() instead. - /home/brlfuser/public_html/src/Controller/ArtileDetailController.php, line: 151
 You can disable deprecation warnings by setting `Error.errorLevel` to `E_ALL & ~E_USER_DEPRECATED` in your config/app.php. [CORE/src/Core/functions.php, line 311]
Code Context


        trigger_error($message, E_USER_DEPRECATED);

    }
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 You can disable deprecation warnings by setting `Error.errorLevel` to `E_ALL & ~E_USER_DEPRECATED` in your config/app.php.'
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deprecationWarning - CORE/src/Core/functions.php, line 311
Cake\Http\ServerRequest::offsetGet() - CORE/src/Http/ServerRequest.php, line 2421
App\Controller\ArtileDetailController::index() - APP/Controller/ArtileDetailController.php, line 151
Cake\Controller\Controller::invokeAction() - CORE/src/Controller/Controller.php, line 610
Cake\Http\ActionDispatcher::_invoke() - CORE/src/Http/ActionDispatcher.php, line 120
Cake\Http\ActionDispatcher::dispatch() - CORE/src/Http/ActionDispatcher.php, line 94
Cake\Http\BaseApplication::__invoke() - CORE/src/Http/BaseApplication.php, line 235
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Routing\Middleware\RoutingMiddleware::__invoke() - CORE/src/Routing/Middleware/RoutingMiddleware.php, line 162
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Routing\Middleware\AssetMiddleware::__invoke() - CORE/src/Routing/Middleware/AssetMiddleware.php, line 97
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Error\Middleware\ErrorHandlerMiddleware::__invoke() - CORE/src/Error/Middleware/ErrorHandlerMiddleware.php, line 96
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Http\Runner::run() - CORE/src/Http/Runner.php, line 51
Cake\Http\Server::run() - CORE/src/Http/Server.php, line 98

Warning (512): Unable to emit headers. Headers sent in file=/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Error/Debugger.php line=853 [CORE/src/Http/ResponseEmitter.php, line 48]
Code Context
            if (Configure::read('debug')) {

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        LATEST NEWS UPDATES | India patent bypass delivers life-saving blow against cancer by Raja Murthy    </title>
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India's decision this month to produce Germany-based multinational Bayer's anti-cancer drug Nexavar, in the first use of &quot;compulsory licensing&quot; in South Asia, will save lives but also raises intricate questions.

Under the compulsory licensing process, a government can under World Trade..."/>
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India's decision this month to produce Germany-based multinational Bayer's anti-cancer drug Nexavar, in the first use of &quot;compulsory licensing&quot; in South Asia, will save lives but also raises intricate questions.

Under the compulsory licensing process, a government can under World Trade..." />
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                            <br /><div align="justify">India's decision this month to produce Germany-based multinational Bayer's anti-cancer drug Nexavar, in the first use of &quot;compulsory licensing&quot; in South Asia, will save lives but also raises intricate questions.<br /><br />Under the compulsory licensing process, a government can under World Trade Organization (WTO) rules bypass a patent owner's rights after three years and order the manufacture and sale of life-saving medicines at much cheaper cost than by obtaining the medicine from the original manufacturer. This is third such instance in the world, after Brazil and Thailand, that compulsory licensing has been invoked.<br /><br />The WTO allows countries to set their own rules for compulsory licensing. In this case, India based its case on the affordability of the cancer drug for the common man - nearly three million people in India suffer from cancer.<br /><br />On March 12, the Mumbai-based Controller General of Patents Designs and Trademarks ruled that the life-saving Nexavar was beyond the reach of most Indians. Rejecting Bayer's arguments for pricing its anti-cancer drug Nexavar at 280,000 rupees (US$5,448), India's Patent Office estimated that the lowest paid government employee would have to work three-and-a-half years to pay for one month's dosage of the drug.<br /><br />Nexavar, originally patented as Sorafenib in the US in 1999, is used to treat advanced stages of kidney and liver cancer. The life expectancy of the patient without the drug is four months.<br /><br />After the Indian Patent Office ruling, [1] an Hyderabad-based company Natco Pharma will sell Nexavar at 8,800 rupees (or the equivalent of $172) for a pack of 120 tablets needed for one month's treatment - that is still over twice the government-estimated monthly income of an urban Indian family of five deemed to be living above the poverty line.<br /><br />Natco, which has to provide the medicine free of cost to 600 needy patients every year, will pay Bayer a 6% royalty on net sales of the drug. The company's shares gained 18% between March 9, before the March 12 announcement, and their recent high of 351.05 rupees on March 15. On Tuesday, the shares were trading at 337.50 rupees, up 44% this year.<br /><br />Pittsburgh-based Bayer has said it is reviewing legal options to challenge the order, which makes its anti-cancer drug available at 3% of the price at which the company was marketing it.<br /><br />P H Kurian, the Controller of Patents who signed the Indian compulsory order, reckoned the original cost of the Bayer medicine would push many more families among 72% of India's population living above a &quot;very low poverty line&quot; into extreme poverty.<br /><br />India has more than 2.8 million cancer patients at any one time, according to the National Cancer Registry Program of the Indian Council of Medical Research. About 700,000 new cancer patients are registered every year, and nearly 350,000 people do not survive.<br /><br />The governmental move could revolutionize treatment in seriously life-threatening cases, with the potential of easing suffering not just for patients, but for hundreds of thousands of families ruined by expensive drugs.