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
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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 | Road to cheaper drugs by Rupali Mukherjee    </title>
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The government's decision to bust the price as well as monopoly of Bayer's anti-cancer drug, through the process of compulsory licensing now opens up the field for the generic industry to follow suit and could well pave the way for..."/>
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The government's decision to bust the price as well as monopoly of Bayer's anti-cancer drug, through the process of compulsory licensing now opens up the field for the generic industry to follow suit and could well pave the way for..." />
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                            <div style="text-align: justify"><br /></div><div style="text-align: justify">The government's decision to bust the price as well as monopoly of Bayer's anti-cancer drug, through the process of compulsory licensing now opens up the field for the generic industry to follow suit and could well pave the way for the availability of cheaper drugs for lifestyle diseases.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">More generic companies could invoke the compulsory licensing clause of the Indian Patents Act, following Monday's decision to allow Natco Pharma to sell copycat drugs of Bayer's patented cancer drug at 97 % reduction. The landmark judgment by the Indian Patent Office is now being seen as a test case by the generic industry and has significant implications for both the domestic generic industry as well as MNCs, which spend substantial amounts on R&amp;D before they find a new drug. However, it is almost certain that Bayer will go to court on this issue.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Experts suggest that Natco Pharma's strategy of invoking the compulsory licensing clause could well prove to be a game changer for the generic industry, which has been facing formidable barriers for a long time. Terming the decision as &quot;bold and historic'', Daara Patel, secretary general of industry body, IDMA said it would open up the field for many domestic manufacturers to follow Natco's strategy. But, some companies like Sun Pharma feel that this may be a risky strategy to follow, and will wait and watch to see how the situation unfolds.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">The country's first ever compulsory licensing approval also has significant upsides for consumers, especially the poor since it would open up the field for other generic companies to tap this route, thus forcing MNCs to rethink their pricing strategies for India and other developing countries. Says Prof Shamnad Basheer of National University of Juridical Sciences and an expert on intellectual property : &quot;Not only will MNCs need to revisit their pricing strategy in India, the decision will have a spin off effect in other countries like Thailand and Brazil, as well as in their home markets.&quot;&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Significantly, this would lead to lowering in exorbitant prices of lifesaving cancer drug and HIV drugs. The compulsory licensing mechanism has existed since 2005, when the patent regime was established, and should have kicked in by 2009 or so, but it was only last year that Natco applied to the government. Domestic companies like Cipla feel emboldened by the patent controller's decision, and feel that it will lead to many companies applying for licences to manufacture life-saving drugs, said Cipla director S Radhakishnan. Cipla applied for a compulsory licence to manufacture HIV drug, raltegravir last year.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">MNCs are, however, not amused. They feel that these licences should only be granted in case of a public health crisis. Novartis V-C and MD Ranjit Shahani says ; &quot;We believe compulsory licences should be used only in exceptional circumstances, such as in times of a national health crisis. 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;. Compulsory licences can be issued to generic producers if patented drugs are unavailable or unaffordable. The government can equally notify drugs on which CLs are needed for public non-commercial use and in situations of national emergency or extreme urgency.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Certain section of industry feels that there may be room for both kind of drugs, given the huge disparities in income in the country.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Health groups are meanwhile rejoicing. &quot;India is likely to face exceptional pressure from developed countries and multinational pharma companies in the coming weeks,&quot; cautions Santhosh MR of the Centre for Trade and Development (Centad ). &quot;Already the Indian government is defending India's strict patentability standards from the legal challenge mounted by Novartis in the Supreme Court and fighting the offensive on intellectual property enforcement targeting generic manufacturers launched by the EU in bilateral FTA negotiations,&quot; he adds.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify"><strong>THE RATIONALE IS TO INCREASE PUBLIC WELFARE&nbsp;</strong></div><div style="text-align: justify"><br /></div><div style="text-align: justify"><em>What is a compulsory licence?&nbsp;</em></div><div style="text-align: justify"><br /></div><div style="text-align: justify">Holders of patents have an exclusive right to make and sell their product. They also have the right to charge fees from another producer for allowing it to make and sell their patented product. In certain cases, the government can allow a nonpatent holder to make and sell a patented product without the patent owner's consent. This is known as a compulsory licence&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify"><em>Is this an Indian peculiarity?