Interview with Dr. Yusuf Hamied, chairman, Cipla Limited.
YUSUF K. Hamied is the chairman of Cipla, one of India's largest pharmaceutical companies and the country's fifth largest private spender in research and development. Both an entrepreneur and a scientist, Hamied is considered a pioneer of the Indian drug industry. Since returning from Cambridge with a PhD in organic chemistry in the 1960s, he has fought for the right of the Indian industry to develop drugs for sale at low cost on payment of a royalty to the inventor. In February 2001, he broke the monopoly of multinational drugs companies on HIV/AIDS drugs by offering the world the first triple therapy combination at less than a dollar a day.
Hamied was awarded the Padma Bhushan in 2005 for his efforts in trade and industry. Ironically, that was the same year India amended its patents laws to adhere to the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). In the light of controversies on the Mashelkar Committee report, Hamied spoke to Frontline on the Patents (Amendment) Act, 2005, and the Indian pharmaceutical industry. Exerpts from the interview given in Mumbai:
How does India's Patents Act interplay with international obligations under the TRIPS Agreement?
Patent laws in general are national laws, not international. No two countries have the same patent laws. British law is different, American law is different, German law is different. So every country decides for itself, within a framework, what the national laws should be. And within the needs of that particular time. That is important.
The present problem, which arose after the patents Bill was passed, is what the definition should be for patentability. For that, there was Section 3 (d) [which states] that unless there is a substantial improvement in the efficacy of a drug, you cannot patent a polymorph or a salt or an esther or a metabolite or a pro-drug and so on. Now, that is correct, because that is what stops evergreening. The point they put in was [that there should be a] substantial improvement in efficacy. How do you define that? It's vague, it can go to court. What Mashelkar was saying was that incremental improvements should be allowed to be patented.
What should be the defining criteria for a patent?
A patent has to be something that is totally novel, inventive. Suppose this is a product [holds a business card] and then you just do that [turns it through 90 degrees], is that a novelty or not? In my personal opinion, no. You have a patent or a dozen patents on a product - fine. But some products today have 240 patents - is that what patenting is all about? Take the first anti-AIDS drug, AZT. It was invented in 1963. Only in 1985 did they find out that it was good for HIV/AIDS. So it was re-patented in 1985, [and given a] usage patent for AIDS until 2005. Come 2003, GlaxoSmithKleine says that AZT by itself is no good, and it has to be given in combination with a drug called Lamuvidine. Lamuvidine's patent expires in 2007. They put the two together in one tablet, and took out a patent in 1997. That patent in America and most European countries is valid up to 2017. Now, directly and indirectly, AZT, has a monopoly for 54 years. My fight over this patent issue is not against patents. We have never been against patents. An inventor should be rewarded. But countries in the third world cannot afford a monopoly... .
Now, post-2005, you will see us going back to the pre-1972 era. I call it genocide. In 2015, drugs won't be available at affordable prices. It's going to be a catastrophe.
What would you say to the idea that the Indian pharmaceutical industry's strength is just in making small changes?
What do you mean by small changes? There are two types of R&D [research and development] in the world. One is concept, and the other is `me too'. Now, conceptual research is done essentially by universities, NIH [National Institutes of Health], [and is] government funded. In America, $20 billion is spent in universities and NIH on conceptual research. The multinational pharmaceutical industry, even if it is Pfizer or Bayer, is essentially investing in `me too' research. Diazepam, the first major tranquiliser [is a] concept drug. Then you have Alprazolam and Lorazepam and Midazapam and Temazepam, and so on, [of the same] family. Typically, the breakthrough drugs normally happen through government-supported venture capital or small companies, and then they get taken over by the big boys. Today, 70 per cent or more of all drugs marketed were not invented by the guys who are selling them. I develop something I can't sell; I go to Pfizer and ask them to sell it for me. They'll take it up. Lipitor, the world's number one drug, was not invented by Pfizer. Ninety per cent of the drugs for HIV were not invented by the originator.
In 1987, I came out with Deferiprone, marketed as Kelfer, a drug for thalassemia [an inherited disease of red blood cells]. I thought it would sell well in India; it was an iron chelator. It didn't sell. So, I go to doctors in India and say here is a drug, why aren't you using it? [Their response was:] "Dr Hamied, if the drug is as good as you say it is, how come other companies like Pfizer haven't brought it out?" Even if I do the research, the acceptability is not there. How many countries have come out with a drug on their own steam? None. So, how will I be successful on my own if I bring out a new product? It's very difficult.
Do you think patents should be restricted to new chemical entities? And to what extent do you agree with the analysis of the Mashelkar report?
Definitions should be very exact. There is no real definition of a new chemical entity. I would say "a new chemical entity in relationship to a drug". Then I can say for certain if it is active, if it has some efficacy. Patenting is when someone has invented something [and] needs a suitable award. A patent to me is the grant of a favour by the state to the inventor. You have a monopoly for 20 years. If it is something that I have gifted to you, it is something that I can withdraw as well.
In the context of India's development, a national law should be made to suit India and to suit Indians. Just because six or seven pockets of India are superdeveloped, it doesn't make India a superdeveloped country. There are several Indias within India. If you take Assam, Bihar, Uttar Pradesh and Madhya Pradesh, we are backward. Has the WTO defined `least developed country'? How do you define `least developed' country? I tried to investigate it. There is a U.N. definition - 500 dollars per capita income. Moreover, any country with a population of over 75 million cannot be considered least developed. Why is India not in the least developed category? Look at the Human Development Report. Under Low Human Development Index, India; under medium, even Peru, Sri Lanka and so on. We are in the bottom 50 of 138 countries.What action should the government take?
The issue that makes my blood boil is that this should have been done prior to March 2005, not post-March 2005. I am not against patents, I am against monopoly. The word `incremental' never existed when the patent law was discussed. All this should have been discussed pre-2005. Let Parliament withdraw the patents law of 2005 and reinstate the 1970 Act until it sorts out the problem of defining patentability and so on. And, if not, then get out of the WTO. In what way has membership of the WTO helped India? Not at all. Every deal is bilateral today. China was not a member, yet the Americans gave preferred-country treatment to China, so all the imports to China were duty free.
The Ministers and Secretaries say the government is bowing to the inevitable. Kamal Nath has said we cannot upset the international community...
What do you mean by that? Investment in India is short term. They will only invest in India if they can get their money out in three years. Then they don't mind continuing. We are sitting here like guinea pigs.
What we have [going on] is PR&D [public relations and development] All research has to be accountable. Mashelkar makes a statement that CSIR will take out 1,000 patents every year. Since 1995 they should have taken out 10,000 patents. Has any one drug come out of it? No. Can he explain the outcome of the CSIR research in actual commercial terms? It's very easy to talk, but what is the track record?