<br /><br />It also means a painful change for the US$1 trillion global pharmaceutical industry supposed to heal and ease suffering. The backlash has begun with some of its leaders claiming that the decision could affect investment into research for better lifesaving medicines.<br /><br />Cancer patients and those serving them are more grateful.<br /><br />&quot;I am extremely happy to hear about the compulsory license to Natco for Bayer's life-saving anti-cancer drug,&quot; said Y K Sapru, founder-chairman of the Mumbai-based Cancer Patients Aid Association (CPAA), which since 1969 has served more than 300,000 cancer patients from India, Bangladesh, Bhutan, Nepal and Pakistan.<br /><br />&quot;All the newly patented anti-cancer drugs are very expensive,&quot; Sapru told Asia Times Online via email. &quot;Two typical examples are of Herceptin for breast cancer and Glivec for chronic myloid leukemias - both costing around 200,000 rupees for one month's treatment.&quot;<br /><br />Sapru should know well enough about exorbitantly priced life-saving drugs, having spent his professional career in the pharmaceutical industry. He retired in 1999 as executive director of pharmaceutical giant Johnson &amp; Johnson, and was marketing director of the British pharmaceutical company John Wyeth &amp; Brother Ltd. He expects the Indian government's order will lead to all patented unaffordable drugs being given a compulsory license in India, and treatment of cancer to become available to many more victims.<br /><br />The timeline related to Thailand issuing compulsory license order in 2006, the second country to do so after Brazil in 1996, gives some idea of the opposition India can expect from multinationals and governmental pressure groups in the US and Europe to protect intellectual property rights. [2]<br /><br />Under the Thai government order, the New Jersey-based US company Merck was to receive a royalty of 0.5% of the original cost of the drug Stocrin (brand name efavirenz) used for treatment of HIV/AIDs patients. Merck immediately offered to cut the price of Stocrin by half.<br /><br />Thailand received worldwide support soon after its Department of Disease Control and the Ministry of Public Health issued a compulsory license to the Government Pharmaceutical Organization of Thailand to produce Stocrin. In December 2006, more than 140 organizations and individuals sent a letter to then US secretary of state Condoleezza Rice and US trade representative Susan Schwab asking the US government not to interfere with the Thai decision.<br /><br />Multinational companies, though, insist that compulsory licenses should be used only for public health crises, perhaps reluctant to acknowledge that hundreds of thousands of individuals facing a life threatening emergency counts as a &quot;public health crisis&quot;.<br /><br />&quot;We believe compulsory licenses should be used only in exceptional circumstances, such as in times of a national health crisis,&quot; Ranjit Shahani, managing director of pharma company Novartis V-C, told the Economic Times. &quot;If used arbitrarily, compulsory licenses will serve to undermine the innovative pharmaceutical industry and will be to the long-term detriment of the patient. It will discourage investment in new medicine for patients.&quot;<br /><br />Would the Indian governmental order affect development of better life-saving drugs? Or does it find a balance between saving people from tormenting misery without excessive profiteering and forcibly taking property rights away from someone or some entity?<br /><br />&quot;From its very nature, a right cannot be absolute,&quot; declared the Controller of Patents P Kurian in his 62-page order. &quot;Whenever conferred upon a patentee, the right also carries accompanying obligations towards the public at large. These rights and obligations when religiously enjoyed and discharged, will balance out each other. A slight imbalance may fetch highly undesirable results. It is this fine balance of rights and obligations that is in question in this case.&quot;<br /><br />Perspectives can clearly differ depending on the extent to which one is affected directly or indirectly by cancer, or any other seriously life-threatening medical condition requiring very expensive treatment. Visiting a cancer victim itself is not easily forgotten. Ten years after visiting a cancer-affected child in a darkened room in the Tata Memorial Cancer Hospital in Mumbai, the image remains vivid in this writer's memory. I remember her trying to smile through her pain, with tubes supporting her frail body at an age when she should have been laughing with her playmates, or busy at a play station while working her way through a pizza and a Pepsi.<br /><br />The relative banality of a mind-numbing toothache, a torment that cannot be relieved simply and quickly by a visit to the pharmacy, a doctor or surgery, is a commonplace pointer to the much more extended pain and agony of a person suffering cancer. [3]<br /><br />Sapru, the former pharmaceutical company director and founder of the Cancer Patients Aid Association (CPAA), had his perspectives change after his friend was admitted to Tata Memorial Hospital, India's leading cancer treatment provider since 1941. One of his friend's fellow patients was a little girl, Jaya Jhabbar, battling leukemia. Her family could not afford her treatment. Sapru and his friends raised the money. The girl was cured and CPAA was born.<br /><br />Not just patients, but entire families become victims. Financially challenged family members have no place to stay while they accompany the patient for treatment in a distant city. Siblings have to leave school, and parents have no time to attend to their professions at a time when they need money the most. One middle-class businessman from Kolkata became a hand-cart vendor selling potatoes in Mumbai after his business was ruined while continuing to pay for his daughter's cancer treatment.