&nbsp;</em></div><div style="text-align: justify"><br /></div><div style="text-align: justify">No, the compulsory licence system is part of the WTO's agreement on intellectual property called the TRIPS (Trade Related Aspects of Intellectual Property Rights) Agreement. It has existed since 1995 and was further clarified in 2001 through the Doha Declaration. Most countries have provision for it, except the US&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify"><em>When can a compulsory licence be granted?&nbsp;</em></div><div style="text-align: justify"><br /></div><div style="text-align: justify">TRIPS had allowed countries to set their own conditions. The Indian Patent Act of 2005 laid down three conditions:&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">1 When reasonable requirements of the people about the product have not been fulfilled&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">2 When the patented product is not available at a reasonable price in the country&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">3 When the product is not commercially fully exploited. The rationale is to increase public welfare. There is no requirement for an emergency to exist&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify"><em>So, the patent becomes useless?&nbsp;</em></div><div style="text-align: justify"><br /></div><div style="text-align: justify">No. The compulsory licence holder will still have to pay royalty at a reasonable rate to the patent holder. Also, the patent holder will retain all rights in territories outside of where the compulsory licence operates.</div>                                                           
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    <br><a href="http://timesofindia.indiatimes.com/business/india-business/Road-to-cheaper-drugs/articleshow/12257331.cms" class="re" target="_blank">The Times of India, 14 March, 2012, http://timesofindia.indiatimes.com/business/india-business/Road-to-cheaper-drugs/articleshow/12257331.cms</a><div class="clear"></div>
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The government's decision to bust the price as well as monopoly of Bayer's anti-cancer drug, through the process of compulsory licensing now opens up the field for the generic industry to follow suit and could well pave the way for..."/>
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    <h1 class="cat-box-title">Road to cheaper drugs by Rupali Mukherjee</h1>
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		 Published on</span><span class="text-date"> Mar 14, 2012</span>
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                            <div style="text-align: justify"><br /></div><div style="text-align: justify">The government's decision to bust the price as well as monopoly of Bayer's anti-cancer drug, through the process of compulsory licensing now opens up the field for the generic industry to follow suit and could well pave the way for the availability of cheaper drugs for lifestyle diseases.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">More generic companies could invoke the compulsory licensing clause of the Indian Patents Act, following Monday's decision to allow Natco Pharma to sell copycat drugs of Bayer's patented cancer drug at 97 % reduction. The landmark judgment by the Indian Patent Office is now being seen as a test case by the generic industry and has significant implications for both the domestic generic industry as well as MNCs, which spend substantial amounts on R&amp;D before they find a new drug. However, it is almost certain that Bayer will go to court on this issue.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Experts suggest that Natco Pharma's strategy of invoking the compulsory licensing clause could well prove to be a game changer for the generic industry, which has been facing formidable barriers for a long time. Terming the decision as &quot;bold and historic'', Daara Patel, secretary general of industry body, IDMA said it would open up the field for many domestic manufacturers to follow Natco's strategy. But, some companies like Sun Pharma feel that this may be a risky strategy to follow, and will wait and watch to see how the situation unfolds.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">The country's first ever compulsory licensing approval also has significant upsides for consumers, especially the poor since it would open up the field for other generic companies to tap this route, thus forcing MNCs to rethink their pricing strategies for India and other developing countries. Says Prof Shamnad Basheer of National University of Juridical Sciences and an expert on intellectual property : &quot;Not only will MNCs need to revisit their pricing strategy in India, the decision will have a spin off effect in other countries like Thailand and Brazil, as well as in their home markets.&quot;&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Significantly, this would lead to lowering in exorbitant prices of lifesaving cancer drug and HIV drugs. The compulsory licensing mechanism has existed since 2005, when the patent regime was established, and should have kicked in by 2009 or so, but it was only last year that Natco applied to the government. Domestic companies like Cipla feel emboldened by the patent controller's decision, and feel that it will lead to many companies applying for licences to manufacture life-saving drugs, said Cipla director S Radhakishnan. Cipla applied for a compulsory licence to manufacture HIV drug, raltegravir last year.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">MNCs are, however, not amused. They feel that these licences should only be granted in case of a public health crisis. Novartis V-C and MD Ranjit Shahani says ; &quot;We believe compulsory licences should be used only in exceptional circumstances, such as in times of a national health crisis. 