Delhi High Court bars export of Natco’s generic cancer treatment drug

New Delhi March 28, 2014 – The Delhi High Court has barred export of generic kidney and liver cancer medication Sorefenat manufactured by Natco Pharma Ltd on a plea of German drug major Bayer Corporation.

Justice Manmohan, however, gave liberty to Natco to seek the court’s permission to export the drug as and when it gets the nod from the Drug Controlling Authority.

The court also issued notices to the Centre, customs authorities and Natco, seeking their replies on the plea of Bayer, which has alleged that the generic drug is being made under compulsory licence for sale in India and, thus, cannot be exported.

“Notice. Respondents 1 to 4 (Centre and others) and Respondent 5 (Natco) to file their responses in six weeks… Respondents 1 to 4 are directed to ensure that no consignment from India containing Sorefenat, covered by compulsory licence, is exported,” the court said and listed the matter for further hearing on August 11.

Bayer in its plea has sought directions to the customs authorities to seize and confiscate the consignment containing Sorafenat manufactured by Natco Pharma under compulsory licence granted by the patent office on March 9, 2012.

The company, represented by senior advocate Mukul Rohatgi, has contended that the compulsory licence was granted with the condition that permission is being granted for making and selling the drug “within the territory of India”.

Natco, represented by senior advocate Anand Grover, submitted before the court that it has been selling the drug Sorefenat only in India and that it cannot be faulted in the event purchasers and retailers of its medicine sell it abroad.

Sorafenat is the generic alternative to Bayer’s Nexavar and is used to treat a type of kidney cancer called advanced renal cell carcinoma as well as liver cancer.