P.T. Jyothi Datta

Mumbai , Oct. 13

CALL it "the fear of the unknown" or efforts to thwart monopolistic practices that drug companies may adopt once the patent regime comes into vogue in about 80-odd days. But the domestic drug industry has further queered the pitch on patent-related issues.

At the eye of the storm is the "mail-box provision", where companies have been sending in their applications for patents. According to industry representatives, about 4,000 of the 7,000-odd applications in the mail-box are related to pharma.

"The major challenge to face the Indian pharma industry is the patent-regime that will be upon us in about 80 days. What will happen when the mail-box is opened up. Will it lead to more products being withdrawn from the market, as one saw with Glivec (the cancer drug from Novartis)?" was the concern expressed by Mr Satish Reddy, Managing Director and Chief Operating Officer, Dr Reddy's Laboratories Ltd.

Similar concerns were expressed by another young turk in the industry, Mr Malvinder Mohan Singh, Ranbaxy's President-Pharmaceuticals and Executive Director. "One doesn't know what will happen when the mail-box is opened," he said responding to a media-query on whether some local drugs may go out of the market.

And even as the Patents Third Amendment Bill is being reviewed by a Group of Ministers - sections of the pharma industry underline the importance of retaining provisions like the pre-grant opposition. This provision allows objections to be raised before a patent is granted.

"The changes made in the Bill will affect the easy availability of key drugs at competitive prices. The prices of vital medicines under patent are bound to go up manifold. The Government has to be very careful and must take all precautions," they point out.

"One such precaution is to see that the right of third parties (i.e. affected parties and public at large) to file `objections' officially to a patent application which they consider not falling within patentability criteria." Further, they argue, that in a post-grant opposition scenario, the case lands up in the courts and the process could be time-consuming. The law in its present "avatar" allows pre-grant opposition.

However, another section of industry supports post-grant opposition, as they feel that companies would any way take legal recourse, if decisions went against them. "If pre-grant is allowed and a company is unhappy with the verdict, it would take it to court and so on. So the law courts in the country are anyway going to be over-burdened once the product patent regime comes into vogue," argues an industry representative.

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