In March 2018, the Office of the United States Trade Representative (USTR) published its 2018 National Trade Estimate Report on Foreign Trade Barriers (NTE). Every year, the USTR is mandated to “submit to the President,the Senate Finance Committee, and appropriate committees in the House of Representatives, an annual report on significant foreign trade barriers.” (Source: USTR 2018 National Trade Estimate Report on Foreign Trade Barriers).
While the NTE report has a broader remit than the USTR Special 301 report, it foreshadows the policy contours of the Special 301 report. As noted by Kim Treanor, “[t]he Special 301 Report is a yearly review by the US Trade Representative of the global state of intellectual property rights enforcement…Placement [in the Special 301 report] indicates that the US has identified particular problems in that country relating to IP protection, and a priority watch list designation leads USTR to develop an action plan on how to address IP protections. (Source: PhRMA and BIO request EU be added to USTR Watch List over review of incentives)
In the opening line of the NTE entry on India and intellectual property rights, USTR upbraids India for what it describes as “its vocal encouragement and propagation of initiatives that promote the erosion of IPR around the world through multilateral and other forums”. (Source: Ibid, page 229). This singling out of India’s policies on the international stage harkens back to the pre-Doha Declaration era when in 1999, USTR condemned South Africa for playing an active part in the passage of the Revised Drug Strategy at the World Heath Assembly: “During the past year, South African representatives have led a faction of nation’s in the World Health Organization (WHO) in calling for a reduction in the level of protection provided for pharmaceuticals in TRIPS.” (Source: 1999 Special 301 Report). It remains to be seen if the upcoming Special 301 report will target India’s positions in multilateral fora.
The NTE report flagged patent revocations and India’s “application of its compulsory licensing law” as areas of interest.
While certain administrative decisions in 2017 upheld patent rights, and certain tools and remedies to support patent holders’ rights exist in India, concerns remain over revocations and other challenges to patents, particularly patents for pharmaceutical products. The United States also continues to monitor India’s application of its compulsory licensing law. (Source: USTR 2018 National Trade Estimate Report on Foreign Trade Barriers, page 229).
In addition, USTR raised concerns with India’s patentability criteria:
Furthermore, in 2013, the Indian Supreme Court stated that India’s Patent Law creates a second tier of requirements for patenting certain technologies, like pharmaceuticals, and this interpretation may have the effect of limiting the patentability of an array of potentially beneficial innovations.” (Source: Ibid, page 230).