[Ip-health] Compulsory License granted in India

leena menghaney leenamenghaney at gmail.com
Mon Mar 12 01:09:33 PDT 2012

India has just granted a CL to a generic company. See decision at:

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
Tel: 46573730/1, 9811365412

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