The Curious Case of ‘Sorafenib Tosylate’

‘Sorafenib Tosylate’ drug, which is sold as ‘Nexavar’, has hit the headlines once again. Brushing off Bayer Corporation's claims, the Bombay High Court ruled out the German based drug maker's challenge of the Controller of Patents decision to grant compulsory license to Natco Pharma Ltd, a Hyderabad based pharmaceutical company. The court rejected Bayer’s plea and thus declined to intervene with the Controller's original decision. A division bench of Justice M S Sanklecha and Chief Justice Mohit Shah observed that the rights of a patent holder of a drug or medicine should not strip a patient from getting the required medication, and hence the IPAB’s decision was upheld.

Let me recap you briefly. The contenders in the arena are Bayer and Natco. Sorafenib Tosylate, a drug used in the treatment of kidney and liver cancer, was developed by Bayer and Onyx. It was traded under the name ‘Nexavar’. Bayer is a drug invention giant company, based in Germany. In April 2011, an Indian company Natco Pharma Ltd, a generic medicine maker, registered an application with the Bayer, asking for a voluntary license to manufacture and distribute 'Nexavar' in India. The request was refused and hence Natco went to the doors of the Controller of Patents to apply for a compulsory license. According to the new WTO rules, the then Controller of Patents, Mr. P.H. Kurian, on March 9th, 2012 granted Natco permission to manufacture generic version of Nexavar in India. This judgment was a landmark in the history India’s Patent Law, as it became the first ever case of compulsory licensing in India. Surely this news broke all grounds, and Bayer was shown a cold cheek.

The Controller General (CG) ascertained three reasons to justify its decision. Firstly as Bayer provided Nexavar only to 2% of the total cancer patient population in India, public requirements were far from being met. Secondly, the pricing of the drug at Rs.2.8 Lakhs was exorbitant and this was suffice to say that it was not a “reasonably affordable” price. And lastly, it stated that Bayer has not shown proof of the patented invention being “worked” in India.

The order is completely justified. While it’s a well-known fact the treatment process of cancer is extremely expensive, Bayer Corporation's tactics of pricing the drug at a whooping Rs.2.84 lakhs does no good to those in need. Given the fact that Bayer has invented this breakthrough drug, I would place it on record, that, Natco is the Robin Hood to all those people counting hopes and days by making the drug available at Rs.8800. I mean, what good is a drug if the one who needs it can't afford it? India is a country where millions still go to sleep hungry, as the food produced does not reach everyone. At least we can expect the medicine to be available to almost every patient who needs it. With Natco now free to manufacture and distribute the drug, there’s another reason for Cancer patients and Natco to celebrate this Diwali!

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