Access to Affordable Medicines in the Current Patent Regime: An Indian Perspective

Abstract

The objective of the paper is to study the trends of various Courts and Intellectual Property Offices decisions on issues of evergreening of Drug Patents, Compulsory Licenses to manufacture drugs in case of public health needs. Another objective is to identify cases where Indian Pharma Companies are preparing to address public health problems of Least Developed Countries (LDCs) and exported medicines to these LDCs under section 92 A of Indian Patent Act. Further objective of the paper is to elaborate section 107A (a) of the Patent Act i.e. Bolar Provison to appreciate its importance for drugs availability at affordable prices. The author has followed The Patents Act, 1970 and specifically picked up section 3(d), Sections 82 to 94 (Chapter XVI of the Act) and Section 107 A (a) of the Act for study. The author has taken ample case laws and orders to analyze the trend of decision of judiciary and patent office to provide easy access to affordable medicines by limiting the monopoly. The author after studying the trends finds that Indian patent system is friendly to support access to affordable medicines. The Courts and Intellectual Property Offices have also given priority to public health issue while giving judgments. The Indian Patent Act empowers Controller of Patents to issue compulsory licenses to deal with the certain extreme and/or urgent situations. The Courts have even refused to grant injunction and allowed a cheaper version manufacturer to continue selling a generic version of cancer drug despite it having been granted a patent in India. Indian pharmaceuticals companies like Natco Pharmaceuticals, applied for the export of Roche’s Erlotinib (Tarceva) to Nepal. This application is for export of 30,000 tablets to Nepal and Natco offered Roche a 5% royalty. It can be noted that some other countries have already taken initiatives to issues such licenses. Section 107 A (a) also known as Bolar provision allows generics to produce or import patented drugs for the purpose of development and submission of information for regulatory trials before patents expire. This provision will definitely create a competitive market and it is obvious that it will ultimately result in manufacture affordable drug. So, public health issue will be taken care of.