<br /><br />&quot;Big hospitals are inundated with such a huge number of patients that they tend to forget that they are dealing with human beings, often frightened, ignorant and in strange surroundings,&quot; says Sapru, whose organization, under its concept of &quot;Total Management of Cancer&quot; [4] also sometimes find accommodation in Mumbai for a family from a remote part of India, gets a sibling admitted in school, arranges for the father's employment, besides providing medical aid and guidance for the patient.<br /><br />The basic reality remains that no one loses anything by having their services used to save lives, and Bayer has all to gain. But its marketing men though, blinded by profit margins, might not be rejoicing greatly now over how much more suffering that could be eased, and how many more lives their medicines could now save - until perhaps cancer knocks on their family doors.<br /><br /><strong><em>Notes</em></strong><br /></div><div align="justify">&nbsp;</div><div align="justify">1. The Controller General issues order granting Compulsory License in the matter of Natco Vs. Bayer, March 12, 2012, Controller General of Patents Designs and Trademarks, Government of India.<br />2. Timeline for Thailand's Compulsory Licenses Version 2 (up to March 2008), American University Washington College of Law.<br />3. Psychological Aspects of Cancer Pain , The International Association for the Study of Pain (IASP), Seattle, Washington, USA.<br />4. Cancer Patients Aid Association, Total Management of Cancer, Mumbai, India.<br /><br /><em>This version of Raja Murthy does not exist in any social, professional networking site. He currently 'exists' somewhere in the Himalayas, other times in Mumbai, happily investing more time practicing Vipassana (http://www.vridhamma.org/VRI-Introduction), in order to more deeply practice Metta Bhavana (http://www.vridhamma.org/en1992-02). Home is the universe, and all beings are one's family. <br /></em><br /></div>                                                           
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    <br><a href="http://www.atimes.com/atimes/South_Asia/NC21Df01.html" class="re" target="_blank">Asia Times, 21 March, 2012, http://www.atimes.com/atimes/South_Asia/NC21Df01.html</a><div class="clear"></div>
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India's decision this month to produce Germany-based multinational Bayer's anti-cancer drug Nexavar, in the first use of &quot;compulsory licensing&quot; in South Asia, will save lives but also raises intricate questions.

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    <h1 class="cat-box-title">India patent bypass delivers life-saving blow against cancer by Raja Murthy</h1>
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		 Published on</span><span class="text-date"> Mar 21, 2012</span>
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                            <br /><div align="justify">India's decision this month to produce Germany-based multinational Bayer's anti-cancer drug Nexavar, in the first use of &quot;compulsory licensing&quot; in South Asia, will save lives but also raises intricate questions.<br /><br />Under the compulsory licensing process, a government can under World Trade Organization (WTO) rules bypass a patent owner's rights after three years and order the manufacture and sale of life-saving medicines at much cheaper cost than by obtaining the medicine from the original manufacturer. This is third such instance in the world, after Brazil and Thailand, that compulsory licensing has been invoked.<br /><br />The WTO allows countries to set their own rules for compulsory licensing. In this case, India based its case on the affordability of the cancer drug for the common man - nearly three million people in India suffer from cancer.<br /><br />On March 12, the Mumbai-based Controller General of Patents Designs and Trademarks ruled that the life-saving Nexavar was beyond the reach of most Indians. Rejecting Bayer's arguments for pricing its anti-cancer drug Nexavar at 280,000 rupees (US$5,448), India's Patent Office estimated that the lowest paid government employee would have to work three-and-a-half years to pay for one month's dosage of the drug.<br /><br />Nexavar, originally patented as Sorafenib in the US in 1999, is used to treat advanced stages of kidney and liver cancer. The life expectancy of the patient without the drug is four months.<br /><br />After the Indian Patent Office ruling, [1] an Hyderabad-based company Natco Pharma will sell Nexavar at 8,800 rupees (or the equivalent of $172) for a pack of 120 tablets needed for one month's treatment - that is still over twice the government-estimated monthly income of an urban Indian family of five deemed to be living above the poverty line.<br /><br />Natco, which has to provide the medicine free of cost to 600 needy patients every year, will pay Bayer a 6% royalty on net sales of the drug. The company's shares gained 18% between March 9, before the March 12 announcement, and their recent high of 351.05 rupees on March 15. On Tuesday, the shares were trading at 337.50 rupees, up 44% this year.<br /><br />Pittsburgh-based Bayer has said it is reviewing legal options to challenge the order, which makes its anti-cancer drug available at 3% of the price at which the company was marketing it.<br /><br />P H Kurian, the Controller of Patents who signed the Indian compulsory order, reckoned the original cost of the Bayer medicine would push many more families among 72% of India's population living above a &quot;very low poverty line&quot; into extreme poverty.<br /><br />India has more than 2.8 million cancer patients at any one time, according to the National Cancer Registry Program of the Indian Council of Medical Research. About 700,000 new cancer patients are registered every year, and nearly 350,000 people do not survive.<br /><br />The governmental move could revolutionize treatment in seriously life-threatening cases, with the potential of easing suffering not just for patients, but for hundreds of thousands of families ruined by expensive drugs.