India Stays on USTR Blacklist Despite New Patent Law
The Office of the US Trade Representative (USTR) has opted to maintain India's "priority watch" status on intellectual property compliance, despite the country's recent approval of a much tougher patent law.
The USTR's 2005 "Special 301" review justifies its decision on the grounds that existing laws are still inadequate to protect undisclosed test data for use in pharmaceuticals and agrochemical products. The organisation is also especially critical of the enforcement of patents granted under the "mailbox" system, or products for which patents proving novelty were delayed pending India's implementation of TRIPS. According to the USTR, the new Patent Law does not enable those with patents filed under this system to prevent generic drugs from being sold after the date when the patent is granted.
The USTR has pledged to continue to monitor India's progress on protecting
test data exclusivity and enforcing patents. For its part, an influential Indian
government commission currently studying data exclusivity is due to report by
end June. It is expected that to the likely frustration of innovative
drugmakers the committee will recommend that India provide protection
of test data without granting marketing exclusivity, as is the case in some
of India's "priority watch" peers, such as Brazil and Argentina.