Abstract
In this research, I have to grapple with the Supreme Court with respect to the decision of Supreme court in Novartis AG v. Union of India. This study starts with a detailed discussion of the case background, covering the journey of India’s patent law development and the reasons for Novartis’s patent application of the beta crystalline form of imatinib mesylate. Finally, it focuses on the central legal issues that the Court considered, especially the exercise of interpretation and application of Section 3(d) of the Indian Patents Act which was enacted in order to ban the practice of ‘evergreening’, that is, patenting new forms of known substances that do not result in enhanced therapeutic efficacy. 3. The Paper analyzes the arguments presented by both Novartis and the Union of India. In addition, it also discusses the Court’s ruling and the reasons underpinning the Court’s decision to refuse Novartis’ patent application. This analysis highlights the implications of the judgment for pharmaceutical innovation and public health in India, as well as for access to affordable medicines. This paper contributes to the larger discussion related to balancing intellectual property rights with public health in developing countries by critically examining this landmark case.
Introduction
The case of Novartis AG versus Union of India has emerged as a landmark case in the Indian legal landscape concerning the intersection between intellectual property rights and public health. In its historic ruling, Supreme Court has dealt with the contentious issue of patentability of pharmaceuticals, especially in respect to the anti-cancer drug Glivec. When Novartis sought a patent on the beta crystalline form of imatinib mesylate, it was rejected, relying on Section 3(d) of the Indian Patents Act, which was specifically provided to prevent what is known as evergreeningpreventing new forms of old substances from receiving a patentunless the new form is an example of significantly improved therapeutic efficacy. This case comment discusses the nuanced details of the judgment, focusing on the Court’s interpretation of the term ‘therapeutic efficacy’, particularly with respect to its impact on pharmaceutical innovation vis overarching access to affordable medicines. Drawing from the arguments made in the courts, the reasoning employed by the Court and the larger influence it would have on the Indian patent regime, this commentary aims to reflect on how this decision harmonizes the dynamic between patent holders and public health.