<br /><br />It also means a painful change for the US$1 trillion global pharmaceutical industry supposed to heal and ease suffering. The backlash has begun with some of its leaders claiming that the decision could affect investment into research for better lifesaving medicines.<br /><br />Cancer patients and those serving them are more grateful.<br /><br />&quot;I am extremely happy to hear about the compulsory license to Natco for Bayer's life-saving anti-cancer drug,&quot; said Y K Sapru, founder-chairman of the Mumbai-based Cancer Patients Aid Association (CPAA), which since 1969 has served more than 300,000 cancer patients from India, Bangladesh, Bhutan, Nepal and Pakistan.<br /><br />&quot;All the newly patented anti-cancer drugs are very expensive,&quot; Sapru told Asia Times Online via email. &quot;Two typical examples are of Herceptin for breast cancer and Glivec for chronic myloid leukemias - both costing around 200,000 rupees for one month's treatment.&quot;<br /><br />Sapru should know well enough about exorbitantly priced life-saving drugs, having spent his professional career in the pharmaceutical industry. He retired in 1999 as executive director of pharmaceutical giant Johnson &amp; Johnson, and was marketing director of the British pharmaceutical company John Wyeth &amp; Brother Ltd. He expects the Indian government's order will lead to all patented unaffordable drugs being given a compulsory license in India, and treatment of cancer to become available to many more victims.<br /><br />The timeline related to Thailand issuing compulsory license order in 2006, the second country to do so after Brazil in 1996, gives some idea of the opposition India can expect from multinationals and governmental pressure groups in the US and Europe to protect intellectual property rights. [2]<br /><br />Under the Thai government order, the New Jersey-based US company Merck was to receive a royalty of 0.5% of the original cost of the drug Stocrin (brand name efavirenz) used for treatment of HIV/AIDs patients. Merck immediately offered to cut the price of Stocrin by half.<br /><br />Thailand received worldwide support soon after its Department of Disease Control and the Ministry of Public Health issued a compulsory license to the Government Pharmaceutical Organization of Thailand to produce Stocrin. In December 2006, more than 140 organizations and individuals sent a letter to then US secretary of state Condoleezza Rice and US trade representative Susan Schwab asking the US government not to interfere with the Thai decision.<br /><br />Multinational companies, though, insist that compulsory licenses should be used only for public health crises, perhaps reluctant to acknowledge that hundreds of thousands of individuals facing a life threatening emergency counts as a &quot;public health crisis&quot;.<br /><br />&quot;We believe compulsory licenses should be used only in exceptional circumstances, such as in times of a national health crisis,&quot; Ranjit Shahani, managing director of pharma company Novartis V-C, told the Economic Times. &quot;If used arbitrarily, compulsory licenses will serve to undermine the innovative pharmaceutical industry and will be to the long-term detriment of the patient. It will discourage investment in new medicine for patients.&quot;<br /><br />Would the Indian governmental order affect development of better life-saving drugs? Or does it find a balance between saving people from tormenting misery without excessive profiteering and forcibly taking property rights away from someone or some entity?<br /><br />&quot;From its very nature, a right cannot be absolute,&quot; declared the Controller of Patents P Kurian in his 62-page order. &quot;Whenever conferred upon a patentee, the right also carries accompanying obligations towards the public at large. These rights and obligations when religiously enjoyed and discharged, will balance out each other. A slight imbalance may fetch highly undesirable results. It is this fine balance of rights and obligations that is in question in this case.&quot;<br /><br />Perspectives can clearly differ depending on the extent to which one is affected directly or indirectly by cancer, or any other seriously life-threatening medical condition requiring very expensive treatment. Visiting a cancer victim itself is not easily forgotten. Ten years after visiting a cancer-affected child in a darkened room in the Tata Memorial Cancer Hospital in Mumbai, the image remains vivid in this writer's memory. I remember her trying to smile through her pain, with tubes supporting her frail body at an age when she should have been laughing with her playmates, or busy at a play station while working her way through a pizza and a Pepsi.<br /><br />The relative banality of a mind-numbing toothache, a torment that cannot be relieved simply and quickly by a visit to the pharmacy, a doctor or surgery, is a commonplace pointer to the much more extended pain and agony of a person suffering cancer. [3]<br /><br />Sapru, the former pharmaceutical company director and founder of the Cancer Patients Aid Association (CPAA), had his perspectives change after his friend was admitted to Tata Memorial Hospital, India's leading cancer treatment provider since 1941. One of his friend's fellow patients was a little girl, Jaya Jhabbar, battling leukemia. Her family could not afford her treatment. Sapru and his friends raised the money. The girl was cured and CPAA was born.<br /><br />Not just patients, but entire families become victims. Financially challenged family members have no place to stay while they accompany the patient for treatment in a distant city. Siblings have to leave school, and parents have no time to attend to their professions at a time when they need money the most. One middle-class businessman from Kolkata became a hand-cart vendor selling potatoes in Mumbai after his business was ruined while continuing to pay for his daughter's cancer treatment.<br /><br />&quot;Big hospitals are inundated with such a huge number of patients that they tend to forget that they are dealing with human beings, often frightened, ignorant and in strange surroundings,&quot; says Sapru, whose organization, under its concept of &quot;Total Management of Cancer&quot; [4] also sometimes find accommodation in Mumbai for a family from a remote part of India, gets a sibling admitted in school, arranges for the father's employment, besides providing medical aid and guidance for the patient.