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Roche warns against generic Tamiflu

Pharmaceutical company Roche Holding AG on Monday cautioned against countries producing on their own a generic version Tamiflu.
/ Source: The Associated Press

Swiss pharmaceutical company Roche Holding AG on Monday cautioned against countries producing on their own a generic version Tamiflu, the drug that experts believe is most effective in protecting humans from bird flu.

Roche, the sole manufacturer of Tamiflu, has ruled out relinquishing the patent on the antiviral drug, which is protected until 2016. But orders have soared as bird flu has spread from Asia to southeast Europe, and the company is coming under increasing pressure from a number of countries to allow others to produce a copy of the drug.

India said Monday it would consider whether to invoke a special law allowing its drug manufacturers to copy Tamiflu without getting a license from Roche.

"It needs special knowledge, special know-how to produce this drug," Roche spokeswoman Martina Rupp told The Associated Press. "Since we have been making this drug for the last 10 years, it would be best for countries to enter into a discussion with us."

Health experts have been pinning their hopes on Tamiflu in case bird flu mutates so that it could pass easily between people. While there is no human vaccine for the spreading strain of bird flu, scientists believe Tamiflu may help humans fight a mutated virus.

Indian authorities are weighing whether there is enough of a risk of bird flu spreading in India to invoke the so-called compulsory licensing clause and lift Roche's patent protections, said Health Secretary Prasanna Kumar Hota.

The World Trade Organization in 2003 decided to allow governments to override patents during national health crises, but no member state has yet invoked the clause.

India has yet to report any cases of bird flu this year, but it imports poultry on a large scale from its Asian neighbors.

Indian drugmaker Cipla Ltd. — which says it has developed a generic version of Tamiflu — pushed authorities to invoke the clause, although it has also applied to Roche for permission to copy the flu drug.

Another Indian company, Ranbaxy Laboratories Ltd., said last week it could develop the drug in a couple of months and has also applied to Roche for a license.

Also Monday, a Taiwanese official said the island had no plans to begin manufacture of the Tamiflu because it has not yet received permission from Roche.

Rupp said the 10-step process to make Tamiflu is complex and, since it involves acids, can be "potentially explosive." She said it was important that companies and countries seeking to produce the drug "have a fact-based discussion" with Roche.

The Basel-based drug giant has said it was seeking other companies to help speed up Tamiflu's production due to the increased demand. But it has advised against countries simply breaking its patent, asking them instead to work with Roche to produce the drug under license.

"We're willing to enter discussions with any party who can produce enough quantity," Rupp said.

Rupp said Roche had received a number of requests to make licensed versions, but would not say which companies and countries it had been in contact with.

"At the moment we are in a period of evaluation," she said. "We have received offers from many parties. Many might be in a position to produce."

Last week, Roche said it would meet with four companies and maybe more in coming weeks to work out licensing agreements that would allow other companies to produce Tamiflu.

Bird flu has killed more than 60 people since late 2003, all of them in Asia. Most human cases have been linked to contact with sick birds.