The government tonight issued an ordinance for introducing a product patent regime for pharmacueticals and agro-chemicals from January 1, 2005. The ordinance has been issued to fulfil India's obligation to the World Trade Organisation.

Commerce and Industry Minister Kamal Nath told Business Standard the Ordinance had been issued after obtaining the Presidential assent. The Cabinet had on Friday cleared the ordinance, but did not make a formal announcement since Parliament had not been prorogued.

The ordinance, allowing for full introduction of product patents will delete the exclusive marketing rights, a transitional arrangement provided to drug companies until a full product patent regime was introduced.

"The EMRs had been provided in 1995 as a facilitating measure until the full product patent regime was introduced. This was a lower flexibility provided to countries that did not have a product patent regime. This facility will now be withdrawn," a government official said.

Officials said under the product patent regime, no new-use patents would be granted. "If a new use is discovered of an already patented drug, it cannot be granted a patent. It has to be a new invention," an official said.

The ordinance also seeks to strengthen opposition proceedings by allowing for both pre-grant and post-grant opposition.

"Pre-grant opposition can be filed anytime after publication. While earlier there was no time-frame, the ordinance states that if a pre-grant application is filed close to a patent being granted then in certain cases it has to be cleared within 90 days," the official said.

The ordinance also seeks to simplify and rationalise the time-frame for process of patents. The time limit for giving requests for examination has been reduced to 36 months from 48 months earlier.

Security provisions will also be tightened, particularly for dual-use patent applications. "Such patents will now be scrutinised by the patent office," an official said.

Officials said while software would continue to be copyright protected, embedded software that has technical applications can now be patented.

The measures contained in the ordinance are based on the recommendation of a group of ministers headed by Defence Minister Pranab Mukherjee.

Highlights Product patent for pharmaceutical and agro-chemicals Exclusive marketing rights deleted Pre-grant and post grant opposition provided Embedded software can be patented No new-use patent to be granted