HUMAN RIGHTS VIS-A-VIS PATENT PROTECTION: A CASE STUDY OF NOVARTIS AG V. UNION OF INDIA

Abstract

The Indian Supreme Court’s (SC) decision in Novartis v Union of India (UOI) was enough to drastically affect the booming and vibrant pharmaceutical industry and developed the goals which are focusing more on the public health in India. “Novartis” a pharmaceutical company produced GLIVEC (IMATNIB MESYLATE). In 2006 after putting the controversy before IPAB, the board refused “GLIVEC’S” patent under section 3(d) by arguing that it was only a modified version of an existing drugs therefore the drug was not an innovative one. Section 3 of the Patent Act identifies the cases of inventions which are not patentable and its letter (d) as amended in 2005.The interpretation of Supreme Court for the above section was simply to limit the pharmaceutical companies in order to obtain secondary patents on the life saving drugs and to improve their availability focusing on a goal that the public health interest supersedes the commercial interest. Novartis battled the litigation with the Indian government but the foremost and final outcome of Supreme court in 2013 was that the new form of known substance is not eligible for patent because of lack of ‘enhanced efficacy’ and hence defined it as ‘therapeutic efficacy’. The core problem is the controversy surround section 3(d) which shows the paradoxical nature of the above section in three different aspects which are the main issues of the case. Firstly, because it imposes a requirement of enhanced efficacy over a prior art before a patent on reformulation of an original pharmaceutical compound can be obtained. Secondly, the above section has limited itself and is exhaustive only upon pharmaceutical product. Thirdly, the narrow interpretation of the word “therapeutic efficacy”. Moreover the decision affects the interpretation of article 27 of TRIPS Agreements.This paper includes the multidisciplinary notion to answer the well suited questions raised by the Novartis AG with an analysis of TRIPS agreement and social–economic impact of different interpretation as there is complex game that results in tension between the global trade commitment and domestic public health concern.