New Delhi: Breaking his silence for the first time over a hotly contested patent lawsuit with Cipla Ltd on cancer drug Tarceva, Girish Telang, managing director of Roche Scientific India Pvt Ltd, the Indian unit of Switzerland-based F Hoffmann-La Roche Ltd, tries to explain why innovator drug makers are not solely responsible for high medicine prices. A combative Telang insists that innovative companies should be rewarded for their products and notes Tarceva’s price is largely influenced by customs duties and not that much higher than the generic version. Edited excerpts:
Roche has kept a very low public profile in India so far. Why has that been the case?
We are not keeping a low profile. We keep an optimal profile. Roche has been very progressive in announcing what it has done for people and we have got our rewards in that respect. What is the need to speak to media? We are in the media to inform the people about the latest therapies, about new developments in areas we operate. We don’t want to make a story when there is no story.
Tarceva litigation is being touted by several public health experts as a test case in the way courts read patent law after a patent has been granted. Do you agree?
I won’t call it a test because the Indian patent law is very precise and we are all expected to follow it. Roche has followed the law and if our patent has been infringed by a company, we have every right to go to the court. Since the case is sub judice, I won’t like to comment beyond that. However, there is one thing I want to be clear about. Tarceva costs Rs3,200 and that’s because we only give out the drug through our company distributor outlets. We have not sold a single strip for Rs4,500 or Rs4,800 as being quoted in the media. Moreover, the Rs3,200 tag includes 32% customs duty. If you remove this duty and then look at the cost, it is only 15% more than that of the generic version, and I’m sure that much reward the innovator should be allowed to have.
Cautious view: Roche Scientific managing director Girish Telang says the Indian patent law is ‘one of the good laws... What we are facing is not an issue of law but that of enforcement.’ (Photo: Abhijit Bhatlekar/ Mint)
The country has a foolproof, three-tiered scrutiny system where a patent filing is first published and can then be challenged through pre-grant and post-grant oppositions. So, no judicial role is required there. Patent infringement should not be there and if there is any other issue (with the patent), there is the Intellectual Property Appellate Board.
We have assistance programmes where we support patients, free of cost. I don’t have numbers but, whenever a patient needs assistance and the doctor requests us, we always provide it. And, it is not just for Tarceva, it is for all our oncology products but, we don’t highlight such efforts.
We strictly go by DCGI’s (Drug Controller General of India) approval as our drugs are second-line treatments, to be used only after primary treatment has failed. Hence, the patients who use these medicines for varying lengths of time from a month to a year, are in 100s, not millions. One cannot assess patient support here in terms of number of people.
The point is that people today are paying more not because Roche is charging more than Cipla. We are charging because of the taxes imposed by the government. Why is that point not being brought out?
Why doesn’t Roche manufacture the drug in the country and eliminate duty component in the cost?
Roche believes in manufacturing these speciality products only in its (global) centres of excellence. The demand for such a tertiary level products doesn’t meet the economies of scale and they are very modern therapies. These are the major issues.
What are your views on the way the Indian patent law has rolled out in the country.
The Indian patent law is one of the good laws. Now, enforcement has to be there. What we are facing is not an issue of law but that of enforcement.
Do you think patent lawsuits in India have virtually become a trial by public where everybody, from media and public health groups, jump in rather than letting two companies to slug it out?
In general I see is people trying to highlight a problem that doesn’t exist, to divert our attention from the patent. We look at price, we look at accessibility…these are not issues under patentability. Patent is the blessing for an innovation, we have to make that clear.
How come the innovator drug companies have launched several patented drugs when, in the years gone by, they have repeatedly said the current Indian patent law will discourage them from doing so? Was the market too big to ignore?
How many patented drugs are there in the country? Less than a dozen are patented and marketed even now. Speaking for Roche, we will give access to Indian patients for all our innovative drugs. We launched these products even when this patent law was not there. We will bring new developments to India which make a real difference to patient lives, we will not deny them such therapies. Obviously, any product launch has to be commercially viable.
Why are innovator drug makers so secretive about the patents they receive?
We have tremendous faith in this government. Otherwise we would not be launching the molecules. We have tremendous faith in the judiciary ... India is a signatory to the product patent law and we are following it.
Who is secretive? What is the secret in it when the patent office lists out the patented drugs? Tarceva, Herceptin, Pegasys, Bondronate, Mircera and Valcyte are the six drugs in India Roche has a patent for.
Do you have a structured patient assistance programme? Does Roche plan to introduce differential pricing?
We go by the recommendation of the doctors in supporting patients. Our drugs are coming out of biotechnology and don’t lend themselves to a mass scale patients access programme.
What is differential pricing? Our MRP (maximum retail price) never changes. However, we support the proposal mooted by ministry of chemicals and fertilizers for giving the drug at 50% of the cost to government institutions. Beyond that, Roche looks at recommendations from doctors, financial status of the patients and whether they are supported by insurance before supporting them with free drugs.
Roche in India is unlisted and very little is known about its operations…
Roche has 18 products in India and alliances with Elder Pharmaceuticals Ltd and Nicholas Piramal India Ltd, among others.
We focus on therapeutic areas of oncology, organ and bone marrow transplantation, virology, osteoporosis, anaemia and rheumatoid arthritis. We don’t disclose numbers of our revenues or profits. There are no plans to list the company in India.