TWN Info Service on WTO and Trade Issues (Mar12/02)
13 March 2012
Third World Network

Dear friends and colleagues,

We are very pleased to share the news released by the Medecins Sans Frontieres (MSF) Access Campaign in India that the Indian Patent Controller has issued a compulsory licence on sorafenib tosylate, an important anti-cancer medicine that covers the remaining period of the patent protection term, until 2020. The decision that was made after hearings and the accompanying documents are provided in web links below.

With best wishes,
Third World Network

Announcement by MSF Access Campaign, India

India has just granted a CL to a generic company

See decision at:

The CL on sorafenib tosylate, the anti-cancer drug has been granted to Natco Pharma till 2020 (balance of the patent term). Natco will be required to pay 6% of net sales as royalty to Bayer. Natco's right to manufacture and sell the drug is limited to the territory of India.

Background: In July 2011, NATCO, an Indian pharmaceutical company, applied for a compulsory licence (CL) in the Mumbai patent office to manufacture an affordable generic version of sorafenib tosylate the anti-cancer drug for which Bayer has obtained a patent IN215758 in India in 2008. The patent expires in 2020.

In its CL application NATCO is proposing to market the same drug at Rs. 8,800 per patient per month if the patent office grants it a compulsory license. The price is likely to come down to 3% of what Bayer is charging. Bayer currently markets the drug at a high price of approximately Rs. 2,80,000 per patient per month. This case is also important as it will test Section 84 of the Indian Patent Act, under which the CL mechanism kicks in when generic competitors request a CL.

Several hearing have been held by the Indian Patent Controller in the last nine months. Bayer aggressively opposed and tried to delay the grant of the CL. Now a decision granting a CL has been published today by the Patent Office in India.

Under the WTO's TRIPS Agreement, CLs are a legally recognised means to overcome barriers in accessing affordable medicines.

The CL documents and information regarding the hearings are available at:

Leena Menghaney

MSF Access Campaign, India
Tel: 46573730/1, 9811365412