The ‘Tarceva’ Patent Case

Roche vs. Cipla marks the end of the first phase of a key battle between big pharma and the Indian generic industry. The infringement action brought by Roche against Cipla and Cipla's counterclaim for Roche's patent invalidity was both dismissed.

Roche was granted Indian Patent No. IN '774 in February 2007, under which per Claim 1, they had patent rights over the Erlotinib Hydrochloride (EH) molecule (which has demonstrated breakthrough capabilities as an Epidermal Growth Factor Receptor (EGFR) inhibitor which spiked survival benefit in non-small cell lung cancer (NSLC) patients). Based on media reports declaring Cipla's intention to launch a generic version of Roche's drug in January 2008, Roche moved the Delhi High Court seeking to injunct Cipla from marketing Erlocip. Cipla counterclaimed, arguing that Roche's patent was invalid. The judgment deals with two key issues: