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Bombay High Court upholds Nexavar compulsory licence

The Bombay High Court has rejected Bayer’s challenge to the compulsory licence granted for its Nexavar cancer treatment drug

According to Livemint, Justice MS Sanklecha stated that the court saw no reason to overturn the Intellectual Property Appellate Board’s (IPAB) ruling from last February upholding the licence.

Bayer has stated that it will appeal the decision to the Supreme Court.

The Bombay High Court decision is the latest development involving India’s first compulsory licence, which was granted in March 2012. Then controller of patents PH Kurian granted the application from generic manufacturer Natco under section 84 of the Patents Act. This says that a compulsory licence may be granted if (a) the reasonable requirements of the public with respect to the drug have not been satisfied, (b) the patented invention is not available to the public at a reasonably affordable price, or (c) the patented invention is not worked in India.

The patent controller found that Natco established all three grounds and he granted a compulsory licence with a royalty rate of 6% of net sales.

Bayer appealed the patent controller’s decision to the IPAB. Last February, the Board upheld the compulsory licence grant, though it noted that the patent controller erred in finding that a drug not manufactured in India automatically meant it was not being worked in India. The IPAB also raised the royalty rate to 7%.

To this date, Nexavar is the only drug that has been subjected to a compulsory licence in India, though several other applications have been rejected.



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