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

Megha Lodha - Mumbai

WHEN Novartis (India) Ltd’s cancer drug Glivec (imatinib mesylate) got the 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’s Indian arm is maintaining a studied silence on the 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 stand 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.”

“We had emphatically stated that we will fight the EMR,” Nannapeneni said, 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 be 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 would be able to enjoy its EMR unperturbed. The crucial issue would then be of the 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 — 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