BAYER CORPORATION Vs. UNION OF INDIA

JUDGEMENT

(1.) This petition under Article 226 of the Constitution of India challenges the order dated 4 March 2013 passed by the Intellectual Property Appellate Board (Tribunal). By the impugned order the Tribunal upheld the order dated 9 March 2012 passed by the Controller of Patents (Controller) granting Compulsory License to M/s. Natco Pharmaceuticals Limited (Natco) under Section 84 of the Patent Act 1970 (the Act). This compulsory licence was in respect of the petitioner's patented invented drug Sorafenib Tosylate (compound of Carboxyaryl Substituted Diphenyl Ureas) sold under brand name Nexavar (patented drug).

(2.) This petition arises out of orders granting a compulsory license of the patented drug owned by the petitioner to Natco on application of the provisions of Chapter XVI and in particular Section 84 of the Act. The challenge of the petitioner is to the allowing of the application of Natco for compulsory licence and to the manner in which Chapter XVI of the Act and in particular Section 84 of the Act has been applied. We are informed at the Bar that it is for the first time after India became a signatory to Trade Related Aspects of Intellectual Property Rights (TRIPS) followed by the Doha Declaration in 2001 and the amendments to the said Act in 2003 and 2005 that the issue of compulsory licence has arisen for consideration before the authorities under the said Act and consequently also before this Court. The result of the examination of Chapter XVI of the Act and the manner of its application by the authorities under the Act would have far reaching impact as it would govern the issue of grant of compulsory license in respect of patented drugs.

(3.) The bare facts necessary to consider the challenge in this petition are as follows: