First Compulsory License granted in India to generic company for anti-cancer drug

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.

See the decision here:

compulsory_License_12032012

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.

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3 Responses to First Compulsory License granted in India to generic company for anti-cancer drug

  1. Giten. Khwairakpam says:

    This is great news…hopefully this will set the precedence for access to affordable life saving medicines. Pegylated interferon should be in line or the generic producers wins the heraing in April 2012.

  2. Pingback: India Overturns Pharmaceutical Patents « This Day – One Day

  3. Pingback: Bayer seeks to stay the operation of the CL order – files appeal against the grant of the CL, before the IPAB in Chennai (India) | Don't trade our lives away

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