BAYER CORPORATION Vs. UNION OF INDIA

JUDGEMENT

(1.) THIS is an application filed on behalf of respondent no.5 (hereafter referred to as 'NPL') inter alia praying for permission to export 1 kg. of Active Pharmaceutical Ingredient (hereafter 'API') Sorafenib for the purposes of conducting development/clinical studies and trials. The said application was necessitated because of an interim order dated 26.03.2014 passed by this Court whereby respondent nos. 1 to 4 were directed to ensure that no consignment from India containing 'Sorafenat' covered by compulsory license be exported.

(2.) THE controversy to be addressed is whether, the export of API by the applicant would fall within the affirmative defense to infringement of the non -applicant's patent as available by virtue of section 107A of the Patents Act, 1970 (hereafter the 'Act').

(3.) BRIEFLY stated the relevant facts for considering the controversy are that the petitioner (hereafter referred to as 'Bayer') was granted a patent for a pharmaceutical product titled "Carboxyaryl Substituted Diphenyl Ureas" under the Indian Patent No.215758, for a period of 20 years from 12.01.2000. 'Sorafenib tosylate' is a compound, which is sold by Bayer under the brand name 'Nexavar'. The said product is used for treatment of patients with advanced stages of kidney and liver cancer. The said drug is stated to be a life extending drug, which extends the life of a patient by four to five years in case of kidney cancer and six to eight months in case of liver cancer.