'India has to work on its patent laws'

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'India has to work on its patent laws'

Joe C Mathew in Mumbai

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November 24, 2008

Swiss pharma major Novartis [Get Quote] AG has as many as 140 research projects, including new drug discovery and finding new uses for existing medicines, in various stages of clinical development.

Paul Herrling, global head of Novartis' corporate research, spoke to Business Standard about the changing concepts in R&D and Novartis' strategy. Excerpts:

How is Novartis dealing with the changes in drug research?

Pharma research is turning more collaborative due to the advances in biomedical sciences. Research today is multidisciplinary and one needs to be part of the developments in all streams of sciences to understand the advances in biomedical sciences.

One way to do it, is to set up research centres next to the best academic labs in the world. Novartis research labs are thus situated next to globally renowned research labs.

We are moving away from the old model research to cut short the time span of drug research.

So every scientific team (of Novartis) that proposes a new project today is required to ask a limited number of questions at the very beginning of clinical trials to support the soundness of their scientific hypothesis.

Either they come with a clear hypothesis to suggest that the drug has to specifically do this and that and that, or they stop the trials.

How does this integration happen among Novartis research institutes?

Earlier we used to feel that small research centres work faster. It is not possible anymore.

The technology that you use today, the machines you need for sequencing are huge factories that are extremely expensive technical infrastructure.

You would ruin yourself if you are to put these machines in each one of your institutes.

So integration is essential. Novartis has two major research hubs - one in the US and the other in Basel - all others are linked with these two centres.

The hubs have all the technologies. They also have the duplication of all our compound libraries. All the databases are also doubled for safety reasons.

What are your priority areas of research?

We are very strong in cancer and Glivec (cancer medicine) was a very important discovery that opened up a tool. As we were pioneers in this field ,we want to exploit it.

We want to use what we have learnt around Glivec in different forms of cancers. So that's one area where we would like to continue to be leaders.

Another major area is the diseases of immune system. There is a whole family of diseases which results from malfunction of the immune system.

That's an important area for Novartis because, historically, as a transplantation company we have lot of know how on how to modulate immune system.

Third is the metabolic diseases. Diabetes being the most important. So that is a priority for us.

Then comes cardiovascular and brain sciences. These are some of the key areas. And normally it takes 12 - 15 years to develop a medicine. But our Glivec successor, the second Glivec took only about 7 years to develop.

Because we could build with all the data we had on Glivec and specifically address those mutations.

There is a raging issue in India about the patentability of Glivec, is it about your second Glivec?

That's crazy (the issue). The second Glivec would probably be patentable in India because it is a new chemical entity and its first among the category.

It is not simply an incremental improvement of the same molecule. But then I don't know, even that they might say No.

Any plans for a research centre in India?

Indians will still have to work a little bit on their patent law, then maybe we will make some research centres there (laughs). Well, we have some collaborations with Indian industry.

For instance, we do a lot of chemistry with GVK. As Indian pharma industry evolves, and Indian companies engage in more and more innovation rather than generic industry, I am totally convinced that India will want to protect their own innovation.

By the way, if you look at European history, many countries were outside the patent system in the early days. And only when they started innovation, they adopted the patent system.

If it took 100 years in Europe, why should it happen in five years in India? I think eventually we will be able to take advantage of all the talent in India too.

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