Roche sues Biocon and Mylan over Herceptin biosimilar; US puts pressure on India over IP

Swiss pharma major Roche’s (ROG: SIX) Indian subsidiary has sued Bangalore-based Biocon (BSE: 532523) and US generics firm Mylan (Nasdaq: MYL), just as the companies were launching the world's first biosimilar version of Roche blockbuster breast cancer drug Herceptin (trastuzumab) in India (The Pharma Letter February 3), report the Economic Times and other media.

The Delhi High Court has restrained Mylan and Biocon from "relying upon" or "referring to Herceptin" or any data relating to it for selling or promoting their brands Canmab (Biocon) and Hertraz (Mylan) until the next hearing, according to an order reviewed by ET. Trastuzumab, and other leading drugs, were being considered for a compulsory license by the Indian government (TPL January 1, 2013), but Roche pre-empted the move by not renewing the patent there in August last year.

Roche has also sued the Drug Controller General of India for giving approval to the biosimilar versions of Herceptin. The Swiss company argues that there is no public record available, in the clinical trial registry India (CTRI) or elsewhere, to show that these firms actually conducted Phase I or Phase II clinical trials for their drug.