E-Paper
'Patents law will lead to monopoly'
The chairman of Rs 2300 crore pharma major Cipla is saddened with the haste with which the Patents Amendment Bill was passed by Parliament.
Your first reaction after the passage of the Bill was one of happiness, why is it that you are angry now?
I am not angry, I am sad. We have passed a Bill which will affect the lives of over a billion people in half a day without any debate. I feel sad for my countrymen that they have chosen not to pay attention to the fine print. The provision for patenting of products between 1995-2005 is unjustifiable. TRIPS permitted India to introduce product patents on 1-1-2005. There is no reason why India has not taken full advantage of this window. I don’t think our countrymen in power feel enough for the country. The poor people of this country will not get cheap medicines.
Is it true that Indian companies cannot sell patented drugs in India in the new regime?
While the government allows us to manufacture patented drugs to the mandated 49 least developed countries after first applying for compulsory licensing and maybe even having to pay royalty to the patent holders, these medicines cannot be used here unless there is compulsory licensing. I am clear that there should be automatic licensing of right and 2 per cent royalty should be paid to the patent holder.
There is no compulsory licensing within three years of a patent being granted. This is dangerous, since even in an emergency, the patent holder can maintain his monopoly. Compulsory licensing should be introduced either automatically for all drugs or at least for all diseases which are chronic like TB, malaria, asthama, cancer, diabetes, HIV AIDS and for anti-infectives and antibiotics.
What has changed now for Indian pharma companies which have done wonderfully well in the process patent raj?
Post 2015, I envisage a scenario which will be exactly similar to pre-1971.
That is why I liken it to genocide because the MNCs will once again dominate the Indian pharma industry. They will control 70 to 80 per cent of the market
and Indian companies will get wiped out.
Monopoly leads to high prices. Until Cipla came on the scene with its Aids cocktail, GSK was selling its version at $12000 per patient per year and we introduced the drug for $300 in Africa.
But we had to meet our international obligations and sign the dotted line on patents...
This is absolute rubbish. See the fine print of TRIPS — you have to make your own laws so that they are in sync with the needs of the land. Health for all is a fundamental right and I think we have given it up.
Then you reckon there will be litigation?
I am sure some pharma association of NGO will take the legal route. I foresee massive litigation on the issue of reasonable royalty which is completely open ended. There is no guideline or limit to determine this, nor have any parameters been laid down. The limit should be fixed below 2 per cent. I think the government may have to amend or finetune some of the clauses.
The permissibility of patenting chemical derivatives such as salts, esters, polymers separately from the molecule opens a window to subjective interpretation and litigation. It is also illogical because it would mean that one person can patent the molecule and another the derivative, if they are separately patentable.
Then has the deathknell of Indian pharma been sounded?
Yes, unless they participate through tie ups with MNCs. You will erode the base that Indian companies like Ranbaxy, Cipla, Dr Reddy's have created. And our only salvation will be exports of generics. India is entitled to and must take into Compulsory licensing should be made permanent.
