Post-TRIPS Thrust Triggers for Indian Pharmaceuticals in the IP Context

Abstract

<span style="font-size:11.0pt;font-family: " times="" new="" roman";mso-fareast-font-family:"times="" roman";mso-bidi-font-family:="" mangal;mso-ansi-language:en-gb;mso-fareast-language:en-us;mso-bidi-language:="" hi"="" lang="EN-GB">The impact of the transition of Indian patent regime from pre-TRIPS to post TRIPS and the post-2005 product patent regime is discussed sequentially with evaluation thereof. Contrary to general perception and negative expectations, India appears to have driven through the anticipated ‘rough weather’, most successfully and creditably, largely thanks to the lawmakers making best use of the flexibilities permitted in TRIPS. The intervening Doha Declaration, wherein, the open unanimous admission of sovereign rights to incorporate measures for protecting public health and nutrition was adopted, also came in good time. With the entrepreneurial enthusiasm, due diligence and newly acquired patent proficiency, the Indian pharmaceutical industry has moved on to a globally dominant position at least as the leader of generic medicines. The early patent litigations have alerted and awakened the domestic pharmaceutical industry to take preventive or defensive measures as well as to go on the offensive where the patents are vulnerable. The awareness and practice of the new patent regime has helped Indian pharmaceutical companies to successfully redirect themselves to regulated markets with largest number of USFDA and EMA/EDQM approved manufacturing sites and large DMF/ANDA filings and approvals. The R&D allocations and IP protection by Indian pharmaceuticals has also gone up creditably, even though early drug initiatives have not borne fruits yet. With increased Government funding and participation, the Indian pharmaceutical industry appears to be gearing up for entering the drug discovery band wagon too. The provisions adopted in the amended Patents Act, 1970 and decisions thereof, including the latest grant of the first compulsory licence, appears to be drawing considerable global attention and fair appreciation, for its equitable balance of rights and obligations.</span>