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Indian pharmaceutical firms have got away with a process patent regime by which a known product is simply processed in a different manner.

Inventions that involve like forms or “traditional knowledge” cannot be patented.

 


During a recent panel television discussion, the chairman of one of the country’s leading pharmaceutical firms, Ranbaxy, was waxing eloquent on his company’s contribution to public health and what not. But one simple question later floored him. The question was: How much does Ranbaxy, or any other Indian drug firm for that matter, invest in research and development of new drugs, or, how many genuine new drugs have come forth from these quarters over the past decade or two? The chairman’s silence on the point was eloquent.

This lies at the core of a ticking time bomb which has been triggered by the passage of the Patent (Second Amendment) Bill by both Houses of Parliament. Trade Related Intellectual Property Rights (TRIPS) were not specifically mentioned in the Bill, because there was no need to do so immediately, but as a follow-up a Third Amendment Bill will have to be enacted by 2005 if India is to fulfil its commitments under the World Trade Organisation (WTO) agreement signed at Doha, Qatar, late last year.

For very long, Indian pharmaceutical firms have got away with a process patent regime by which a known product is simply processed in a different manner. As a result, India is not only a net exporter of generic medicines but is also emerging as the new leader of knowledge-based drug-production, after software and information technology. But the crucial question which the much-maligned multinational drug companies tend to ask is, where does that "knowledge" come from? From researching to actually introducing a pharma product in the market, a minimum of 10 years is involved. Give three years for marketing thereafter, and just about seven years are left for the patentee to enjoy the fruits of that patent. Does any Indian drug firm really invest that amount of funds to develop new medicines? All that they do is a copy-cat process, and even on that they enjoy huge profits. A single example will suffice to drive home the point. The international drug firm, Pfizer, has not introduced any new drug in India in the past two decades for fear of copying (process patent). During this period, neither private sector firms nor the Central Drug Research Institute (CDRI) in Lucknow has cared to take up the challenge.

This issue was not fully addressed by the joint consultative committee of Parliament. It simply ducked the issue because there is a respite till 2005 under WTO regulations. But the fact remains that the Indian patent law has been crying for reforms ever since it was originally enacted in 1970. Now, the WTO agreement makes it imperative on India to change its patent laws along with reforms in other sectors of the economy.

The Second Amendment Bill is basically a first step in that direction, aimed at giving protection to sectors which are of vital interest to India, while at the same time it holds out a warning that weak institutions will not be molly coddled for ever on the basis of process patenting. Within the three-year grace period provided by the WTO agreement, Indian firms, particularly in the pharma sector, will have to take the plunge and invest in a product patent system. The present Bill also makes clear the official Indian definition of a patent. Inventions that involve like forms or "traditional knowledge" cannot be patented. This covers anything which has its origins in our history. By that token, all Ayurvedic drugs will be protected.

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