Delhi High Court Bans Generic Medication Sorefenat

The Delhi High Court has temporarily banned the export of Sorefenat, a generic kidney and liver cancer medication. The medication is manufactured by Natco Pharma and the move was made on behalf of the Bayer Corporation. Sorafenat is the generic version of Nexavar. Justice Manmohan allowed for Natco to petition the court for the ban to be dropped once the company received approval to do so from the Drug Controlling Authority. Bayer has alleged that Natco is making the drug under a compulsory license for sale in India and not in other countries. As a result, the drug 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. There are more hearings on the matter scheduled for August of this year.

Bayer had asked for customs authorities to seize any shipments containing the Sorafenat drug manufactured by Natco under the compulsory license granted in India. Bayer has continually stated that the drug's compulsory license is only for manufacture “within the territory of India.”

Natco has claimed that it has not exported any of the Sorafenat manufactured in India, and that it cannot be held legally liable for those who purchase the drug legally in India and then choose to export the drug. The company's compulsory license for manufacturing the generic was granted by the country's patent office on March 9, 2012.