The Hindu Business Line : `Emergency drugs must be easily available in post-patent regime'

Certain drugs, which are protected by patent, must be made available through the compulsory licence route, said the Minister of Chemicals and Fertilisers, Mr Ram Vilas Paswan.

New Delhi , Oct. 14

KEEPING the Common Minimum Programme's (CMP) promise of affordable drugs in mind, the Ministry of Chemicals and Fertilisers has said that drugs needed for national calamities and emergency situations should be easily available even when the Patent Act comes into effect in 2005.

Certain drugs, which are protected by patent, must be made available through the compulsory licence route, said the Minister of Chemicals and Fertilisers, Mr Ram Vilas Paswan, to the Group of Ministers (GoM) set up to look into the amendments to the Patent (Amendment) Bill 2004.

But there are differences between the Ministry of Commerce and Industry and the Ministry of Chemicals and Fertilisers. Sources said, "The former is supportive of the Paris Convention on Intellectual Property Rights under which a cooling off period of three years is prescribed for the patent holder to launch the product. Under it if the patent holder fails to do so, the Government can give the drug to another manufacturer under the compulsory licensing clause. However, the chemicals and fertilisers industry prefers the TRIPS agreement under which there is no cooling off period and compulsory licenses can be issued to manufacturers during an emergency. The latter has pushed its case at the GoM meeting."

Mr Paswan pushed for prevention of evergreening of patents. "The Ministry wants to define patentability very clearly in order to prevent evergreening of patents. Companies could otherwise make small changes in the formulations and take the shield of patents," said the sources.

Another issue that the Ministry has flagged off is the large number of pharma patent applications filed in the Mail Box facility. "Nearly 4,000 applications have been filed using the Mail Box facility. But several of these molecules were invented pre-1995. The Ministry is of the view that since these molecules have been launched earlier, patents should not be granted to them," said sources.

The fourth area of discussion was the issue of pre-grant opposition to patents. The proposed amendment to Section 25 removes this right of hearing and provides it only post grant opposition.

"Our Ministry feels that pre-grant opposition would help curb the fraudulent and frivolous patents. Hence, companies should be allowed to oppose patents before they are granted," said the Government source.

The domestic pharmaceutical industry has also been pitching for similar changes in the Patents Amendment Bill.

The Indian Pharmaceutical Alliance has said that the safeguards to prevent evergreening of patents, pre-grant opposition and careful scrutiny of the Mail Box facility would help the domestic industry grow.