Novartis VS Govt. of India

The Case of Novartis Vs Govt. of India

Novartis field patent applications for the cancer drug imatinib in most countries in 1993. The company was not able to do so in India, as the country was not granting product patents at that time. In 1997, Novartis applied for a more specific patent on the beta-crystalline polymorph of a mesylate salt of imatinib, i.e. imatinib mesylate, in order to try to obtain a patent monopoly in India.

The Case of Novartis Vs Govt. of India

Novartis field patent applications for the cancer drug imatinib in most countries in 1993. The company was not able to do so in India, as the country was not granting product patents at that time. In 1997, Novartis applied for a more specific patent on the beta-crystalline polymorph of a mesylate salt of imatinib, i.e. imatinib mesylate, in order to try to obtain a patent monopoly in India.

In January 2006, the patent on imatinib mesylate, which Novartis produces under the brand name Gleevec, was rejected in India on the grounds that it only represented a new form of a known substance and therefore was not an innovation and not patentable under Indian Law. In May 2006, the company filed an appeal to the patent rejection, as well as a challenge against Section 3(d) of India's Patent Act in the High Court in Chennai.

A Division Bench of the Madras High Court head this case through February and March 2007. On April 2^nd 2007, the Central Government issued a notification which triggered Section 117G of the Patents Act 1970. So now a Patent Appellate Board has been constituted. From now on all applications that challenge the decisions of patent controllers will be heard by this Board. This Board will decide on these appeals.

Following this notification, on 04-04-2007, Justice R.Balasubramaniam and Justice Prabha Sridevan of the Madras High Court transferred the case of Novartis regarding rejection of its patent application for beta-crystalline form of imatinib mesylate by the patent office in Chennai to the Patent Applellate Board.

Regarding the second part of Novartis's case, i.e., whereby it challenged the constitutional validity of Section 3(d) of the Patents Act, 1970, the court has concluded its hearings and reserved its judgement.

Patients' groups, NGOs and the large mass of people all over the world, pray that the High  Court upholds Section 3(d), which prevents evergreening of patents by ambitious MNCs.