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.”