Patents and health emergencies: the take from Financial Times

Correcting some misinformation from the Financial Times, the relevant patent is owned by Gilead, and licensed to Roche, and, although extract from the star anise plan can be used as a precursor, a synthetic route (not involving anise) has been devised.

From Financial Times:

This problem concerns wealthy and poor nations as Roche has a backlog of orders even at the current price. Encouragingly, Roche said this week that it would consider granting other companies licences to make Tamiflu.

And so it should. If bird flu becomes a national emergency, any country can legally invoke compulsory licences and manufacture generic Tamiflu. But by the time the emergency occurs, it may be too late. Moreover, Tamiflu is complex to manufacture and - as shown by the agreements for Aids drugs - companies with voluntary licences can benefit from the licensor's manufacturing expertise. Another advantage of voluntary licences is co-ordinated sourcing of the active ingredient - extracted from a Chinese plant that is already in short supply. Generics companies will help no one if they make Tamiflu to the detriment of existing production.

Roche can defend its [sic] patent but must remain open to proposals for increasing production, and these may best be co-ordinated by an international organisation. Patents were created to encourage innovation for the public good. It is in Roche's best interests to ensure that they live up to this promise.

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Roche has already donated 3m courses of Tamiflu to the World Health Organisation but it needs to do more to make it accessible. In particular, it should use tiered pricing, a system that has greatly increased access to Aids drugs, to make it affordable for developing countries. Tiered pricing makes economic and ethical sense: drugs are sold at the price that each market can afford, but not below the cost of production. It also reduces the incentive for counterfeiting and the risk that the poorest countries will resort to buying inferior quality drugs from less reputable manufacturers.

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Ironically, some of the people in Mumbai seem to have a better grasp on the patent ownership issue than does the Financial Times-->

from SIFY:

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, 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.