New Delhi: In a first, India on Tuesday 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.
An order, which would be of great relief to the kidney and liver cancer 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 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.
Explaining, the order said: "The patentee (Bayer) did not import the drug at all in 2008 and imported in small quantities in 2009 and 2010."
As per WTO agreement, a compulsory license can be invoked by a national government allowing someone else to produce a patented product or process without the consent of the patent owner. It is done for the cause of public health.
Kurian said: "I do not also see any prompt action in the part of the patentee to start the working of the invention in the territory of India on a commercial scale and to an adequate extent."
Commenting on the development, Natco Pharma said: "Natco welcomes this order and opines that this opens up a new avenue of availability of life saving drugs at an affordable price to the suffering masses in India."
Comments from Bayer Corporation could not be obtained as query sent remained unanswered.