The Hindu Business Line : Ranbaxy seeks directive on generic manufacture of Tamiflu

AFTER China recently reported deaths due to avian influenza (bird flu), domestic pharmaceutical companies are seeking a clear directive from the Government on manufacturing of Tamiflu (Oseltamivir Phosphate) in India.

While officials in the Chemicals and Fertilisers Ministry on Friday said that generic companies could manufacture this drugand that the pending patents would not be a hurdle, the Indian pharma industry maintained that the Government has not formally intimated its position to them.

In a letter written by Ranbaxy Laboratories Ltd to the Health Ministry, the Delhi-based generic company has urged the Department of Industrial Policy & Promotion to take a favourable stand on allowing generic manufacturing of the drug for domestic and international use.

Ithas also requested the Drug Controller General of India to issue fast track permission to companies like Ranbaxy to manufacture and market the generic version of the drug.

Elaborating on the filings by Roche and innovator company Gilead Sciences, the letter said of the seven patent applications, two were mailbox applications filed by the latter.

"One of them very broadly claims compositions comprising Oseltamivir or its salts. Any Oseltamivir composition will fall within the scope of such claims. The claims of the other application are equally broad-based except for the limitation that they claim only enteric-coated compositions," it said. (Drugs may have an enteric coating which is designed to allow the drug to pass through the stomach intact with the drug being released in the intestines.)

Ranbaxy said that since the Patent (Amendment) Act 2005 did not permit patenting of mere admixture resulting only in aggregation of properties or the process for producing such substance, "the claims of these applications may not be granted as they stand".

Regarding the second application, Ranbaxy said Tamiflu, which is currently being marketed was not enteric-coated. Also, under the present law, "Gilead is not entitled to any damages for Oseltamivir compositions made and marketed till the patents are granted," it said. Further Ranbaxy has said, "If the patents are indeed granted with the same or similar broad claims, then all other manufacturers would need to get either a voluntary licence (from Roche/Gilead) or compulsory licence from the Indian Government."

Regarding the process patent applications pending, the domestic company is of the view that licences may be required, as there may not be many viable options available to manufacture the drug, especially in view of the shortage in raw material.

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