[Ip-health] Day 1 of product patent regime — Pharmaceu tical industry kept guessing

[robin koshy]

Day 1 of product patent regime — Pharmaceutical
industry kept guessing

The Hindu Business Line

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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