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;. Compulsory licences can be issued to generic producers if patented drugs are unavailable or unaffordable. The government can equally notify drugs on which CLs are needed for public non-commercial use and in situations of national emergency or extreme urgency.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Certain section of industry feels that there may be room for both kind of drugs, given the huge disparities in income in the country.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Health groups are meanwhile rejoicing. &quot;India is likely to face exceptional pressure from developed countries and multinational pharma companies in the coming weeks,&quot; cautions Santhosh MR of the Centre for Trade and Development (Centad ). &quot;Already the Indian government is defending India's strict patentability standards from the legal challenge mounted by Novartis in the Supreme Court and fighting the offensive on intellectual property enforcement targeting generic manufacturers launched by the EU in bilateral FTA negotiations,&quot; he adds.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify"><strong>THE RATIONALE IS TO INCREASE PUBLIC WELFARE&nbsp;</strong></div><div style="text-align: justify"><br /></div><div style="text-align: justify"><em>What is a compulsory licence?&nbsp;</em></div><div style="text-align: justify"><br /></div><div style="text-align: justify">Holders of patents have an exclusive right to make and sell their product. They also have the right to charge fees from another producer for allowing it to make and sell their patented product. In certain cases, the government can allow a nonpatent holder to make and sell a patented product without the patent owner's consent. This is known as a compulsory licence&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify"><em>Is this an Indian peculiarity?&nbsp;</em></div><div style="text-align: justify"><br /></div><div style="text-align: justify">No, the compulsory licence system is part of the WTO's agreement on intellectual property called the TRIPS (Trade Related Aspects of Intellectual Property Rights) Agreement. It has existed since 1995 and was further clarified in 2001 through the Doha Declaration. Most countries have provision for it, except the US&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify"><em>When can a compulsory licence be granted?&nbsp;</em></div><div style="text-align: justify"><br /></div><div style="text-align: justify">TRIPS had allowed countries to set their own conditions. The Indian Patent Act of 2005 laid down three conditions:&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">1 When reasonable requirements of the people about the product have not been fulfilled&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">2 When the patented product is not available at a reasonable price in the country&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">3 When the product is not commercially fully exploited. The rationale is to increase public welfare. There is no requirement for an emergency to exist&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify"><em>So, the patent becomes useless?&nbsp;</em></div><div style="text-align: justify"><br /></div><div style="text-align: justify">No. The compulsory licence holder will still have to pay royalty at a reasonable rate to the patent holder. Also, the patent holder will retain all rights in territories outside of where the compulsory licence operates.</div>                                                           
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    <br><a href="http://timesofindia.indiatimes.com/business/india-business/Road-to-cheaper-drugs/articleshow/12257331.cms" class="re" target="_blank">The Times of India, 14 March, 2012, http://timesofindia.indiatimes.com/business/india-business/Road-to-cheaper-drugs/articleshow/12257331.cms</a><div class="clear"></div>
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        LATEST NEWS UPDATES | Road to cheaper drugs by Rupali Mukherjee    </title>
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The government's decision to bust the price as well as monopoly of Bayer's anti-cancer drug, through the process of compulsory licensing now opens up the field for the generic industry to follow suit and could well pave the way for..."/>
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The government's decision to bust the price as well as monopoly of Bayer's anti-cancer drug, through the process of compulsory licensing now opens up the field for the generic industry to follow suit and could well pave the way for..." />
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                            <div style="text-align: justify"><br /></div><div style="text-align: justify">The government's decision to bust the price as well as monopoly of Bayer's anti-cancer drug, through the process of compulsory licensing now opens up the field for the generic industry to follow suit and could well pave the way for the availability of cheaper drugs for lifestyle diseases.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">More generic companies could invoke the compulsory licensing clause of the Indian Patents Act, following Monday's decision to allow Natco Pharma to sell copycat drugs of Bayer's patented cancer drug at 97 % reduction. The landmark judgment by the Indian Patent Office is now being seen as a test case by the generic industry and has significant implications for both the domestic generic industry as well as MNCs, which spend substantial amounts on R&amp;D before they find a new drug. However, it is almost certain that Bayer will go to court on this issue.