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Bayer challenges Nexavar generic licence order

Earlier this year, Natco Pharma was allowed to sell a generic version of their cancer drug

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Drugmaker has filed an appeal against an Indian Patents Office's order, which allowed domestic drug maker Natco Pharma to sell a generic version of the German firm's '' in India, with the Intellectual Property Appellate Board.

In March this year, India had invoked a law permitting Hyderabad-based Natco Pharma to manufacture and sell cancer-treatment drug Nexavar at a price over 30 times lower than charged by its patent-holder Bayer Corporation.

"We strongly disagree with the conclusions of the Patent Controller of India and have appealed his order on May 4, 2012 with the Intellectual Property Appellate Board," a Bayer Spokesperson said in a statement.

"We will rigorously continue to defend our intellectual property rights which are a prerequisite for bringing innovative medicines to patients," the spokesperson added.

An order, which would be of great relief to the kidney and patients, was issued by India Patents Office as a 'Compulsory Licence' under Section 84 of the Indian Patent Act, which is in compliance with the TRIPS agreement of the World Trade Organisation.

In his order, Controller of Patents P H Kurian had said the move followed Bayer not doing enough to scale up the sale of the drug despite getting patent for it in India in 2008.

Natco has been allowed to sell the drug at a price not exceeding Rs 8,880 for a pack of 120 tablets required for a month's treatment as compared to a whopping Rs 2.80 lakh per month charged by Bayer for its patented Nexavar drug.

The German firm said the challenges faced by the Indian healthcare system have little or nothing to do with patents on pharmaceutical products as all products on India's essential drug list are not patented.

"Rather, the order of the Patent Controller of India damages the international patent system and endangers pharmaceutical research," the company said.

The company said the limited period of marketing exclusivity made possible by patents ensures that the costs associated with the research and development of innovative medicines can be recovered.

In March, 2010 Bayer had also filed a patent infringement suit against domestic drug firm at the High Court in New Delhi over Nexavar. The next hearing is set for August 14, 2012 to direct the further schedule for the proceedings, it said.

Last week, Cipla had slashed the prices by up to 76% of its generic drugs, used in treating cancers of brain, lung and kidney.

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