Novartis challenges rejection of patent application (Glivec)

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Novartis challenges rejection of patent application

Business Line - Aug. 13, 2006

from BUSINESS LINE, August 13, 2006 Mumbai, Aug. 12 - The saga of

litigation on Novartis' cancer drug Glivec is far from over. The company

has filed multiple writs at the Madras High Court against the Patent

Controller's decision to reject Novartis' patent application on Glivec,

besides seeking an interim stay, among other things

The writ was filed against the Chennai Patent Office's order of January

2006 that rejected Novartis' patent application on Glivec, following the

independent pre-grant oppositions filed by the Cancer Patients Aid

Association and a clutch of domestic drug-makers

Reasons for rejection The Swiss-based drug major has also contested some

of the considerations based on which the Patent Office rejected

Novartis' patent application. This includes Section 3 (d) of the Patents

Act 1970 as amended by the Patents (Amendment) Act 2005

The Chennai Patent Office had rejected Novartis' patent application

using, among other parameters, Section 3 (d) of the Indian law

This meant that Novartis' Glivec was not significantly different in

properties from an existing compound, though there was a 30 per cent

increase in the bio-availability of this drug over the existing version

Another contention by generic companies (that made similar versions of

Glivec) is that Novartis's Glivec was known before 1995 and hence did

not merit a patent

Glivec or Gleevec is the brand name under which Novartis' cancer drug

'imatinib mesylate' was sold. And, the drug has been attracting

controversy and litigation ever since it was given an Exclusive

Marketing Right in 2003, in a build up to the product-patent regime in

2005

Pricing issue The drug is used to treat Chronic Myeloid Leukemia, but

its pricing has been a thorny issue. The international price of

Novartis' drug costs a patient about $27,000 for a one-year course,

while the generic price is about $2,700

That estimates to about Rs 1 lakh a month for Novartis' Glivec, while

the copy-cat versions cost the patient about Rs 10,000-odd per month.

Natco, Cipla, Ranbaxy and Hetero are some of the domestic companies

making generic versions of Glivec

When India adopted the product-patent regime in January 2005, Novartis

obtained a stay against some of these local companies that were

marketing similar versions of the drug. And when the Patent Controller

rejected Novartis' patent application, these companies set about

vacating the stay on their drug. Novartis' recent writ at the Madras

High Court is the latest in this saga

P.T. Jyothi Datta - 2006 Business Line