P.T. Jyothi Datta

Mumbai, Oct. 26

THERE is an uneasy calm surrounding anti-viral oseltamivir, popular these days by its brandname Tamiflu a sought-after drug to mitigate the effects of bird flu.

As governments go into a flutter over stocking the medicine, oseltamivir is caught in a silent global tug-of-war between its developer, Gilead Sciences, and the company marketing it worldwide, Roche.

Gilead had served a notice of termination to Roche in June, allegedly for not being committed to promoting the drug, among other things. And though the subsequent demand for Tamiflu may have changed Roche's approach towards the drug, the spat still remains to be resolved.

Responding to a query from Business Line, the California-based Gilead's Director-Public Affairs, Ms Amy Flood, said: "Regarding the licensing agreement, we issued the Notice of Termination to Roche in June. We did not resolve the dispute within the cure period specified by our agreement, and as a result, we have submitted the matter for confidential binding arbitration (also as per the terms of the agreement). The arbitration must be completed within 18 months."

But till a decision is made, producers of Tamiflu copies will have to obtain their licence from Roche, she indicated. Globally, Gilead Sciences' patent on oseltamivir expires in December 2016.

Explaining the complex patent-maze around the drug in India and abroad, a patent attorney said that India, in fact, has it easy. Although the product-patent regime came into effect this January, no patents have been issued yet. So companies like Ranbaxy (which already makes the active ingredient in Tamiflu) and Cipla are free to make Tamiflu (oseltamivir) clones.

However, in India, there is a patent pending on oseltamivir in the mailbox system from Gilead Sciences Inc, filed on this "carbocyclic compound" in February 1996, the attorney said. The mailbox facility was instituted by the Centre for transitioning into the patent regime. But with certain issues yet to be ironed out, no patents have been issued in the country yet, the attorney said.

So with no patent on oseltamivir, the question of going in for a compulsory licence does not arise. A compulsory licence involves breaking a patent, or the exclusivity that a company has on a drug. Producers allowed to make copies of the drug after a compulsory licence is issued will have to pay a royalty to the original patent holder.

Globally, the patent has been "assigned" to Roche. And it will continue to be at the centre of controversies to make the drug available, until the arbitration process is completed in favour or against Roche, the attorney said.

(This article was published in the Business Line print edition dated October 27, 2005)
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