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Experts suggest that Natco Pharma's strategy of invoking the compulsory licensing clause could well prove to be a game changer for the generic industry, which has been facing formidable barriers for a long time. Terming the decision as &quot;bold and historic'', Daara Patel, secretary general of industry body, IDMA said it would open up the field for many domestic manufacturers to follow Natco's strategy. But, some companies like Sun Pharma feel that this may be a risky strategy to follow, and will wait and watch to see how the situation unfolds.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">The country's first ever compulsory licensing approval also has significant upsides for consumers, especially the poor since it would open up the field for other generic companies to tap this route, thus forcing MNCs to rethink their pricing strategies for India and other developing countries. Says Prof Shamnad Basheer of National University of Juridical Sciences and an expert on intellectual property : &quot;Not only will MNCs need to revisit their pricing strategy in India, the decision will have a spin off effect in other countries like Thailand and Brazil, as well as in their home markets.&quot;&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Significantly, this would lead to lowering in exorbitant prices of lifesaving cancer drug and HIV drugs. The compulsory licensing mechanism has existed since 2005, when the patent regime was established, and should have kicked in by 2009 or so, but it was only last year that Natco applied to the government. Domestic companies like Cipla feel emboldened by the patent controller's decision, and feel that it will lead to many companies applying for licences to manufacture life-saving drugs, said Cipla director S Radhakishnan. Cipla applied for a compulsory licence to manufacture HIV drug, raltegravir last year.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">MNCs are, however, not amused. They feel that these licences should only be granted in case of a public health crisis. Novartis V-C and MD Ranjit Shahani says ; &quot;We believe compulsory licences should be used only in exceptional circumstances, such as in times of a national health crisis. 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;. Compulsory licences can be issued to generic producers if patented drugs are unavailable or unaffordable. The government can equally notify drugs on which CLs are needed for public non-commercial use and in situations of national emergency or extreme urgency.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Certain section of industry feels that there may be room for both kind of drugs, given the huge disparities in income in the country.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">Health groups are meanwhile rejoicing. &quot;India is likely to face exceptional pressure from developed countries and multinational pharma companies in the coming weeks,&quot; cautions Santhosh MR of the Centre for Trade and Development (Centad ). &quot;Already the Indian government is defending India's strict patentability standards from the legal challenge mounted by Novartis in the Supreme Court and fighting the offensive on intellectual property enforcement targeting generic manufacturers launched by the EU in bilateral FTA negotiations,&quot; he adds.&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify"><strong>THE RATIONALE IS TO INCREASE PUBLIC WELFARE&nbsp;</strong></div><div style="text-align: justify"><br /></div><div style="text-align: justify"><em>What is a compulsory licence?&nbsp;</em></div><div style="text-align: justify"><br /></div><div style="text-align: justify">Holders of patents have an exclusive right to make and sell their product. They also have the right to charge fees from another producer for allowing it to make and sell their patented product. In certain cases, the government can allow a nonpatent holder to make and sell a patented product without the patent owner's consent. This is known as a compulsory licence&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify"><em>Is this an Indian peculiarity?&nbsp;</em></div><div style="text-align: justify"><br /></div><div style="text-align: justify">No, the compulsory licence system is part of the WTO's agreement on intellectual property called the TRIPS (Trade Related Aspects of Intellectual Property Rights) Agreement. It has existed since 1995 and was further clarified in 2001 through the Doha Declaration. Most countries have provision for it, except the US&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify"><em>When can a compulsory licence be granted?&nbsp;</em></div><div style="text-align: justify"><br /></div><div style="text-align: justify">TRIPS had allowed countries to set their own conditions. The Indian Patent Act of 2005 laid down three conditions:&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">1 When reasonable requirements of the people about the product have not been fulfilled&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">2 When the patented product is not available at a reasonable price in the country&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify">3 When the product is not commercially fully exploited. The rationale is to increase public welfare. There is no requirement for an emergency to exist&nbsp;</div><div style="text-align: justify"><br /></div><div style="text-align: justify"><em>So, the patent becomes useless?&nbsp;</em></div><div style="text-align: justify"><br /></div><div style="text-align: justify">No. The compulsory licence holder will still have to pay royalty at a reasonable rate to the patent holder. Also, the patent holder will retain all rights in territories outside of where the compulsory licence operates.</div>                                                           
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    <br><a href="http://timesofindia.indiatimes.com/business/india-business/Road-to-cheaper-drugs/articleshow/12257331.cms" class="re" target="_blank">The Times of India, 14 March, 2012, http://timesofindia.indiatimes.com/business/india-business/Road-to-cheaper-drugs/articleshow/12257331.cms</a><div class="clear"></div>
