Analysis of Case: Novartis Ag Vs. Union of India and Others

Table of Contents

Introduction 3

Brief Overview 3

Detailed Analysis 3

Impact of the Case 5

Summary 6

Analysis of Case: Novartis Ag vs. Union of India and Others

Introduction

The case of Novartis Ag vs. Union of India has been debated a lot in the media and has been hailed as a landmark case as far as the Indian Patents Act of 1970 is concerned. The outcome of the Hon. Supreme Court’s verdict on rejecting the patent application of Novartis will not only have a cascading impact on the patentability of pharmaceuticals in the country but also it will immensely affect the Indian pharmaceutical industry.

Brief Overview

Initially when Novartis filed the patent claim, the Patent Act itself was being modified, the grant of new patents was put on hold and the “Mailbox” procedure was in effect. Novartis was thus not able to patent Imatinib Mesylate at that point but it did receive Exclusive Marketing Rights (EMR) for the drug. Subsequently, in the year 2005, Product Patent was re-introduced in India by amending Section 3(d) of the Indian Patents Act. The amendment categorically stated that discovery of any new form of a known and existing substance, could not be patented unless it did not result in enhancement of the effectiveness and efficiency of the substance.

This case essentially revolves around three points:

• The time when the patent was filed

• The validity of the claim as per section 3(d) of the Indian Patents act, 1970

• The validity of the claim as per section 3(b) of the Indian Patents act, 1970

Also, in this case, there are two stages. The first comprises of the decisions taken by the IPAB (Intellectual Property Appellate Board, Chennai) and the second encompasses the decisions taken by the Hon. Supreme Court of India. Novartis had appealed to the Hon. Supreme Court of India against the decision of the IPAB. This case became all the more sensitive because it was about the beta-salt of Imatinib Mesylate, a compound that had the capability to be used as an anti-cancer drug. In our opinion, the high amount of media and public attention received by this case also played a very important part in the decision that was finally made.

Detailed Analysis

We shall start with the analysis of the responses and observations of the IPAB on the case and then move on to the Hon. Supreme Court.

At the