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.