P.T. Jyothi Datta

Mumbai, Oct 20

AS the world watches how Roche supplies its anti-flu medicine Tamiflu to countries faced with the bird-flu problem, a patent twist threatens to add to the existing controversy around the drug and its availability.

Gilead Sciences, the developer of Tamiflu, is believed to have terminated its agreement with Roche, which has the exclusive marketing right on the drug. And generic manufacturers like Cipla, looking to make similar versions of Tamiflu, are now taking a close look at the intricacies of who indeed holds the patent on the drug.

According to a note from Gilead Sciences Inc, dated June 2005, the company has "delivered a notice of termination to F. Hoffmann-La Roche Ltd (Roche) for material breach of the parties' 1996 Development and Licence Agreement for Tamiflu (oseltamivir phosphate), an antiviral pill for the treatment and prevention of influenza. Through this action, Gilead is seeking to terminate the 1996 agreement, which would result in the rights to Tamiflu held by Roche reverting to Gilead."

The Cipla Joint Managing Director, Mr Amar Lulla, told Business Line: "It is a complex issue. We have asked our lawyers to look at whether Roche has a valid licence on the drug. It is a fundamental question."

Roche top-brass in India, when contacted by Business Line, did not clarify on the issue.

Trying to make sense of the development, a patent attorney said that termination could be limited to certain markets, but Gilead has in fact filed for patents in India and other developed markets.

Significantly, Gilead's June note states: "Despite our repeated communication of concerns over the last several years, Roche has not adequately demonstrated the requisite commitment to Tamiflu since its launch in the US nearly six years ago, nor has it allocated the necessary resources to realise the potential of the product as a treatment and preventive for influenza," said Mr John C. Martin, President and Chief Executive Officer, Gilead Sciences.

But all that has changed following the latest panic surrounding bird-flu. As countries stock-piled Tamiflu medicine, fears of a shortage fanned across different countries and Roche came under considerable pressure to scale-up its production.

Eventually Roche agreed to loosen its grip on Tamiflu, by expressing its willingness to talk to generic producers who could make copies of Tamiflu. Just that the generic makers now want to know, who issues a production license on Tamiflu, Roche or Gilead?

(This article was published in the Business Line print edition dated October 21, 2005)
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