India apex court rejects Novartis patent
April 1, 2013, 10:31 am

The drug is used in the treatment of chronic myeloid leukaemia and malignant gastrointestinal stromal tumours [AP]

This ends a seven-year battle of the company to get the drug patented.

Indian drug giants such as Cipla which produce cheaper generic versions of the drug Glivec at a fraction of the cost at which Novartis was pricing it, tend to gain from the ruling.

The Supreme Court has ruled that Novartis’s “application for patent on the beta-crystalline salt does not meet any standard of novelty or inventiveness”, and therefore the company cannot be given any patent for this drug.

The drug is used in the treatment of chronic myeloid leukaemia and malignant gastrointestinal stromal tumours.

A two-judge bench said that Glivec had several beneficial qualities but failed the test of enhanced therapeutic efficiency mandated by Section 3(d).

Justices Aftab Alam and Ranjana Desai also imposed unspecified costs on Novartis for challenging the country’s patent laws.

Shares of Novartis India Ltd fell as much as 7 per cent after the Supreme Court judgement.

The decision comes as a huge blow to MNCs which have been touting local patent laws as a hindrance to drug research. They have been lobbying to dilute the laws whereas local companies and health activists have been opposing any dilution saying it would make drugs costlier.

India denied patent for Glivec, an anti-cancer drug made by Novartis, in 2006 as the drug wasn’t considered a new molecule, but an altered version of one that had already been in the market for around 15 years.

Novartis had challenged the rejection of its patent application for by the Indian patent office and subsequently by the Intellectual Property Appellate Board.

The legal battle for the patent of the blood cancer drug is being closely watched by international pharmaceutical firms.

With inputs from Agencies