<br /><br />The basic reality remains that no one loses anything by having their services used to save lives, and Bayer has all to gain. But its marketing men though, blinded by profit margins, might not be rejoicing greatly now over how much more suffering that could be eased, and how many more lives their medicines could now save - until perhaps cancer knocks on their family doors.<br /><br /><strong><em>Notes</em></strong><br /></div><div align="justify">&nbsp;</div><div align="justify">1. The Controller General issues order granting Compulsory License in the matter of Natco Vs. Bayer, March 12, 2012, Controller General of Patents Designs and Trademarks, Government of India.<br />2. Timeline for Thailand's Compulsory Licenses Version 2 (up to March 2008), American University Washington College of Law.<br />3. Psychological Aspects of Cancer Pain , The International Association for the Study of Pain (IASP), Seattle, Washington, USA.<br />4. Cancer Patients Aid Association, Total Management of Cancer, Mumbai, India.<br /><br /><em>This version of Raja Murthy does not exist in any social, professional networking site. He currently 'exists' somewhere in the Himalayas, other times in Mumbai, happily investing more time practicing Vipassana (http://www.vridhamma.org/VRI-Introduction), in order to more deeply practice Metta Bhavana (http://www.vridhamma.org/en1992-02). Home is the universe, and all beings are one's family. <br /></em><br /></div>                                                           
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    <br><a href="http://www.atimes.com/atimes/South_Asia/NC21Df01.html" class="re" target="_blank">Asia Times, 21 March, 2012, http://www.atimes.com/atimes/South_Asia/NC21Df01.html</a><div class="clear"></div>
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    <h1 class="cat-box-title">India patent bypass delivers life-saving blow against cancer by Raja Murthy</h1>
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                            <br /><div align="justify">India's decision this month to produce Germany-based multinational Bayer's anti-cancer drug Nexavar, in the first use of &quot;compulsory licensing&quot; in South Asia, will save lives but also raises intricate questions.<br /><br />Under the compulsory licensing process, a government can under World Trade Organization (WTO) rules bypass a patent owner's rights after three years and order the manufacture and sale of life-saving medicines at much cheaper cost than by obtaining the medicine from the original manufacturer. This is third such instance in the world, after Brazil and Thailand, that compulsory licensing has been invoked.<br /><br />The WTO allows countries to set their own rules for compulsory licensing. In this case, India based its case on the affordability of the cancer drug for the common man - nearly three million people in India suffer from cancer.<br /><br />On March 12, the Mumbai-based Controller General of Patents Designs and Trademarks ruled that the life-saving Nexavar was beyond the reach of most Indians. Rejecting Bayer's arguments for pricing its anti-cancer drug Nexavar at 280,000 rupees (US$5,448), India's Patent Office estimated that the lowest paid government employee would have to work three-and-a-half years to pay for one month's dosage of the drug.<br /><br />Nexavar, originally patented as Sorafenib in the US in 1999, is used to treat advanced stages of kidney and liver cancer. The life expectancy of the patient without the drug is four months.<br /><br />After the Indian Patent Office ruling, [1] an Hyderabad-based company Natco Pharma will sell Nexavar at 8,800 rupees (or the equivalent of $172) for a pack of 120 tablets needed for one month's treatment - that is still over twice the government-estimated monthly income of an urban Indian family of five deemed to be living above the poverty line.<br /><br />Natco, which has to provide the medicine free of cost to 600 needy patients every year, will pay Bayer a 6% royalty on net sales of the drug. The company's shares gained 18% between March 9, before the March 12 announcement, and their recent high of 351.05 rupees on March 15. On Tuesday, the shares were trading at 337.50 rupees, up 44% this year.<br /><br />Pittsburgh-based Bayer has said it is reviewing legal options to challenge the order, which makes its anti-cancer drug available at 3% of the price at which the company was marketing it.<br /><br />P H Kurian, the Controller of Patents who signed the Indian compulsory order, reckoned the original cost of the Bayer medicine would push many more families among 72% of India's population living above a &quot;very low poverty line&quot; into extreme poverty.<br /><br />India has more than 2.8 million cancer patients at any one time, according to the National Cancer Registry Program of the Indian Council of Medical Research. About 700,000 new cancer patients are registered every year, and nearly 350,000 people do not survive.<br /><br />The governmental move could revolutionize treatment in seriously life-threatening cases, with the potential of easing suffering not just for patients, but for hundreds of thousands of families ruined by expensive drugs.<br /><br />It also means a painful change for the US$1 trillion global pharmaceutical industry supposed to heal and ease suffering. The backlash has begun with some of its leaders claiming that the decision could affect investment into research for better lifesaving medicines.<br /><br />Cancer patients and those serving them are more grateful.<br /><br />&quot;I am extremely happy to hear about the compulsory license to Natco for Bayer's life-saving anti-cancer drug,&quot; said Y K Sapru, founder-chairman of the Mumbai-based Cancer Patients Aid Association (CPAA), which since 1969 has served more than 300,000 cancer patients from India, Bangladesh, Bhutan, Nepal and Pakistan.