Roche Sub-Licenses Indian Tamiflu Producer

by Robin Pilgrim, LawAndTax-News.com, London

28 December 2005

Swiss drug company Roche announced last Friday that it had granted a sub-license to the Indian company Hetero Drugs for the production of Tamiflu, as part of continued efforts to increase and speed up availability of the medicine for influenza pandemic planning world wide.

The agreement with Hetero, says Roche, is focused on providing oseltamivir (Tamiflu) for government pandemic use and will have an immediate effect on the availability in India and developing countries – both directly and through further agreements with local companies.

David Reddy, Roche’s Pandemic Taskforce Leader, commented: “As a result of a period of intense production planning, we are pleased to announce the partnership with Hetero Drugs as the latest step in our scale-up efforts to meet the needs of governments in preparing for the potential public health threat posed by avian influenza. This is another demonstration of Roche’s commitment to working as a collaborative and responsible partner with governments and the World Health Organization (WHO) to assist in pandemic planning”.

Roche says it remains on schedule to meet the current orders received from over 50 governments, but that the collaboration with Hetero will enhance the supply of oseltamivir in some of the world’s poorest countries, resulting in earlier than anticipated delivery timelines and more capacity for further orders. Hetero is the first company that was identified to be able to speed up agreed delivery timelines in the first half of 2006. Following two and a half years of work, Hetero recently received approval to manufacture the medicine, have demonstrated that they meet the criteria which Roche defined in terms of technical ability, capacity and the speed of bringing that capacity on stream.

With this agreement, Roche says, Hetero is respecting Roche's and Gilead's intellectual property on Tamiflu in India. The recognition of intellectual property in India through this partnership with Hetero therefore is very significant as it respects the new Indian Patent legislation which came into effect on January 1, 2005.

Roche owns the right to produce and supply Tamiflu, but has come under increasing international pressure to ease its monopoly grip on the drug. The company has been pressed to step up production, cut prices and allow other companies to make copies of the drug. Roche says it has chosen 12 potential partners for the production of Tamiflu and earlier in December granted a sublicense to China-based Shanghai Pharmaceutical to produce the drug to meet Chinese government orders.

In October, UN Secretary-General, Kofi Annan hinted that it may be necessary for national governments to step in after the company ruled out relinquishing its exclusive patent rights voluntarily, but Roche seems to have risen satisfactorily to the challenge without external compulsion. Scare stories that circulated in December about side-effects were strongly denied by Roche, and both US and EU experts have reassured Tamiflu users about its safety. On December 15th, the European Medicines Agency said it was recommending no changes in the safety information for Tamiflu, following a review of possible links with psychiatric disorders, and extended its usage recommendations to include prevention in children over the age of 1 year - the guideline had previously been 13 years.

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