Lakshmi Kumaran & Sridharan AttorneysAn ISO 9001 / 27001 certified law firm

Compulsory license granted to produce life-extending drug

23rd March, 2012

India has allowed application for compulsory licensing - the first of its kind. The Controller of Patents, Mumbai on 9th March, 2012, allowed Natco Pharma’s application for compulsory licensing to produce generic version of ‘Nexavar’ i.e. ‘Sorafenib Tosylate’ used for the treatment of advanced stages of kidney and liver cancer. The compound is presently covered by a patent held by Bayer Corporation.

The Controller while allowing such application held that the reasonable requirement of the public with respect to the patented invention had not been satisfied as even after 3 years, the patentee had made available only insignificant proportion of the patented product. He observed that the term “reasonably affordable price” has to be used to balance the interest of consumer without compromising the interest of the innovator and noted that the patented invention is not available to the public at a reasonably affordable price.

It was also held that the patented invention is not worked in the territory of India. While holding so the Controller held that ‘worked in the territory of India’ means ‘manufactured to a reasonable extent in India’.  As per the order, the working statements (Form-27) filed by the patentee would be considered as material information as to the extent to which the patented product was made available in India.

Holding that grant of such licensing did not violate any provision of the TRIPS agreement under the WTO, the Controller disregarded plea on supply of allegedly infringing generic substitutes in assessing whether the reasonable requirements of the public have been met by the patentee. This is the first time such provisions of the Patent Act namely Section 84 have been invoked in India
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