The report of the crucial expert committee, set up by the Central Government to define the patentability criteria in the Patent Act, will be delayed by another two to three months. The committee had planned January 31, 2006 as the deadline for submitting its recommendations.

The panel was set up by the Department of Industrial Policy and Promotion (DIPP) and the Ministry of Commerce to see whether it would be TRIPs (Trade-Related Intellectual Property Rights) compatible to limit the grant of patents for pharmaceutical substance to new chemical entity or to new medical entity involving one or more inventive steps.

Talking to Pharmabiz on the sidelines of a function in Mumbai, Dr R A Mashelkar, panel chairman and director general of Council for Scientific & Industrial Research (CSIR) said a few more rounds of discussions are necessary with the industry associations, NGOs and other interested stakeholders to finalise the committee recommendations.

"We have received viewpoints and representations from various industry associations, overseas interest groups, NGOs and other related stakeholders. But it needs some more rounds of discussions to finalize our report. I think we will be able to submit the recommendations within two to three months," said Mashelkar.

He also said the Department of Industrial Policy and Promotion and the Ministry of Commerce had not specified any deadline for the panel to recommend its observations. A few months ago, Dr Mashelkar had told Pharmabiz that the panel was planning to submit its recommendations by January 31, 2006.

The committee was appointed following widespread demand from the domestic industry to clearly define the issue of patent availability of new chemical entities and microorganisms in the Patents Act to protect interests of the domestic industry. While presenting the Patents (Amendment) Bill 2005 in the Lok Sabha on March 22, 2005, Union Commerce Minister Kamal Nath had said an expert committee would look into the issue of NCE patentability, and depending on its recommendation, any amendments required to safeguard the interests of these products would be incorporated with a new legislation in the Patents Act.

The five-member technical expert group looking into the areas of concern in the amended Patent Act includes Dr R A Mashelkar, director general, Council of Scientific and Industrial Research (CSIR), New Delhi, Prof. Goverdhan Mehta, director, Indian Institute of Science, Bangalore; Prof. Asis Datta, director, National Centre for Plant Genome Research, New Delhi; Prof. Madhav Menon, National Judicial Academy, Bhopal and Prof. Moolchand Sharma, director, National Law Institute University, Bhopal.

As reported, related Indian interest groups are of the opinion that the scope of patentability, as it stands today, is very wide. Multinational drug companies will be able to take advantage of loopholes to improperly extend their monopolies and price important medicines out of reach for the majority of Indians. Unless the government decides to specifically say that only basic inventions are allowed to be patented, domestic industry is going to be badly hit in the coming years. It is estimated that about 80 per cent of the life saving drugs may move towards patent protection in the coming years and 70-75 per cent of the turnover of drug companies is going to be from patented drugs. Hence there is an urgent need to define the role of domestic industry.