The Central government appointed a high powered committee under the chairmanship Dr R. A. Mashelkar, an eminent scientist of the country, to study the issue of patentability in drug industry as a part of the ongoing implementation of the new patent law which was notified in January 2005. The recommendations of this Technical Expert Group instantly became the target of sharp criticism from the domestic pharmaceutical industry. The expert group was to decide whether it would be TRIPS compatible to limit the grant of patents to new chemical entities or to new medical entities involving one or more inventive steps. The Group was also expected to study whether it would be TRIPS compatible to exclude microorganisms from patenting. The future of majority of the mailbox applications that are being processed by various Patent offices in the country may depend on the recommendations of Dr Mashelkar on "patentability". These recommendations were thus, considered crucial for the future of research and development of Indian pharmaceutical industry. Criticism on the Mashelkar Committee continues to pour in to media even now. Latest being none other than the Union Chemicals & Fertilisers Minister, Ram Vilas Paswan who has dropped enough hints that the report might not see the day of the light in its present form. Amidst controversies and allegations, Dr R. A. Mashelkar spoke to Pharmabiz to remove the haze over his report. Excerpts from the free-wheeling telephonic interview from his Pune residence with Ramesh Shankar.

Your report on patent has created a furore in the country. Your comment?
There is a confusion in understanding the terms of reference of the committee among some sector of the industry. If you go back to the terms of reference of the committee, the issue before us was whether the amendments made were TRIPS-compatible or not. Basically, it is a legal and technical issue. And there can be no deviation or digression from the core issue of the committee as it consisted of such legal experts as Madhava Menon, Goverdhan Mehta and Asit Datta. To call it a Mashelkar Committee is also wrong, it is a panel report.

As far as patentability is concerned, Article 27 is clear that you cannot restrict the patentability to new chemical entity. We have seen what is permissible and compatible.

If that is the case, why is the domestic pharmaceutical sector is so much agitated about your committee's recommendations?
Nothing, people have missed the point and tripped the reference of the committee. We have studied the issue for the last more than one and a half years and consulted all the concerned people and also studied the 27 submissions made to us.

There are allegations that you sided with the MNCs while making the recommendations?
India is a free country. I take all these things in my stride. There is no question of siding with anybody. We are also against allowing frivolous patents.

But, in your report you have said that excluding microorganisms per se from patent protection would be violative of TRIPS Agreement?
That is the legal side of the issue. But, we have given clear point to the patent office. It is the patent office that decides whether there is something novel or not. Make the patent office strong.

There is a talk of your report being rejected by the government. How will you react to such an eventuality?
It is up to the government. We are simply professionals. We have done our duty and we have simply looked up to it legally. I also came from a poor family. I am all for getting cheap medicines for the poor people of the country.

If the government asks you to modify the report in view of the stiff resistance from domestic industries, will you go for that?
Yes. It is up to the government to decide. I have made the report after due deliberations and in the national interest.

Will your report anyway help the domestic pharma industry?
Definitely. You tell me, whether there is any Indian company which holds a patent among the 30-35 patents in the global pharmaceutical industry. It is in the incremental innovations, the Indian companies figure. Our poor people will also benefit if patent is given on incremental innovations.

But some people have double standards. While Ranbaxy was on record supporting patent on incremental innovations, Indian Pharmaceutical Alliance, of which Ranbaxy is one of the prominent members, is opposing it tooth and nail.