Ranbaxy, Cipla in race for bird flu drug patent

Despite the government granting emergency marketing approval to Swiss drug maker Roche's avian influenza drug Tamiflu, Ranbaxy and Cipla remain in the fray to produce the drug's generic version, Oseltamivir.

The Indian companies are already looking to export Oseltamivir dosages to western and Southeast Asian countries.

A high-level committee's decision not to circumvent the pending patent application of Roche, filed in 2001, will delay but not deny the launch of the domestic version of the drug, as the Indian companies will now have to wait for a licence from the patent-holder.

"Ranbaxy is going to be a part of this public health programme. We are in touch with the government and Roche for ironing out the intellectual property issues. We intend to make the generic version available by the first quarter of 2006," said Ramesh L Adige, director of Ranbaxy Laboratories Ltd.

Ranbaxy is in talks with the governments of Thailand and Malaysia, among others, to provide the drug. "We will enter the Indian market for commercial production when we are ready, most likely by the year-end. We are also in talks with many countries for drug supplies," said Cipla's Joint Managing Director Amar Lulla.

DG Shah, secretary-general, Indian Pharmaceutical Alliance, thinks it is heartening that the government has recognised the emergency, but feels it should have been more proactive by invoking Section 92 (provision of compulsory licence issue) to expedite domestic production. Roche's Indian executives were unavailable for comments.

"Marketing authorisation is a good thing but the provision for a compulsory licence should have been invoked. Now, the launch of the generic version by Indian companies like Ranbaxy and Cipla will be delayed as the licencer will take time in responding to them. After that happens, there will be negotiations on the royalty rate," explains Shah.

Both Ranbaxy and Cipla do not feel that the presence of Roche will take their market away as and when they enter. While Lulla feels there is "still room for others", Adige says one player is not enough to meet the entire demand, so, there is a role for Ranbaxy.

"We already have fast-track clearance by the government. Our scientists have worked out the complex synthesis of the drug, steps have been taken to procure the intermediates and the manufacturing will be upscaled suitably," Adige adds.

CHILL PILL
Ranbaxy, Cipla already looking at overseas markets to export generic version Oseltamivir

Panel's decision not to circumvent Roche's pending patent application, filed in 2001, will delay launch of domestic version

The Indian companies have to wait for a licence from the patent holder

Generic version to be available by first quarter of 2006