The expert committee set up by the Central Government to define the patentability criteria in the Patent Act has submitted its report to the Government, and the crucial expert committee on data protection will submit its report within a month.

Addressing the Indian Drug Manufacturers Association (IDMA) annual convention in Mumbai, last week, Prithviraj Chavan, Minister of State, PMO, Government of India said the Mashelkar Committee on patentability criteria submitted its report on 28th December 2006. The Committee has recommended various options and adequate safeguards to protect the interests of the Indian pharma industry, while defining patentability of NCEs. The committee has also suggested restricting of patentability to manmade and biological microorganisms and the Government is likely to accept this recommendation, considering the concerns of domestic industry, said Chavan.

The Committee 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, he said the Government was evaluating the suggestions of the Mashelkar Committee and soon the details will be announced. "There is no need to amend the Patents Act or DC Act to incorporate these decisions, which can be done by a notification. The Government is studying the recommendations and will soon announce the criteria" he said.

He also said the Committee on data protection, headed by the Joint Secretary, Dept. of Chemicals & petrochemicals, will submit the recommendations either by the end of this month or early next month. He said the Government was exploring various models followed by other countries, especially like that of Brazil, which did not heed to the pressure from the US interest groups.