<br /><br />&quot;All the newly patented anti-cancer drugs are very expensive,&quot; Sapru told Asia Times Online via email. &quot;Two typical examples are of Herceptin for breast cancer and Glivec for chronic myloid leukemias - both costing around 200,000 rupees for one month's treatment.&quot;<br /><br />Sapru should know well enough about exorbitantly priced life-saving drugs, having spent his professional career in the pharmaceutical industry. He retired in 1999 as executive director of pharmaceutical giant Johnson &amp; Johnson, and was marketing director of the British pharmaceutical company John Wyeth &amp; Brother Ltd. He expects the Indian government's order will lead to all patented unaffordable drugs being given a compulsory license in India, and treatment of cancer to become available to many more victims.<br /><br />The timeline related to Thailand issuing compulsory license order in 2006, the second country to do so after Brazil in 1996, gives some idea of the opposition India can expect from multinationals and governmental pressure groups in the US and Europe to protect intellectual property rights. [2]<br /><br />Under the Thai government order, the New Jersey-based US company Merck was to receive a royalty of 0.5% of the original cost of the drug Stocrin (brand name efavirenz) used for treatment of HIV/AIDs patients. Merck immediately offered to cut the price of Stocrin by half.<br /><br />Thailand received worldwide support soon after its Department of Disease Control and the Ministry of Public Health issued a compulsory license to the Government Pharmaceutical Organization of Thailand to produce Stocrin. In December 2006, more than 140 organizations and individuals sent a letter to then US secretary of state Condoleezza Rice and US trade representative Susan Schwab asking the US government not to interfere with the Thai decision.<br /><br />Multinational companies, though, insist that compulsory licenses should be used only for public health crises, perhaps reluctant to acknowledge that hundreds of thousands of individuals facing a life threatening emergency counts as a &quot;public health crisis&quot;.<br /><br />&quot;We believe compulsory licenses should be used only in exceptional circumstances, such as in times of a national health crisis,&quot; Ranjit Shahani, managing director of pharma company Novartis V-C, told the Economic Times. &quot;If used arbitrarily, compulsory licenses will serve to undermine the innovative pharmaceutical industry and will be to the long-term detriment of the patient. It will discourage investment in new medicine for patients.&quot;<br /><br />Would the Indian governmental order affect development of better life-saving drugs? Or does it find a balance between saving people from tormenting misery without excessive profiteering and forcibly taking property rights away from someone or some entity?<br /><br />&quot;From its very nature, a right cannot be absolute,&quot; declared the Controller of Patents P Kurian in his 62-page order. &quot;Whenever conferred upon a patentee, the right also carries accompanying obligations towards the public at large. These rights and obligations when religiously enjoyed and discharged, will balance out each other. A slight imbalance may fetch highly undesirable results. It is this fine balance of rights and obligations that is in question in this case.&quot;<br /><br />Perspectives can clearly differ depending on the extent to which one is affected directly or indirectly by cancer, or any other seriously life-threatening medical condition requiring very expensive treatment. Visiting a cancer victim itself is not easily forgotten. Ten years after visiting a cancer-affected child in a darkened room in the Tata Memorial Cancer Hospital in Mumbai, the image remains vivid in this writer's memory. I remember her trying to smile through her pain, with tubes supporting her frail body at an age when she should have been laughing with her playmates, or busy at a play station while working her way through a pizza and a Pepsi.<br /><br />The relative banality of a mind-numbing toothache, a torment that cannot be relieved simply and quickly by a visit to the pharmacy, a doctor or surgery, is a commonplace pointer to the much more extended pain and agony of a person suffering cancer. [3]<br /><br />Sapru, the former pharmaceutical company director and founder of the Cancer Patients Aid Association (CPAA), had his perspectives change after his friend was admitted to Tata Memorial Hospital, India's leading cancer treatment provider since 1941. One of his friend's fellow patients was a little girl, Jaya Jhabbar, battling leukemia. Her family could not afford her treatment. Sapru and his friends raised the money. The girl was cured and CPAA was born.<br /><br />Not just patients, but entire families become victims. Financially challenged family members have no place to stay while they accompany the patient for treatment in a distant city. Siblings have to leave school, and parents have no time to attend to their professions at a time when they need money the most. One middle-class businessman from Kolkata became a hand-cart vendor selling potatoes in Mumbai after his business was ruined while continuing to pay for his daughter's cancer treatment.<br /><br />&quot;Big hospitals are inundated with such a huge number of patients that they tend to forget that they are dealing with human beings, often frightened, ignorant and in strange surroundings,&quot; says Sapru, whose organization, under its concept of &quot;Total Management of Cancer&quot; [4] also sometimes find accommodation in Mumbai for a family from a remote part of India, gets a sibling admitted in school, arranges for the father's employment, besides providing medical aid and guidance for the patient.<br /><br />The basic reality remains that no one loses anything by having their services used to save lives, and Bayer has all to gain. But its marketing men though, blinded by profit margins, might not be rejoicing greatly now over how much more suffering that could be eased, and how many more lives their medicines could now save - until perhaps cancer knocks on their family doors.