India: Effects of Tariffs and Nontariff Measures on U.S. ... - USITC

that the public sector in <strong>India</strong> has an ongoing role in the seed sector <strong>and</strong>, like the private
sector, is focused on protecting its IPR in plant varieties. 27 606
FIGURE 9.1 Plant variety protection applications filed in <strong>India</strong>,
2007–present
90
11
577
ICAR Private Sector SAUs Farmers
Source: <strong>India</strong>n PPV&FR Authority.
The process for approval <strong>of</strong> new plant varieties reportedly requires the deposit <strong>of</strong> the
parental lines used for making hybrid seeds, as well as a gene bank deposit <strong>of</strong> the genetic
material for biotech seeds. These deposits can be used for resolving legal disputes <strong>and</strong> for
“compulsory licensing” in cases <strong>of</strong> famine or other emergency. 28 U.S. <strong>and</strong> other global
seed firms have expressed substantial concern with the deposit requirements, particularly
with whether the confidentiality <strong>of</strong> the deposits will be maintained during testing by
public-sector scientists or whether instead seed technologies will be shared with public<strong>and</strong>
private-sector competitors. 29
Patent Protection
<strong>India</strong>’s patent law with respect to seed technologies is complex. It excludes plants, seeds,
varieties, <strong>and</strong> species from patenting, but for the production <strong>of</strong> plants, it permits the
patenting <strong>of</strong> microorganisms <strong>and</strong> processes that are not “essentially biological.” 30 There
has been substantial discussion within <strong>India</strong> <strong>of</strong> the appropriate scope <strong>of</strong> coverage for
microorganisms <strong>and</strong> biotechnology. Recently, a government-appointed expert group
concluded that although some protection for microorganisms was required by the TRIPS
Agreement, strict guidelines should be implemented to limit patents to cases <strong>of</strong>
“substantial human intervention <strong>and</strong> utility.” 31 The <strong>India</strong>n Patent Office reportedly is
considering how to address the suggestions <strong>of</strong> the expert group. 32
27 Ibid.; Government <strong>of</strong>ficial, interview by Commission staff, New Delhi, <strong>India</strong>, May 4, 2009.
28 Government <strong>of</strong>ficial, interview by Commission staff, New Delhi, May 4, 2009. The PPV&FR permits
compulsory licensing three years after the registration <strong>of</strong> the protected seed where the reasonable
requirements <strong>of</strong> the public are not met or the seed is not available at a reasonable price. Protection <strong>of</strong> Plant
Varieties <strong>and</strong> Farmers’ Rights Act (2001), Chapter VII, Section 47.
29 Industry representative, e-mail message to Commission staff, June 19, 2009; industry representative,
telephone interview by Commission staff, March 30, 2009; <strong>and</strong> World Bank, Intellectual Property Rights,
2006, 24.
30 <strong>India</strong> Patents Act, 1970 (2005), Section 3(j).
31 While initially issued in December 2006, this expert report was withdrawn in 2007, <strong>and</strong> then reissued
in March <strong>of</strong> 2009. Technical Expert Group on Patent Law Issues, “Report <strong>of</strong> the Technical Expert Group on
Patent Law Issues” (revised March 2009), 15.
32 Government <strong>of</strong>ficial, interview by Commission staff, May 8, 2009.
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