In a new twist in the Tamiflu drama being playing out across the globe, it’s now being reported that Gilead Sciences, Inc., the developer of Tamiflu, is believed to have terminated its agreement with Roche, which has the exclusive marketing right on the drug. Now, generic manufacturers like India’s Cipla Ltd., are wondering who holds the patent rights on the drug.

According to a note from Gilead Sciences, 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.”

Nothing has been clarified yet by Roche or Gilead so the termination could be limited to certain markets and there could be a “cure” of any breach. Gilead’s 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 John C. Martin, President and Chief Executive Officer, Gilead Sciences.

Following the recent political-panic and stockpiling of Tamiflu, there has been a lot of pressure on Roche to scale-up production. This is probably what led to Roche agreeing to talk to generic manufacturers about additional production of Tamiflu.

See Notice here.

See Redacted License Agreement here.

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