[Ip-health] Sify.com: Generic cos permitted to make bird flu drug

[Thiru Balasubramaniam]

http://sify.com/finance/fullstory.php?id=13982089


Generic cos permitted to make bird flu drug

Friday, 11 November , 2005, 07:59

*New Delhi:* The Industry Ministry has given a green signal for allowing
domestic pharmaceutical companies to manufacture generic versions of
Tamiflu (oseltamivir), considered the most effective drug to treat avian
influenza, commonly called bird flu.

Clearing the air surrounding the patents for the drug filed by Swiss
drug major Roche and the innovator company, Gilead Sciences, the
Ministry has said that under the present policy a compulsory license is
not necessary, as a product patent has not yet been granted for the
molecule. In fact, the nearly half-a-dozen patents pending in the Mail
Box do not cover the molecule, but are for some of its intermediate
compounds, said top Government officials.

"So far, only a process patent has been granted for Tamiflu and not a
product patent. Therefore, generic companies who want to follow the same
process to manufacture the drug would have to seek permission from the
innovator," added officials.

According to Government sources, the Industry Ministry conveyed this to
representatives of an inter-Ministerial Committee set up to tackle the
bird flu outbreak at a meeting held earlier in the week.

"Also, Roche has been granted marketing rights for Tamiflu in India,"
they said. | Read more Finance news. <http://sify.com/finance> |

At present, three Indian companies, Cipla, Ranbaxy and Hetero, have
stated that they are ready to manufacture the drugs. Malvinder Mohan
Singh, President - Pharmaceuticals, Ranbaxy, today reiterated that the
company is capable of manufacturing the drug in lab scale. "We are now
preparing for commercial production. We have had discussions with Roche
and are expecting a decision soon," he said.

Roche has indicated that it has received about 150 requests for licenses
to manufacture the drug, and has already held discussions with eight
possible partners.

It expects to shortlist the candidates later this month.

Meanwhile, domestic industry is of the view that just like other
South-East Asian countries, Government must be ready with a concrete
plan to tackle the spread of bird flu. Officials said that companies
have asked the Government to give it some indication of the size of the
order, so that it could make investments in sourcing raw materials and
manufacturing the drugs.