<br /><br /><strong><em>Notes</em></strong><br /></div><div align="justify">&nbsp;</div><div align="justify">1. The Controller General issues order granting Compulsory License in the matter of Natco Vs. Bayer, March 12, 2012, Controller General of Patents Designs and Trademarks, Government of India.<br />2. Timeline for Thailand's Compulsory Licenses Version 2 (up to March 2008), American University Washington College of Law.<br />3. Psychological Aspects of Cancer Pain , The International Association for the Study of Pain (IASP), Seattle, Washington, USA.<br />4. Cancer Patients Aid Association, Total Management of Cancer, Mumbai, India.<br /><br /><em>This version of Raja Murthy does not exist in any social, professional networking site. He currently 'exists' somewhere in the Himalayas, other times in Mumbai, happily investing more time practicing Vipassana (http://www.vridhamma.org/VRI-Introduction), in order to more deeply practice Metta Bhavana (http://www.vridhamma.org/en1992-02). Home is the universe, and all beings are one's family. <br /></em><br /></div>                                                           
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    <br><a href="http://www.atimes.com/atimes/South_Asia/NC21Df01.html" class="re" target="_blank">Asia Times, 21 March, 2012, http://www.atimes.com/atimes/South_Asia/NC21Df01.html</a><div class="clear"></div>
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Home हिन्दी

India patent bypass delivers life-saving blow against cancer by Raja Murthy

Published on Mar 21, 2012   Modified on Mar 21, 2012

India's decision this month to produce Germany-based multinational Bayer's anti-cancer drug Nexavar, in the first use of "compulsory licensing" in South Asia, will save lives but also raises intricate questions. Under the compulsory licensing process, a government can under World Trade Organization (WTO) rules bypass a patent owner's rights after three years and order the manufacture and sale of life-saving medicines at much cheaper cost than by obtaining the medicine from the original manufacturer. This is third such instance in the world, after Brazil and Thailand, that compulsory licensing has been invoked. The WTO allows countries to set their own rules for compulsory licensing. In this case, India based its case on the affordability of the cancer drug for the common man - nearly three million people in India suffer from cancer. On March 12, the Mumbai-based Controller General of Patents Designs and Trademarks ruled that the life-saving Nexavar was beyond the reach of most Indians. Rejecting Bayer's arguments for pricing its anti-cancer drug Nexavar at 280,000 rupees (US$5,448), India's Patent Office estimated that the lowest paid government employee would have to work three-and-a-half years to pay for one month's dosage of the drug. Nexavar, originally patented as Sorafenib in the US in 1999, is used to treat advanced stages of kidney and liver cancer. The life expectancy of the patient without the drug is four months. After the Indian Patent Office ruling, [1] an Hyderabad-based company Natco Pharma will sell Nexavar at 8,800 rupees (or the equivalent of $172) for a pack of 120 tablets needed for one month's treatment - that is still over twice the government-estimated monthly income of an urban Indian family of five deemed to be living above the poverty line. Natco, which has to provide the medicine free of cost to 600 needy patients every year, will pay Bayer a 6% royalty on net sales of the drug. The company's shares gained 18% between March 9, before the March 12 announcement, and their recent high of 351.05 rupees on March 15. On Tuesday, the shares were trading at 337.50 rupees, up 44% this year. Pittsburgh-based Bayer has said it is reviewing legal options to challenge the order, which makes its anti-cancer drug available at 3% of the price at which the company was marketing it. P H Kurian, the Controller of Patents who signed the Indian compulsory order, reckoned the original cost of the Bayer medicine would push many more families among 72% of India's population living above a "very low poverty line" into extreme poverty. India has more than 2.8 million cancer patients at any one time, according to the National Cancer Registry Program of the Indian Council of Medical Research. About 700,000 new cancer patients are registered every year, and nearly 350,000 people do not survive. The governmental move could revolutionize treatment in seriously life-threatening cases, with the potential of easing suffering not just for patients, but for hundreds of thousands of families ruined by expensive drugs. It also means a painful change for the US$1 trillion global pharmaceutical industry supposed to heal and ease suffering. The backlash has begun with some of its leaders claiming that the decision could affect investment into research for better lifesaving medicines. Cancer patients and those serving them are more grateful. "I am extremely happy to hear about the compulsory license to Natco for Bayer's life-saving anti-cancer drug," said Y K Sapru, founder-chairman of the Mumbai-based Cancer Patients Aid Association (CPAA), which since 1969 has served more than 300,000 cancer patients from India, Bangladesh, Bhutan, Nepal and Pakistan. "All the newly patented anti-cancer drugs are very expensive," Sapru told Asia Times Online via email. "Two typical examples are of Herceptin for breast cancer and Glivec for chronic myloid leukemias - both costing around 200,000 rupees for one month's treatment." Sapru should know well enough about exorbitantly priced life-saving drugs, having spent his professional career in the pharmaceutical industry. He retired in 1999 as executive director of pharmaceutical giant Johnson & Johnson, and was marketing director of the British pharmaceutical company John Wyeth & Brother Ltd. He expects the Indian government's order will lead to all patented unaffordable drugs being given a compulsory license in India, and treatment of cancer to become available to many more victims. The timeline related to Thailand issuing compulsory license order in 2006, the second country to