The Hindu Business Line : Patient vs Patent debate: Move on Tamiflu to set the trend

FOR a product-patent regime that is less than a year old, it will be a test case how India chooses to make the bird-flu drug Tamiflu available to the people.

Across the world, arguments on making Tamiflu available are reaching a shrill pitch in favour of putting patients before patents. But the Indian Government will have to walk its talk on protecting product-patents, even as it keeps its home-base well covered with the medicine, says a pharma industry representative.

India kicked in its product-patent regime in January 2005, which means it is now committed to honouring the period of exclusivity that a company gets on a drug/product it has patented. This would also mean, with respect to medicines, that companies will not be allowed to make copies of a patent-protected medicine, except in the face a health emergency.

Globally, the patent vs patient debate was last visited on a major scale when the anthrax-scare in 2001 almost forced the US Government to over-rule Bayer's patent on antibiotic Ciprofloxacin.

But for India's new-born patent regime, the debate is already knocking at its door. And how the Centre balances its act between patients and patents would set a precedent of sorts for India, say drug industry representatives.

This is a classic example of what the Indian consumer will have to face, if there is a health crisis. It is the shape of things to come on every new drug in the market, said a top-honcho with a domestic drug company.

But another representative with a pharma MNC said that there was a patent pending in India on Tamiflu, from Gilead - the company that developed the drug. The right way to go about it would be to first negotiate with Roche - the company assigned by Gilead to market the drug worldwide.

If that does not work out, the patent on Gilead-Roche should be prioritised and issued. And to make the medicine available in India in large volumes, generic drug makers can be allowed to make the same drug, but with a royalty payment to the originator of the drug, he said.

This will put the Centre on a strong footing both politically and economically - doing the right thing for the country, even as it protects the intellectual property of the innovator company, he observed.

On the other hand, the Centre could allow generic players to make similar versions of Tamiflu, even as the patent on the drug is pending.

Governments can over-rule patents in the face of a public-health crisis, thanks to a break-through that India had pulled-off in world trade negotiations some years ago. But, over-ruling patents on Tamiflu will be seen as "clandestine" and will attract brickbats, he observes.

Echoing similar thoughts, another domestic drug industry representative said the existing patent framework in the country has the flexibility to prioritise the pending patent on Tamiflu. Local generic companies can be allowed to make copies of the same drug, with a royalty or compensation to the innovator company, he said.

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