Delhi HC upholds ruling in Cipla-Roche cancer drug row

23 April 2008

Mumbai: The Delhi High Court has upheld an earlier ruling that allowed generic drug maker Cipla Ltd to manufacture and market a copy of Swiss company Hoffmann La Roche's patented lung cancer drug Tarceva in the domestic market.

In March the Delhi High court had passed an interim order that allows domestic drug maker Cipla to sell its version of the lung cancer treatment drug (See: Cipla to continue selling its version of Roche's lung cancer treatment drug). The generic name of the drug at the centre of the lawsuit is Erlotnib, which Roche markets as Tarceva, and Cipla sells as Erlocip. The Delhi High court had asked Cipla to maintain records of Erlocip sales before the next hearing and had admitted a counter-claim filed by Cipla, which questions the validity of the Roche patent.

A division bench of the high court, however, restrained Cipla from exporting 'Tarceva' to those countries where Roche has patent registration for the anti-cancer drug.

"Respondent (Cipla) in the meantime shall, while complying with the order of single bench, not export the drug in the question where plaintiff (La Roche) has patent registration," a bench of Justice Manmohan Sarin and Justice Manmohan said.

The bench also insisted that only one cheaper generic version of the patented drug will be permitted in the local market.

It, however, made it clear that observations made by the single bench shall not be used by any third party as precedent for the purpose of manufacturing the drug.