Intellectual property rights in the pharmaceutical sector

Abstract

Need For the Proposed Work We believe there is need for the proposed work because the scenario in the pharmaceutical sector in India is likely to change drastically post-2005. The introduction of product patents, as per Article 65.4 of the TRIPS Agreement to extend patent protection to pharmaceutical products from the beginning of 2005, will have a significant impact on the existing scenario in the pharmaceutical industry. India is currently one of the few developing countries that has a robust pharmaceutical sector and is self-sufficient once it comes to the supply of medicines. However, with the new product patent regime in place, Indian companies will no longer be able to manufacture cheap generics. This may result in a significant rise in the price of medicines, putting a few of them beyond the reach of the common man. However, the new regime could also encourage originality in the Indian pharmaceutical sector and help it make the transition from an efficient generic manufacturer to a truly global pharmaceutical major. The right of any person to be able to exploit his/her innovation commercially should be sacrosanct and hence there was always a need for a suitably stringent law in India to protect the same. Our task here would be to look at the new system, analyze where it differs from the previous system, and determine its advantages and disadvantages. We will also attempt to determine the effect of the new regime on the pharmaceutical industry. Objectives The purpose of this project is to: • Determine whether the new IPR regime (TRIPS) is in fact a new barrier that is preventing Indian companies like DRL and Ranbaxy from becoming a global Pharma major • How the Indian pharmaceutical Industry can best position itself to deal with the threats and opportunities that will arise on account of the new regime• Our attempt is to determine the effect of the new regime on the pharmaceutical industry different stakeholders in the pharmaceutical industry, viz.: • Indian pharmaceutical companies • Global pharmaceutical companies • Policy Makers • Patient/Consumer The move towards product patents is likely to have a significant impact on these players in terms of changed strategies, research expenditure, new legal angles, foreign investment into the Pharma industry in India and (possibly) increased drug prices. Based on this, we will attempt to identify areas of opportunity for Indian pharmaceutical companies (specifically Ranbaxy and DRL) and outline specific strategies for them to follow in this changed scenario. Brief Description of Methodology Our effort involved collecting secondary data regarding patent laws and Intellectual Property Rights. The sources used for these include online resources and published material, including books and journals. We have also collected data regarding the structure and nature of the pharmaceutical industry, as well as information pertaining specifically to Ranbaxy and DRL. The sources used for these include company published material. We also conducted primary research by means of a mailed questionnaire and personnel interviews with people from the industry. This data has then been used to analyze the impact of TRIPS on the major stakeholders in this industry and arrive at recommendations specific to DRL and Ranbaxy.