Generic flu drug threatens Tamiflu

An Indian pharmaceutical company is gearing up to sell a cheap version of the leading patented antiviral flu drug Tamiflu to emerging economies, in a move that will pitch intellectual property rights against affordable access to medicines.

Cipla, based in Mumbai, said on Wednesday it had agreed to sell significant quantities of its Antiflu preparation to Mexico, the country at the centre of the current flu outbreak.

The move came only hours after the World Health Organisation said the drug was as effective as Tamiflu.

Yusuf Hamied, the head of Cipla, confirmed that Mexico had already agreed in principle to purchase stocks of Antiflu, and talks were under way with a number of other governments in Latin America, the Middle East and Africa.

The launch risks provoking a clash with Gilead and Roche, the large pharmaceutical companies that developed and distribute Tamiflu, the drug known generically as oseltamivir, which Antiflu replicates.

Cipla recently won a case within India against Gilead, which holds the patents on Tamiflu, paving the way for the manufacture of its version.

If Mexico now issues a compulsory licence to waive the patent on the drug, existing international trade rules would allow purchases of Antiflu, although intense lobbying by large pharmaceutical companies has severely limited such practices until now.

Amar Lulla, Cipla's managing director, stressed he would only sell stocks of Antiflu to Mexico and other countries on condition that they indemnified the company against any legal action over patents.

He said his company would offer Antiflu for sale at about $10 per course of treatment. Roche sells Tamiflu for government pandemic stockpiles at Euro 15 ($20) for richer countries and Euro 12 for poorer ones.

Roche refused to say on Wednesday whether it would launch legal action, but stressed it was in continuing discussion with Mexico, to which it had supplied 1m doses of Tamiflu in recent weeks.

It said: "We appreciate the current health situation in Mexico and we respect the right of all governments to take action on behalf of its citizens. Roche has confirmed its willingness and ability to provide the Mexican government with Tamiflu in significant quantities in a timely manner and therefore sees no rationale for compulsory licensing."

The company has already licensed several other generic companies with the right to produce Tamiflu, although only Cipla -- with which it did not agree any deal -- has so far filed for "pre-qualification" with the WHO, a process certifying the quality of its manufacturing and equivalence to another drug.

Copyright: The Financial Times Limited 2009