[Ip-health] India's official statement on CL - TRIPS flexibility

leena menghaney leenamenghaney at gmail.com
Fri May 4 05:19:57 PDT 2012

Ministry of Chemicals and Fertilizers
03-May, 2012 15:57 IST, Press Information Bureau, Government of India

Manufacturing of Generic Version of Drugs

The Government has recently decided to invoke 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.



Leena Menghaney
Tel: 46573730/1, 9811365412

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