This post was first published on 18th May, 2014.<\/p>\n
The 25th\u00a0Special 301 Report of 2014 keeps India on the\u00a0Priority Watch List<\/strong>\u00a0and the USTR hopes to run an out-of-cycle review in Fall, after the New Indian Government is formed. After emphasizing on the need to balance\u00a0Incentives for Innovation <\/strong>and<\/strong> Domestic issues<\/strong>\u00a0in India, the Report puts forth the various concerns on the Patent System in India:<\/p>\n Patent Process<\/p>\n Commending the measures taken by the Indian Government, such as Digitization<\/strong>, Online<\/strong> Search & e-Filing upgrades <\/strong>and<\/strong> Initiatives to hire Examiners<\/strong>, <\/strong>the Report focuses on the need for steps to clear the backlog of patent applications through proactive measures, technical collaboration with the USPTO and so on. The Report also raises concerns with respect to opposition grounds and processes, which result in costly and time-consuming challenge proceedings that carry on for years, which can go on to shorten the effective patent term and adversely affect investments\/businesses.<\/p>\n The Report emphasizes the need for\u00a0India to\u00a0endeavor to promote both cutting-edge innovation in order to address important health challenges, and a robust generic market. Speaking of the Novartis case, the Report points out that\u00a0Section 3(d)<\/strong> sets a 2nd tier and higher threshold for patentability of chemical \/ pharmaceutical inventions, differentiating them from other classes of inventions. By requiring that a new form of a known substance must have enhanced efficacy,\u00a0Section 3(d)<\/strong> excludes certain beneficial innovations such as drugs with fewer side effects, decreased toxicity, improved delivery systems, and temperature\/storage stability, which requirement, according to the Report, is not beneficial for the country.<\/p>\n The Report urges that India provide greater transparency with respect to its ongoing inter-ministerial process, which process is considering over a dozen patented medicines as candidates for government-initiated\u00a0Compulsory Licenses (CL)<\/strong>, while also\u00a0urging that opportunities must be given to the right holders before any decisions on such CLs were made. The Report\u00a0also expresses concerns about the Bayer (Nexavar) CL\u00a0decision of the IPAB with respect to the requirement of\u00a0local working<\/strong>. Further expressing that\u00a0local manufacturing<\/strong>\u00a0<\/strong>was not required and that\u00a0importing<\/strong>\u00a0might be sufficient\u00a0to meet the requirement of\u00a0local working<\/strong>, the Report seeks\u00a0clarity on how the requirement could be met without\u00a0local manufacturing<\/strong>. Referring specifically to the National Manufacturing Policy of India, which mentions Compulsory Licensing\u00a0as a tool for\u00a0effective\u00a0technology transfer in the clean\u00a0energy sector, the Report expresses its concerns on India’s approach towards disseminating Green technologies.<\/p>\n The Report specifically talks about the inability of\u00a0patent holders<\/strong>\u00a0to get interim injunctions against infringers, from the Indian courts. Further, it\u00a0highlights\u00a0the lack of a link between\u00a0patent holding <\/strong>and regulatory\u00a0<\/strong>approvals<\/strong>. The Report also urges India to consider data exclusivity in the Pharma sector.<\/p>\n IP and Health Policy<\/p>\n In the Intellectual Property (IP) and Health Policy section, the Report states that an effective, transparent, and predictable IP system is necessary for both manufacturers of\u00a0innovative medicines <\/strong>and generic\u00a0<\/strong>medicines<\/strong>\u00a0alike. Acknowledging the\u00a0DOHA declaration<\/strong>\u00a0and the US trading partners’ right to grant Compulsory Licenses in the interests of public health and access to medicine, and the impact of IP protection on prices, the Report encourages countries to consider ways to address their public health challenges while maintaining IPR systems that promote innovation.<\/p>\n Various developments have re-kindled the debate on Pharma patents at regular intervals and it is our wish, through numerous upcoming posts, to throw some light on the matter. Our focus, as mentioned earlier, will primarily be on two issues \u2013\u00a0Section 3(d) <\/strong>and<\/strong>\u00a0Compulsory Licensing<\/strong>. With the objective of understanding the pith of the matter, we will delve into select submissions made to the USTR.<\/p>\n To begin, a\u00a0post by Vinita Radhakrishnan will throw light on what\u00a0E<\/strong>vergreening<\/strong>\u00a0means and whether\u00a0Section 3(d)<\/strong>\u00a0actually does play a role in its prevention.<\/p>\nPatentability<\/h2>\n
Compulsory Licensing<\/h2>\n
Enforcement<\/h2>\n