[Ip-health] Indian cos stand a good chance of winning against Novartis: Natco

[Joana Ramos]

10 December 2003

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Indian cos stand a good chance of winning against Novartis: Natco

Megha Lodha - Mumbai

WHEN Novartis (India) Ltd=B9s cancer drug Glivec (imatinib mesylate) got th=
e
Exclusive Marketing Rights (EMR), it was touted as the first such in a
country inching towards a patent friendly regime.

Glivec is also the first pharma EMR recipient embroiled in a series of
controversies including litigation threats as soon as the US $27,000 drug
achieved the distinction on November 11, 2003.

In just over two weeks, the chorus of confusion triggered by the EMR has
deepened with the first generic entrant Hyderabad based Natco Pharma Ltd
describing the issue as complicated.

On its part, Novartis=B9s Indian arm is maintaining a studied silence on th=
e
matter involving its number two drug in international sales. However, an
industry source has said that a public interest litigation is likely on the
matter. Speaking to this reporter, Natco Pharma Ltd CEO Rajeec Nannapeneni
said, "The Issue is quite compilicated as no one has seen a copy of the
Novartis patent except for the company and the Indian patent office. As of
now, we too are speculating that the patent that they filed for is a
modified version of the earlier patent (US 5521184).

We can take a look at that only when it gets published in the gazette in
December. But in spite of that I think that the Indian companies still stan=
d
a good chance of winning against Novartis looking at the history of the
molecule in question and from previous cases of EMR that were rejected on
the same grounds like the SKB product Rosiglitazone.=B2

=B3We had emphatically stated that we will fight the EMR,=B2 Nannapeneni sa=
id,
but refused to disclose how he would do that. However, Dr. Gopakumar Nair,
Mumbai-based IPR consultant and advisor, said the Novartis EMR appears to b=
e
valid as it is for a modified crystalline formulation of the molecule
imatinib mesylate.

This would not affect the sale of generics and there will be no need for
them to take their products off the shelf. It also means that Novartis woul=
d
be able to enjoy its EMR unperturbed. The crucial issue would then be of th=
e
product cost to consumer which might still swing in favour of the generics
unless Novartis claims a higher benefit ratio.

Anil Matai, CEO of Novartis, said that they would stick to the claims that
they have made earlier =8B that of the patent being filed in 1998 in India =
and
therefore making it eligible for EMR.

He further added that if the Indian patent office took more than two years
to grant the EMR, they surely must have looked into the application
thoroughly.

What does seem to be clear is that India needs to pull up its socks before
the product patent regime dawns. Not having strong intellectual property
laws would only invite further controversies and create confusion.

meghalodha@express2.indexp.co.in