The Government has recently decided to revoke the flexibility under the World Trade Organisation (WTO) agreement on trade related Intellectual Property Rights for compulsory licensing of patented drugs to ensure availability of patented drugs at affordable prices.
This was stated by the Minister of State for Chemicals and Fertilisers, Shri Srikant Kumar Jena in a written reply in the Lok Sabha today. He said the Department of Industrial Policy and Promotion has informed that so far one Compulsory license has been granted by the Controller General of Patents, Designs and Trade Marks to a drug manufacturing company since the amendment of the Patents Act in 2005 for an application filed under Section 84 of the Patents Act (as amended in 2005). The details are given as under:
• The Compulsory license has been granted by the Controller General of Patents, Designs and Trade Marks for the anti-cancer drug in which the compound is “Sorafenib Tosylate” (Patent No. 215758). The patent was granted to M/s Bayer Corporation, USA on 03.03.2008 by the Indian Patent Office, consequent to their filing a national phase application in India.
• M/s Bayer Corporation, USA developed the drug under trade name “NEXAVAR” and received regulatory approval for importing and marketing the drug in India and launched it in India in the year 2008.
• The Compulsory license for the drug has been granted to M/s Natco Pharma Ltd., Hyderabad, Andhra Pradesh.
As per the orders of the Controller of Patents, Mumbai compulsory license has been granted to M/s Natco for manufacture of “NEXAVAR”. M/s Natco Pharma Ltd. are required to sell this drug at a price not exceeding Rs. 8880/- for a pack of 120 tablets, required for a month’s treatment which was earlier being sold by M/s Bayer Corporation at Rs. 2,80,428/- for one month treatment.
This was stated by the Minister of State for Chemicals and Fertilisers, Shri Srikant Kumar Jena in a written reply in the Lok Sabha today. He said the Department of Industrial Policy and Promotion has informed that so far one Compulsory license has been granted by the Controller General of Patents, Designs and Trade Marks to a drug manufacturing company since the amendment of the Patents Act in 2005 for an application filed under Section 84 of the Patents Act (as amended in 2005). The details are given as under:
• The Compulsory license has been granted by the Controller General of Patents, Designs and Trade Marks for the anti-cancer drug in which the compound is “Sorafenib Tosylate” (Patent No. 215758). The patent was granted to M/s Bayer Corporation, USA on 03.03.2008 by the Indian Patent Office, consequent to their filing a national phase application in India.
• M/s Bayer Corporation, USA developed the drug under trade name “NEXAVAR” and received regulatory approval for importing and marketing the drug in India and launched it in India in the year 2008.
• The Compulsory license for the drug has been granted to M/s Natco Pharma Ltd., Hyderabad, Andhra Pradesh.
As per the orders of the Controller of Patents, Mumbai compulsory license has been granted to M/s Natco for manufacture of “NEXAVAR”. M/s Natco Pharma Ltd. are required to sell this drug at a price not exceeding Rs. 8880/- for a pack of 120 tablets, required for a month’s treatment which was earlier being sold by M/s Bayer Corporation at Rs. 2,80,428/- for one month treatment.