do so after Brazil in 1996, gives some idea of the opposition India can expect from multinationals and governmental pressure groups in the US and Europe to protect intellectual property rights. [2] Under the Thai government order, the New Jersey-based US company Merck was to receive a royalty of 0.5% of the original cost of the drug Stocrin (brand name efavirenz) used for treatment of HIV/AIDs patients. Merck immediately offered to cut the price of Stocrin by half. Thailand received worldwide support soon after its Department of Disease Control and the Ministry of Public Health issued a compulsory license to the Government Pharmaceutical Organization of Thailand to produce Stocrin. In December 2006, more than 140 organizations and individuals sent a letter to then US secretary of state Condoleezza Rice and US trade representative Susan Schwab asking the US government not to interfere with the Thai decision. Multinational companies, though, insist that compulsory licenses should be used only for public health crises, perhaps reluctant to acknowledge that hundreds of thousands of individuals facing a life threatening emergency counts as a "public health crisis". "We believe compulsory licenses should be used only in exceptional circumstances, such as in times of a national health crisis," Ranjit Shahani, managing director of pharma company Novartis V-C, told the Economic Times. "If used arbitrarily, compulsory licenses will serve to undermine the innovative pharmaceutical industry and will be to the long-term detriment of the patient. It will discourage investment in new medicine for patients." Would the Indian governmental order affect development of better life-saving drugs? Or does it find a balance between saving people from tormenting misery without excessive profiteering and forcibly taking property rights away from someone or some entity? "From its very nature, a right cannot be absolute," declared the Controller of Patents P Kurian in his 62-page order. "Whenever conferred upon a patentee, the right also carries accompanying obligations towards the public at large. These rights and obligations when religiously enjoyed and discharged, will balance out each other. A slight imbalance may fetch highly undesirable results. It is this fine balance of rights and obligations that is in question in this case." Perspectives can clearly differ depending on the extent to which one is affected directly or indirectly by cancer, or any other seriously life-threatening medical condition requiring very expensive treatment. Visiting a cancer victim itself is not easily forgotten. Ten years after visiting a cancer-affected child in a darkened room in the Tata Memorial Cancer Hospital in Mumbai, the image remains vivid in this writer's memory. I remember her trying to smile through her pain, with tubes supporting her frail body at an age when she should have been laughing with her playmates, or busy at a play station while working her way through a pizza and a Pepsi. The relative banality of a mind-numbing toothache, a torment that cannot be relieved simply and quickly by a visit to the pharmacy, a doctor or surgery, is a commonplace pointer to the much more extended pain and agony of a person suffering cancer. [3] Sapru, the former pharmaceutical company director and founder of the Cancer Patients Aid Association (CPAA), had his perspectives change after his friend was admitted to Tata Memorial Hospital, India's leading cancer treatment provider since 1941. One of his friend's fellow patients was a little girl, Jaya Jhabbar, battling leukemia. Her family could not afford her treatment. Sapru and his friends raised the money. The girl was cured and CPAA was born. Not just patients, but entire families become victims. Financially challenged family members have no place to stay while they accompany the patient for treatment in a distant city. Siblings have to leave school, and parents have no time to attend to their professions at a time when they need money the most. One middle-class businessman from Kolkata became a hand-cart vendor selling potatoes in Mumbai after his business was ruined while continuing to pay for his daughter's cancer treatment. "Big hospitals are inundated with such a huge number of patients that they tend to forget that they are dealing with human beings, often frightened, ignorant and in strange surroundings," says Sapru, whose organization, under its concept of "Total Management of Cancer" [4] also sometimes find accommodation in Mumbai for a family from a remote part of India, gets a sibling admitted in school, arranges for the father's employment, besides providing medical aid and guidance for the patient. The basic reality remains that no one loses anything by having their services used to save lives, and Bayer has all to gain. But its marketing men though, blinded by profit margins, might not be rejoicing greatly now over how much more suffering that could be eased, and how many more lives their medicines could now save - until perhaps cancer knocks on their family doors. Notes   1. The Controller General issues order granting Compulsory License in the matter of Natco Vs. Bayer, March 12, 2012, Controller General of Patents Designs and Trademarks, Government of India. 2. Timeline for Thailand's Compulsory Licenses Version 2 (up to March 2008), American University Washington College of Law. 3. Psychological Aspects of Cancer Pain , The International Association for the Study of Pain (IASP), Seattle, Washington, USA. 4. Cancer Patients Aid Association, Total Management of Cancer, Mumbai, India. This version of Raja Murthy does not exist in any social, professional networking site. He currently 'exists' somewhere in the Himalayas, other times in Mumbai, happily investing more time practicing Vipassana (http://www.vridhamma.org/VRI-Introduction), in order to more deeply practice Metta Bhavana (http://www.vridhamma.org/en1992-02). Home is the universe, and all beings are one's family.

Asia Times, 21 March, 2012, http://www.atimes.com/atimes/South_Asia/NC21Df01.html

Tagged with: medicines patents Health

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