Ramesh ShankarWednesday, August 3, 2022, 08:00 Hrs  [IST]

The Office of the United States Trade Representative (USTR) had once again placed India, along with nine other countries, on the Priority Watch List in its Special 301 USTR 2021 Report. USTR is the United States government agency responsible for developing and recommending United States trade policy to the president of the US, conducting trade negotiations at bilateral and multilateral levels, and coordinating trade policy within the government through the inter agency Trade Policy Staff Committee (TPSC) and Trade Policy Review Group (TPRG). While retaining India on Priority Watch List, the US Trade Representative, which conducted the Special 301 Review to identify countries that deny adequate and effective protection of IPR, stated that India remained one of the world’s most challenging major economies with respect to protection and enforcement of IP. The 2021 Report voiced concern that ‘patent applicants continue to confront costly and time consuming pre- and post-grant oppositions, long waiting periods to receive patent approval, and excessive reporting requirements. Quite understandably, the Indian pharmaceutical industry has taken strong objection to the USTR decision. The Indian Pharmaceutical Alliance (IPA) representing 24 research-based pharmaceutical companies which collectively account for about 85 per cent of private sector investment on pharmaceutical research and development in India, has appealed to the USTR to remove India from the Priority Watch List citing in support several actions taken by the government for improving the IPR environment and enforcement. To drive home its point, the IPA said that during the unprecedented time of pandemic in 2021, extensive initiatives have been undertaken by the government of India to strengthen the significance of IPR in the country through various knowledge sharing platforms and awareness programmes. India has taken active steps in strengthening its existing international relations, especially in the field of IP with various countries across the globe and has taken further initiatives with the US, Denmark and Korea as well as the European Union over the last two years. India has moved significantly on the Global Innovation Index in the last six years (Rank 81 in 2015) to 46th in 2021 amongst 131 economies and has now entered the league of top 50 economies of the world.

On the issue of pre- and post-grant oppositions raised by the USTR, the IPA stated that even if the pre-grant opposition adds time to the patent prosecution time, it is less time consuming and less costly than defending the post-grant opposition proceedings. Pre-grant opposition provides an opportunity of quick assessment for patentability for the patent application. On the contentious issue of Section 3(d), IPA clarified that Section 3(d) of the Patents Act only limits secondary patents that do not enhance efficacy and typically result in evergreening. Evergreening of patents delays the entry of generic drugs which in turn adversely impacts the accessibility of drugs to the patients across the world. Undoubtedly, India has taken some substantial and consistent measures on number of issues on which the US companies have for long been raising apprehensions and concerns including that of IP environment in India. India is fully compliant with the multilateral TRIPS agreement and continues to take steps in accordance with international trends and progress. There has been no grant of a compulsory license in the last eight years in India even during the Covid-19 pandemic. Besides, India has made progress in the procedural aspects by abolishing the Intellectual Property Appellate Board (IPAB) with a view to resolve IP disputes efficiently and creating specialized courts and rules for handling IP matters across India. The High Courts in the states are now taking up the matters related to IP. So, while finalizing the Report, the USTR should not have overlooked the substantial and consistent progress made by India.