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Home हिन्दी

Road to cheaper drugs by Rupali Mukherjee

Published on Mar 14, 2012   Modified on Mar 14, 2012

The government's decision to bust the price as well as monopoly of Bayer's anti-cancer drug, through the process of compulsory licensing now opens up the field for the generic industry to follow suit and could well pave the way for the availability of cheaper drugs for lifestyle diseases.  More generic companies could invoke the compulsory licensing clause of the Indian Patents Act, following Monday's decision to allow Natco Pharma to sell copycat drugs of Bayer's patented cancer drug at 97 % reduction. The landmark judgment by the Indian Patent Office is now being seen as a test case by the generic industry and has significant implications for both the domestic generic industry as well as MNCs, which spend substantial amounts on R&D before they find a new drug. However, it is almost certain that Bayer will go to court on this issue.  Experts suggest that Natco Pharma's strategy of invoking the compulsory licensing clause could well prove to be a game changer for the generic industry, which has been facing formidable barriers for a long time. Terming the decision as "bold and historic'', Daara Patel, secretary general of industry body, IDMA said it would open up the field for many domestic manufacturers to follow Natco's strategy. But, some companies like Sun Pharma feel that this may be a risky strategy to follow, and will wait and watch to see how the situation unfolds.  The country's first ever compulsory licensing approval also has significant upsides for consumers, especially the poor since it would open up the field for other generic companies to tap this route, thus forcing MNCs to rethink their pricing strategies for India and other developing countries. Says Prof Shamnad Basheer of National University of Juridical Sciences and an expert on intellectual property : "Not only will MNCs need to revisit their pricing strategy in India, the decision will have a spin off effect in other countries like Thailand and Brazil, as well as in their home markets."  Significantly, this would lead to lowering in exorbitant prices of lifesaving cancer drug and HIV drugs. The compulsory licensing mechanism has existed since 2005, when the patent regime was established, and should have kicked in by 2009 or so, but it was only last year that Natco applied to the government. Domestic companies like Cipla feel emboldened by the patent controller's decision, and feel that it will lead to many companies applying for licences to manufacture life-saving drugs, said Cipla director S Radhakishnan. Cipla applied for a compulsory licence to manufacture HIV drug, raltegravir last year.  MNCs are, however, not amused. They feel that these licences should only be granted in case of a public health crisis. Novartis V-C and MD Ranjit Shahani says ; "We believe compulsory licences should be used only in exceptional circumstances, such as in times of a national health crisis. 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 ...". Compulsory licences can be issued to generic producers if patented drugs are unavailable or unaffordable. The government can equally notify drugs on which CLs are needed for public non-commercial use and in situations of national emergency or extreme urgency.  Certain section of industry feels that there may be room for both kind of drugs, given the huge disparities in income in the country.  Health groups are meanwhile rejoicing. "India is likely to face exceptional pressure from developed countries and multinational pharma companies in the coming weeks," cautions Santhosh MR of the Centre for Trade and Development (Centad ). "Already the Indian government is defending India's strict patentability standards from the legal challenge mounted by Novartis in the Supreme Court and fighting the offensive on intellectual property enforcement targeting generic manufacturers launched by the EU in bilateral FTA negotiations," he adds.  THE RATIONALE IS TO INCREASE PUBLIC WELFARE  What is a compulsory licence?  Holders of patents have an exclusive right to make and sell their product. They also have the right to charge fees from another producer for allowing it to make and sell their patented product. In certain cases, the government can allow a nonpatent holder to make and sell a patented product without the patent owner's consent. This is known as a compulsory licence  Is this an Indian peculiarity?  No, the compulsory licence system is part of the WTO's agreement on intellectual property called the TRIPS (Trade Related Aspects of Intellectual Property Rights) Agreement. It has existed since 1995 and was further clarified in 2001 through the Doha Declaration. Most countries have provision for it, except the US  When can a compulsory licence be granted?  TRIPS had allowed countries to set their own conditions. The Indian Patent Act of 2005 laid down three conditions:  1 When reasonable requirements of the people about the product have not been fulfilled  2 When the patented product is not available at a reasonable price in the country  3 When the product is not commercially fully exploited. The rationale is to increase public welfare. There is no requirement for an emergency to exist  So, the patent becomes useless?  No. The compulsory licence holder will still have to pay royalty at a reasonable rate to the patent holder. Also, the patent holder will retain all rights in territories outside of where the compulsory licence operates.

The Times of India, 14 March, 2012, http://timesofindia.indiatimes.com/business/india-business/Road-to-cheaper-drugs/articleshow/12257331.cms

Tagged with: medicines Health patents

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