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Day 1 of product patent regime — Pharmaceutical industry kept guessing

P.T. Jyothi Datta

Mumbai , Jan. 3

THE Indian patent office's mailbox facility is turning out to be the proverbial Pandora's box! It has kept the pharmaceutical industry guessing on how many patent applications have been filed in the 10-year period leading to the product patent regime that kicked-in this month.

Are there 7,000-odd applications, as the pharma companies were given to believe through their own intelligence sources? Or is it 12,000 applications, as mentioned recently by the Union Commerce Minister, Mr Kamal Nath? Probe the Indian patent controller's office and a third figure emerged. About 10,000 applications would be a realistic figure, an official told Business Line.

Monday was the official Day 1 under the product patent regime for the Patent Controller General of India in Mumbai and its associated offices in Chennai, Kolkata and Delhi.

And opening the mailbox is one of the main tasks that the patents office is faced with.

The mailbox provision was a facility that the Government put in place for the transitory period from 1995 to 2005. Drug firms interested in getting a 20-year exclusivity or patents on the sales of their medicines were asked to mail in their applications, which were to be opened up from January 2005.

But the lack of clarity on the final number of product patent applications in the box has left the domestic drug industry worried.

By its own earlier estimates, the pharma industry had said that of the 7,000-odd applications in the mail-box, about 4,000 were related to pharmaceuticals and of this about one-quarter were applications filed by local companies.

The significance of an increased number of pharma-related applications for product patents is that more drugs would come under an exclusive umbrella, which would block local generic companies from making chemically-similar versions of the same drug. And this practice, domestic drug industry representatives apprehend, would increase the price of drugs.

Representatives with multinational drug companies (MNC) too fear the mailbox, but for different reasons. If a company gets a patent in August, for example, a generic company will not be prevented from making copies of that drug till that month. Worse, the innovator company (with the patent) will not be able to file for damages with retrospective effect either, laments an MNC official. So, if a patent gets delayed for some reason, generic companies will still be able to market the drug. This is a back-door entry for them, he points out.

But a patent office official defends: no more back-door entries will take place. Applications will be cleared quickly and on a first to file basis, he said.

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