The Hindu Business Line : Novartis challenges rejection of patent application

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.

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