The government is likely to invoke the compulsory licensing (CL) provision in the Patents Act that would enable domestic drug firms to produce and stockpile Swiss drug maker Roche's patented drug Tamiflu, useful in combating the global threat against the most dreaded avian flu virus.
Section 92 empowers the government to issue CL without receipt of an application from the industry. Furthermore, the issue of such license is independent of third party consent. The following proposal is expected to help cope up with a public health emergency that might arise in case the pandemic hits India. Once compulsory licensing has been issued, manufacture of the drug can be initiated, to ensure both domestic and international supply.
The drug companies in India are more than willing to participate in the initiative. Ranbaxy Laboratories has already initiated talks with the Swiss pharma company regarding the issue. The company is also getting in touch with governments across the world, interested in sourcing the drug from it.
The situation would however require a critical analysis of patents issue across the world. It would be six months before the drug can actually be manufactured following regulatory approvals.
In response to the above situation, Roche has announced it would not welcome interventions by generic drug makers in Tamiflu market, the demand for which has increased manifold following reports that the pandemic has reached Europe and SE Asia.
Medindia on Bird Flu:
Avian influenza (AI) or Bird Flu is a disease of viral etiology that ranges from a mild or even asymptomatic infection to an acute, fatal disease of chickens, turkeys, guinea fowls, and other avian species, especially migratory waterfowl.