Thursday, February 15, 2007
In a case that has got the world’s attention, Swiss multinational Novartis AG has challenged the Indian Patent Office’s decision to deny it a patent on cancer drug Glivec, in the Madras High Court. Novartis has also questioned provisions in the Indian Patent Act under which the patent was denied (under these provisions, incremental improvements to existing drugs cannot be patented). The $37-billion drug maker, best known here for Calcium Sandoz and pain-killer Voveran, had earlier won an exclusive marketing right— now lapsed — on Glivec in India. With its patent claim rejected, cheaper copies of Gli-vec are free to sell in the Indian market. The lawsuit has drawn the ire of humanitarian organisations such as Medicins Sans Frontieres (MSF) and Cancer Patients’ Aid Association (CPAA) for its potential to deny these cheaper generics to patients and for its possible impact on the Indian Patent Act, which currently restricts patenting to completely new drugs. Recently, a quarter of a million people signed a petition demanding that Novartis drop the case. Activists have held protests against the company in India and Switzerland. The backlash is reminiscent of a time, not too long ago, when 39 multinationals, including Novartis, sued the South African government to drop certain provisions in its law that governed access to medicines that the companies thought threatened their patents. Those companies were eventually forced to withdraw the lawsuit. Will this case go the same way? Paul Herrling, Novartis’ head of corporate research, who is also in charge of the Singapore-based Novartis Institute for Tropical Diseases, was in India for a day to address members of a business association. In an interview with BW’s Gauri Kamath, Herrling explains why Novartis is fighting tooth and nail for a case that is, no doubt, causing great harm to its public image.
Your visit is against the backdrop of the Glivec lawsuit. Any comments?
Fundamentally, this is about patents. And I am in research. Our view in research is that patents save lives. You need to invest for 15 years to translate a scientific idea into a breakthrough medicine such as Glivec. Nobody could or would do that kind of research if there was not a hope to recover the investment at the end of the day.
Do you think that the price that you have paid in terms of your public image is worth this patent that you might get if you win?
It is a problem that so many people are upset. We do not want to be seen the way we are being portrayed. One of the leaders of this petition against us is MSF. As you may also know, I am the chairman of the Novartis Institute for Tropical Diseases in Singapore that makes drugs against tuberculosis, dengue and malaria for patients in poor countries — which we will sell at no profit. I work with many people from MSF on projects. And, they are actually wonderful people. But they were never into drug discovery. They do not know the conditions that are needed to make a new drug. They think if one would weaken or abolish patents, then the problem of access for medicines would be solved. This is wrong. I do not think the patent issue is nowadays a major impediment to making drugs available. Novartis has the world’s best malaria drug— Coartem— which is a joint project with Chinese scientists. We give it at no profit, and in 2006 we delivered 62 million treatments, which make it the biggest selling Novartis drug ever. The reason why we can do this is because we have enough business in markets where people can afford (to pay more for) it. This enables us to allocate some of our earnings to access-to-medicine projects where we have life-saving drugs. And the same happens with Glivec in India. As much as 99 per cent of all the Glivec in India is given for free. So, patents have not prevented access, it is how you use them. We have patents on Coartem and there are companies that are now copying it and selling it. We have never done anything to stop them from doing it.
This case really is not about whether India respects product patents per se. It is challenging certain provisions that define what can be patented and what cannot.
The amendments (to the patent law) undermine a significant aspect of patents. They say if it is essentially the same idea and you make improvements on it, then you cannot patent it. But that is not the way science works. For example, children with thalassemia need a lot of blood transfusions. When you do frequent transfusions, iron accumulates in your body which could eventually ruin the liver. We had a drug that was able to take the iron back out of the blood, but it had to be given in continuous intravenous infusion. That meant these children had to have a pump, that was bigger than a cellular phone, on them all day and a needle that was going into one of their veins. So, here what would be considered an incremental innovation(under the Indian law) was to find a version of this drug that children could take as a pill. Under the current amendment, this would not get patent protection, which in turn means nobody would invest because when you do this new version you still have to do all the safety studies and prove that, in fact, the effect is the same.
What is the issue with the patent application on Glivec?
There are two aspects. In Glivec’s case, the issue is a new form of the drug. So, the active ingredient is the same and the salt is different. And we have seen that the absorption of this is better than the original. It is true that the original patent with the original salt form could not be granted for a technical reason because everything before 1995 could not. In this case, we patented this new salt form in 40 countries because we had evidence from our experiments that this would make it easier to absorb, which again means better levels in the body, less variability in the effect. So, that’s again an advantage to the patient. Now, India says, no, you are not going to patent that until you have proven in people that this really translates into the advantage that you foresee from animal studies. Patents (all over the world) are normally given at a time when a scientist can document any invention — a molecule in this case — and some of its effects. In this case, it was through animal experiments, solubility experiments and so on. Once I get the patent at this point —which is early in its life — then I invest. If I am being told that I have to first invest hundreds of millions, and then maybe I can get a patent, then I do not invest. That is the other issue.
Then, in this particular case, would Novartis be willing to do those human studies just to make a point?
Such studies are happening all over the world.
So, you have that supporting documentation.
No. Because that takes time to do.
Is there a point beyond which you don’t believe that this particular case is worth fighting for?
It is difficult to say what the future will look like. If we had solved 99 per cent of all the medical problems on this planet, we would not fight that much. Then there would not be any need for any new drugs and we would sell the old ones, fine. But the big problems are not solved. We believe if the system were to be undermined, it would not be to the advantage of humanity in general.
Does the rejection of the patent on Glivec, or the way people have broadly reacted to the lawsuit, affect your R&D investments or collaborations in India in any way?
Yes. When I was asked why we created our research institute in Singapore, not in India, which also has the talent, the same diseases and so on, that is the reason. We have announced the creation of a major research institute in Shanghai. There we see that it’s not perfect but the system is in place to get to a better and better improvement of intellectual properties.
What about the R&D collaborations that you already have?
They are successful, but because of this intellectual property (IP) insecurity we are not doing chemistry that leads directly to a potential medicine but only supportive work. If this point would be clarified in the positive, we could expand it. Then there would be no difference in the collaborations we do in India versus the US, China or any other place.
But not investing in a country just because of IP issues is like throwing the baby out with the bathwater. Just because pirated copies of Windows Vista sell in China, you don’t see Bill Gates saying he is going to stop investing there. The economics overrides everything else.
I cannot judge the computer industry at all.
There, too, it is the IP issue.
We are talking about other things here. We are talking about products that potentially save lives. And in contrast to the IT industry, we are the most regulated industry on this planet. And the investment level that you have to have for each product is such that we have to look at the world and decide where are the best conditions (to invest).
Is there any attempt to meet with the government?
Oh, no. The courts will decide and we do not want to interfere with this process at all. But what we do is talk to you. It is very vital to us that people understand that we are not doing this out of spite. And we just want to explain our view to people who hear only one side in the press because NGOs are very vocal
Links to this post: